Digital Omnibus — September Presidency compromise

This Regulation lays down:

1. (a)

   conditions for the re-use, within the Union, of certain categories of data held by public sector bodies;

2. (b)

   a notification and supervisory framework for the provision of data intermediation services;

3. (c)

   a framework for voluntary registration of entities which collect and process data made available for altruistic purposes; and

4. (d)

   a framework for the establishment of a European Data Innovation Board.

This Regulation does not create any obligation on public sector bodies to allow the re-use of data, nor does it release public sector bodies from their confidentiality obligations under Union or national law.

This Regulation is without prejudice to:

Where sector-specific Union or national law requires public sector bodies, data intermediation services providers or 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 shall also apply. Any such specific additional requirements shall be non-discriminatory, proportionate and objectively justified.

1. (a)

   specific provisions in Union or national law regarding the access to or re-use of certain categories of data, in particular with regard to the granting of access to and disclosure of official documents; and

2. (b)

   the obligations of public sector bodies under Union or national law to allow the re-use of data or to requirements related to processing of non-personal data.

Union and national law on the protection of personal data shall apply to any personal data processed in connection with this Regulation. In particular, this Regulation is without prejudice to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directives 2002/58/EC and (EU) 2016/680, including with regard to the powers and competences of supervisory authorities. 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 shall prevail. This Regulation does not create a legal basis for the processing of personal data, nor does it affect any of the rights and obligations set out in Regulations (EU) 2016/679 or (EU) 2018/1725 or Directives 2002/58/EC or (EU) 2016/680.

This Regulation is without prejudice to the application of competition law.

This Regulation is without prejudice to the competences of the Member States with regard to their activities concerning public security, defence and national security.

‘data’ means any digital representation of acts, facts or information and any compilation of such acts, facts or information, including in the form of sound, visual or audiovisual recording;

‘re-use’ means the use by natural or legal persons of data held by public sector bodies, for commercial or non-commercial purposes other than the initial purpose within the public task for which the data were produced, except for the exchange of data between public sector bodies purely in pursuit of their public tasks;

‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;

‘non-personal data’ means data other than personal data;

‘consent’ means consent as defined in Article 4, point (11), of Regulation (EU) 2016/679;

‘permission’ means giving data users the right to the processing of non-personal data;

‘data subject’ means data subject as referred to in Article 4, point (1), of Regulation (EU) 2016/679;

‘data holder’ means a legal person, including public sector bodies and international organisations, or a natural person who is not a data subject with respect to the specific data in question, which, in accordance with applicable Union or national law, has the right to grant access to or to share certain personal data or non-personal data;

‘data user’ means a natural or legal person who has lawful access to certain personal or non-personal data and has the right, including under Regulation (EU) 2016/679 in the case of personal data, to use that data for commercial or non-commercial purposes;

‘data sharing’ means the provision of data by a data subject or a data holder to a data user for the purpose of the joint or individual use of such data, based on voluntary agreements or Union or national law, directly or through an intermediary, for example under open or commercial licences subject to a fee or free of charge;

‘data intermediation service’ means a service which aims 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, excluding at least the following:

1. (a)

   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;

2. (b)

   services that focus on the intermediation of copyright-protected content;

3. (c)

   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;

4. (d)

   data sharing services offered by public sector bodies that do not aim to establish commercial relationships;

‘processing’ means processing as defined in Article 4, point (2), of Regulation (EU) 2016/679 with regard to personal data or Article 3, point (2), of Regulation (EU) 2018/1807 with regard to non-personal data;

‘access’ means data use, in accordance with specific technical, legal or organisational requirements, without necessarily implying the transmission or downloading of data;

‘main establishment’ of a legal person means the place of its central administration in the Union;

‘services of data cooperatives’ means data intermediation services offered by an organisational structure constituted by data subjects, one-person undertakings or SMEs who are members of that structure, having as its main objectives to support its members in the exercise of their rights with respect to certain data, including with regard to making informed choices before they consent to data processing, to exchange views on data processing purposes and conditions that would best represent the interests of its members in relation to their data, and to negotiate terms and conditions for data processing on behalf of its members before giving permission to the processing of non-personal data or before they consent to the processing of personal data;

‘data altruism’ means the voluntary sharing of data on the basis of the consent of data subjects to process personal data pertaining to them, or permissions of data holders to allow the use of their non-personal data without seeking or receiving a reward that goes beyond compensation related to the costs that they incur where they make their data available for objectives of general interest as provided for in national law, where applicable, such as healthcare, combating climate change, improving mobility, facilitating the development, production and dissemination of official statistics, improving the provision of public services, public policy making or scientific research purposes in the general interest;

‘public sector body’ means the State, regional or local authorities, bodies governed by public law or associations formed by one or more such authorities, or one or more such bodies governed by public law;

‘bodies governed by public law’ means bodies that have the following characteristics:

1. (a)

   they are established for the specific purpose of meeting needs in the general interest, and do not have an industrial or commercial character;

2. (b)

   they have legal personality;

3. (c)

   they are financed, for the most part, by the State, regional or local authorities, or other bodies governed by public law, are subject to management supervision by those authorities or bodies, or have an administrative, managerial or supervisory board, more than half of whose members are appointed by the State, regional or local authorities, or by other bodies governed by public law;

‘public undertaking’ means any undertaking over which the public sector bodies may exercise directly or indirectly a dominant influence by virtue of their ownership of it, their financial participation therein, or the rules which govern it; for the purposes of this definition, a dominant influence on the part of the public sector bodies shall be presumed in any of the following cases in which those bodies, directly or indirectly:

1. (a)

   hold the majority of the undertaking’s subscribed capital;

2. (b)

   control the majority of the votes attaching to shares issued by the undertaking;

3. (c)

   can appoint more than half of the undertaking’s administrative, management or supervisory body;

‘secure processing environment’ means the physical or virtual environment and organisational means to ensure compliance with Union law, such as Regulation (EU) 2016/679, in particular with regard to data subjects’ rights, intellectual property rights, and commercial and statistical confidentiality, integrity and accessibility, as well as with applicable national law, and to allow the entity providing the secure processing environment to determine and supervise all data processing actions, including the display, storage, download and export of data and the calculation of derivative data through computational algorithms;

‘legal representative’ means a natural or legal person established in the Union explicitly designated to act on behalf of a data intermediation services provider or an entity that collects data for objectives of general interest made available by natural or legal persons on the basis of data altruism not established in the Union, which may be addressed by the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations in addition to or instead of the data intermediation services provider or entity with regard to the obligations under this Regulation, including with regard to initiating enforcement proceedings against a non-compliant data intermediation services provider or entity not established in the Union.

This Chapter applies to data held by public sector bodies which are protected on grounds of:

1. (a)

   commercial confidentiality, including business, professional and company secrets;

2. (b)

   statistical confidentiality;

3. (c)

   the protection of intellectual property rights of third parties; or

4. (d)

   the protection of personal data, insofar as such data fall outside the scope of Directive (EU) 2019/1024.

This Chapter does not apply to:

1. (a)

   data held by public undertakings;

2. (b)

   data held by public service broadcasters and their subsidiaries, and by other bodies or their subsidiaries for the fulfilment of a public service broadcasting remit;

3. (c)

   data held by cultural establishments and educational establishments;

4. (d)

   data held by public sector bodies which are protected for reasons of public security, defence or national security; or

5. (e)

   data the supply of which is an activity falling outside the scope of the public task of the public sector bodies concerned as defined by law or by other binding rules in the Member State concerned, or, in the absence of such rules, as defined in accordance with common administrative practice in that Member State, provided that the scope of the public tasks is transparent and subject to review.

This Chapter is without prejudice to:

1. (a)

   Union and national law and international agreements to which the Union or Member States are party on the protection of categories of data referred to in paragraph 1; and

2. (b)

   Union and national law on access to documents.

Agreements or other practices pertaining to the re-use of data held by public sector bodies containing categories of data referred to in Article 3(1) which grant exclusive rights or which have as their objective or effect to grant such exclusive rights or to restrict the availability of data for re-use by entities other than the parties to such agreements or other practices shall be prohibited.

By way of derogation from paragraph 1, an exclusive right to re-use data referred to in that paragraph may be granted to the extent necessary for the provision of a service or the supply of a product in the general interest that would not otherwise be possible.

An exclusive right as referred to in paragraph 2 shall be granted through an administrative act or contractual arrangement in accordance with applicable Union or national law and in compliance with the principles of transparency, equal treatment and non-discrimination.

The duration of an exclusive right to re-use data shall not exceed 12 months. Where a contract is concluded, the duration of the contract shall be the same as the duration of the exclusive right.

The grant of an exclusive right pursuant to paragraphs 2, 3 and 4, including the reasons as to why it is necessary to grant such a right, shall be transparent and be made publicly available online, in a form that complies with relevant Union law on public procurement.

Agreements or other practices falling within the scope of the prohibition referred to in paragraph 1 which do not meet the conditions laid down in paragraphs 2 and 3 and which were concluded before 23 June 2022 shall be terminated at the end of the applicable contract and in any event by 24 December 2024.

Public sector bodies which are competent under national law to grant or refuse access for the re-use of one or more of the categories of data referred to in Article 3(1) shall make publicly available the conditions for allowing such re-use and the procedure to request the re-use via the single information point referred to in Article 8. Where they grant or refuse access for re-use, they may be assisted by the competent bodies referred to in Article 7(1).

Member States shall ensure that public sector bodies are equipped with the necessary resources to comply with this Article.

Conditions for re-use shall be non-discriminatory, transparent, proportionate and objectively justified with regard to the categories of data and the purposes of re-use and the nature of the data for which re-use is allowed. Those conditions shall not be used to restrict competition.

Public sector bodies shall, in accordance with Union and national law, ensure that the protected nature of data is preserved. They may provide for the following requirements:

1. (a)

   to grant access for the re-use of data only where the public sector body or the competent body, following the request for re-use, has ensured that data has been:

   1. (i)

      anonymised, in the case of personal data; and

   2. (ii)

      modified, aggregated or treated by any other method of disclosure control, in the case of commercially confidential information, including trade secrets or content protected by intellectual property rights;

2. (b)

   to access and re-use the data remotely within a secure processing environment that is provided or controlled by the public sector body;

3. (c)

   to access and re-use the data within the physical premises in which the secure processing environment is located in accordance with high security standards, provided that remote access cannot be allowed without jeopardising the rights and interests of third parties.

In the case of re-use allowed in accordance with paragraph 3, points (b) and (c), the public sector bodies shall impose conditions that preserve the integrity of the functioning of the technical systems of the secure processing environment used. The public sector body shall reserve the right to verify the process, the means and any results of processing of data undertaken by the re-user to preserve the integrity of the protection of the data and reserve the right to prohibit the use of results that contain information jeopardising the rights and interests of third parties. The decision to prohibit the use of the results shall be comprehensible and transparent to the re-user.

Unless national law provides for specific safeguards on applicable confidentiality obligations relating to the re-use of data referred to in Article 3(1), the public sector body shall make the re-use of data provided in accordance with paragraph 3 of this Article conditional on the adherence by the re-user to a confidentiality obligation that prohibits the disclosure of any information that jeopardises the rights and interests of third parties that the re-user may have acquired despite the safeguards put in place. Re-users shall be prohibited from re-identifying any data subject to whom the data relates and shall take technical and operational measures to prevent re-identification and to notify any data breach resulting in the re-identification of the data subjects concerned to the public sector body. In the event of the unauthorised re-use of non-personal data, the re-user shall, without delay, where appropriate with the assistance of the public sector body, inform the legal persons whose rights and interests may be affected.

Where the re-use of data cannot be allowed in accordance with the obligations laid down in paragraphs 3 and 4 of this Article and there is no legal basis for transmitting the data under Regulation (EU) 2016/679, the public sector body shall make best efforts, in accordance with Union and national law, to provide assistance to potential re-users in seeking consent of the data subjects or permission from the data holders whose rights and interests may be affected by such re-use, where it is feasible without a disproportionate burden on the public sector body. Where it provides such assistance, the public sector body may be assisted by the competent bodies referred to in Article 7(1).

Re-use of data shall be allowed only in compliance with intellectual property rights. The right of the maker of a database as provided for in Article 7(1) of Directive 96/9/EC shall not be exercised by public sector bodies in order to prevent the re-use of data or to restrict re-use beyond the limits set by this Regulation.

Where data requested is considered to be confidential, in accordance with Union or national law on commercial or statistical confidentiality, the public sector bodies shall ensure that the confidential data is not disclosed as a result of allowing re-use, unless such re-use is allowed in accordance with paragraph 6.

Where a re-user intends to transfer non-personal data protected on the grounds set out in Article 3(1) to a third country, it shall inform the public sector body of its intention to transfer such data and the purpose of such transfer at the time of requesting the re-use of such data. In the case of re-use in accordance with paragraph 6 of this Article, the re-user shall, where appropriate with the assistance of the public sector body, inform the legal person whose rights and interests may be affected of that intention, purpose and the appropriate safeguards. The public sector body shall not allow the re-use unless the legal person gives permission for the transfer.

Public sector bodies shall transmit non-personal confidential data or data protected by intellectual property rights to a re-user which intends to transfer those data to a third country other than a country designated in accordance with paragraph 12 only if the re-user contractually commits to:

1. (a)

   complying with the obligations imposed in accordance with paragraphs 7 and 8 even after the data is transferred to the third country; and

2. (b)

   accepting the jurisdiction of the courts or tribunals of the Member State of the transmitting public sector body with regard to any dispute related to compliance with paragraphs 7 and 8.

Public sector bodies shall, where relevant and to the extent of their capabilities, provide guidance and assistance to re-users in complying with the obligations referred to in paragraph 10 of this Article.

In order to assist public sector bodies and re-users, the Commission may adopt implementing acts establishing model contractual clauses for complying with the obligations referred to in paragraph 10 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(3).

Where justified because of the substantial number of requests across the Union concerning the re-use of non-personal data in specific third countries, the Commission may adopt implementing acts declaring that the legal, supervisory and enforcement arrangements of a third country:

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(3).

1. (a)

   ensure protection of intellectual property and trade secrets in a way that is essentially equivalent to the protection ensured under Union law;

2. (b)

   are being effectively applied and enforced; and

3. (c)

   provide effective judicial redress.

Specific Union legislative acts may deem certain non-personal data categories held by public sector bodies to be highly sensitive for the purposes of this Article where their transfer to third countries may put at risk Union public policy objectives, such as safety and public health or may lead to the risk of re-identification of non-personal, anonymised data. Where such an act is adopted, the Commission shall adopt delegated acts in accordance with Article 32 supplementing this Regulation by laying down special conditions applicable to the transfers of such data to third countries.

Those special conditions shall be based on the nature of the non-personal data categories identified in the specific Union legislative act and on the grounds for deeming those categories to be highly sensitive, taking into account the risks of re-identification of non-personal, anonymised data. They shall be non-discriminatory and limited to what is necessary to achieve the Union public policy objectives identified in that act, in accordance with the Union’s international obligations.

If required by specific Union legislative acts as referred to in the first subparagraph, such special conditions may include terms applicable for the transfer or technical arrangements in this regard, 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, in exceptional cases, restrictions with regard to transfers to third countries.

The natural or legal person to which the right to re-use non-personal data was granted may transfer the data only to those third countries for which the requirements in paragraphs 10, 12 and 13 are met.

Public sector bodies which allow re-use of the categories of data referred to in Article 3(1) may charge fees for allowing the re-use of such data.

Any fees charged pursuant to paragraph 1 shall be transparent, non-discriminatory, proportionate and objectively justified and shall not restrict competition.

Public sector bodies shall ensure that any fees can also be paid online through widely available cross-border payment services, without discrimination based on the place of establishment of the payment service provider, the place of issue of the payment instrument or the location of the payment account within the Union.

Where public sector bodies charge fees, they shall take measures to provide incentives for the re-use of the categories of data referred to in Article 3(1) for non-commercial purposes, such as scientific research purposes, and by SMEs and start-ups in accordance with State aid rules. In that regard, public sector bodies may also make the data available at a discounted fee or free of charge, in particular to SMEs and start-ups, civil society and educational establishments. To that end, public sector bodies may establish a list of categories of re-users to which data for re-use is made available at a discounted fee or free of charge. That list, together with the criteria used to establish it, shall be made public.

Any fees shall be derived from the costs related to conducting the procedure for requests for the re-use of the categories of data referred to in Article 3(1) and limited to the necessary costs in relation to:

1. (a)

   the reproduction, provision and dissemination of data;

2. (b)

   the clearance of rights;

3. (c)

   anonymisation or other forms of preparation of personal data and commercially confidential data as provided for in Article 5(3);

4. (d)

   the maintenance of the secure processing environment;

5. (e)

   the acquisition of the right to allow re-use in accordance with this Chapter by third parties outside the public sector; and

6. (f)

   assisting re-users in seeking consent from data subjects and permission from data holders whose rights and interests may be affected by such re-use.

The criteria and methodology for calculating fees shall be laid down by the Member States and published. The public sector body shall publish a description of the main categories of costs and the rules used for the allocation of costs.

For the purpose of carrying out the tasks referred to in this Article, each Member State shall designate one or more competent bodies, which may be competent for particular sectors, to assist the public sector bodies which grant or refuse access for the re-use of the categories of data referred to in Article 3(1). Member States may either establish one or more new competent bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions laid down in this Regulation.

The competent bodies may be empowered to grant access for the re-use of the categories of data referred to in Article 3(1) pursuant to Union or national law which provides for such access to be granted. Where they grant or refuse access for the re-use, Articles 4, 5, 6 and 9 shall apply to those competent bodies.

The competent bodies shall have adequate legal, financial, technical and human resources to carry out the tasks assigned to them, including the necessary technical knowledge to be able to comply with relevant Union or national law concerning the access regimes for the categories of data referred to in Article 3(1).

The assistance provided for in paragraph 1 shall include, where necessary:

1. (a)

   providing technical support by making available a secure processing environment for providing access for the re-use of data;

2. (b)

   providing guidance and technical support on how to best structure and store data to make that data easily accessible;

3. (c)

   providing technical support for pseudonymisation and ensuring data processing in a manner that effectively preserves the privacy, confidentiality, integrity and accessibility of the information contained in the data for which re-use is allowed, including techniques for the anonymisation, generalisation, suppression and randomisation of personal data or other state-of-the-art privacy-preserving methods, and the deletion of commercially confidential information, including trade secrets or content protected by intellectual property rights;

4. (d)

   assisting the public sector bodies, where relevant, to provide support to re-users in requesting consent for re-use from data subjects or permission from data holders in line with their specific decisions, including on the jurisdiction in which the data processing is intended to take place and assisting the public sector bodies in establishing technical mechanisms that allow the transmission of requests for consent or permission from re-users, where practically feasible;

5. (e)

   providing public sector bodies with assistance in assessing the adequacy of contractual commitments made by a re-user pursuant to Article 5(10).

Each Member State shall notify the Commission of the identity of the competent bodies designated pursuant to paragraph 1 by 24 September 2023. Each Member State shall also notify the Commission of any subsequent change to the identity of those competent bodies.

Member States shall ensure that all relevant information concerning the application of Articles 5 and 6 is available and easily accessible through a single information point. Member States shall establish a new body or designate an existing body or structure as the single information point. The single information point may be linked to sectoral, regional or local information points. The functions of the single information point may be automated provided that the public sector body ensures adequate support.

The single information point shall be competent to receive enquiries or requests for the re-use of the categories of data referred to in Article 3(1) and shall transmit them, where possible and appropriate by automated means, to the competent public sector bodies, or the competent bodies referred to in Article 7(1), where relevant. The single information point shall make available by electronic means a searchable 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, including at least the data format and size and the conditions for their re-use.

The single information point may establish a separate, simplified and well-documented information channel for SMEs and start-ups, addressing their needs and capabilities in requesting the re-use of the categories of data referred to in Article 3(1).

The Commission shall establish a European single access point offering a searchable electronic register of data available in the national single information points and further information on how to request data via those national single information points.

Unless shorter time limits have been established in accordance with national law, the competent public sector bodies or the competent bodies referred to in Article 7(1) shall adopt a decision on the request for the re-use of the categories of data referred to in Article 3(1) within two months of the date of receipt of the request.

In the case of exceptionally extensive and complex requests for re-use, that two-month period may be extended by up to 30 days. In such cases the competent public sector bodies or the competent bodies referred to in Article 7(1) shall notify the applicant as soon as possible that more time is needed for conducting the procedure, together with the reasons for the delay.

Any natural or legal person directly affected by a decision as referred to in paragraph 1 shall have an effective right of redress in the Member State where the relevant body is located. Such a right of redress shall be laid down in national law and shall include the possibility of review by an impartial body with the appropriate expertise, such as the national competition authority, the relevant access-to-documents authority, the supervisory authority established in accordance with Regulation (EU) 2016/679 or a national judicial authority, whose decisions are binding upon the public sector body or the competent body concerned.

intermediation services between data holders and potential data users, including making available the technical or other means to enable such services; those services may include bilateral or multilateral exchanges of data or the creation of platforms or databases enabling the exchange or joint use of data, as well as the establishment of other specific infrastructure for the interconnection of data holders with data users;

intermediation services between data subjects that seek to make their personal data available or natural persons that seek to make non-personal data available, and potential data users, including making available the technical or other means to enable such services, and in particular enabling the exercise of the data subjects’ rights provided in Regulation (EU) 2016/679;

services of data cooperatives.

Any data intermediation services provider who intends to provide the data intermediation services referred to in Article 10 shall submit a notification to the competent authority for data intermediation services.

For the purposes of this Regulation, a data intermediation services provider with establishments in more than one Member State shall be deemed to be under the jurisdiction of the Member State in which it has its main establishment, without prejudice to Union law regulating cross-border actions for damages and related proceedings.

A data intermediation services provider that is not established in the Union, but which offers the data intermediation services referred to in Article 10 within the Union, shall designate a legal representative in one of the Member States in which those services are offered.

For the purpose of ensuring compliance with this Regulation, the legal representative shall be mandated by the data intermediation services provider to be addressed in addition to or instead of it by competent authorities for data intermediation services or data subjects and data holders, with regard to all issues related to the data intermediation services provided. The legal representative shall cooperate with and comprehensively demonstrate to the competent authorities for data intermediation services, upon request, the actions taken and provisions put in place by the data intermediation services provider to ensure compliance with this Regulation.

The data intermediation services provider shall be deemed to be under the jurisdiction of the Member State in which the legal representative is located. The designation of a legal representative by the data intermediation services provider shall be without prejudice to any legal actions which could be initiated against the data intermediation services provider.

After having submitted a notification in accordance with paragraph 1, the data intermediation services provider may start the activity subject to the conditions laid down in this Chapter.

The notification referred to in paragraph 1 shall entitle the data intermediation services provider to provide data intermediation services in all Member States.

The notification referred to in paragraph 1 shall include the following information:

1. (a)

   the name of the data intermediation services provider;

2. (b)

   the data intermediation services provider’s legal status, form, ownership structure, relevant subsidiaries and, where the data intermediation services provider is registered in a trade or other similar public national register, registration number;

3. (c)

   the address of the data intermediation services provider’s main establishment in the Union, if any, and, where applicable, of any secondary branch in another Member State or that of the legal representative;

4. (d)

   a public website where complete and up-to-date information on the data intermediation services provider and the activities can be found, including as a minimum the information referred to in points (a), (b), (c) and (f);

5. (e)

   the data intermediation services provider’s contact persons and contact details;

6. (f)

   a description of the data intermediation service the data intermediation services provider intends to provide, and an indication of the categories listed in Article 10 under which such data intermediation service falls;

7. (g)

   the estimated date for starting the activity, if different from the date of the notification.

The competent authority for data intermediation services shall ensure that the notification procedure is non-discriminatory and does not distort the competition.

At the request of the data intermediation services provider, the competent authority for data intermediation services shall, within one week of a duly and fully completed notification, issue a standardised declaration, confirming that the data intermediation services provider has submitted the notification referred to in paragraph 1 and that the notification contains the information referred to in paragraph 6.

At the request of the data intermediation services provider, the competent authority for data intermediation services shall confirm that the data intermediation services provider complies with this Article and Article 12. Upon receipt of such a confirmation, that data intermediation services provider may use the label ‘data intermediation services provider recognised in the Union’ in its written and spoken communication, as well as a common logo.

In order to ensure that data intermediation services providers recognised in the Union are easily identifiable throughout the Union, the Commission shall, by means of implementing acts, establish a design for the common logo. Data intermediation services providers recognised in the Union shall display the common logo clearly on every online and offline publication that relates to their data intermediation activities.

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 33(2).

The competent authority for data intermediation services shall notify the Commission of each new notification by electronic means without delay. The Commission shall keep and regularly update a public register of all data intermediation services providers providing their services in the Union. The information referred to in paragraph 6, points (a), (b), (c), (d), (f) and (g), shall be published in the public register.

The competent authority for data intermediation services may charge fees for the notification in accordance with national law. Such fees shall be proportionate and objective and be based on the administrative costs related to the monitoring of compliance and other market control activities of the competent authority for data intermediation services in relation to notifications of data intermediation services providers. In the case of SMEs and start-ups, the competent authority for data intermediation services may charge a discounted fee or waive the fee.

Data intermediation services providers shall notify the competent authority for data intermediation services of any changes to the information provided pursuant to paragraph 6 within 14 days of the date of the change.

Where a data intermediation services provider ceases its activities, it shall notify the relevant competent authority for data intermediation services determined pursuant to paragraphs 1, 2 and 3 within 15 days.

The competent authority for data intermediation services shall notify the Commission of each notification referred to in paragraphs 12 and 13 by electronic means without delay. The Commission shall update the public register of the data intermediation services providers in the Union accordingly.

the data intermediation services provider shall not use the data for which it provides data intermediation services for purposes other than to put them at the disposal of data users and shall provide data intermediation services through a separate legal person;

the commercial terms, including pricing, for the provision of data intermediation services to a data holder or data user shall not be dependent upon whether the data holder or data user uses other services 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;

the data collected with respect to any activity of a natural or legal person for the purpose of the provision of the data intermediation service, including the date, time and geolocation data, duration of activity and connections to other natural or legal persons established by the person who uses the data intermediation service, shall be used only for the development of that data intermediation service, which may entail the use of data for the detection of fraud or cybersecurity, and shall be made available to the data holders upon request;

the data intermediation services provider shall facilitate the exchange of the data in the format in which it receives it from a data subject or a data holder, shall convert the data into specific formats only to enhance interoperability within and across sectors or if requested by the data user or where mandated by Union law or to ensure harmonisation with international or European data standards and shall offer an opt-out possibility regarding those conversions to data subjects or data holders, unless the conversion is mandated by Union law;

data intermediation services may include offering 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, such tools being used only at the explicit request or approval of the data holder or data subject and third-party tools offered in that context not being used for other purposes;

the data intermediation services provider shall ensure that the procedure for access to its service is fair, transparent and non-discriminatory for both data subjects and data holders, as well as for data users, including with regard to prices and terms of service;

the data intermediation services provider shall have procedures in place to prevent fraudulent or abusive practices in relation to parties seeking access through its data intermediation services;

the data intermediation services provider shall, in the event of its insolvency, ensure a reasonable continuity of the provision of its data intermediation services and, where such data intermediation services ensure the storage of data, shall have mechanisms in place to allow data holders and data users to obtain access to, to transfer or to retrieve their data and, where such data intermediation services are provided between data subjects and data users, to allow data subjects to exercise their rights;

the data intermediation services provider shall take appropriate measures to ensure interoperability with other data intermediation services, inter alia, by means of commonly used open standards in the sector in which the data intermediation services provider operates;

the data intermediation services provider shall put in place adequate technical, legal and organisational measures in order to prevent the transfer of or access to non-personal data that is unlawful under Union law or the national law of the relevant Member State;

the data intermediation services provider shall without delay inform data holders in the event of an unauthorised transfer, access or use of the non-personal data that it has shared;

the data intermediation services provider shall take necessary measures to ensure an appropriate level of security for the storage, processing and transmission of non-personal data, and the data intermediation services provider shall further ensure the highest level of security for the storage and transmission of competitively sensitive information;

the data intermediation services provider offering services to data subjects shall act in the data subjects’ best interest where it facilitates the exercise of their rights, in particular by informing and, where appropriate, advising data subjects in a concise, transparent, intelligible and easily accessible manner about intended data uses by data users and standard terms and conditions attached to such uses before data subjects give consent;

where a data intermediation services provider provides tools for obtaining consent from data subjects or permissions to process data made available by data holders, it shall, where relevant, specify the third-country jurisdiction in which the data use is intended to take place and provide data subjects with tools to both give and withdraw consent and data holders with tools to both give and withdraw permissions to process data;

the data intermediation services provider shall maintain a log record of the data intermediation activity.

Each Member State shall designate one or more competent authorities to carry out the tasks related to the notification procedure for data intermediation services and shall notify the Commission of the identity of those competent authorities by 24 September 2023. Each Member State shall also notify the Commission of any subsequent change to the identity of those competent authorities.

The competent authorities for data intermediation services shall comply with the requirements set out in Article 26.

The powers of the competent authorities for data intermediation services are without prejudice to the powers of the data protection authorities, national competition authorities, authorities in charge of cybersecurity and other relevant sectoral authorities. In accordance with their respective competences under Union and national law, those authorities shall establish strong cooperation and exchange information as is necessary for the exercise of their tasks in relation to data intermediation services providers, and shall aim to achieve consistency in the decisions taken in applying this Regulation.

The competent authorities for data intermediation services shall monitor and supervise compliance of data intermediation services providers with the requirements of this Chapter. The competent authorities for data intermediation services may also monitor and supervise the compliance of data intermediation services providers, on the basis of a request by a natural or legal person.

The competent authorities for data intermediation services shall have the power to request from data intermediation services providers or their legal representatives all the information that is necessary to verify compliance with the requirements of this Chapter. Any request for information shall be proportionate to the performance of the task and shall be reasoned.

Where the competent authority for data intermediation services finds that a data intermediation services provider does not comply with one or more of the requirements of this Chapter, it shall notify that data intermediation services provider of those findings and give it the opportunity to state its views, within 30 days of the receipt of the notification.

The competent authority for data intermediation services shall have the power to require the cessation of the infringement referred to in paragraph 3 within a reasonable time limit or immediately in the case of a serious infringement and shall take appropriate and proportionate measures with the aim of ensuring compliance. In that regard, the competent authority for data intermediation services shall have the power, where appropriate:

The competent authority for data intermediation services shall request the Commission to remove the data intermediation services provider from the register of data intermediation services providers once it has ordered the cessation of the provision of the data intermediation service in accordance with the first subparagraph, point (c).

If a data intermediation services provider remedies infringements, that data intermediation services provider shall re-notify the competent authority for data intermediation services. The competent authority for data intermediation services shall notify the Commission of each new re-notification.

1. (a)

   to impose, through administrative procedures, dissuasive financial penalties, which may include periodic penalties and penalties with retroactive effect, to initiate legal proceedings for the imposition of fines, or both;

2. (b)

   to require a postponement of the commencement or a suspension of the provision of the data intermediation service until any changes to the conditions requested by the competent authority for data intermediation services have been made; or

3. (c)

   to require the cessation of the provision of the data intermediation service in the event that serious or repeated infringements have not been remedied despite prior notification in accordance with paragraph 3.

Where a data intermediation services provider that is not established in the Union fails to designate a legal representative or the legal representative fails, upon request of the competent authority for data intermediation services, to provide the necessary information that comprehensively demonstrates compliance with this Regulation, the competent authority for data intermediation services shall have the power to postpone the commencement of or to suspend the provision of the data intermediation service until the legal representative is designated or the necessary information is provided.

The competent authorities for data intermediation services shall notify the data intermediation services provider concerned of the measures imposed pursuant to paragraphs 4 and 5 and the reasons on which they are based, as well as the necessary steps to be taken to rectify the relevant shortcomings, without delay, and shall stipulate a reasonable period, which shall not be longer than 30 days, for the data intermediation services provider to comply with those measures.

If a data intermediation services provider has its main establishment or its legal representative in a Member State but provides services in other Member States, the competent authority for data intermediation services of the Member State of the main establishment or where the legal representative is located and the competent authorities for data intermediation services of those other Member States shall cooperate and assist each other. Such assistance and cooperation may cover information exchanges between the competent authorities for data intermediation services concerned for the purposes of their tasks under this Regulation and reasoned requests to take the measures referred to in this Article.

Where a competent authority for data intermediation services in one Member State requests assistance from a competent authority for data intermediation services in another Member State, it shall submit a reasoned request. The competent authority for data intermediation services shall, upon such a request, provide a response without delay and within a timeframe proportionate to the urgency of the request.

Any information exchanged in the context of assistance requested and provided under this paragraph shall be used only in respect of the matter for which it was requested.

Each competent authority for the registration of data altruism organisations shall keep and regularly update a public national register of recognised data altruism organisations.

The Commission shall maintain a public Union register of recognised data altruism organisations for information purposes. Provided that an entity is registered in the public national register of recognised data altruism organisations in accordance with Article 18, it may use the label ‘data altruism organisation recognised in the Union’ in its written and spoken communication, as well as a common logo.

In order to ensure that recognised data altruism organisations are easily identifiable throughout the Union, the Commission shall, by means of implementing acts, establish a design for the common logo. Recognised data altruism organisations shall display the common logo clearly on every online and offline publication that relates to their data altruism activities. The common logo shall be accompanied by a QR code with a link to the public Union register of recognised data altruism organisations.

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 33(2).

carry out data altruism activities;

be a legal person established pursuant to national law to meet objectives of general interest as provided for in national law, where applicable;

operate on a not-for-profit basis and be legally independent from any entity that operates on a for-profit basis;

carry out its data altruism activities through a structure that is functionally separate from its other activities;

comply with the rulebook referred to Article 22(1), at the latest 18 months after the date of entry into force of the delegated acts referred to in that paragraph.

An entity which meets the requirements of Article 18 may submit an application for registration in the public national register of recognised data altruism organisations in the Member State in which it is established.

An entity which meets the requirements of Article 18 and has establishments in more than one Member State may submit an application for registration in the public national register of recognised data altruism organisations in the Member State in which it has its main establishment.

An entity which meets the requirements of Article 18 but which is not established in the Union shall designate a legal representative in one of the Member States in which the data altruism services are offered.

For the purpose of ensuring compliance with this Regulation, the legal representative shall be mandated by the entity to be addressed in addition to or instead of it by competent authorities for the registration of data altruism organisations or data subjects and data holders, with regard to all issues related to that entity. The legal representative shall cooperate with and comprehensively demonstrate to the competent authorities for the registration of data altruism organisations, upon request, the actions taken and provisions put in place by the entity to ensure compliance with this Regulation.

The entity shall be deemed to be under the jurisdiction of the Member State in which the legal representative is located. Such an entity may submit an application for registration in the public national register of recognised data altruism organisations in that Member State. The designation of a legal representative by the entity shall be without prejudice to any legal actions which could be initiated against the entity.

Applications for registration referred to in paragraphs 1, 2 and 3 shall contain the following information:

1. (a)

   the name of the entity;

2. (b)

   the entity’s legal status, form and, where the entity is registered in a public national register, registration number;

3. (c)

   the statutes of the entity, where appropriate;

4. (d)

   the entity’s sources of income;

5. (e)

   the address of the entity’s main establishment in the Union, if any, and, where applicable, any secondary branch in another Member State or that of the legal representative;

6. (f)

   a public website where complete and up-to-date information on the entity and the activities can be found, including as a minimum the information referred to in points (a), (b), (d), (e) and (h);

7. (g)

   the entity’s contact persons and contact details;

8. (h)

   the objectives of general interest it intends to promote when collecting data;

9. (i)

   the nature of the data that the entity intends to control or process, and, in the case of personal data, an indication of the categories of personal data;

10. (j)

    any other documents which demonstrate that the requirements of Article 18 are met.

Where the entity has submitted all necessary information pursuant to paragraph 4 and after the competent authority for the registration of data altruism organisations has evaluated the application for registration and found that the entity complies with the requirements of Article 18, it shall register the entity in the public national register of recognised data altruism organisations within 12 weeks after the receipt of the application for registration. The registration shall be valid in all Member States.

The competent authority for the registration of data altruism organisations shall notify the Commission of any registration. The Commission shall include that registration in the public Union register of recognised data altruism organisations.

The information referred to in paragraph 4, points (a), (b), (f), (g) and (h), shall be published in the relevant public national register of recognised data altruism organisations.

A recognised data altruism organisation shall notify the relevant competent authority for the registration of data altruism organisations of any changes to the information provided pursuant to paragraph 4 within 14 days of the date of the change.

The competent authority for the registration of data altruism organisations shall notify the Commission of each such notification by electronic means without delay. Based on such a notification, the Commission shall update the public Union register of recognised data altruism organisations without delay.

A recognised data altruism organisation shall keep full and accurate records concerning:

1. (a)

   all natural or legal persons that were given the possibility to process data held by that recognised data altruism organisation, and their contact details;

2. (b)

   the date or duration of the processing of personal data or use of non-personal data;

3. (c)

   the purpose of the processing as declared by the natural or legal person that was given the possibility of processing;

4. (d)

   the fees paid by natural or legal persons processing the data, if any.

A recognised data altruism organisation shall draw up and transmit to the relevant competent authority for the registration of data altruism organisations an annual activity report which shall contain at least the following:

1. (a)

   information on the activities of the recognised data altruism organisation;

2. (b)

   a description of the way in which the objectives of general interest for which data was collected have been promoted during the given financial year;

3. (c)

   a list of all natural and legal persons that were allowed to process data it holds, including a summary description of the objectives of general interest pursued by such data processing and the description of the technical means used for it, including a description of the techniques used to preserve privacy and data protection;

4. (d)

   a summary of the results of the data processing allowed by the recognised data altruism organisation, where applicable;

5. (e)

   information on sources of revenue of the recognised data altruism organisation, in particular all revenue from allowing access to the data, and on expenditure.

A recognised data altruism organisation shall inform data subjects or data holders prior to any processing of their data in a clear and easily comprehensible manner of:

1. (a)

   the objectives of general interest and, if applicable, the specified, explicit and legitimate purpose for which personal data is to be processed, and for which it permits the processing of their data by a data user;

2. (b)

   the location of and the objectives of general interest for which it permits any processing carried out in a third country, where the processing is carried out by the recognised data altruism organisation.

The recognised data altruism organisation shall not use the data for other objectives than those of general interest for which the data subject or data holder allows the processing. The recognised data altruism organisation shall not use misleading marketing practices to solicit the provision of data.

The recognised data altruism organisation shall provide tools for obtaining consent from data subjects or permissions to process data made available by data holders. The recognised data altruism organisation shall also provide tools for easy withdrawal of such consent or permission.

The recognised data altruism organisation shall take measures to ensure an appropriate level of security for the storage and processing of non-personal data that it has collected based on data altruism.

The recognised data altruism organisation shall, without delay, inform data holders in the event of any unauthorised transfer, access or use of the non-personal data that it has shared.

Where the recognised data altruism organisation facilitates data processing by third parties, including by providing tools for obtaining consent from data subjects or permissions to process data made available by data holders, it shall, where relevant, specify the third-country jurisdiction in which the data use is intended to take place.

The Commission shall adopt delegated acts in accordance with Article 32, supplementing this Regulation by establishing a rulebook laying down:

1. (a)

   appropriate information requirements to ensure that data subjects and data holders are provided, before a consent or permission for data altruism is given, with sufficiently detailed, clear and transparent information regarding the use of data, the tools for giving and withdrawing consent or permission, and the measures taken to avoid misuse of the data shared with the data altruism organisation;

2. (b)

   appropriate technical and security requirements to ensure the appropriate level of security for the storage and processing of data, as well as for the tools for giving and withdrawing consent or permission;

3. (c)

   communication roadmaps taking a multi-disciplinary approach to raise awareness of data altruism, of the designation as a ‘data altruism organisation recognised in the Union’ and of the rulebook among relevant stakeholders, in particular data holders and data subjects that would potentially share their data;

4. (d)

   recommendations on relevant interoperability standards.

The rulebook referred to in paragraph 1 shall be prepared in close cooperation with data altruism organisations and relevant stakeholders.

Each Member State shall designate one or more competent authorities responsible for its public national register of recognised data altruism organisations.

The competent authorities for the registration of data altruism organisations shall comply with the requirements set out in Article 26.

Each Member State shall notify the Commission of the identity of their competent authorities for the registration of data altruism organisations by 24 September 2023. Each Member State shall also notify the Commission of any subsequent change to the identity of those competent authorities.

The competent authority for the registration of data altruism organisations of a Member State shall undertake its tasks in cooperation with the relevant data protection authority, where such tasks are related to processing of personal data, and with relevant sectoral authorities of that Member State.

The competent authorities for the registration of data altruism organisations shall monitor and supervise compliance of recognised data altruism organisations with the requirements laid down in this Chapter. The competent authority for the registration of data altruism organisations may also monitor and supervise the compliance of such recognised data altruism organisations, on the basis of a request by a natural or legal person.

The competent authorities for the registration of data altruism organisations shall have the power to request information from recognised data altruism organisations that is necessary to verify compliance with the requirements of this Chapter. Any request for information shall be proportionate to the performance of the task and shall be reasoned.

Where the competent authority for the registration of data altruism organisations finds that a recognised data altruism organisation does not comply with one or more of the requirements of this Chapter, it shall notify the recognised data altruism organisation of those findings and give it the opportunity to state its views within 30 days of the receipt of the notification.

The competent authority for the registration of data altruism organisations shall have the power to require the cessation of the infringement referred to in paragraph 3 either immediately or within a reasonable time limit and shall take appropriate and proportionate measures with the aim of ensuring compliance.

If a recognised data altruism organisation does not comply with one or more of the requirements of this Chapter even after having been notified in accordance with paragraph 3 by the competent authority for the registration of data altruism organisations, that recognised data altruism organisation shall:

Any decision revoking the right to use the label ‘data altruism organisation recognised in the Union’ under the first subparagraph, point (a), shall be made public by the competent authority for the registration of data altruism organisations.

1. (a)

   lose its right to use the label ‘data altruism organisation recognised in the Union’ in any written and spoken communication;

2. (b)

   be removed from the relevant public national register of recognised data altruism organisations and the public Union register of recognised data altruism organisations.

If a recognised data altruism organisation has its main establishment or its legal representative in a Member State but is active in other Member States, the competent authority for the registration of data altruism organisations of the Member State of the main establishment or where the legal representative is located and the competent authorities for the registration of data altruism organisations of those other Member States shall cooperate and assist each other. Such assistance and cooperation may cover information exchanges between the competent authorities for the registration of data altruism organisations concerned for the purposes of their tasks under this Regulation and reasoned requests to take the measures referred to in this Article.

Where a competent authority for the registration of data altruism organisations in one Member State requests assistance from a competent authority for the registration of data altruism organisations in another Member State, it shall submit a reasoned request. The competent authority for the registration of data altruism organisations shall, upon such a request, provide a response without delay and within a timeframe proportionate to the urgency of the request.

Any information exchanged in the context of assistance requested and provided under this paragraph shall be used only in respect of the matter for which it was requested.

In order to facilitate the collection of data based on data altruism, the Commission shall adopt implementing acts establishing and developing a European data altruism consent form, after consulting the European Data Protection Board, taking into account the advice of the European Data Innovation Board and duly involving relevant stakeholders. The form shall allow the collection of consent or permission across Member States in a uniform format. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 33(2).

The European data altruism consent form shall use a modular approach allowing customisation for specific sectors and for different purposes.

Where personal data are provided, the European data altruism consent form shall ensure that data subjects are able to give consent to and withdraw consent from a specific data processing operation in compliance with the requirements of Regulation (EU) 2016/679.

The form shall be available in a manner that can be printed on paper and is easily understandable as well as in an electronic, machine-readable form.

The competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations shall be legally distinct from, and functionally independent of, any data intermediation services provider or recognised data altruism organisation. The functions of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations may be carried out by the same authority. Member States may either establish one or more new authorities for those purposes or rely on existing ones.

Competent authorities for data intermediation services and competent authorities for the registration of data altruism organisations shall exercise their tasks in an impartial, transparent, consistent, reliable and timely manner. Where they exercise their tasks, they shall safeguard fair competition and non-discrimination.

The top-level management and personnel responsible for carrying out the relevant tasks of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the services which they evaluate, nor the authorised representative of any of those parties. This shall not preclude the use of evaluated services that are necessary for the operations of the competent authority for data intermediation services and the competent authority for the registration of data altruism organisations or the use of such services for personal purposes.

The top-level management and personnel of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations shall not engage in any activity that may conflict with their independence of judgment or integrity in relation to evaluation activities assigned to them.

The competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations shall have at their disposal the adequate financial and human resources to carry out the tasks assigned to them, including the necessary technical knowledge and resources.

The competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations of a Member State shall provide the Commission and competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations from other Member States, on reasoned request and without delay, with the information necessary to carry out their tasks under this Regulation. Where a competent authority for data intermediation services or a competent authority for the registration of data altruism organisations considers the information requested to be confidential in accordance with Union and national law on commercial and professional confidentiality, the Commission and any other competent authorities for data intermediation services or competent authorities for the registration of data altruism organisations concerned shall ensure such confidentiality.

Natural and legal persons shall have the right to lodge a complaint in relation to any matter falling within the scope of this Regulation, individually or, where relevant, collectively, with the relevant competent authority for data intermediation services against a data intermediation services provider or with the relevant competent authority for the registration of data altruism organisations against a recognised data altruism organisation.

The competent authority for data intermediation services or the competent authority for the registration of data altruism organisations with which the complaint has been lodged shall inform the complainant of:

1. (a)

   the progress of the proceedings and of the decision taken; and

2. (b)

   the judicial remedies provided for in Article 28.

Notwithstanding any administrative or other non-judicial remedies, any affected natural and legal persons shall have the right to an effective judicial remedy with regard to legally binding decisions referred to in Article 14 taken by the competent authorities for data intermediation services in the management, control and enforcement of the notification regime for data intermediation services providers and legally binding decisions referred to in Articles 19 and 24 taken by the competent authorities for the registration of data altruism organisations in the monitoring of recognised data altruism organisations.

Proceedings pursuant to this Article shall be brought before the courts or tribunals of the Member State of the competent authority for data intermediation services or the competent authority for the registration of data altruism organisations against which the judicial remedy is sought individually or, where relevant, collectively by the representatives of one or more natural or legal persons.

Where a competent authority for data intermediation services or a competent authority for the registration of data altruism organisations fails to act on a complaint, any affected natural and legal persons shall, in accordance with national law, either have the right to an effective judicial remedy or access to review by an impartial body with the appropriate expertise.

The Commission shall establish a European Data Innovation Board in the form of an expert group, consisting 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, 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. In its appointments of individual experts, the Commission shall aim to achieve gender and geographical balance among the members of the expert group.

The European Data Innovation Board shall consist of at least the following three subgroups:

1. (a)

   a subgroup composed of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations, with a view to carrying out the tasks pursuant to Article 30, points (a), (c), (j) and (k);

2. (b)

   a subgroup for technical discussions on standardisation, portability and interoperability pursuant to Article 30, points (f) and (g);

3. (c)

   a subgroup for stakeholder involvement composed of relevant representatives from industry, research, academia, civil society, standardisation organisations, relevant common European data spaces and other relevant stakeholders and third parties advising the European Data Innovation Board on tasks pursuant to Article 30, points (d), (e), (f), (g) and (h).

The Commission shall chair the meetings of the European Data Innovation Board.

The European Data Innovation Board shall be assisted by a secretariat provided by the Commission.

to advise and assist the Commission with regard to developing a consistent practice of public sector bodies and competent bodies referred to in Article 7(1) in handling requests for the re-use of the categories of data referred to in Article 3(1);

to advise and assist the Commission with regard to developing a consistent practice for data altruism across the Union;

to advise and assist the Commission with regard to developing a consistent practice of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations in the application of requirements applicable to data intermediation services providers and recognised data altruism organisations;

to advise and assist the Commission with regard to developing consistent guidelines on how to best protect, in the context of this Regulation, commercially sensitive non-personal data, in particular trade secrets, but also non-personal data representing content protected by intellectual property rights from unlawful access that risks intellectual property theft or industrial espionage;

to advise and assist the Commission with regard to developing consistent guidelines for cybersecurity requirements for the exchange and storage of data;

to advise the Commission, in particular taking into account the input from standardisation organisations, on the prioritisation of cross-sector standards to be used and developed for data use and cross-sector data sharing between emerging common European data spaces, cross-sectoral comparison and exchange of best practices with regard to sectoral requirements for security and access procedures, taking into account sector-specific standardisation activities, in particular clarifying and distinguishing which standards and practices are cross-sectoral and which are sectoral;

to assist the Commission, in particular taking into account the input from standardisation organisations, in addressing fragmentation of the internal market and the data economy in the internal market by enhancing cross-border, cross-sector interoperability of data as well as data sharing services between different sectors and domains, building on existing European, international or national standards, inter alia with the aim of encouraging the creation of common European data spaces;

to propose guidelines for 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, such common standards and practices taking into account existing standards, complying with the competition rules and ensuring non-discriminatory access to all participants, for the purpose of facilitating data sharing in the Union and reaping the potential of existing and future data spaces, addressing, inter alia:

1. (i)

   cross-sectoral standards to be used and developed for data use and cross-sector data sharing, cross-sectoral comparison and exchange of best practices with regard to sectoral requirements for security and access procedures, taking into account sector-specific standardisation activities, in particular clarifying and distinguishing which standards and practices are cross-sectoral and which are sectoral;

2. (ii)

   requirements to counter barriers to market entry and to avoid lock-in effects, for the purpose of ensuring fair competition and interoperability;

3. (iii)

   adequate protection for lawful data transfers to third countries, including safeguards against any transfers prohibited by Union law;

4. (iv)

   adequate and non-discriminatory representation of relevant stakeholders in the governance of common European data spaces;

5. (v)

   adherence to cybersecurity requirements in accordance with Union law;

to facilitate cooperation between Member States with regard to setting harmonised conditions allowing for the re-use of the categories of data referred to in Article 3(1) held by public sector bodies across the internal market;

to facilitate cooperation between competent authorities for data intermediation services and competent authorities for the registration of data altruism organisations through capacity-building and the exchange of information, in particular by establishing methods for the efficient exchange of information relating to the notification procedure for data intermediation services providers and the registration and monitoring of recognised data altruism organisations, including coordination with regard to the setting of fees or penalties, as well as facilitate cooperation between competent authorities for data intermediation services and competent authorities for the registration of data altruism organisations with regard to international access and transfer of data;

to advise and assist the Commission with regard to evaluating whether the implementing acts referred to in Article 5(11) and (12) are to be adopted;

to advise and assist the Commission with regard to developing the European data altruism consent form in accordance with Article 25(1);

to advise the Commission on improving the international regulatory environment for non-personal data, including standardisation.

The public sector body, the natural or legal person to which the right to re-use data was granted under Chapter II, the data intermediation services provider or the recognised data altruism organisation shall take all reasonable technical, legal and organisational measures, including contractual arrangements, in order to prevent international transfer or governmental access to non-personal data held in the Union where such transfer or access would create a conflict with Union law or the national law of the relevant Member State, without prejudice to paragraph 2 or 3.

Any decision or judgment of a third-country court or tribunal and any decision of a third-country administrative authority requiring a public sector body, a natural or legal person to which the right to re-use data was granted under Chapter II, a data intermediation services provider or recognised data altruism organisation to transfer or give access to non-personal data within the scope of this Regulation held in the Union shall be recognised or enforceable in any manner only if based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or any such agreement between the requesting third country and a Member State.

In the absence of an international agreement as referred to in paragraph 2 of this Article, where a public sector body, a natural or legal person to which the right to re-use data was granted under Chapter II, a data intermediation services provider or recognised data altruism organisation is the addressee of a decision or judgment of a third-country court or tribunal or a decision of a third-country administrative authority to transfer or give access to non-personal data within the scope of this Regulation held in the Union and compliance with such a decision would risk putting the addressee in conflict with Union law or with the national law of the relevant Member State, transfer to or access to such data by that third-country authority shall take place only where:

1. (a)

   the third-country system requires the reasons and proportionality of such a decision or judgment to be set out and requires such a decision or judgment to be specific in character, for instance by establishing a sufficient link to certain suspected persons or infringements;

2. (b)

   the reasoned objection of the addressee is subject to a review by a competent third-country court or tribunal; and

3. (c)

   the competent third-country court or tribunal issuing the decision or judgment or reviewing the decision of an administrative authority is empowered under the law of that third country to take duly into account the relevant legal interests of the provider of the data protected under Union law or the national law of the relevant Member State.

If the conditions laid down in paragraph 2 or 3 are met, the public sector body, the natural or legal person to which the right to re-use data was granted under Chapter II, the data intermediation services provider or the recognised data altruism organisation shall provide the minimum amount of data permissible in response to a request, based on a reasonable interpretation of the request.

The public sector body, the natural or legal person to which the right to re-use data was granted under Chapter II, the data intermediation services provider and the recognised data altruism organisation shall inform the data holder about the existence of a request of a third-country administrative authority to access its data before complying with that request, except where the request serves law enforcement purposes and for as long as this is necessary to preserve the effectiveness of the law enforcement activity.

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

The power to adopt delegated acts referred to in Article 5(13) and Article 22(1) shall be conferred on the Commission for an indeterminate period of time from 23 June 2022.

The delegation of power referred to in Article 5(13) and Article 22(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

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

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

A delegated act adopted pursuant to Article 5(13) or Article 22(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.

The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Member States shall lay down the rules on penalties applicable to infringements of the obligations regarding transfers of non-personal data to third countries pursuant to Article 5(14) and Article 31, the notification obligation of data intermediation services providers pursuant to Article 11, the conditions for providing data intermediation services pursuant to Article 12 and the conditions for the registration as a recognised data altruism organisation pursuant to Articles 18, 20, 21 and 22, and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. In their rules on penalties, Member States shall take into account the recommendations of the European Data Innovation Board. Member States shall, by 24 September 2023, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

Member States shall take into account the following non-exhaustive and indicative criteria for the imposition of penalties on data intermediation services providers and recognised data altruism organisations for infringements of this Regulation, where appropriate:

1. (a)

   the nature, gravity, scale and duration of the infringement;

2. (b)

   any action taken by the data intermediation services provider or recognised data altruism organisation to mitigate or remedy the damage caused by the infringement;

3. (c)

   any previous infringements by the data intermediation services provider or recognised data altruism organisation;

4. (d)

   the financial benefits gained or losses avoided by the data intermediation services provider or recognised data altruism organisation due to the infringement, insofar as such benefits or losses can be reliably established;

5. (e)

   any other aggravating or mitigating factors applicable to the circumstances of the case.

the application and functioning of the rules on penalties laid down by the Member States pursuant to Article 34;

the level of compliance of the legal representatives of data intermediation services providers and recognised data altruism organisations that are not established in the Union with this Regulation and the level of enforceability of penalties imposed on those providers and organisations;

the type of data altruism organisations registered under Chapter IV and an overview of the objectives of general interests for which data are shared in view of establishing clear criteria in that respect.

Procedures

This Regulation lays down:

1. (a)

   conditions for the re-use, within the Union, of certain categories of data held by public sector bodies;

2. (b)

   a notification and supervisory framework for the provision of data intermediation services;

3. (c)

   a framework for voluntary registration of entities which collect and process data made available for altruistic purposes; and

4. (d)

   a framework for the establishment of a European Data Innovation Board.

This Regulation does not create any obligation on public sector bodies to allow the re-use of data, nor does it release public sector bodies from their confidentiality obligations under Union or national law.

This Regulation is without prejudice to:

Where sector-specific Union or national law requires public sector bodies, data intermediation services providers or 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 shall also apply. Any such specific additional requirements shall be non-discriminatory, proportionate and objectively justified.

1. (a)

   specific provisions in Union or national law regarding the access to or re-use of certain categories of data, in particular with regard to the granting of access to and disclosure of official documents; and

2. (b)

   the obligations of public sector bodies under Union or national law to allow the re-use of data or to requirements related to processing of non-personal data.

Union and national law on the protection of personal data shall apply to any personal data processed in connection with this Regulation. In particular, this Regulation is without prejudice to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directives 2002/58/EC and (EU) 2016/680, including with regard to the powers and competences of supervisory authorities. 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 shall prevail. This Regulation does not create a legal basis for the processing of personal data, nor does it affect any of the rights and obligations set out in Regulations (EU) 2016/679 or (EU) 2018/1725 or Directives 2002/58/EC or (EU) 2016/680.

This Regulation is without prejudice to the application of competition law.

This Regulation is without prejudice to the competences of the Member States with regard to their activities concerning public security, defence and national security.

‘data’ means any digital representation of acts, facts or information and any compilation of such acts, facts or information, including in the form of sound, visual or audiovisual recording;

‘re-use’ means the use by natural or legal persons of data held by public sector bodies, for commercial or non-commercial purposes other than the initial purpose within the public task for which the data were produced, except for the exchange of data between public sector bodies purely in pursuit of their public tasks;

‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;

‘non-personal data’ means data other than personal data;

‘consent’ means consent as defined in Article 4, point (11), of Regulation (EU) 2016/679;

‘permission’ means giving data users the right to the processing of non-personal data;

‘data subject’ means data subject as referred to in Article 4, point (1), of Regulation (EU) 2016/679;

‘data holder’ means a legal person, including public sector bodies and international organisations, or a natural person who is not a data subject with respect to the specific data in question, which, in accordance with applicable Union or national law, has the right to grant access to or to share certain personal data or non-personal data;

‘data user’ means a natural or legal person who has lawful access to certain personal or non-personal data and has the right, including under Regulation (EU) 2016/679 in the case of personal data, to use that data for commercial or non-commercial purposes;

‘data sharing’ means the provision of data by a data subject or a data holder to a data user for the purpose of the joint or individual use of such data, based on voluntary agreements or Union or national law, directly or through an intermediary, for example under open or commercial licences subject to a fee or free of charge;

‘data intermediation service’ means a service which aims 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, excluding at least the following:

1. (a)

   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;

2. (b)

   services that focus on the intermediation of copyright-protected content;

3. (c)

   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;

4. (d)

   data sharing services offered by public sector bodies that do not aim to establish commercial relationships;

‘processing’ means processing as defined in Article 4, point (2), of Regulation (EU) 2016/679 with regard to personal data or Article 3, point (2), of Regulation (EU) 2018/1807 with regard to non-personal data;

‘access’ means data use, in accordance with specific technical, legal or organisational requirements, without necessarily implying the transmission or downloading of data;

‘main establishment’ of a legal person means the place of its central administration in the Union;

‘services of data cooperatives’ means data intermediation services offered by an organisational structure constituted by data subjects, one-person undertakings or SMEs who are members of that structure, having as its main objectives to support its members in the exercise of their rights with respect to certain data, including with regard to making informed choices before they consent to data processing, to exchange views on data processing purposes and conditions that would best represent the interests of its members in relation to their data, and to negotiate terms and conditions for data processing on behalf of its members before giving permission to the processing of non-personal data or before they consent to the processing of personal data;

‘data altruism’ means the voluntary sharing of data on the basis of the consent of data subjects to process personal data pertaining to them, or permissions of data holders to allow the use of their non-personal data without seeking or receiving a reward that goes beyond compensation related to the costs that they incur where they make their data available for objectives of general interest as provided for in national law, where applicable, such as healthcare, combating climate change, improving mobility, facilitating the development, production and dissemination of official statistics, improving the provision of public services, public policy making or scientific research purposes in the general interest;

‘public sector body’ means the State, regional or local authorities, bodies governed by public law or associations formed by one or more such authorities, or one or more such bodies governed by public law;

‘bodies governed by public law’ means bodies that have the following characteristics:

1. (a)

   they are established for the specific purpose of meeting needs in the general interest, and do not have an industrial or commercial character;

2. (b)

   they have legal personality;

3. (c)

   they are financed, for the most part, by the State, regional or local authorities, or other bodies governed by public law, are subject to management supervision by those authorities or bodies, or have an administrative, managerial or supervisory board, more than half of whose members are appointed by the State, regional or local authorities, or by other bodies governed by public law;

‘public undertaking’ means any undertaking over which the public sector bodies may exercise directly or indirectly a dominant influence by virtue of their ownership of it, their financial participation therein, or the rules which govern it; for the purposes of this definition, a dominant influence on the part of the public sector bodies shall be presumed in any of the following cases in which those bodies, directly or indirectly:

1. (a)

   hold the majority of the undertaking’s subscribed capital;

2. (b)

   control the majority of the votes attaching to shares issued by the undertaking;

3. (c)

   can appoint more than half of the undertaking’s administrative, management or supervisory body;

‘secure processing environment’ means the physical or virtual environment and organisational means to ensure compliance with Union law, such as Regulation (EU) 2016/679, in particular with regard to data subjects’ rights, intellectual property rights, and commercial and statistical confidentiality, integrity and accessibility, as well as with applicable national law, and to allow the entity providing the secure processing environment to determine and supervise all data processing actions, including the display, storage, download and export of data and the calculation of derivative data through computational algorithms;

‘legal representative’ means a natural or legal person established in the Union explicitly designated to act on behalf of a data intermediation services provider or an entity that collects data for objectives of general interest made available by natural or legal persons on the basis of data altruism not established in the Union, which may be addressed by the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations in addition to or instead of the data intermediation services provider or entity with regard to the obligations under this Regulation, including with regard to initiating enforcement proceedings against a non-compliant data intermediation services provider or entity not established in the Union.

This Chapter applies to data held by public sector bodies which are protected on grounds of:

1. (a)

   commercial confidentiality, including business, professional and company secrets;

2. (b)

   statistical confidentiality;

3. (c)

   the protection of intellectual property rights of third parties; or

4. (d)

   the protection of personal data, insofar as such data fall outside the scope of Directive (EU) 2019/1024.

This Chapter does not apply to:

1. (a)

   data held by public undertakings;

2. (b)

   data held by public service broadcasters and their subsidiaries, and by other bodies or their subsidiaries for the fulfilment of a public service broadcasting remit;

3. (c)

   data held by cultural establishments and educational establishments;

4. (d)

   data held by public sector bodies which are protected for reasons of public security, defence or national security; or

5. (e)

   data the supply of which is an activity falling outside the scope of the public task of the public sector bodies concerned as defined by law or by other binding rules in the Member State concerned, or, in the absence of such rules, as defined in accordance with common administrative practice in that Member State, provided that the scope of the public tasks is transparent and subject to review.

This Chapter is without prejudice to:

1. (a)

   Union and national law and international agreements to which the Union or Member States are party on the protection of categories of data referred to in paragraph 1; and

2. (b)

   Union and national law on access to documents.

Agreements or other practices pertaining to the re-use of data held by public sector bodies containing categories of data referred to in Article 3(1) which grant exclusive rights or which have as their objective or effect to grant such exclusive rights or to restrict the availability of data for re-use by entities other than the parties to such agreements or other practices shall be prohibited.

By way of derogation from paragraph 1, an exclusive right to re-use data referred to in that paragraph may be granted to the extent necessary for the provision of a service or the supply of a product in the general interest that would not otherwise be possible.

An exclusive right as referred to in paragraph 2 shall be granted through an administrative act or contractual arrangement in accordance with applicable Union or national law and in compliance with the principles of transparency, equal treatment and non-discrimination.

The duration of an exclusive right to re-use data shall not exceed 12 months. Where a contract is concluded, the duration of the contract shall be the same as the duration of the exclusive right.

The grant of an exclusive right pursuant to paragraphs 2, 3 and 4, including the reasons as to why it is necessary to grant such a right, shall be transparent and be made publicly available online, in a form that complies with relevant Union law on public procurement.

Agreements or other practices falling within the scope of the prohibition referred to in paragraph 1 which do not meet the conditions laid down in paragraphs 2 and 3 and which were concluded before 23 June 2022 shall be terminated at the end of the applicable contract and in any event by 24 December 2024.

Public sector bodies which are competent under national law to grant or refuse access for the re-use of one or more of the categories of data referred to in Article 3(1) shall make publicly available the conditions for allowing such re-use and the procedure to request the re-use via the single information point referred to in Article 8. Where they grant or refuse access for re-use, they may be assisted by the competent bodies referred to in Article 7(1).

Member States shall ensure that public sector bodies are equipped with the necessary resources to comply with this Article.

Conditions for re-use shall be non-discriminatory, transparent, proportionate and objectively justified with regard to the categories of data and the purposes of re-use and the nature of the data for which re-use is allowed. Those conditions shall not be used to restrict competition.

Public sector bodies shall, in accordance with Union and national law, ensure that the protected nature of data is preserved. They may provide for the following requirements:

1. (a)

   to grant access for the re-use of data only where the public sector body or the competent body, following the request for re-use, has ensured that data has been:

   1. (i)

      anonymised, in the case of personal data; and

   2. (ii)

      modified, aggregated or treated by any other method of disclosure control, in the case of commercially confidential information, including trade secrets or content protected by intellectual property rights;

2. (b)

   to access and re-use the data remotely within a secure processing environment that is provided or controlled by the public sector body;

3. (c)

   to access and re-use the data within the physical premises in which the secure processing environment is located in accordance with high security standards, provided that remote access cannot be allowed without jeopardising the rights and interests of third parties.

In the case of re-use allowed in accordance with paragraph 3, points (b) and (c), the public sector bodies shall impose conditions that preserve the integrity of the functioning of the technical systems of the secure processing environment used. The public sector body shall reserve the right to verify the process, the means and any results of processing of data undertaken by the re-user to preserve the integrity of the protection of the data and reserve the right to prohibit the use of results that contain information jeopardising the rights and interests of third parties. The decision to prohibit the use of the results shall be comprehensible and transparent to the re-user.

Unless national law provides for specific safeguards on applicable confidentiality obligations relating to the re-use of data referred to in Article 3(1), the public sector body shall make the re-use of data provided in accordance with paragraph 3 of this Article conditional on the adherence by the re-user to a confidentiality obligation that prohibits the disclosure of any information that jeopardises the rights and interests of third parties that the re-user may have acquired despite the safeguards put in place. Re-users shall be prohibited from re-identifying any data subject to whom the data relates and shall take technical and operational measures to prevent re-identification and to notify any data breach resulting in the re-identification of the data subjects concerned to the public sector body. In the event of the unauthorised re-use of non-personal data, the re-user shall, without delay, where appropriate with the assistance of the public sector body, inform the legal persons whose rights and interests may be affected.

Where the re-use of data cannot be allowed in accordance with the obligations laid down in paragraphs 3 and 4 of this Article and there is no legal basis for transmitting the data under Regulation (EU) 2016/679, the public sector body shall make best efforts, in accordance with Union and national law, to provide assistance to potential re-users in seeking consent of the data subjects or permission from the data holders whose rights and interests may be affected by such re-use, where it is feasible without a disproportionate burden on the public sector body. Where it provides such assistance, the public sector body may be assisted by the competent bodies referred to in Article 7(1).

Re-use of data shall be allowed only in compliance with intellectual property rights. The right of the maker of a database as provided for in Article 7(1) of Directive 96/9/EC shall not be exercised by public sector bodies in order to prevent the re-use of data or to restrict re-use beyond the limits set by this Regulation.

Where data requested is considered to be confidential, in accordance with Union or national law on commercial or statistical confidentiality, the public sector bodies shall ensure that the confidential data is not disclosed as a result of allowing re-use, unless such re-use is allowed in accordance with paragraph 6.

Where a re-user intends to transfer non-personal data protected on the grounds set out in Article 3(1) to a third country, it shall inform the public sector body of its intention to transfer such data and the purpose of such transfer at the time of requesting the re-use of such data. In the case of re-use in accordance with paragraph 6 of this Article, the re-user shall, where appropriate with the assistance of the public sector body, inform the legal person whose rights and interests may be affected of that intention, purpose and the appropriate safeguards. The public sector body shall not allow the re-use unless the legal person gives permission for the transfer.

Public sector bodies shall transmit non-personal confidential data or data protected by intellectual property rights to a re-user which intends to transfer those data to a third country other than a country designated in accordance with paragraph 12 only if the re-user contractually commits to:

1. (a)

   complying with the obligations imposed in accordance with paragraphs 7 and 8 even after the data is transferred to the third country; and

2. (b)

   accepting the jurisdiction of the courts or tribunals of the Member State of the transmitting public sector body with regard to any dispute related to compliance with paragraphs 7 and 8.

Public sector bodies shall, where relevant and to the extent of their capabilities, provide guidance and assistance to re-users in complying with the obligations referred to in paragraph 10 of this Article.

In order to assist public sector bodies and re-users, the Commission may adopt implementing acts establishing model contractual clauses for complying with the obligations referred to in paragraph 10 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(3).

Where justified because of the substantial number of requests across the Union concerning the re-use of non-personal data in specific third countries, the Commission may adopt implementing acts declaring that the legal, supervisory and enforcement arrangements of a third country:

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 33(3).

1. (a)

   ensure protection of intellectual property and trade secrets in a way that is essentially equivalent to the protection ensured under Union law;

2. (b)

   are being effectively applied and enforced; and

3. (c)

   provide effective judicial redress.

Specific Union legislative acts may deem certain non-personal data categories held by public sector bodies to be highly sensitive for the purposes of this Article where their transfer to third countries may put at risk Union public policy objectives, such as safety and public health or may lead to the risk of re-identification of non-personal, anonymised data. Where such an act is adopted, the Commission shall adopt delegated acts in accordance with Article 32 supplementing this Regulation by laying down special conditions applicable to the transfers of such data to third countries.

Those special conditions shall be based on the nature of the non-personal data categories identified in the specific Union legislative act and on the grounds for deeming those categories to be highly sensitive, taking into account the risks of re-identification of non-personal, anonymised data. They shall be non-discriminatory and limited to what is necessary to achieve the Union public policy objectives identified in that act, in accordance with the Union’s international obligations.

If required by specific Union legislative acts as referred to in the first subparagraph, such special conditions may include terms applicable for the transfer or technical arrangements in this regard, 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, in exceptional cases, restrictions with regard to transfers to third countries.

The natural or legal person to which the right to re-use non-personal data was granted may transfer the data only to those third countries for which the requirements in paragraphs 10, 12 and 13 are met.

Public sector bodies which allow re-use of the categories of data referred to in Article 3(1) may charge fees for allowing the re-use of such data.

Any fees charged pursuant to paragraph 1 shall be transparent, non-discriminatory, proportionate and objectively justified and shall not restrict competition.

Public sector bodies shall ensure that any fees can also be paid online through widely available cross-border payment services, without discrimination based on the place of establishment of the payment service provider, the place of issue of the payment instrument or the location of the payment account within the Union.

Where public sector bodies charge fees, they shall take measures to provide incentives for the re-use of the categories of data referred to in Article 3(1) for non-commercial purposes, such as scientific research purposes, and by SMEs and start-ups in accordance with State aid rules. In that regard, public sector bodies may also make the data available at a discounted fee or free of charge, in particular to SMEs and start-ups, civil society and educational establishments. To that end, public sector bodies may establish a list of categories of re-users to which data for re-use is made available at a discounted fee or free of charge. That list, together with the criteria used to establish it, shall be made public.

Any fees shall be derived from the costs related to conducting the procedure for requests for the re-use of the categories of data referred to in Article 3(1) and limited to the necessary costs in relation to:

1. (a)

   the reproduction, provision and dissemination of data;

2. (b)

   the clearance of rights;

3. (c)

   anonymisation or other forms of preparation of personal data and commercially confidential data as provided for in Article 5(3);

4. (d)

   the maintenance of the secure processing environment;

5. (e)

   the acquisition of the right to allow re-use in accordance with this Chapter by third parties outside the public sector; and

6. (f)

   assisting re-users in seeking consent from data subjects and permission from data holders whose rights and interests may be affected by such re-use.

The criteria and methodology for calculating fees shall be laid down by the Member States and published. The public sector body shall publish a description of the main categories of costs and the rules used for the allocation of costs.

For the purpose of carrying out the tasks referred to in this Article, each Member State shall designate one or more competent bodies, which may be competent for particular sectors, to assist the public sector bodies which grant or refuse access for the re-use of the categories of data referred to in Article 3(1). Member States may either establish one or more new competent bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions laid down in this Regulation.

The competent bodies may be empowered to grant access for the re-use of the categories of data referred to in Article 3(1) pursuant to Union or national law which provides for such access to be granted. Where they grant or refuse access for the re-use, Articles 4, 5, 6 and 9 shall apply to those competent bodies.

The competent bodies shall have adequate legal, financial, technical and human resources to carry out the tasks assigned to them, including the necessary technical knowledge to be able to comply with relevant Union or national law concerning the access regimes for the categories of data referred to in Article 3(1).

The assistance provided for in paragraph 1 shall include, where necessary:

1. (a)

   providing technical support by making available a secure processing environment for providing access for the re-use of data;

2. (b)

   providing guidance and technical support on how to best structure and store data to make that data easily accessible;

3. (c)

   providing technical support for pseudonymisation and ensuring data processing in a manner that effectively preserves the privacy, confidentiality, integrity and accessibility of the information contained in the data for which re-use is allowed, including techniques for the anonymisation, generalisation, suppression and randomisation of personal data or other state-of-the-art privacy-preserving methods, and the deletion of commercially confidential information, including trade secrets or content protected by intellectual property rights;

4. (d)

   assisting the public sector bodies, where relevant, to provide support to re-users in requesting consent for re-use from data subjects or permission from data holders in line with their specific decisions, including on the jurisdiction in which the data processing is intended to take place and assisting the public sector bodies in establishing technical mechanisms that allow the transmission of requests for consent or permission from re-users, where practically feasible;

5. (e)

   providing public sector bodies with assistance in assessing the adequacy of contractual commitments made by a re-user pursuant to Article 5(10).

Each Member State shall notify the Commission of the identity of the competent bodies designated pursuant to paragraph 1 by 24 September 2023. Each Member State shall also notify the Commission of any subsequent change to the identity of those competent bodies.

Member States shall ensure that all relevant information concerning the application of Articles 5 and 6 is available and easily accessible through a single information point. Member States shall establish a new body or designate an existing body or structure as the single information point. The single information point may be linked to sectoral, regional or local information points. The functions of the single information point may be automated provided that the public sector body ensures adequate support.

The single information point shall be competent to receive enquiries or requests for the re-use of the categories of data referred to in Article 3(1) and shall transmit them, where possible and appropriate by automated means, to the competent public sector bodies, or the competent bodies referred to in Article 7(1), where relevant. The single information point shall make available by electronic means a searchable 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, including at least the data format and size and the conditions for their re-use.

The single information point may establish a separate, simplified and well-documented information channel for SMEs and start-ups, addressing their needs and capabilities in requesting the re-use of the categories of data referred to in Article 3(1).

The Commission shall establish a European single access point offering a searchable electronic register of data available in the national single information points and further information on how to request data via those national single information points.

Unless shorter time limits have been established in accordance with national law, the competent public sector bodies or the competent bodies referred to in Article 7(1) shall adopt a decision on the request for the re-use of the categories of data referred to in Article 3(1) within two months of the date of receipt of the request.

In the case of exceptionally extensive and complex requests for re-use, that two-month period may be extended by up to 30 days. In such cases the competent public sector bodies or the competent bodies referred to in Article 7(1) shall notify the applicant as soon as possible that more time is needed for conducting the procedure, together with the reasons for the delay.

Any natural or legal person directly affected by a decision as referred to in paragraph 1 shall have an effective right of redress in the Member State where the relevant body is located. Such a right of redress shall be laid down in national law and shall include the possibility of review by an impartial body with the appropriate expertise, such as the national competition authority, the relevant access-to-documents authority, the supervisory authority established in accordance with Regulation (EU) 2016/679 or a national judicial authority, whose decisions are binding upon the public sector body or the competent body concerned.

intermediation services between data holders and potential data users, including making available the technical or other means to enable such services; those services may include bilateral or multilateral exchanges of data or the creation of platforms or databases enabling the exchange or joint use of data, as well as the establishment of other specific infrastructure for the interconnection of data holders with data users;

intermediation services between data subjects that seek to make their personal data available or natural persons that seek to make non-personal data available, and potential data users, including making available the technical or other means to enable such services, and in particular enabling the exercise of the data subjects’ rights provided in Regulation (EU) 2016/679;

services of data cooperatives.

Any data intermediation services provider who intends to provide the data intermediation services referred to in Article 10 shall submit a notification to the competent authority for data intermediation services.

For the purposes of this Regulation, a data intermediation services provider with establishments in more than one Member State shall be deemed to be under the jurisdiction of the Member State in which it has its main establishment, without prejudice to Union law regulating cross-border actions for damages and related proceedings.

A data intermediation services provider that is not established in the Union, but which offers the data intermediation services referred to in Article 10 within the Union, shall designate a legal representative in one of the Member States in which those services are offered.

For the purpose of ensuring compliance with this Regulation, the legal representative shall be mandated by the data intermediation services provider to be addressed in addition to or instead of it by competent authorities for data intermediation services or data subjects and data holders, with regard to all issues related to the data intermediation services provided. The legal representative shall cooperate with and comprehensively demonstrate to the competent authorities for data intermediation services, upon request, the actions taken and provisions put in place by the data intermediation services provider to ensure compliance with this Regulation.

The data intermediation services provider shall be deemed to be under the jurisdiction of the Member State in which the legal representative is located. The designation of a legal representative by the data intermediation services provider shall be without prejudice to any legal actions which could be initiated against the data intermediation services provider.

After having submitted a notification in accordance with paragraph 1, the data intermediation services provider may start the activity subject to the conditions laid down in this Chapter.

The notification referred to in paragraph 1 shall entitle the data intermediation services provider to provide data intermediation services in all Member States.

The notification referred to in paragraph 1 shall include the following information:

1. (a)

   the name of the data intermediation services provider;

2. (b)

   the data intermediation services provider’s legal status, form, ownership structure, relevant subsidiaries and, where the data intermediation services provider is registered in a trade or other similar public national register, registration number;

3. (c)

   the address of the data intermediation services provider’s main establishment in the Union, if any, and, where applicable, of any secondary branch in another Member State or that of the legal representative;

4. (d)

   a public website where complete and up-to-date information on the data intermediation services provider and the activities can be found, including as a minimum the information referred to in points (a), (b), (c) and (f);

5. (e)

   the data intermediation services provider’s contact persons and contact details;

6. (f)

   a description of the data intermediation service the data intermediation services provider intends to provide, and an indication of the categories listed in Article 10 under which such data intermediation service falls;

7. (g)

   the estimated date for starting the activity, if different from the date of the notification.

The competent authority for data intermediation services shall ensure that the notification procedure is non-discriminatory and does not distort the competition.

At the request of the data intermediation services provider, the competent authority for data intermediation services shall, within one week of a duly and fully completed notification, issue a standardised declaration, confirming that the data intermediation services provider has submitted the notification referred to in paragraph 1 and that the notification contains the information referred to in paragraph 6.

At the request of the data intermediation services provider, the competent authority for data intermediation services shall confirm that the data intermediation services provider complies with this Article and Article 12. Upon receipt of such a confirmation, that data intermediation services provider may use the label ‘data intermediation services provider recognised in the Union’ in its written and spoken communication, as well as a common logo.

In order to ensure that data intermediation services providers recognised in the Union are easily identifiable throughout the Union, the Commission shall, by means of implementing acts, establish a design for the common logo. Data intermediation services providers recognised in the Union shall display the common logo clearly on every online and offline publication that relates to their data intermediation activities.

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 33(2).

The competent authority for data intermediation services shall notify the Commission of each new notification by electronic means without delay. The Commission shall keep and regularly update a public register of all data intermediation services providers providing their services in the Union. The information referred to in paragraph 6, points (a), (b), (c), (d), (f) and (g), shall be published in the public register.

The competent authority for data intermediation services may charge fees for the notification in accordance with national law. Such fees shall be proportionate and objective and be based on the administrative costs related to the monitoring of compliance and other market control activities of the competent authority for data intermediation services in relation to notifications of data intermediation services providers. In the case of SMEs and start-ups, the competent authority for data intermediation services may charge a discounted fee or waive the fee.

Data intermediation services providers shall notify the competent authority for data intermediation services of any changes to the information provided pursuant to paragraph 6 within 14 days of the date of the change.

Where a data intermediation services provider ceases its activities, it shall notify the relevant competent authority for data intermediation services determined pursuant to paragraphs 1, 2 and 3 within 15 days.

The competent authority for data intermediation services shall notify the Commission of each notification referred to in paragraphs 12 and 13 by electronic means without delay. The Commission shall update the public register of the data intermediation services providers in the Union accordingly.

the data intermediation services provider shall not use the data for which it provides data intermediation services for purposes other than to put them at the disposal of data users and shall provide data intermediation services through a separate legal person;

the commercial terms, including pricing, for the provision of data intermediation services to a data holder or data user shall not be dependent upon whether the data holder or data user uses other services 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;

the data collected with respect to any activity of a natural or legal person for the purpose of the provision of the data intermediation service, including the date, time and geolocation data, duration of activity and connections to other natural or legal persons established by the person who uses the data intermediation service, shall be used only for the development of that data intermediation service, which may entail the use of data for the detection of fraud or cybersecurity, and shall be made available to the data holders upon request;

the data intermediation services provider shall facilitate the exchange of the data in the format in which it receives it from a data subject or a data holder, shall convert the data into specific formats only to enhance interoperability within and across sectors or if requested by the data user or where mandated by Union law or to ensure harmonisation with international or European data standards and shall offer an opt-out possibility regarding those conversions to data subjects or data holders, unless the conversion is mandated by Union law;

data intermediation services may include offering 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, such tools being used only at the explicit request or approval of the data holder or data subject and third-party tools offered in that context not being used for other purposes;

the data intermediation services provider shall ensure that the procedure for access to its service is fair, transparent and non-discriminatory for both data subjects and data holders, as well as for data users, including with regard to prices and terms of service;

the data intermediation services provider shall have procedures in place to prevent fraudulent or abusive practices in relation to parties seeking access through its data intermediation services;

the data intermediation services provider shall, in the event of its insolvency, ensure a reasonable continuity of the provision of its data intermediation services and, where such data intermediation services ensure the storage of data, shall have mechanisms in place to allow data holders and data users to obtain access to, to transfer or to retrieve their data and, where such data intermediation services are provided between data subjects and data users, to allow data subjects to exercise their rights;

the data intermediation services provider shall take appropriate measures to ensure interoperability with other data intermediation services, inter alia, by means of commonly used open standards in the sector in which the data intermediation services provider operates;

the data intermediation services provider shall put in place adequate technical, legal and organisational measures in order to prevent the transfer of or access to non-personal data that is unlawful under Union law or the national law of the relevant Member State;

the data intermediation services provider shall without delay inform data holders in the event of an unauthorised transfer, access or use of the non-personal data that it has shared;

the data intermediation services provider shall take necessary measures to ensure an appropriate level of security for the storage, processing and transmission of non-personal data, and the data intermediation services provider shall further ensure the highest level of security for the storage and transmission of competitively sensitive information;

the data intermediation services provider offering services to data subjects shall act in the data subjects’ best interest where it facilitates the exercise of their rights, in particular by informing and, where appropriate, advising data subjects in a concise, transparent, intelligible and easily accessible manner about intended data uses by data users and standard terms and conditions attached to such uses before data subjects give consent;

where a data intermediation services provider provides tools for obtaining consent from data subjects or permissions to process data made available by data holders, it shall, where relevant, specify the third-country jurisdiction in which the data use is intended to take place and provide data subjects with tools to both give and withdraw consent and data holders with tools to both give and withdraw permissions to process data;

the data intermediation services provider shall maintain a log record of the data intermediation activity.

Each Member State shall designate one or more competent authorities to carry out the tasks related to the notification procedure for data intermediation services and shall notify the Commission of the identity of those competent authorities by 24 September 2023. Each Member State shall also notify the Commission of any subsequent change to the identity of those competent authorities.

The competent authorities for data intermediation services shall comply with the requirements set out in Article 26.

The powers of the competent authorities for data intermediation services are without prejudice to the powers of the data protection authorities, national competition authorities, authorities in charge of cybersecurity and other relevant sectoral authorities. In accordance with their respective competences under Union and national law, those authorities shall establish strong cooperation and exchange information as is necessary for the exercise of their tasks in relation to data intermediation services providers, and shall aim to achieve consistency in the decisions taken in applying this Regulation.

The competent authorities for data intermediation services shall monitor and supervise compliance of data intermediation services providers with the requirements of this Chapter. The competent authorities for data intermediation services may also monitor and supervise the compliance of data intermediation services providers, on the basis of a request by a natural or legal person.

The competent authorities for data intermediation services shall have the power to request from data intermediation services providers or their legal representatives all the information that is necessary to verify compliance with the requirements of this Chapter. Any request for information shall be proportionate to the performance of the task and shall be reasoned.

Where the competent authority for data intermediation services finds that a data intermediation services provider does not comply with one or more of the requirements of this Chapter, it shall notify that data intermediation services provider of those findings and give it the opportunity to state its views, within 30 days of the receipt of the notification.

The competent authority for data intermediation services shall have the power to require the cessation of the infringement referred to in paragraph 3 within a reasonable time limit or immediately in the case of a serious infringement and shall take appropriate and proportionate measures with the aim of ensuring compliance. In that regard, the competent authority for data intermediation services shall have the power, where appropriate:

The competent authority for data intermediation services shall request the Commission to remove the data intermediation services provider from the register of data intermediation services providers once it has ordered the cessation of the provision of the data intermediation service in accordance with the first subparagraph, point (c).

If a data intermediation services provider remedies infringements, that data intermediation services provider shall re-notify the competent authority for data intermediation services. The competent authority for data intermediation services shall notify the Commission of each new re-notification.

1. (a)

   to impose, through administrative procedures, dissuasive financial penalties, which may include periodic penalties and penalties with retroactive effect, to initiate legal proceedings for the imposition of fines, or both;

2. (b)

   to require a postponement of the commencement or a suspension of the provision of the data intermediation service until any changes to the conditions requested by the competent authority for data intermediation services have been made; or

3. (c)

   to require the cessation of the provision of the data intermediation service in the event that serious or repeated infringements have not been remedied despite prior notification in accordance with paragraph 3.

Where a data intermediation services provider that is not established in the Union fails to designate a legal representative or the legal representative fails, upon request of the competent authority for data intermediation services, to provide the necessary information that comprehensively demonstrates compliance with this Regulation, the competent authority for data intermediation services shall have the power to postpone the commencement of or to suspend the provision of the data intermediation service until the legal representative is designated or the necessary information is provided.

The competent authorities for data intermediation services shall notify the data intermediation services provider concerned of the measures imposed pursuant to paragraphs 4 and 5 and the reasons on which they are based, as well as the necessary steps to be taken to rectify the relevant shortcomings, without delay, and shall stipulate a reasonable period, which shall not be longer than 30 days, for the data intermediation services provider to comply with those measures.

If a data intermediation services provider has its main establishment or its legal representative in a Member State but provides services in other Member States, the competent authority for data intermediation services of the Member State of the main establishment or where the legal representative is located and the competent authorities for data intermediation services of those other Member States shall cooperate and assist each other. Such assistance and cooperation may cover information exchanges between the competent authorities for data intermediation services concerned for the purposes of their tasks under this Regulation and reasoned requests to take the measures referred to in this Article.

Where a competent authority for data intermediation services in one Member State requests assistance from a competent authority for data intermediation services in another Member State, it shall submit a reasoned request. The competent authority for data intermediation services shall, upon such a request, provide a response without delay and within a timeframe proportionate to the urgency of the request.

Any information exchanged in the context of assistance requested and provided under this paragraph shall be used only in respect of the matter for which it was requested.

Each competent authority for the registration of data altruism organisations shall keep and regularly update a public national register of recognised data altruism organisations.

The Commission shall maintain a public Union register of recognised data altruism organisations for information purposes. Provided that an entity is registered in the public national register of recognised data altruism organisations in accordance with Article 18, it may use the label ‘data altruism organisation recognised in the Union’ in its written and spoken communication, as well as a common logo.

In order to ensure that recognised data altruism organisations are easily identifiable throughout the Union, the Commission shall, by means of implementing acts, establish a design for the common logo. Recognised data altruism organisations shall display the common logo clearly on every online and offline publication that relates to their data altruism activities. The common logo shall be accompanied by a QR code with a link to the public Union register of recognised data altruism organisations.

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 33(2).

carry out data altruism activities;

be a legal person established pursuant to national law to meet objectives of general interest as provided for in national law, where applicable;

operate on a not-for-profit basis and be legally independent from any entity that operates on a for-profit basis;

carry out its data altruism activities through a structure that is functionally separate from its other activities;

comply with the rulebook referred to Article 22(1), at the latest 18 months after the date of entry into force of the delegated acts referred to in that paragraph.

An entity which meets the requirements of Article 18 may submit an application for registration in the public national register of recognised data altruism organisations in the Member State in which it is established.

An entity which meets the requirements of Article 18 and has establishments in more than one Member State may submit an application for registration in the public national register of recognised data altruism organisations in the Member State in which it has its main establishment.

An entity which meets the requirements of Article 18 but which is not established in the Union shall designate a legal representative in one of the Member States in which the data altruism services are offered.

For the purpose of ensuring compliance with this Regulation, the legal representative shall be mandated by the entity to be addressed in addition to or instead of it by competent authorities for the registration of data altruism organisations or data subjects and data holders, with regard to all issues related to that entity. The legal representative shall cooperate with and comprehensively demonstrate to the competent authorities for the registration of data altruism organisations, upon request, the actions taken and provisions put in place by the entity to ensure compliance with this Regulation.

The entity shall be deemed to be under the jurisdiction of the Member State in which the legal representative is located. Such an entity may submit an application for registration in the public national register of recognised data altruism organisations in that Member State. The designation of a legal representative by the entity shall be without prejudice to any legal actions which could be initiated against the entity.

Applications for registration referred to in paragraphs 1, 2 and 3 shall contain the following information:

1. (a)

   the name of the entity;

2. (b)

   the entity’s legal status, form and, where the entity is registered in a public national register, registration number;

3. (c)

   the statutes of the entity, where appropriate;

4. (d)

   the entity’s sources of income;

5. (e)

   the address of the entity’s main establishment in the Union, if any, and, where applicable, any secondary branch in another Member State or that of the legal representative;

6. (f)

   a public website where complete and up-to-date information on the entity and the activities can be found, including as a minimum the information referred to in points (a), (b), (d), (e) and (h);

7. (g)

   the entity’s contact persons and contact details;

8. (h)

   the objectives of general interest it intends to promote when collecting data;

9. (i)

   the nature of the data that the entity intends to control or process, and, in the case of personal data, an indication of the categories of personal data;

10. (j)

    any other documents which demonstrate that the requirements of Article 18 are met.

Where the entity has submitted all necessary information pursuant to paragraph 4 and after the competent authority for the registration of data altruism organisations has evaluated the application for registration and found that the entity complies with the requirements of Article 18, it shall register the entity in the public national register of recognised data altruism organisations within 12 weeks after the receipt of the application for registration. The registration shall be valid in all Member States.

The competent authority for the registration of data altruism organisations shall notify the Commission of any registration. The Commission shall include that registration in the public Union register of recognised data altruism organisations.

The information referred to in paragraph 4, points (a), (b), (f), (g) and (h), shall be published in the relevant public national register of recognised data altruism organisations.

A recognised data altruism organisation shall notify the relevant competent authority for the registration of data altruism organisations of any changes to the information provided pursuant to paragraph 4 within 14 days of the date of the change.

The competent authority for the registration of data altruism organisations shall notify the Commission of each such notification by electronic means without delay. Based on such a notification, the Commission shall update the public Union register of recognised data altruism organisations without delay.

A recognised data altruism organisation shall keep full and accurate records concerning:

1. (a)

   all natural or legal persons that were given the possibility to process data held by that recognised data altruism organisation, and their contact details;

2. (b)

   the date or duration of the processing of personal data or use of non-personal data;

3. (c)

   the purpose of the processing as declared by the natural or legal person that was given the possibility of processing;

4. (d)

   the fees paid by natural or legal persons processing the data, if any.

A recognised data altruism organisation shall draw up and transmit to the relevant competent authority for the registration of data altruism organisations an annual activity report which shall contain at least the following:

1. (a)

   information on the activities of the recognised data altruism organisation;

2. (b)

   a description of the way in which the objectives of general interest for which data was collected have been promoted during the given financial year;

3. (c)

   a list of all natural and legal persons that were allowed to process data it holds, including a summary description of the objectives of general interest pursued by such data processing and the description of the technical means used for it, including a description of the techniques used to preserve privacy and data protection;

4. (d)

   a summary of the results of the data processing allowed by the recognised data altruism organisation, where applicable;

5. (e)

   information on sources of revenue of the recognised data altruism organisation, in particular all revenue from allowing access to the data, and on expenditure.

A recognised data altruism organisation shall inform data subjects or data holders prior to any processing of their data in a clear and easily comprehensible manner of:

1. (a)

   the objectives of general interest and, if applicable, the specified, explicit and legitimate purpose for which personal data is to be processed, and for which it permits the processing of their data by a data user;

2. (b)

   the location of and the objectives of general interest for which it permits any processing carried out in a third country, where the processing is carried out by the recognised data altruism organisation.

The recognised data altruism organisation shall not use the data for other objectives than those of general interest for which the data subject or data holder allows the processing. The recognised data altruism organisation shall not use misleading marketing practices to solicit the provision of data.

The recognised data altruism organisation shall provide tools for obtaining consent from data subjects or permissions to process data made available by data holders. The recognised data altruism organisation shall also provide tools for easy withdrawal of such consent or permission.

The recognised data altruism organisation shall take measures to ensure an appropriate level of security for the storage and processing of non-personal data that it has collected based on data altruism.

The recognised data altruism organisation shall, without delay, inform data holders in the event of any unauthorised transfer, access or use of the non-personal data that it has shared.

Where the recognised data altruism organisation facilitates data processing by third parties, including by providing tools for obtaining consent from data subjects or permissions to process data made available by data holders, it shall, where relevant, specify the third-country jurisdiction in which the data use is intended to take place.

The Commission shall adopt delegated acts in accordance with Article 32, supplementing this Regulation by establishing a rulebook laying down:

1. (a)

   appropriate information requirements to ensure that data subjects and data holders are provided, before a consent or permission for data altruism is given, with sufficiently detailed, clear and transparent information regarding the use of data, the tools for giving and withdrawing consent or permission, and the measures taken to avoid misuse of the data shared with the data altruism organisation;

2. (b)

   appropriate technical and security requirements to ensure the appropriate level of security for the storage and processing of data, as well as for the tools for giving and withdrawing consent or permission;

3. (c)

   communication roadmaps taking a multi-disciplinary approach to raise awareness of data altruism, of the designation as a ‘data altruism organisation recognised in the Union’ and of the rulebook among relevant stakeholders, in particular data holders and data subjects that would potentially share their data;

4. (d)

   recommendations on relevant interoperability standards.

The rulebook referred to in paragraph 1 shall be prepared in close cooperation with data altruism organisations and relevant stakeholders.

Each Member State shall designate one or more competent authorities responsible for its public national register of recognised data altruism organisations.

The competent authorities for the registration of data altruism organisations shall comply with the requirements set out in Article 26.

Each Member State shall notify the Commission of the identity of their competent authorities for the registration of data altruism organisations by 24 September 2023. Each Member State shall also notify the Commission of any subsequent change to the identity of those competent authorities.

The competent authority for the registration of data altruism organisations of a Member State shall undertake its tasks in cooperation with the relevant data protection authority, where such tasks are related to processing of personal data, and with relevant sectoral authorities of that Member State.

The competent authorities for the registration of data altruism organisations shall monitor and supervise compliance of recognised data altruism organisations with the requirements laid down in this Chapter. The competent authority for the registration of data altruism organisations may also monitor and supervise the compliance of such recognised data altruism organisations, on the basis of a request by a natural or legal person.

The competent authorities for the registration of data altruism organisations shall have the power to request information from recognised data altruism organisations that is necessary to verify compliance with the requirements of this Chapter. Any request for information shall be proportionate to the performance of the task and shall be reasoned.

Where the competent authority for the registration of data altruism organisations finds that a recognised data altruism organisation does not comply with one or more of the requirements of this Chapter, it shall notify the recognised data altruism organisation of those findings and give it the opportunity to state its views within 30 days of the receipt of the notification.

The competent authority for the registration of data altruism organisations shall have the power to require the cessation of the infringement referred to in paragraph 3 either immediately or within a reasonable time limit and shall take appropriate and proportionate measures with the aim of ensuring compliance.

If a recognised data altruism organisation does not comply with one or more of the requirements of this Chapter even after having been notified in accordance with paragraph 3 by the competent authority for the registration of data altruism organisations, that recognised data altruism organisation shall:

Any decision revoking the right to use the label ‘data altruism organisation recognised in the Union’ under the first subparagraph, point (a), shall be made public by the competent authority for the registration of data altruism organisations.

1. (a)

   lose its right to use the label ‘data altruism organisation recognised in the Union’ in any written and spoken communication;

2. (b)

   be removed from the relevant public national register of recognised data altruism organisations and the public Union register of recognised data altruism organisations.

If a recognised data altruism organisation has its main establishment or its legal representative in a Member State but is active in other Member States, the competent authority for the registration of data altruism organisations of the Member State of the main establishment or where the legal representative is located and the competent authorities for the registration of data altruism organisations of those other Member States shall cooperate and assist each other. Such assistance and cooperation may cover information exchanges between the competent authorities for the registration of data altruism organisations concerned for the purposes of their tasks under this Regulation and reasoned requests to take the measures referred to in this Article.

Where a competent authority for the registration of data altruism organisations in one Member State requests assistance from a competent authority for the registration of data altruism organisations in another Member State, it shall submit a reasoned request. The competent authority for the registration of data altruism organisations shall, upon such a request, provide a response without delay and within a timeframe proportionate to the urgency of the request.

Any information exchanged in the context of assistance requested and provided under this paragraph shall be used only in respect of the matter for which it was requested.

In order to facilitate the collection of data based on data altruism, the Commission shall adopt implementing acts establishing and developing a European data altruism consent form, after consulting the European Data Protection Board, taking into account the advice of the European Data Innovation Board and duly involving relevant stakeholders. The form shall allow the collection of consent or permission across Member States in a uniform format. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 33(2).

The European data altruism consent form shall use a modular approach allowing customisation for specific sectors and for different purposes.

Where personal data are provided, the European data altruism consent form shall ensure that data subjects are able to give consent to and withdraw consent from a specific data processing operation in compliance with the requirements of Regulation (EU) 2016/679.

The form shall be available in a manner that can be printed on paper and is easily understandable as well as in an electronic, machine-readable form.

The competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations shall be legally distinct from, and functionally independent of, any data intermediation services provider or recognised data altruism organisation. The functions of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations may be carried out by the same authority. Member States may either establish one or more new authorities for those purposes or rely on existing ones.

Competent authorities for data intermediation services and competent authorities for the registration of data altruism organisations shall exercise their tasks in an impartial, transparent, consistent, reliable and timely manner. Where they exercise their tasks, they shall safeguard fair competition and non-discrimination.

The top-level management and personnel responsible for carrying out the relevant tasks of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the services which they evaluate, nor the authorised representative of any of those parties. This shall not preclude the use of evaluated services that are necessary for the operations of the competent authority for data intermediation services and the competent authority for the registration of data altruism organisations or the use of such services for personal purposes.

The top-level management and personnel of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations shall not engage in any activity that may conflict with their independence of judgment or integrity in relation to evaluation activities assigned to them.

The competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations shall have at their disposal the adequate financial and human resources to carry out the tasks assigned to them, including the necessary technical knowledge and resources.

The competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations of a Member State shall provide the Commission and competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations from other Member States, on reasoned request and without delay, with the information necessary to carry out their tasks under this Regulation. Where a competent authority for data intermediation services or a competent authority for the registration of data altruism organisations considers the information requested to be confidential in accordance with Union and national law on commercial and professional confidentiality, the Commission and any other competent authorities for data intermediation services or competent authorities for the registration of data altruism organisations concerned shall ensure such confidentiality.

Natural and legal persons shall have the right to lodge a complaint in relation to any matter falling within the scope of this Regulation, individually or, where relevant, collectively, with the relevant competent authority for data intermediation services against a data intermediation services provider or with the relevant competent authority for the registration of data altruism organisations against a recognised data altruism organisation.

The competent authority for data intermediation services or the competent authority for the registration of data altruism organisations with which the complaint has been lodged shall inform the complainant of:

1. (a)

   the progress of the proceedings and of the decision taken; and

2. (b)

   the judicial remedies provided for in Article 28.

Notwithstanding any administrative or other non-judicial remedies, any affected natural and legal persons shall have the right to an effective judicial remedy with regard to legally binding decisions referred to in Article 14 taken by the competent authorities for data intermediation services in the management, control and enforcement of the notification regime for data intermediation services providers and legally binding decisions referred to in Articles 19 and 24 taken by the competent authorities for the registration of data altruism organisations in the monitoring of recognised data altruism organisations.

Proceedings pursuant to this Article shall be brought before the courts or tribunals of the Member State of the competent authority for data intermediation services or the competent authority for the registration of data altruism organisations against which the judicial remedy is sought individually or, where relevant, collectively by the representatives of one or more natural or legal persons.

Where a competent authority for data intermediation services or a competent authority for the registration of data altruism organisations fails to act on a complaint, any affected natural and legal persons shall, in accordance with national law, either have the right to an effective judicial remedy or access to review by an impartial body with the appropriate expertise.

The Commission shall establish a European Data Innovation Board in the form of an expert group, consisting 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, 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. In its appointments of individual experts, the Commission shall aim to achieve gender and geographical balance among the members of the expert group.

The European Data Innovation Board shall consist of at least the following three subgroups:

1. (a)

   a subgroup composed of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations, with a view to carrying out the tasks pursuant to Article 30, points (a), (c), (j) and (k);

2. (b)

   a subgroup for technical discussions on standardisation, portability and interoperability pursuant to Article 30, points (f) and (g);

3. (c)

   a subgroup for stakeholder involvement composed of relevant representatives from industry, research, academia, civil society, standardisation organisations, relevant common European data spaces and other relevant stakeholders and third parties advising the European Data Innovation Board on tasks pursuant to Article 30, points (d), (e), (f), (g) and (h).

The Commission shall chair the meetings of the European Data Innovation Board.

The European Data Innovation Board shall be assisted by a secretariat provided by the Commission.

to advise and assist the Commission with regard to developing a consistent practice of public sector bodies and competent bodies referred to in Article 7(1) in handling requests for the re-use of the categories of data referred to in Article 3(1);

to advise and assist the Commission with regard to developing a consistent practice for data altruism across the Union;

to advise and assist the Commission with regard to developing a consistent practice of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations in the application of requirements applicable to data intermediation services providers and recognised data altruism organisations;

to advise and assist the Commission with regard to developing consistent guidelines on how to best protect, in the context of this Regulation, commercially sensitive non-personal data, in particular trade secrets, but also non-personal data representing content protected by intellectual property rights from unlawful access that risks intellectual property theft or industrial espionage;

to advise and assist the Commission with regard to developing consistent guidelines for cybersecurity requirements for the exchange and storage of data;

to advise the Commission, in particular taking into account the input from standardisation organisations, on the prioritisation of cross-sector standards to be used and developed for data use and cross-sector data sharing between emerging common European data spaces, cross-sectoral comparison and exchange of best practices with regard to sectoral requirements for security and access procedures, taking into account sector-specific standardisation activities, in particular clarifying and distinguishing which standards and practices are cross-sectoral and which are sectoral;

to assist the Commission, in particular taking into account the input from standardisation organisations, in addressing fragmentation of the internal market and the data economy in the internal market by enhancing cross-border, cross-sector interoperability of data as well as data sharing services between different sectors and domains, building on existing European, international or national standards, inter alia with the aim of encouraging the creation of common European data spaces;

to propose guidelines for 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, such common standards and practices taking into account existing standards, complying with the competition rules and ensuring non-discriminatory access to all participants, for the purpose of facilitating data sharing in the Union and reaping the potential of existing and future data spaces, addressing, inter alia:

1. (i)

   cross-sectoral standards to be used and developed for data use and cross-sector data sharing, cross-sectoral comparison and exchange of best practices with regard to sectoral requirements for security and access procedures, taking into account sector-specific standardisation activities, in particular clarifying and distinguishing which standards and practices are cross-sectoral and which are sectoral;

2. (ii)

   requirements to counter barriers to market entry and to avoid lock-in effects, for the purpose of ensuring fair competition and interoperability;

3. (iii)

   adequate protection for lawful data transfers to third countries, including safeguards against any transfers prohibited by Union law;

4. (iv)

   adequate and non-discriminatory representation of relevant stakeholders in the governance of common European data spaces;

5. (v)

   adherence to cybersecurity requirements in accordance with Union law;

to facilitate cooperation between Member States with regard to setting harmonised conditions allowing for the re-use of the categories of data referred to in Article 3(1) held by public sector bodies across the internal market;

to facilitate cooperation between competent authorities for data intermediation services and competent authorities for the registration of data altruism organisations through capacity-building and the exchange of information, in particular by establishing methods for the efficient exchange of information relating to the notification procedure for data intermediation services providers and the registration and monitoring of recognised data altruism organisations, including coordination with regard to the setting of fees or penalties, as well as facilitate cooperation between competent authorities for data intermediation services and competent authorities for the registration of data altruism organisations with regard to international access and transfer of data;

to advise and assist the Commission with regard to evaluating whether the implementing acts referred to in Article 5(11) and (12) are to be adopted;

to advise and assist the Commission with regard to developing the European data altruism consent form in accordance with Article 25(1);

to advise the Commission on improving the international regulatory environment for non-personal data, including standardisation.

The public sector body, the natural or legal person to which the right to re-use data was granted under Chapter II, the data intermediation services provider or the recognised data altruism organisation shall take all reasonable technical, legal and organisational measures, including contractual arrangements, in order to prevent international transfer or governmental access to non-personal data held in the Union where such transfer or access would create a conflict with Union law or the national law of the relevant Member State, without prejudice to paragraph 2 or 3.

Any decision or judgment of a third-country court or tribunal and any decision of a third-country administrative authority requiring a public sector body, a natural or legal person to which the right to re-use data was granted under Chapter II, a data intermediation services provider or recognised data altruism organisation to transfer or give access to non-personal data within the scope of this Regulation held in the Union shall be recognised or enforceable in any manner only if based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or any such agreement between the requesting third country and a Member State.

In the absence of an international agreement as referred to in paragraph 2 of this Article, where a public sector body, a natural or legal person to which the right to re-use data was granted under Chapter II, a data intermediation services provider or recognised data altruism organisation is the addressee of a decision or judgment of a third-country court or tribunal or a decision of a third-country administrative authority to transfer or give access to non-personal data within the scope of this Regulation held in the Union and compliance with such a decision would risk putting the addressee in conflict with Union law or with the national law of the relevant Member State, transfer to or access to such data by that third-country authority shall take place only where:

1. (a)

   the third-country system requires the reasons and proportionality of such a decision or judgment to be set out and requires such a decision or judgment to be specific in character, for instance by establishing a sufficient link to certain suspected persons or infringements;

2. (b)

   the reasoned objection of the addressee is subject to a review by a competent third-country court or tribunal; and

3. (c)

   the competent third-country court or tribunal issuing the decision or judgment or reviewing the decision of an administrative authority is empowered under the law of that third country to take duly into account the relevant legal interests of the provider of the data protected under Union law or the national law of the relevant Member State.

If the conditions laid down in paragraph 2 or 3 are met, the public sector body, the natural or legal person to which the right to re-use data was granted under Chapter II, the data intermediation services provider or the recognised data altruism organisation shall provide the minimum amount of data permissible in response to a request, based on a reasonable interpretation of the request.

The public sector body, the natural or legal person to which the right to re-use data was granted under Chapter II, the data intermediation services provider and the recognised data altruism organisation shall inform the data holder about the existence of a request of a third-country administrative authority to access its data before complying with that request, except where the request serves law enforcement purposes and for as long as this is necessary to preserve the effectiveness of the law enforcement activity.

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

The power to adopt delegated acts referred to in Article 5(13) and Article 22(1) shall be conferred on the Commission for an indeterminate period of time from 23 June 2022.

The delegation of power referred to in Article 5(13) and Article 22(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

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

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

A delegated act adopted pursuant to Article 5(13) or Article 22(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.

The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Member States shall lay down the rules on penalties applicable to infringements of the obligations regarding transfers of non-personal data to third countries pursuant to Article 5(14) and Article 31, the notification obligation of data intermediation services providers pursuant to Article 11, the conditions for providing data intermediation services pursuant to Article 12 and the conditions for the registration as a recognised data altruism organisation pursuant to Articles 18, 20, 21 and 22, and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. In their rules on penalties, Member States shall take into account the recommendations of the European Data Innovation Board. Member States shall, by 24 September 2023, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

Member States shall take into account the following non-exhaustive and indicative criteria for the imposition of penalties on data intermediation services providers and recognised data altruism organisations for infringements of this Regulation, where appropriate:

1. (a)

   the nature, gravity, scale and duration of the infringement;

2. (b)

   any action taken by the data intermediation services provider or recognised data altruism organisation to mitigate or remedy the damage caused by the infringement;

3. (c)

   any previous infringements by the data intermediation services provider or recognised data altruism organisation;

4. (d)

   the financial benefits gained or losses avoided by the data intermediation services provider or recognised data altruism organisation due to the infringement, insofar as such benefits or losses can be reliably established;

5. (e)

   any other aggravating or mitigating factors applicable to the circumstances of the case.

the application and functioning of the rules on penalties laid down by the Member States pursuant to Article 34;

the level of compliance of the legal representatives of data intermediation services providers and recognised data altruism organisations that are not established in the Union with this Regulation and the level of enforceability of penalties imposed on those providers and organisations;

the type of data altruism organisations registered under Chapter IV and an overview of the objectives of general interests for which data are shared in view of establishing clear criteria in that respect.

Procedures