Digital Omnibus — September Presidency compromise

This Regulation lays down harmonised rules, inter alia, on:

1. (a)

   the making available of product data and related service data to the user of the connected product or related service;

2. (b)

   the making available of data by data holders to data recipients;

3. (c)

   the making available of data by data holders to public sector bodies, the Commission, the European Central Bank and Union bodies, where there is an exceptional need for those data for the performance of a specific task carried out in the public interest;

4. (d)

   facilitating switching between data processing services;

5. (e)

   introducing safeguards against unlawful third-party access to non-personal data; and

6. (f)

   the development of interoperability standards for data to be accessed, transferred and used.

This Regulation covers personal and non-personal data, including the following types of data, in the following contexts:

1. (a)

   Chapter II applies to data, with the exception of content, concerning the performance, use and environment of connected products and related services;

2. (b)

   Chapter III applies to any private sector data that is subject to statutory data sharing obligations;

3. (c)

   Chapter IV applies to any private sector data accessed and used on the basis of contract between enterprises;

4. (d)

   Chapter V applies to any private sector data with a focus on non-personal data;

5. (e)

   Chapter VI applies to any data and services processed by providers of data processing services;

6. (f)

   Chapter VII applies to any non-personal data held in the Union by providers of data processing services.

This Regulation applies to:

1. (a)

   manufacturers of connected products placed on the market in the Union and providers of related services, irrespective of the place of establishment of those manufacturers and providers;

2. (b)

   users in the Union of connected products or related services as referred to in point (a);

3. (c)

   data holders, irrespective of their place of establishment, that make data available to data recipients in the Union;

4. (d)

   data recipients in the Union to whom data are made available;

5. (e)

   public sector bodies, the Commission, the European Central Bank and Union bodies that request data holders to make data available where there is an exceptional need for those data for the performance of a specific task carried out in the public interest and to the data holders that provide those data in response to such request;

6. (f)

   providers of data processing services, irrespective of their place of establishment, providing such services to customers in the Union;

7. (g)

   participants in data spaces and vendors of applications using smart contracts and persons whose trade, business or profession involves the deployment of smart contracts for others in the context of executing an agreement.

Where this Regulation refers to connected products or related services, such references are also understood to include virtual assistants insofar as they interact with a connected product or related service.

This Regulation is without prejudice to Union and national law on the protection of personal data, privacy and confidentiality of communications and integrity of terminal equipment, which shall apply to personal data processed in connection with the rights and obligations laid down herein, in particular Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive 2002/58/EC, including the powers and competences of supervisory authorities and the rights of data subjects. Insofar as users are data subjects, the rights laid down in Chapter II of this Regulation shall complement the rights of access by data subjects and rights to data portability under Articles 15 and 20 of Regulation (EU) 2016/679. In the event of a conflict between this Regulation and Union law on the protection of personal data or privacy, or national legislation adopted in accordance with such Union law, the relevant Union or national law on the protection of personal data or privacy shall prevail.

This Regulation does not apply to or pre-empt voluntary arrangements for the exchange of data between private and public entities, in particular voluntary arrangements for data sharing.

This Regulation does not affect Union or national legal acts providing for the sharing of, access to and the use of data for the purpose of the prevention, investigation, detection or prosecution of criminal offences or for the execution of criminal penalties, or for customs and taxation purposes, in particular Regulations (EU) 2021/784, (EU) 2022/2065 and (EU) 2023/1543 and Directive (EU) 2023/1544, or international cooperation in that area. This Regulation does not apply to the collection or sharing of, access to or the use of data under Regulation (EU) 2015/847 and Directive (EU) 2015/849. This Regulation does not apply to areas that fall outside the scope of Union law and in any event does not affect the competences of the Member States concerning public security, defence or national security, regardless of the type of entity entrusted by the Member States to carry out tasks in relation to those competences, or their power to safeguard other essential State functions, including ensuring the territorial integrity of the State and the maintenance of law and order. This Regulation does not affect the competences of the Member States concerning customs and tax administration or the health and safety of citizens.

This Regulation complements the self-regulatory approach of Regulation (EU) 2018/1807 by adding generally applicable obligations on cloud switching.

This Regulation is without prejudice to Union and national legal acts providing for the protection of intellectual property rights, in particular Directives 2001/29/EC, 2004/48/EC and (EU) 2019/790.

This Regulation complements and is without prejudice to Union law which aims to promote the interests of consumers and ensure a high level of consumer protection, and to protect their health, safety and economic interests, in particular Directives 93/13/EEC, 2005/29/EC and 2011/83/EU.

This Regulation does not preclude the conclusion of voluntary lawful data sharing contracts, including contracts concluded on a reciprocal basis, which comply with the requirements laid down in this Regulation.

This Regulation lays down harmonised rules, inter alia, on:

1. (a)

   the making available of product data and related service data to the user of the connected product or related service;

2. (b)

   the making available of data by data holders to data recipients;

3. (c)

   the making available of data by data holders to public sector bodies, the Commission, the European Central Bank and Union bodies, where there is the need for those data for the performance of a specific task carried out in the public interest

4. (d)

   facilitating switching between data processing services;

5. (e)

   introducing safeguards against unlawful third-party access to non-personal data; and

6. (ea)

   voluntary registration of data intermediation services;

7. (eb)

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

8. (ec)

   the establishment of a European Data Innovation Board;

9. (ed)

   data localisation requirements;

10. (ee)

    the re-use of certain data and documents held by public sector bodies or by certain public undertakings, and of research data.

11. (f)

    the development of interoperability standards for data to be accessed, transferred and used.

This Regulation covers personal and non-personal data, including the following types of data, in the following contexts:

1. (a)

   Chapter II applies to data, with the exception of content, concerning the performance, use and environment of connected products and related services;

2. (b)

   Chapter III applies to any private sector data that is subject to statutory data sharing obligations;

3. (c)

   Chapter IV applies to any private sector data accessed and used on the basis of contract between enterprises;

4. (d)

   Chapter V applies to any private sector data with a focus on non-personal data;

5. (e)

   Chapter VI applies to any data and services processed by providers of data processing services;

6. (f)

   Chapter VII applies to any non-personal data held in the Union by providers of data processing services.

7. (h)

   Chapter VIIb applies to any non-personal data;

This Regulation applies to:

1. (a)

   manufacturers of connected products placed on the market in the Union and providers of related services, irrespective of the place of establishment of those manufacturers and providers;

2. (b)

   users in the Union of connected products or related services as referred to in point (a);

3. (c)

   data holders, irrespective of their place of establishment, that make data available to data recipients in the Union;

4. (d)

   data recipients in the Union to whom data are made available;

5. (e)

   publi r bodies, the Commissi he Eur ntral Bank and need for those data for the performance of a specific task carried out in the ic interest an data h ide those 0 suc *

6. (f)

   providers of data processing services, irrespective of their place of establishment, providing such services to customers in the Union;

7. (g)

   participants in data spaces.

Where this Regulation refers to connected products or related services, such references are also understood to include virtual assistants insofar as they interact with a connected product or related service.

This Regulation does not apply to or pre-empt voluntary arrangements for the exchange of data between private and public entities, in particular voluntary arrangements for data sharing.

This Regulation does not affect Union or national legal acts providing for the sharing of, access to and the use of data for the purpose of the prevention, investigation, detection or prosecution of criminal offences or for the execution of criminal penalties, or for customs and taxation purposes, in particular Regulations (EU) 2021/784, (EU) 2022/2065 and (EU) 2023/1543 and Directive (EU) 2023/1544, or international cooperation in that area. This Regulation does not apply to the collection or sharing of, access to or the use of data under Regulation (EU) 2015/847 and Directive (EU) 2015/849. This Regulation does not apply to areas that fall outside the scope of Union law and in any event does not affect the competences of the Member States concerning public security, defence or national security, regardless of the type of entity entrusted by the Member States to carry out tasks in relation to those competences, or their power to safeguard other essential State functions, including ensuring the territorial integrity of the State and the maintenance of law and order. This Regulation does not affect the competences of the Member States concerning customs and tax administration or the health and safety of citizens.

This Regulation is without prejudice to Union and national legal acts providing for the protection of intellectual property rights, in particular Directives 2001/29/EC, 2004/48/EC and (EU) 2019/790.

This Regulation complements and is without prejudice to Union law which aims to promote the interests of consumers and ensure a high level of consumer protection, and to protect their health, safety and economic interests, in particular Directives 93/13/EEC, 2005/29/EC and 2011/83/EU.

This Regulation does not preclude the conclusion of voluntary lawful data sharing contracts, including contracts concluded on a reciprocal basis, which comply with the requirements laid down in this Regulation.

‘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 audio-visual recording;

‘metadata’ means a structured description of the contents or the use of data facilitating the discovery or use of that data;

‘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;

‘connected product’ means an item that obtains, generates or collects data concerning its use or environment and that is able to communicate product data via an electronic communications service, physical connection or on-device access, and whose primary function is not the storing, processing or transmission of data on behalf of any party other than the user;

‘related service’ means a digital service, other than an electronic communications service, including software, which is connected with the product at the time of the purchase, rent or lease in such a way that its absence would prevent the connected product from performing one or more of its functions, or which is subsequently connected to the product by the manufacturer or a third party to add to, update or adapt the functions of the connected product;

‘processing’ means any operation or set of operations which is performed on data or on sets of data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination, or other means of making them available, alignment or combination, restriction, erasure or destruction;

‘data processing service’ means a digital service that is provided to a customer and that enables ubiquitous and on-demand network access to a shared pool of configurable, scalable and elastic computing resources of a centralised, distributed or highly distributed nature that can be rapidly provisioned and released with minimal management effort or service provider interaction;

‘same service type’ means a set of data processing services that share the same primary objective, data processing service model and main functionalities;

‘data intermediation service’ means data intermediation service as defined in Article 2, point (11), of Regulation (EU) 2022/868;

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

‘user’ means a natural or legal person that owns a connected product or to whom temporary rights to use that connected product have been contractually transferred, or that receives related services;

‘data holder’ means a natural or legal person that has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation adopted in accordance with Union law, to use and make available data, including, where contractually agreed, product data or related service data which it has retrieved or generated during the provision of a related service;

‘data recipient’ means a natural or legal person, acting for purposes which are related to that person’s trade, business, craft or profession, other than the user of a connected product or related service, to whom the data holder makes data available, including a third party following a request by the user to the data holder or in accordance with a legal obligation under Union law or national legislation adopted in accordance with Union law;

‘product data’ means data generated by the use of a connected product that the manufacturer designed to be retrievable, via an electronic communications service, physical connection or on-device access, by a user, data holder or a third party, including, where relevant, the manufacturer;

‘related service data’ means data representing the digitisation of user actions or of events related to the connected product, recorded intentionally by the user or generated as a by-product of the user’s action during the provision of a related service by the provider;

‘readily available data’ means product data and related service data that a data holder lawfully obtains or can lawfully obtain from the connected product or related service, without disproportionate effort going beyond a simple operation;

‘trade secret’ means trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;

‘trade secret holder’ means a trade secret holder as defined in Article 2, point (2), of Directive (EU) 2016/943;

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

‘making available on the market’ means any supply of a connected product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

‘placing on the market’ means the first making available of a connected product on the Union market;

‘consumer’ means any natural person who is acting for purposes which are outside that person’s trade, business, craft or profession;

‘enterprise’ means a natural or legal person that, in relation to contracts and practices covered by this Regulation, is acting for purposes which are related to that person’s trade, business, craft or profession;

‘small enterprise’ means a small enterprise as defined in Article 2(2) of the Annex to Recommendation 2003/361/EC;

‘microenterprise’ means a microenterprise as defined in Article 2(3) of the Annex to Recommendation 2003/361/EC;

‘Union bodies’ means the Union bodies, offices and agencies set up by or pursuant to acts adopted on the basis of the Treaty on European Union, the TFEU or the Treaty establishing the European Atomic Energy Community;

‘public sector body’ means national, regional or local authorities of the Member States and bodies governed by public law of the Member States, or associations formed by one or more such authorities or one or more such bodies;

‘public emergency’ means an exceptional situation, limited in time, such as a public health emergency, an emergency resulting from natural disasters, a human-induced major disaster, including a major cybersecurity incident, negatively affecting the population of the Union or the whole or part of a Member State, with a risk of serious and lasting repercussions for living conditions or economic stability, financial stability, or the substantial and immediate degradation of economic assets in the Union or the relevant Member State and which is determined or officially declared in accordance with the relevant procedures under Union or national law;

‘customer’ means a natural or legal person that has entered into a contractual relationship with a provider of data processing services with the objective of using one or more data processing services;

‘virtual assistants’ means software that can process demands, tasks or questions including those based on audio, written input, gestures or motions, and that, based on those demands, tasks or questions, provides access to other services or controls the functions of connected products;

‘digital assets’ means elements in digital form, including applications, for which the customer has the right of use, independently from the contractual relationship with the data processing service it intends to switch from;

‘on-premises ICT infrastructure’ means ICT infrastructure and computing resources owned, rented or leased by the customer, located in the data centre of the customer itself and operated by the customer or by a third-party;

‘switching’ means the process involving a source provider of data processing services, a customer of a data processing service and, where relevant, a destination provider of data processing services, whereby the customer of a data processing service changes from using one data processing service to using another data processing service of the same service type, or other service, offered by a different provider of data processing services, or to an on-premises ICT infrastructure, including through extracting, transforming and uploading the data;

‘data egress charges’ means data transfer fees charged to customers for extracting their data through the network from the ICT infrastructure of a provider of data processing services to the system of a different provider or to on-premises ICT infrastructure;

‘switching charges’ means charges, other than standard service fees or early termination penalties, imposed by a provider of data processing services on a customer for the actions mandated by this Regulation for switching to the system of a different provider or to on-premises ICT infrastructure, including data egress charges;

‘functional equivalence’ means re-establishing on the basis of the customer’s exportable data and digital assets, a minimum level of functionality in the environment of a new data processing service of the same service type after the switching process, where the destination data processing service delivers a materially comparable outcome in response to the same input for shared features supplied to the customer under the contract;

‘exportable data’, for the purpose of Articles 23 to 31 and Article 35, means the input and output data, including metadata, directly or indirectly generated, or cogenerated, by the customer’s use of the data processing service, excluding any assets or data protected by intellectual property rights, or constituting a trade secret, of providers of data processing services or third parties;

‘smart contract’ means a computer program used for the automated execution of an agreement or part thereof, using a sequence of electronic data records and ensuring their integrity and the accuracy of their chronological ordering;

‘interoperability’ means the ability of two or more data spaces or communication networks, systems, connected products, applications, data processing services or components to exchange and use data in order to perform their functions;

‘open interoperability specification’ means a technical specification in the field of information and communication technologies which is performance oriented towards achieving interoperability between data processing services;

‘common specifications’ means a document, other than a standard, containing technical solutions providing a means to comply with certain requirements and obligations established under this Regulation;

‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012.

‘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 audio-visual recording;

‘metadata’ means a structured description of the contents or the use of data facilitating the discovery or use of that data;

‘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;

‘connected product’ means an item that obtains, generates or collects data concerning its use or environment and that is able to communicate product data via an electronic communications service, physical connection or on-device access, and whose primary function is not the storing, processing or transmission of data on behalf of any party other than the user;

‘related service’ means a digital service, other than an electronic communications service, including software, which is connected with the product at the time of the purchase, rent or lease in such a way that its absence would prevent the connected product from performing one or more of its functions, or which is subsequently connected to the product by the manufacturer or a third party to add to, update or adapt the functions of the connected product;

‘processing’ means any operation or set of operations which is performed on data or on sets of data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination, or other means of making them available, alignment or combination, restriction, erasure or destruction;

‘data processing service’ means a digital service that is provided to a customer and that enables ubiquitous and on-demand network access to a shared pool of configurable, scalable and elastic computing resources of a centralised, distributed or highly distributed nature that can be rapidly provisioned and released with minimal management effort or service provider interaction;

‘same service type’ means a set of data processing services that share the same primary objective, data processing service model and main functionalities;

‘data intermediation service’ means data intermediation service as defined in Article 2, point (11), of Regulation (EU) 2022/868;

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

‘user’ means a natural or legal person that owns a connected product or to whom temporary rights to use that connected product have been contractually transferred, or that receives related services;

‘data recipient’ means a natural or legal person, acting for purposes which are related to that person’s trade, business, craft or profession, other than the user of a connected product or related service, to whom the data holder makes data available, including a third party following a request by the user to the data holder or in accordance with a legal obligation under Union law or national legislation adopted in accordance with Union law;

‘product data’ means data generated by the use of a connected product that the manufacturer designed to be retrievable, via an electronic communications service, physical connection or on-device access, by a user, data holder or a third party, including, where relevant, the manufacturer;

‘related service data’ means data representing the digitisation of user actions or of events related to the connected product, recorded intentionally by the user or generated as a by-product of the user’s action during the provision of a related service by the provider;

‘readily available data’ means product data and related service data that a data holder lawfully obtains or can lawfully obtain from the connected product or related service, without disproportionate effort going beyond a simple operation;

‘trade secret’ means trade secret as defined in Article 2, point (1), of Directive (EU) 2016/943;

‘trade secret holder’ means a trade secret holder as defined in Article 2, point (2), of Directive (EU) 2016/943;

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

‘making available on the market’ means any supply of a connected product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

‘placing on the market’ means the first making available of a connected product on the Union market;

‘consumer’ means any natural person who is acting for purposes which are outside that person’s trade, business, craft or profession;

‘enterprise’ means a natural or legal person that, in relation to contracts and practices covered by this Regulation, is acting for purposes which are related to that person’s trade, business, craft or profession;

‘small enterprise’ means a small enterprise as defined in Article 2(2) of the Annex to Recommendation 2003/361/EC;

‘microenterprise’ means a microenterprise as defined in Article 2(3) of the Annex to Recommendation 2003/361/EC;

‘Union bodies’ means the Union bodies, offices and agencies set up by or pursuant to acts adopted on the basis of the Treaty on European Union, the TFEU or the Treaty establishing the European Atomic Energy Community;

‘public sector body’ means national, regional or local authorities of the Member States and bodies governed by public law of the Member States, or associations formed by one or more such authorities or one or more such bodies;

‘public emergency’ means an exceptional situation, limited in time, such as a public health emergency, an emergency resulting from natural disasters, a human-induced major disaster, including a major cybersecurity incident, negatively affecting the population of the Union or the whole or part of a Member State, with a risk of serious and lasting repercussions for living conditions or economic stability, financial stability, or the substantial and immediate degradation of economic assets in the Union or the relevant Member State and which is determined or officially declared in accordance with the relevant procedures under Union or national law;

‘customer’ means a natural or legal person that has entered into a contractual relationship with a provider of data processing services with the objective of using one or more data processing services;

‘virtual assistants’ means software that can process demands, tasks or questions including those based on audio, written input, gestures or motions, and that, based on those demands, tasks or questions, provides access to other services or controls the functions of connected products;

‘digital assets’ means elements in digital form, including applications, for which the customer has the right of use, independently from the contractual relationship with the data processing service it intends to switch from;

‘on-premises ICT infrastructure’ means ICT infrastructure and computing resources owned, rented or leased by the customer, located in the data centre of the customer itself and operated by the customer or by a third-party;

‘switching’ means the process involving a source provider of data processing services, a customer of a data processing service and, where relevant, a destination provider of data processing services, whereby the customer of a data processing service changes from using one data processing service to using another data processing service of the same service type, or other service, offered by a different provider of data processing services, or to an on-premises ICT infrastructure, including through extracting, transforming and uploading the data;

‘data egress charges’ means data transfer fees charged to customers for extracting their data through the network from the ICT infrastructure of a provider of data processing services to the system of a different provider or to on-premises ICT infrastructure;

‘switching charges’ means charges, other than standard service fees or early termination penalties, imposed by a provider of data processing services on a customer for the actions mandated by this Regulation for switching to the system of a different provider or to on-premises ICT infrastructure, including data egress charges;

‘functional equivalence’ means re-establishing on the basis of the customer’s exportable data and digital assets, a minimum level of functionality in the environment of a new data processing service of the same service type after the switching process, where the destination data processing service delivers a materially comparable outcome in response to the same input for shared features supplied to the customer under the contract;

‘exportable data’, for the purpose of Articles 23 to 31 and Article 35, means the input and output data, including metadata, directly or indirectly generated, or cogenerated, by the customer’s use of the data processing service, excluding any assets or data protected by intellectual property rights, or constituting a trade secret, of providers of data processing services or third parties;

‘smart contract’ means a computer program used for the automated execution of an agreement or part thereof, using a sequence of electronic data records and ensuring their integrity and the accuracy of their chronological ordering;

‘interoperability’ means the ability of two or more data spaces or communication networks, systems, connected products, applications, data processing services or components to exchange and use data in order to perform their functions;

‘open interoperability specification’ means a technical specification in the field of information and communication technologies which is performance oriented towards achieving interoperability between data processing services;

‘common specifications’ means a document, other than a standard, containing technical solutions providing a means to comply with certain requirements and obligations established under this Regulation;

‘harmonised standard’ means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012.

Where data cannot be directly accessed by the user from the connected product or related service, data holders shall make readily available data, as well as the relevant metadata necessary to interpret and use those data, accessible to the user without undue delay, of the same quality as is available to the data holder, easily, securely, free of charge, in a comprehensive, structured, commonly used and machine-readable format and, where relevant and technically feasible, continuously and in real-time. This shall be done on the basis of a simple request through electronic means where technically feasible.

Users and data holders may contractually restrict or prohibit accessing, using or further sharing data, if such processing could undermine security requirements of the connected product, as laid down by Union or national law, resulting in a serious adverse effect on the health, safety or security of natural persons. Sectoral authorities may provide users and data holders with technical expertise in that context. Where the data holder refuses to share data pursuant to this Article, it shall notify the competent authority designated pursuant to Article 37.

Without prejudice to the user’s right to seek redress at any stage before a court or tribunal of a Member State, the user may, in relation to any dispute with the data holder concerning the contractual restrictions or prohibitions referred to in paragraph 2:

1. (a)

   lodge, in accordance with Article 37(5), point (b), a complaint with the competent authority; or

2. (b)

   agree with the data holder to refer the matter to a dispute settlement body in accordance with Article 10(1).

Data holders shall not make the exercise of choices or rights under this Article by the user unduly difficult, including by offering choices to the user in a non-neutral manner or by subverting or impairing the autonomy, decision-making or choices of the user via the structure, design, function or manner of operation of a user digital interface or a part thereof.

For the purpose of verifying whether a natural or legal person qualifies as a user for the purposes of paragraph 1, a data holder shall not require that person to provide any information beyond what is necessary. Data holders shall not keep any information, in particular log data, on the user’s access to the data requested beyond what is necessary for the sound execution of the user’s access request and for the security and maintenance of the data infrastructure.

Trade secrets shall be preserved and shall be disclosed only where the data holder and the user take all necessary measures prior to the disclosure to preserve their confidentiality in particular regarding third parties. The data holder or, where they are not the same person, the trade secret holder shall identify the data which are protected as trade secrets, including in the relevant metadata, and shall agree with the user proportionate technical and organisational measures necessary to preserve the confidentiality of the shared data, in particular in relation to third parties, such as model contractual terms, confidentiality agreements, strict access protocols, technical standards and the application of codes of conduct.

Where there is no agreement on the necessary measures referred to in paragraph 6, or if the user fails to implement the measures agreed pursuant to paragraph 6 or undermines the confidentiality of the trade secrets, the data holder may withhold or, as the case may be, suspend the sharing of data identified as trade secrets. The decision of the data holder shall be duly substantiated and provided in writing to the user without undue delay. In such cases, the data holder shall notify the competent authority designated pursuant to Article 37 that it has withheld or suspended data sharing and identify which measures have not been agreed or implemented and, where relevant, which trade secrets have had their confidentiality undermined.

In exceptional circumstances, where the data holder who is a trade secret holder is able to demonstrate that it is highly likely to suffer serious economic damage from the disclosure of trade secrets, despite the technical and organisational measures taken by the user pursuant to paragraph 6 of this Article, that data holder may refuse on a case-by-case basis a request for access to the specific data in question. That demonstration shall be duly substantiated on the basis of objective elements, in particular the enforceability of trade secrets protection in third countries, the nature and level of confidentiality of the data requested, and the uniqueness and novelty of the connected product, and shall be provided in writing to the user without undue delay. Where the data holder refuses to share data pursuant to this paragraph, it shall notify the competent authority designated pursuant to Article 37.

Without prejudice to a user’s right to seek redress at any stage before a court or tribunal of a Member State, a user wishing to challenge a data holder’s decision to refuse or to withhold or suspend data sharing pursuant to paragraphs 7 and 8 may:

1. (a)

   lodge, in accordance with Article 37(5), point (b), a complaint with the competent authority, which shall, without undue delay, decide whether and under which conditions data sharing is to start or resume; or

2. (b)

   agree with the data holder to refer the matter to a dispute settlement body in accordance with Article 10(1).

The user shall not use the data obtained pursuant to a request referred to in paragraph 1 to develop a connected product that competes with the connected product from which the data originate, nor share the data with a third party with that intent and shall not use such data to derive insights about the economic situation, assets and production methods of the manufacturer or, where applicable the data holder.

The user shall not use coercive means or abuse gaps in the technical infrastructure of a data holder which is designed to protect the data in order to obtain access to data.

Where the user is not the data subject whose personal data is requested, any personal data generated by the use of a connected product or related service shall be made available by the data holder to the user only where there is a valid legal basis for processing under Article 6 of Regulation (EU) 2016/679 and, where relevant, the conditions of Article 9 of that Regulation and of Article 5(3) of Directive 2002/58/EC are fulfilled.

A data holder shall only use any readily available data that is non-personal data on the basis of a contract with the user. A data holder shall not use such data to derive insights about the economic situation, assets and production methods of, or the use by, the user in any other manner that could undermine the commercial position of that user on the markets in which the user is active.

Data holders shall not make available non-personal product data to third parties for commercial or non-commercial purposes other than the fulfilment of their contract with the user. Where relevant, data holders shall contractually bind third parties not to further share data received from them.

Where data cannot be directly accessed by the user from the connected product or related service, data holders shall make readily available data, as well as the relevant metadata necessary to interpret and use those data, accessible to the user without undue delay, of the same quality as is available to the data holder, easily, securely, free of charge, in a comprehensive, structured, commonly used and machine-readable format and, where relevant and technically feasible, continuously and in real-time. This shall be done on the basis of a simple request through electronic means where technically feasible.

Users and data holders may contractually restrict or prohibit accessing, using or further sharing data, if such processing could undermine security requirements of the connected product, as laid down by Union or national law, resulting in a serious adverse effect on the health, safety or security of natural persons. Sectoral authorities may provide users and data holders with technical expertise in that context. Where the data holder refuses to share data pursuant to this Article, it shall notify the competent authority designated pursuant to Article 37.

Without prejudice to the user’s right to seek redress at any stage before a court or tribunal of a Member State, the user may, in relation to any dispute with the data holder concerning the contractual restrictions or prohibitions referred to in paragraph 2:

1. (a)

   lodge, in accordance with Article 37(5), point (b), a complaint with the competent authority; or

2. (b)

   agree with the data holder to refer the matter to a dispute settlement body in accordance with Article 10(1).

Data holders shall not make the exercise of choices or rights under this Article by the user unduly difficult, including by offering choices to the user in a non-neutral manner or by subverting or impairing the autonomy, decision-making or choices of the user via the structure, design, function or manner of operation of a user digital interface or a part thereof.

For the purpose of verifying whether a natural or legal person qualifies as a user for the purposes of paragraph 1, a data holder shall not require that person to provide any information beyond what is necessary. Data holders shall not keep any information, in particular log data, on the user’s access to the data requested beyond what is necessary for the sound execution of the user’s access request and for the security and maintenance of the data infrastructure.

Trade secrets shall be preserved and shall be disclosed only where the data holder and the user take all necessary measures prior to the disclosure to preserve their confidentiality in particular regarding third parties. The data holder or, where they are not the same person, the trade secret holder shall identify the data which are protected as trade secrets, including in the relevant metadata, and shall agree with the user proportionate technical and organisational measures necessary to preserve the confidentiality of the shared data, in particular in relation to third parties, such as model contractual terms, confidentiality agreements, strict access protocols, technical standards and the application of codes of conduct.

Where there is no agreement on the necessary measures referred to in paragraph 6, or if the user fails to implement the measures agreed pursuant to paragraph 6 or undermines the confidentiality of the trade secrets, the data holder may withhold or, as the case may be, suspend the sharing of data identified as trade secrets. The decision of the data holder shall be duly substantiated and provided in writing to the user without undue delay. In such cases, the data holder shall notify the competent authority designated pursuant to Article 37 that it has withheld or suspended data sharing and identify which measures have not been agreed or implemented and, where relevant, which trade secrets have had their confidentiality undermined.

Without prejudice to a user’s right to seek redress at any stage before a court or tribunal of a Member State, a user wishing to challenge a data holder’s decision to refuse or to withhold or suspend data sharing pursuant to paragraphs 7 and 8 may:

1. (a)

   lodge, in accordance with Article 37(5), point (b), a complaint with the competent authority, which shall, without undue delay, decide whether and under which conditions data sharing is to start or resume; or

2. (b)

   agree with the data holder to refer the matter to a dispute settlement body in accordance with Article 10(1).

The user shall not use the data obtained pursuant to a request referred to in paragraph 1 to develop a connected product that competes with the connected product from which the data originate, nor share the data with a third party with that intent and shall not use such data to derive insights about the economic situation, assets and production methods of the manufacturer or, where applicable the data holder.

The user shall not use coercive means or abuse gaps in the technical infrastructure of a data holder which is designed to protect the data in order to obtain access to data.

Where the user is not the data subject whose personal data is requested, any personal data generated by the use of a connected product or related service shall be made available by the data holder to the user only where there is a valid legal basis for processing under Article 6 of Regulation (EU) 2016/679 and, where relevant, the conditions of Article 9 of that Regulation and of Article 5(3) of Directive 2002/58/EC are fulfilled.

A data holder shall only use any readily available data that is non-personal data on the basis of a contract with the user. A data holder shall not use such data to derive insights about the economic situation, assets and production methods of, or the use by, the user in any other manner that could undermine the commercial position of that user on the markets in which the user is active.

Data holders shall not make available non-personal product data to third parties for commercial or non-commercial purposes other than the fulfilment of their contract with the user. Where relevant, data holders shall contractually bind third parties not to further share data received from them.

Upon request by a user, or by a party acting on behalf of a user, the data holder shall make available readily available data, as well as the relevant metadata necessary to interpret and use those data, to a third party without undue delay, of the same quality as is available to the data holder, easily, securely, free of charge to the user, in a comprehensive, structured, commonly used and machine-readable format and, where relevant and technically feasible, continuously and in real-time. The data shall be made available by the data holder to the third party in accordance with Articles 8 and 9.

Paragraph 1 shall not apply to readily available data in the context of the testing of new connected products, substances or processes that are not yet placed on the market unless their use by a third party is contractually permitted.

Any undertaking designated as a gatekeeper, pursuant to Article 3 of Regulation (EU) 2022/1925, shall not be an eligible third party under this Article and therefore shall not:

1. (a)

   solicit or commercially incentivise a user in any manner, including by providing monetary or any other compensation, to make data available to one of its services that the user has obtained pursuant to a request under Article 4(1);

2. (b)

   solicit or commercially incentivise a user to request the data holder to make data available to one of its services pursuant to paragraph 1 of this Article;

3. (c)

   receive data from a user that the user has obtained pursuant to a request under Article 4(1).

For the purpose of verifying whether a natural or legal person qualifies as a user or as a third party for the purposes of paragraph 1, the user or the third party shall not be required to provide any information beyond what is necessary. Data holders shall not keep any information on the third party’s access to the data requested beyond what is necessary for the sound execution of the third party’s access request and for the security and maintenance of the data infrastructure.

The third party shall not use coercive means or abuse gaps in the technical infrastructure of a data holder which is designed to protect the data in order to obtain access to data.

A data holder shall not use any readily available data to derive insights about the economic situation, assets and production methods of, or the use by, the third party in any other manner that could undermine the commercial position of the third party on the markets in which the third party is active, unless the third party has given permission to such use and has the technical possibility to easily withdraw that permission at any time.

Where the user is not the data subject whose personal data is requested, any personal data generated by the use of a connected product or related service shall be made available by the data holder to the third party only where there is a valid legal basis for processing under Article 6 of Regulation (EU) 2016/679 and, where relevant, the conditions of Article 9 of that Regulation and of Article 5(3) of Directive 2002/58/EC are fulfilled.

Any failure on the part of the data holder and the third party to agree on arrangements for transmitting the data shall not hinder, prevent or interfere with the exercise of the rights of the data subject under Regulation (EU) 2016/679 and, in particular, with the right to data portability under Article 20 of that Regulation.

Trade secrets shall be preserved and shall be disclosed to third parties only to the extent that such disclosure is strictly necessary to fulfil the purpose agreed between the user and the third party. The data holder or, where they are not the same person, the trade secret holder shall identify the data which are protected as trade secrets, including in the relevant metadata, and shall agree with the third party all proportionate technical and organisational measures necessary to preserve the confidentiality of the shared data, such as model contractual terms, confidentiality agreements, strict access protocols, technical standards and the application of codes of conduct.

Where there is no agreement on the necessary measures referred to in paragraph 9 of this Article or if the third party fails to implement the measures agreed pursuant to paragraph 9 of this Article or undermines the confidentiality of the trade secrets, the data holder may withhold or, as the case may be, suspend the sharing of data identified as trade secrets. The decision of the data holder shall be duly substantiated and provided in writing to the third party without undue delay. In such cases, the data holder shall notify the competent authority designated pursuant to Article 37 that it has withheld or suspended data sharing and identify which measures have not been agreed or implemented and, where relevant, which trade secrets have had their confidentiality undermined.

In exceptional circumstances, where the data holder who is a trade secret holder is able to demonstrate that it is highly likely to suffer serious economic damage from the disclosure of trade secrets, despite the technical and organisational measures taken by the third party pursuant to paragraph 9 of this Article, that data holder may refuse on a case-by-case basis a request for access to the specific data in question. That demonstration shall be duly substantiated on the basis of objective elements, in particular the enforceability of trade secrets protection in third countries, the nature and level of confidentiality of the data requested, and the uniqueness and novelty of the connected product, and shall be provided in writing to the third party without undue delay. Where the data holder refuses to share data pursuant to this paragraph, it shall notify the competent authority designated pursuant to Article 37.

Without prejudice to the third party’s right to seek redress at any stage before a court or tribunal of a Member State, a third party wishing to challenge a data holder’s decision to refuse or to withhold or suspend data sharing pursuant to paragraphs 10 and 11 may:

1. (a)

   lodge, in accordance with Article 37(5), point (b), a complaint with the competent authority, which shall, without undue delay, decide whether and under which conditions the data sharing is to start or resume; or

2. (b)

   agree with the data holder to refer the matter to a dispute settlement body in accordance with Article 10(1).

The right referred to in paragraph 1 shall not adversely affect the rights of data subjects pursuant to the applicable Union and national law on the protection of personal data.

Upon request by a user, or by a party acting on behalf of a user, the data holder shall make available readily available data, as well as the relevant metadata necessary to interpret and use those data, to a third party without undue delay, of the same quality as is available to the data holder, easily, securely, free of charge to the user, in a comprehensive, structured, commonly used and machine-readable format and, where relevant and technically feasible, continuously and in real-time. The data shall be made available by the data holder to the third party in accordance with Articles 8 and 9.

Paragraph 1 shall not apply to readily available data in the context of the testing of new connected products, substances or processes that are not yet placed on the market unless their use by a third party is contractually permitted.

Any undertaking designated as a gatekeeper, pursuant to Article 3 of Regulation (EU) 2022/1925, shall not be an eligible third party under this Article and therefore shall not:

1. (a)

   solicit or commercially incentivise a user in any manner, including by providing monetary or any other compensation, to make data available to one of its services that the user has obtained pursuant to a request under Article 4(1);

2. (b)

   solicit or commercially incentivise a user to request the data holder to make data available to one of its services pursuant to paragraph 1 of this Article;

3. (c)

   receive data from a user that the user has obtained pursuant to a request under Article 4(1).

For the purpose of verifying whether a natural or legal person qualifies as a user or as a third party for the purposes of paragraph 1, the user or the third party shall not be required to provide any information beyond what is necessary. Data holders shall not keep any information on the third party’s access to the data requested beyond what is necessary for the sound execution of the third party’s access request and for the security and maintenance of the data infrastructure.

The third party shall not use coercive means or abuse gaps in the technical infrastructure of a data holder which is designed to protect the data in order to obtain access to data.

A data holder shall not use any readily available data to derive insights about the economic situation, assets and production methods of, or the use by, the third party in any other manner that could undermine the commercial position of the third party on the markets in which the third party is active, unless the third party has given permission to such use and has the technical possibility to easily withdraw that permission at any time.

Where the user is not the data subject whose personal data is requested, any personal data generated by the use of a connected product or related service shall be made available by the data holder to the third party only where there is a valid legal basis for processing under Article 6 of Regulation (EU) 2016/679 and, where relevant, the conditions of Article 9 of that Regulation and of Article 5(3) of Directive 2002/58/EC are fulfilled.

Any failure on the part of the data holder and the third party to agree on arrangements for transmitting the data shall not hinder, prevent or interfere with the exercise of the rights of the data subject under Regulation (EU) 2016/679 and, in particular, with the right to data portability under Article 20 of that Regulation.

Trade secrets shall be preserved and shall be disclosed to third parties only to the extent that such disclosure is strictly necessary to fulfil the purpose agreed between the user and the third party. The data holder or, where they are not the same person, the trade secret holder shall identify the data which are protected as trade secrets, including in the relevant metadata, and shall agree with the third party all proportionate technical and organisational measures necessary to preserve the confidentiality of the shared data, such as model contractual terms, confidentiality agreements, strict access protocols, technical standards and the application of codes of conduct.

Where there is no agreement on the necessary measures referred to in paragraph 9 of this Article or if the third party fails to implement the measures agreed pursuant to paragraph 9 of this Article or undermines the confidentiality of the trade secrets, the data holder may withhold or, as the case may be, suspend the sharing of data identified as trade secrets. The decision of the data holder shall be duly substantiated and provided in writing to the third party without undue delay. In such cases, the data holder shall notify the competent authority designated pursuant to Article 37 that it has withheld or suspended data sharing and identify which measures have not been agreed or implemented and, where relevant, which trade secrets have had their confidentiality undermined.

Without prejudice to the third party’s right to seek redress at any stage before a court or tribunal of a Member State, a third party wishing to challenge a data holder’s decision to refuse or to withhold or suspend data sharing pursuant to paragraphs 10 and 11 may:

1. (a)

   lodge, in accordance with Article 37(5), point (b), a complaint with the competent authority, which shall, without undue delay, decide whether and under which conditions the data sharing is to start or resume; or

2. (b)

   agree with the data holder to refer the matter to a dispute settlement body in accordance with Article 10(1).

The right referred to in paragraph 1 shall not adversely affect the rights of data subjects pursuant to the applicable Union and national law on the protection of personal data.

Users, data holders and data recipients shall have access to a dispute settlement body, certified in accordance with paragraph 5 of this Article, to settle disputes pursuant to Article 4(3) and (9) and Article 5(12) as well as disputes relating to the fair, reasonable and non-discriminatory terms and conditions for, and transparent manner of, making data available in accordance with this Chapter and Chapter IV.

Dispute settlement bodies shall make the fees, or the mechanisms used to determine the fees, known to the parties concerned before those parties request a decision.

For disputes referred to a dispute settlement body pursuant to Article 4(3) and (9) and Article 5(12), where the dispute settlement body decides a dispute in favour of the user or of the data recipient, the data holder shall bear all the fees charged by the dispute settlement body and shall reimburse that user or that data recipient for any other reasonable expenses that it has incurred in relation to the dispute settlement. If the dispute settlement body decides a dispute in favour of the data holder, the user or the data recipient shall not be required to reimburse any fees or other expenses that the data holder paid or is to pay in relation to the dispute settlement, unless the dispute settlement body finds that the user or the data recipient manifestly acted in bad faith.

Customers and providers of data processing services shall have access to a dispute settlement body, certified in accordance with paragraph 5 of this Article, to settle disputes relating to breaches of the rights of customers and the obligations of providers of data processing services, in accordance with Articles 23 to 31.

The Member State where the dispute settlement body is established shall, at the request of that body, certify that body where it has demonstrated that it meets all of the following conditions:

1. (a)

   it is impartial and independent, and it is to issue its decisions in accordance with clear, non-discriminatory and fair rules of procedure;

2. (b)

   it has the necessary expertise, in particular in relation to fair, reasonable and non-discriminatory terms and conditions, including compensation, and on making data available in a transparent manner, allowing the body to effectively determine those terms and conditions;

3. (c)

   it is easily accessible through electronic communication technology;

4. (d)

   it is capable of adopting its decisions in a swift, efficient and cost-effective manner in at least one official language of the Union.

Member States shall notify to the Commission the dispute settlement bodies certified in accordance with paragraph 5. The Commission shall publish a list of those bodies on a dedicated website and keep it updated.

A dispute settlement body shall refuse to deal with a request to resolve a dispute that has already been brought before another dispute settlement body or before a court or tribunal of a Member State.

A dispute settlement body shall grant parties the possibility, within a reasonable period of time, to express their points of view on the matters those parties have brought before that body. In that context, each party to a dispute shall be provided with the submissions of the other party to their dispute and any statements made by experts. The parties shall be given the possibility to comment on those submissions and statements.

A dispute settlement body shall adopt its decision on a matter referred to it within 90 days of receipt of a request pursuant to paragraphs 1 and 4. That decision shall be in writing or on a durable medium and shall be supported by a statement of reasons.

Dispute settlement bodies shall draw up and make publicly available annual activity reports. Such annual reports shall include, in particular, the following general information:

1. (a)

   an aggregation of the outcomes of disputes;

2. (b)

   the average time taken to resolve disputes;

3. (c)

   the most common reasons for disputes.

In order to facilitate the exchange of information and best practices, a dispute settlement body may decide to include recommendations in the report referred to in paragraph 10 as to how problems can be avoided or resolved.

The decision of a dispute settlement body shall be binding on the parties only if the parties have explicitly consented to its binding nature prior to the start of the dispute settlement proceedings.

This Article does not affect the right of parties to seek an effective remedy before a court or tribunal of a Member State.

Users, data holders and data recipients shall have access to a dispute settlement body, certified in accordance with paragraph 5 of this Article, to settle disputes pursuant to Article 4(3) and (9) and Article 5(12) as well as disputes relating to the fair, reasonable and non-discriminatory terms and conditions for, and transparent manner of, making data available in accordance with this Chapter and Chapter IV.

Dispute settlement bodies shall make the fees, or the mechanisms used to determine the fees, known to the parties concerned before those parties request a decision.

For disputes referred to a dispute settlement body pursuant to Article 4(3) and (9) and Article 5(12), where the dispute settlement body decides a dispute in favour of the user or of the data recipient, the data holder shall bear all the fees charged by the dispute settlement body and shall reimburse that user or that data recipient for any other reasonable expenses that it has incurred in relation to the dispute settlement. If the dispute settlement body decides a dispute in favour of the data holder, the user or the data recipient shall not be required to reimburse any fees or other expenses that the data holder paid or is to pay in relation to the dispute settlement, unless the dispute settlement body finds that the user or the data recipient manifestly acted in bad faith.

Customers and providers of data processing services shall have access to a dispute settlement body, certified in accordance with paragraph 5 of this Article, to settle disputes relating to breaches of the rights of customers and the obligations of providers of data processing services, in accordance with Articles 23 to 31.

The Member State where the dispute settlement body is established shall, at the request of that body, certify that body where it has demonstrated that it meets all of the following conditions:

1. (a)

   it is impartial and independent, and it is to issue its decisions in accordance with clear, non-discriminatory and fair rules of procedure;

2. (b)

   it has the necessary expertise, in particular in relation to fair, reasonable and non-discriminatory terms and conditions, including compensation, and on making data available in a transparent manner, allowing the body to effectively determine those terms and conditions;

3. (c)

   it is easily accessible through electronic communication technology;

4. (d)

   it is capable of adopting its decisions in a swift, efficient and cost-effective manner in at least one official language of the Union.

Member States shall notify to the Commission the dispute settlement bodies certified in accordance with paragraph 5. The Commission shall publish a list of those bodies on a dedicated website and keep it updated.

A dispute settlement body shall refuse to deal with a request to resolve a dispute that has already been brought before another dispute settlement body or before a court or tribunal of a Member State.

A dispute settlement body shall grant parties the possibility, within a reasonable period of time, to express their points of view on the matters those parties have brought before that body. In that context, each party to a dispute shall be provided with the submissions of the other party to their dispute and any statements made by experts. The parties shall be given the possibility to comment on those submissions and statements.

A dispute settlement body shall adopt its decision on a matter referred to it within 90 days of receipt of a request pursuant to paragraphs 1 and 4. That decision shall be in writing or on a durable medium and shall be supported by a statement of reasons.

Dispute settlement bodies shall draw up and make publicly available annual activity reports. Such annual reports shall include, in particular, the following general information:

1. (a)

   an aggregation of the outcomes of disputes;

2. (b)

   the average time taken to resolve disputes;

3. (c)

   the most common reasons for disputes.

In order to facilitate the exchange of information and best practices, a dispute settlement body may decide to include recommendations in the report referred to in paragraph 10 as to how problems can be avoided or resolved.

This Article does not affect the right of parties to seek an effective remedy before a court or tribunal of a Member State.

A data holder may apply appropriate technical protection measures, including smart contracts and encryption, to prevent unauthorised access to data, including metadata, and to ensure compliance with Articles 4, 5, 6, 8 and 9, as well as with the agreed contractual terms for making data available. Such technical protection measures shall not discriminate between data recipients or hinder a user’s right to obtain a copy of, retrieve, use or access data, to provide data to third parties pursuant to Article 5 or any right of a third party under Union law or national legislation adopted in accordance with Union law. Users, third parties and data recipients shall not alter or remove such technical protection measures unless agreed by the data holder.

In the circumstances referred to in paragraph 3, the third party or data recipient shall comply, without undue delay, with the requests of the data holder and, where applicable and where they are not the same person, the trade secret holder or the user:

1. (a)

   to erase the data made available by the data holder and any copies thereof;

2. (b)

   to end the production, offering or placing on the market or use of goods, derivative data or services produced on the basis of knowledge obtained through such data, or the importation, export or storage of infringing goods for those purposes, and destroy any infringing goods, where there is a serious risk that the unlawful use of those data will cause significant harm to the data holder, the trade secret holder or the user or where such a measure would not be disproportionate in light of the interests of the data holder, the trade secret holder or the user;

3. (c)

   to inform the user of the unauthorised use or disclosure of the data and of the measures taken to put an end to the unauthorised use or disclosure of the data;

4. (d)

   to compensate the party suffering from the misuse or disclosure of such unlawfully accessed or used data.

Paragraph 2 shall apply where a third party or a data recipient has:

1. (a)

   for the purposes of obtaining data, provided false information to a data holder, deployed deceptive or coercive means or abused gaps in the technical infrastructure of the data holder designed to protect the data;

2. (b)

   used the data made available for unauthorised purposes, including the development of a competing connected product within the meaning of Article 6(2), point (e);

3. (c)

   unlawfully disclosed data to another party;

4. (d)

   not maintained the technical and organisational measures agreed pursuant to Article 5(9); or

5. (e)

   altered or removed technical protection measures applied by the data holder pursuant to paragraph 1 of this Article without the agreement of the data holder.

Paragraph 2 shall also apply where a user alters or removes technical protection measures applied by the data holder or does not maintain the technical and organisational measures taken by the user in agreement with the data holder or, where they are not the same person, the trade secrets holder, in order to preserve trade secrets, as well as in respect of any other party that receives the data from the user by means of an infringement of this Regulation.

Where the data recipient infringes Article 6(2), point (a) or (b), users shall have the same rights as data holders under paragraph 2 of this Article.

In the circumstances referred to in paragraph 3, the third party or data recipient shall comply, without undue delay, with the requests of the data holder and, where applicable and where they are not the same person, the trade secret holder or the user:

1. (a)

   to erase the data made available by the data holder and any copies thereof;

2. (b)

   to end the production, offering or placing on the market or use of goods, derivative data or services produced on the basis of knowledge obtained through such data, or the importation, export or storage of infringing goods for those purposes, and destroy any infringing goods, where there is a serious risk that the unlawful use of those data will cause significant harm to the data holder, the trade secret holder or the user or where such a measure would not be disproportionate in light of the interests of the data holder, the trade secret holder or the user;

3. (c)

   to inform the user of the unauthorised use or disclosure of the data and of the measures taken to put an end to the unauthorised use or disclosure of the data;

4. (d)

   to compensate the party suffering from the misuse or disclosure of such unlawfully accessed or used data.

Paragraph 2 shall apply where a third party or a data recipient has:

1. (a)

   for the purposes of obtaining data, provided false information to a data holder, deployed deceptive or coercive means or abused gaps in the technical infrastructure of the data holder designed to protect the data;

2. (b)

   used the data made available for unauthorised purposes, including the development of a competing connected product within the meaning of Article 6(2), point (e);

3. (c)

   unlawfully disclosed data to another party;

4. (d)

   not maintained the technical and organisational measures agreed pursuant to Article 5(9); or

5. (e)

   altered or removed technical protection measures applied by the data holder pursuant to paragraph 1 of this Article without the agreement of the data holder.

Paragraph 2 shall also apply where a user alters or removes technical protection measures applied by the data holder or does not maintain the technical and organisational measures taken by the user in agreement with the data holder or, where they are not the same person, the trade secrets holder, in order to preserve trade secrets, as well as in respect of any other party that receives the data from the user by means of an infringement of this Regulation.

Where the data recipient infringes Article 6(2), point (a) or (b), users shall have the same rights as data holders under paragraph 2 of this Article.

An exceptional need to use certain data within the meaning of this Chapter shall be limited in time and scope and shall be considered to exist only in any of the following circumstances:

1. (a)

   where the data requested is necessary to respond to a public emergency and the public sector body, the Commission, the European Central Bank or the Union body is unable to obtain such data by alternative means in a timely and effective manner under equivalent conditions;

2. (b)

   in circumstances not covered by point (a) and only insofar as non-personal data is concerned, where:

   1. (i)

      a public sector body, the Commission, the European Central Bank or a Union body is acting on the basis of Union or national law and has identified specific data, the lack of which prevents it from fulfilling a specific task carried out in the public interest, that has been explicitly provided for by law, such as the production of official statistics or the mitigation of or recovery from a public emergency; and

   2. (ii)

      the public sector body, the Commission, the European Central Bank or the Union body has exhausted all other means at its disposal to obtain such data, including purchase of non-personal data on the market by offering market rates, or by relying on existing obligations to make data available or the adoption of new legislative measures which could guarantee the timely availability of the data.

Paragraph 1, point (b), shall not apply to microenterprises and small enterprises.

The obligation to demonstrate that the public sector body was unable to obtain non-personal data by purchasing them on the market shall not apply where the specific task carried out in the public interest is the production of official statistics and where the purchase of such data is not allowed by national law.

This Chapter shall not affect the obligations laid down in Union or national law for the purposes of reporting, complying with requests for access to information or demonstrating or verifying compliance with legal obligations.

This Chapter shall not apply to public sector bodies, the Commission, the European Central Bank or Union bodies carrying out activities for the prevention, investigation, detection or prosecution of criminal or administrative offences or the execution of criminal penalties, or to customs or taxation administration. This Chapter does not affect applicable Union and national law on the prevention, investigation, detection or prosecution of criminal or administrative offences or the execution of criminal or administrative penalties, or for customs or taxation administration.

This Chapter shall not affect the obligations laid down in Union or national law for the purposes of reporting, complying with requests for access to information or demonstrating or verifying compliance with legal obligations.

When requesting data pursuant to Article 14, a public sector body, the Commission, the European Central Bank or a Union body shall:

1. (a)

   specify the data required, including the relevant metadata necessary to interpret and use those data;

2. (b)

   demonstrate that the conditions necessary for the existence of an exceptional need as referred to in Article 15 for the purpose of which the data are requested are met;

3. (c)

   explain the purpose of the request, the intended use of the data requested, including, where applicable, by a third party in accordance with paragraph 4 of this Article, the duration of that use, and, where relevant, how the processing of personal data is to address the exceptional need;

4. (d)

   specify, if possible, when the data are expected to be erased by all parties that have access to them;

5. (e)

   justify the choice of data holder to which the request is addressed;

6. (f)

   specify any other public sector bodies or the Commission, European Central Bank or Union bodies and the third parties with which the data requested is expected to be shared with;

7. (g)

   where personal data are requested, specify any technical and organisational measures necessary and proportionate to implement data protection principles and necessary safeguards, such as pseudonymisation, and whether anonymisation can be applied by the data holder before making the data available;

8. (h)

   state the legal provision allocating to the requesting public sector body, the Commission, the European Central Bank or the Union body the specific task carried out in the public interest relevant for requesting the data;

9. (i)

   specify the deadline by which the data are to be made available and the deadline referred to in Article 18(2) by which the data holder may decline or seek modification of the request;

10. (j)

    make its best efforts to avoid compliance with the data request resulting in the data holders’ liability for infringement of Union or national law.

A request for data made pursuant to paragraph 1 of this Article shall:

The European Central Bank and Union bodies shall inform the Commission of their requests.

1. (a)

   be made in writing and expressed in clear, concise and plain language understandable to the data holder;

2. (b)

   be specific regarding the type of data requested and correspond to data which the data holder has control over at the time of the request;

3. (c)

   be proportionate to the exceptional need and duly justified, regarding the granularity and volume of the data requested and frequency of access of the data requested;

4. (d)

   respect the legitimate aims of the data holder, committing to ensuring the protection of trade secrets in accordance with Article 19(3), and the cost and effort required to make the data available;

5. (e)

   concern non-personal data, and only if this is demonstrated to be insufficient to respond to the exceptional need to use data, in accordance with Article 15(1), point (a), request personal data in pseudonymised form and establish the technical and organisational measures that are to be taken to protect the data;

6. (f)

   inform the data holder of the penalties that are to be imposed pursuant to Article 40 by the competent authority designated pursuant to Article 37 in the event of non-compliance with the request;

7. (g)

   where the request is made by a public sector body, be transmitted to the data coordinator referred to in Article 37 of the Member State where the requesting public sector body is established, who shall make the request publicly available online without undue delay unless the data coordinator considers that such publication would create a risk for public security;

8. (h)

   where the request is made by the Commission, the European Central Bank or a Union body, be made available online without undue delay;

9. (i)

   where personal data are requested, be notified without undue delay to the supervisory authority responsible for monitoring the application of Regulation (EU) 2016/679 in the Member State where the public sector body is established.

A public sector body, the Commission, the European Central Bank or a Union body shall not make data obtained pursuant to this Chapter available for reuse as defined in Article 2, point (2), of Regulation (EU) 2022/868 or Article 2, point (11), of Directive (EU) 2019/1024. Regulation (EU) 2022/868 and Directive (EU) 2019/1024 shall not apply to the data held by public sector bodies obtained pursuant to this Chapter.

Paragraph 3 of this Article does not preclude a public sector body, the Commission, the European Central Bank or a Union body to exchange data obtained pursuant to this Chapter with another public sector body or the Commission, the European Central Bank or a Union body in view of completing the tasks referred to in Article 15, as specified in the request in accordance with paragraph 1, point (f), of this Article or to make the data available to a third party where it has delegated, by means of a publicly available agreement, technical inspections or other functions to that third party. The obligations on public sector bodies pursuant to Article 19, in particular safeguards to preserve the confidentiality of trade secrets, shall apply also to such third parties. Where a public sector body, the Commission, the European Central Bank or a Union body transmits or makes data available under this paragraph, it shall notify the data holder from whom the data was received without undue delay.

Where the data holder considers that its rights under this Chapter have been infringed by the transmission or making available of data, it may lodge a complaint with the competent authority designated pursuant to Article 37 of the Member State where the data holder is established.

The Commission shall develop a model template for requests pursuant to this Article.

A request for data made pursuant to paragraph 1 of this Article shall:

The European Central Bank and Union bodies shall inform the Commission of their requests.

1. (a)

   be made in writing and expressed in clear, concise and plain language understandable to the data holder;

2. (b)

   be specific regarding the type of data requested and correspond to data which the data holder has control over at the time of the request;

3. (c)

   be proportionate to the public emergency and duly justified, regarding the granularity and volume of the data requested and the frequency of access to the data requested:

4. (d)

   respect the legitimate aims of the data holder, committing to ensuring the protection of trade secrets in accordance with Article 19(3), and the cost and effort required to make the data available;

5. (f)

   inform the data holder of the penalties that are to be imposed pursuant to Article 40 by the competent authority designated pursuant to Article 37 in the event of non-compliance with the request;

6. (g)

   where the request is made by a public sector body, be transmitted to the data coordinator referred to in Article 37 of the Member State where the requesting public sector body is established, who shall make the request publicly available online without undue delay unless the data coordinator considers that such publication would create a risk for public security;

7. (h)

   where the request is made by the Commission, the European Central Bank or a Union body, be made available online without undue delay;

8. (i)

   where personal data are requested, be notified without undue delay to the supervisory authority responsible for monitoring the application of Regulation (EU) 2016/679 in the Member State where the public sector body is established.

A public sector body, the Commission, the European Central Bank or a Union body shall not make data obtained pursuant to this Chapter available for reuse as defined in Article 2, point (2), of Regulation (EU) 2022/868 or Article 2, point (11), of Directive (EU) 2019/1024. Regulation (EU) 2022/868 and Directive (EU) 2019/1024 shall not apply to the data held by public sector bodies obtained pursuant to this Chapter.

Paragraph 3 of this Article does not preclude a public sector body, the Commission, the European Central Bank or a Union body to exchange data obtained pursuant to this Chapter with another public sector body or the Commission, the European Central Bank or a Union body in view of completing the tasks referred to in Article 15, as specified in the request in accordance with paragraph 1, point (f), of this Article or to make the data available to a third party where it has delegated, by means of a publicly available agreement, technical inspections or other functions to that third party. The obligations on public sector bodies pursuant to Article 19, in particular safeguards to preserve the confidentiality of trade secrets, shall apply also to such third parties. Where a public sector body, the Commission, the European Central Bank or a Union body transmits or makes data available under this paragraph, it shall notify the data holder from whom the data was received without undue delay.

A data holder receiving a request to make data available under this Chapter shall make the data available to the requesting public sector body, the Commission, the European Central Bank or a Union body without undue delay, taking into account necessary technical, organisational and legal measures.

Without prejudice to specific needs regarding the availability of data defined in Union or national law, a data holder may decline or seek the modification of a request to make data available under this Chapter without undue delay and, in any event, no later than five working days after the receipt of a request for the data necessary to respond to a public emergency and without undue delay and, in any event, no later than 30 working days after the receipt of such a request in other cases of an exceptional need, on any of the following grounds:

1. (a)

   the data holder does not have control over the data requested;

2. (b)

   a similar request for the same purpose has been previously submitted by another public sector body or the Commission, the European Central Bank or a Union body and the data holder has not been notified of the erasure of the data pursuant to Article 19(1), point (c);

3. (c)

   the request does not meet the conditions laid down in Article 17(1) and (2).

If the data holder decides to decline the request or to seek its modification in accordance with paragraph 2, point (b), it shall indicate the identity of the public sector body or the Commission, the European Central Bank or the Union body that previously submitted a request for the same purpose.

Where the data requested includes personal data, the data holder shall properly anonymise the data, unless the compliance with the request to make data available to a public sector body, the Commission, the European Central Bank or a Union body requires the disclosure of personal data. In such cases, the data holder shall pseudonymise the data.

Where the public sector body, the Commission, the European Central Bank or the Union body wishes to challenge a data holder’s refusal to provide the data requested, or where the data holder wishes to challenge the request and the matter cannot be resolved by an appropriate modification of the request, the matter shall be referred to the competent authority designated pursuant to Article 37 of the Member State where the data holder is established.

A data holder receiving a request to make data available under this Chapter shall make the data available to the requesting public sector body, the Commission, the European Central Bank or a Union body without undue delay, taking into account necessary technical, organisational and legal measures.

If the data holder decides to decline the request or to seek its modification in accordance with paragraph 2, point (b), it shall indicate the identity of the public sector body or the Commission, the European Central Bank or the Union body that previously submitted a request for the same purpose.

Where the data requested includes personal data, the data holder shall properly anonymise the data, unless the compliance with the request to make data available to a public sector body, the Commission, the European Central Bank or a Union body requires the disclosure of personal data. In such cases, the data holder shall pseudonymise the data.

A public sector body, the Commission, the European Central Bank or a Union body receiving data pursuant to a request made under Article 14 shall:

1. (a)

   not use the data in a manner incompatible with the purpose for which they were requested;

2. (b)

   have implemented technical and organisational measures that preserve the confidentiality and integrity of the requested data and the security of the data transfers, in particular personal data, and safeguard the rights and freedoms of data subjects;

3. (c)

   erase the data as soon as they are no longer necessary for the stated purpose and inform the data holder and individuals or organisations that received the data pursuant to Article 21(1) without undue delay that the data have been erased, unless archiving of the data is required in accordance with Union or national law on public access to documents in the context of transparency obligations.

A public sector body, the Commission, the European Central Bank, a Union body or a third party receiving data under this Chapter shall not:

1. (a)

   use the data or insights about the economic situation, assets and production or operation methods of the data holder to develop or enhance a connected product or related service that competes with the connected product or related service of the data holder;

2. (b)

   share the data with another third party for any of the purposes referred to in point (a).

Disclosure of trade secrets to a public sector body, the Commission, the European Central Bank or a Union body shall be required only to the extent that it is strictly necessary to achieve the purpose of a request under Article 15. In such a case, the data holder or, where they are not the same person, the trade secret holder shall identify the data which are protected as trade secrets, including in the relevant metadata. The public sector body, the Commission, the European Central Bank or the Union body shall, prior to the disclosure of trade secrets, take all necessary and appropriate technical and organisational measures to preserve the confidentiality of the trade secrets, including, as appropriate, the use of model contractual terms, technical standards and the application of codes of conduct.

A public sector body, the Commission, the European Central Bank or a Union body shall be responsible for the security of the data it receives.

A public sector body, the Commission, the European Central Bank, a Union body or a third party receiving data under this Chapter shall not:

1. (a)

   use the data or insights about the economic situation, assets and production or operation methods of the data holder to develop or enhance a connected product or related service that competes with the connected product or related service of the data holder;

2. (b)

   share the data with another third party for any of the purposes referred to in point (a).

A public sector body, the Commission, the European Central Bank or a Union body shall be responsible for the security of the data it receives.

Data holders other than microenterprises and small enterprises shall make available data necessary to respond to a public emergency pursuant to Article 15(1), point (a), free of charge. The public sector body, the Commission, the European Central Bank or the Union body that has received data shall provide public acknowledgement to the data holder if requested by the data holder.

The data holder shall be entitled to fair compensation for making data available in compliance with a request made pursuant to Article 15(1), point (b). Such compensation shall cover the technical and organisational costs incurred to comply with the request including, where applicable, the costs of anonymisation, pseudonymisation, aggregation and of technical adaptation, and a reasonable margin. Upon request of the public sector body, the Commission, the European Central Bank or the Union body, the data holder shall provide information on the basis for the calculation of the costs and the reasonable margin.

Paragraph 2 shall also apply where a microenterprise and small enterprise claims compensation for making data available.

Data holders shall not be entitled to compensation for making data available in compliance with a request made pursuant to Article 15(1), point (b), where the specific task carried out in the public interest is the production of official statistics and where the purchase of data is not allowed by national law. Member States shall notify the Commission where the purchase of data for the production of official statistics is not allowed by national law.

Where the public sector body, the Commission, the European Central Bank or the Union body disagrees with the level of compensation requested by the data holder, they may lodge a complaint with the competent authority designated pursuant to Article 37 of the Member State where the data holder is established.

A public sector body, the Commission, the European Central Bank or a Union body shall be entitled to share data received under this Chapter:

1. (a)

   with individuals or organisations in view of carrying out scientific research or analytics compatible with the purpose for which the data was requested; or

2. (b)

   with national statistical institutes and Eurostat for the production of official statistics.

Individuals or organisations receiving the data pursuant to paragraph 1 shall act on a not-for-profit basis or in the context of a public-interest mission recognised in Union or national law. They shall not include organisations upon which commercial undertakings have a significant influence which is likely to result in preferential access to the results of the research.

Individuals or organisations receiving the data pursuant to paragraph 1 of this Article shall comply with the same obligations that are applicable to the public sector bodies, the Commission, the European Central Bank or Union bodies pursuant to Article 17(3) and Article 19.

Notwithstanding Article 19(1), point (c), individuals or organisations receiving the data pursuant to paragraph 1 of this Article may keep the data received for the purpose for which the data was requested for up to six months following erasure of the data by the public sector bodies, the Commission, the European Central Bank and Union bodies.

Where a public sector body, the Commission, the European Central Bank or a Union body intends to transmit or make data available under paragraph 1 of this Article, it shall notify without undue delay the data holder from whom the data was received, stating the identity and contact details of the organisation or the individual receiving the data, the purpose of the transmission or making available of the data, the period for which the data is to be used and the technical protection and organisational measures taken, including where personal data or trade secrets are involved. Where the data holder disagrees with the transmission or making available of data, it may lodge a complaint with the competent authority designated pursuant to Article 37 of the Member State where the data holder is established.

A public sector body, the Commission, the European Central Bank or a Union body shall be entitled to share data received under this Chapter:

1. (a)

   with individuals or organisations in view of carrying out scientific research or analytics compatible with the purpose for which the data was requested; or

2. (b)

   with national statistical institutes and Eurostat for the production of official statistics.

Individuals or organisations receiving the data pursuant to paragraph 1 shall act on a not-for-profit basis or in the context of a public-interest mission recognised in Union or national law. They shall not include organisations upon which commercial undertakings have a significant influence which is likely to result in preferential access to the results of the research.

Individuals or organisations receiving the data pursuant to paragraph 1 of this Article shall comply with the same obligations that are applicable to the public sector bodies, the Commission, the European Central Bank or Union bodies pursuant to Article 17(3) and Article 19.

Notwithstanding Article 19(1), point (c), individuals or organisations receiving the data pursuant to paragraph 1 of this Article may keep the data received for the purpose for which the data was requested for up to six months following erasure of the data by the public sector bodies, the Commission, the European Central Bank and Union bodies.

The obligations laid down in Article 23, point (d), Article 29 and Article 30(1) and (3) shall not apply to data processing services of which the majority of main features has been custom-built to accommodate the specific needs of an individual customer or where all components have been developed for the purposes of an individual customer, and where those data processing services are not offered at broad commercial scale via the service catalogue of the provider of data processing services.

The obligations laid down in this Chapter shall not apply to data processing services provided as a non-production version for testing and evaluation purposes and for a limited period of time.

Prior to the conclusion of a contract on the provision of the data processing services referred to in this Article, the provider of data processing services shall inform the prospective customer of the obligations of this Chapter that do not apply.

The obligations laid down in Article 23, point (d), Article 29 and Article 30(1) and (3) shall not apply to data processing services of which the majority of main features has been custom-built to accommodate the specific needs of an individual customer or where all components have been developed for the purposes of an individual customer, and where those data processing services are not offered at broad commercial scale via the service catalogue of the provider of data processing services.

The obligations laid down in this Chapter shall not apply to data processing services provided as a non-production version for testing and evaluation purposes and for a limited period of time.

Prior to the conclusion of a contract on the provision of the data processing services referred to in this Article, the provider of data processing services shall inform the prospective customer of the obligations of this Chapter that do not apply.

Providers of data processing services shall take all adequate technical, organisational and legal measures, including contracts, in order to prevent international and third-country governmental access and transfer of non-personal data held in the Union where such transfer or access would create a conflict with Union law or with 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 provider of data processing services to transfer or give access to non-personal data falling 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, where a provider of data processing services 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 falling 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:

The addressee of the decision or judgment may ask the opinion of the relevant national body or authority competent for international cooperation in legal matters, in order to determine whether the conditions laid down in the first subparagraph are met, in particular when it considers that the decision may relate to trade secrets and other commercially sensitive data as well as to content protected by intellectual property rights or the transfer may lead to re-identification. The relevant national body or authority may consult the Commission. If the addressee considers that the decision or judgment may impinge on the national security or defence interests of the Union or its Member States, it shall ask the opinion of the relevant national body or authority in order to determine whether the data requested concerns national security or defence interests of the Union or its Member States. If the addressee has not received a reply within one month, or if the opinion of such body or authority concludes that the conditions laid down in the first subparagraph are not met, the addressee may reject the request for transfer or access, to non-personal data, on those grounds.

The EDIB referred to in Article 42 shall advise and assist the Commission in developing guidelines on the assessment of whether the conditions laid down in the first subparagraph of this paragraph are met.

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 by Union law or by the national law of the relevant Member State.

If the conditions laid down in paragraph 2 or 3 are met, the provider of data processing services shall provide the minimum amount of data permissible in response to a request, on the basis of the reasonable interpretation of that request by the provider or relevant national body or authority referred to in paragraph 3, second subparagraph.

The provider of data processing services shall inform the customer about the existence of a request of a third-country 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.

Participants in data spaces that offer data or data services to other participants shall comply with the following essential requirements to facilitate the interoperability of data, of data sharing mechanisms and services, as well as of common European data spaces which are purpose- or sector-specific or cross-sectoral interoperable frameworks for 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:

The requirements can have a generic nature or concern specific sectors, while taking fully into account the interrelation with requirements arising from other Union or national law.

1. (a)

   the dataset content, use restrictions, licences, data collection methodology, data quality and uncertainty shall be sufficiently described, where applicable, in a machine-readable format, to allow the recipient to find, access and use the data;

2. (b)

   the data structures, data formats, vocabularies, classification schemes, taxonomies and code lists, where available, shall be described in a publicly available and consistent manner;

3. (c)

   the technical means to access the data, such as application programming interfaces, and their terms of use and quality of service shall be sufficiently described to enable automatic access and transmission of data between parties, including continuously, in bulk download or in real-time in a machine-readable format where that is technically feasible and does not hamper the good functioning of the connected product;

4. (d)

   where applicable, the means to enable the interoperability of tools for automating the execution of data sharing agreements, such as smart contracts shall be provided.

The Commission is empowered to adopt delegated acts, in accordance with Article 45 of this Regulation to supplement this Regulation by further specifying the essential requirements laid down in paragraph 1 of this Article, in relation to those requirements that, by their nature, cannot produce the intended effect unless they are further specified in binding Union legal acts and in order to properly reflect technological and market developments.

The Commission shall when adopting delegated acts take into account the advice of the EDIB in accordance with Article 42, point (c)(iii).

The participants in data spaces that offer data or data services to other participants in data spaces which meet the harmonised standards or parts thereof, the references of which are published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such harmonised standards or parts thereof.

The Commission shall, pursuant to Article 10 of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards that satisfy the essential requirements laid down in paragraph 1 of this Article.

The Commission may, by means of implementing acts, adopt common specifications covering any or all of the essential requirements laid down in paragraph 1 where the following conditions have been fulfilled:

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(2).

1. (a)

   the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard that satisfies the essential requirements laid down in paragraph 1 of this Article and:

   1. (i)

      the request has not been accepted;

   2. (ii)

      the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or

   3. (iii)

      the harmonised standards do not comply with the request; and

2. (b)

   no reference to harmonised standards covering the relevant essential requirements laid down in paragraph 1 of this Article is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period.

Before preparing a draft implementing act referred to in paragraph 5 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 5 of this Article have been fulfilled.

When preparing the draft implementing act referred to in paragraph 5, the Commission shall take into account the advice of the EDIB and views of other relevant bodies or expert groups and shall duly consult all relevant stakeholders.

The participants in data spaces that offer data or data services to other participants in data spaces that meet the common specifications established by implementing acts referred to in paragraph 5 or parts thereof shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such common specifications or parts thereof.

Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. Where the reference of a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 5 of this Article, or parts thereof which cover the same essential requirements as those covered by that harmonised standard.

When a Member State considers that a common specification does not entirely satisfy the essential requirements laid down in paragraph 1, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.

The Commission may adopt guidelines taking into account the proposal of the EDIB in accordance with Article 30, point (h), of Regulation (EU) 2022/868 laying down interoperable frameworks for common standards and practices for the functioning of common European data spaces.

Participants in data spaces that offer data or data services to other participants shall comply with the following essential requirements to facilitate the interoperability of data, of data sharing mechanisms and services, as well as of common European data spaces which are purpose- or sector-specific or cross-sectoral interoperable frameworks for 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:

The requirements can have a generic nature or concern specific sectors, while taking fully into account the interrelation with requirements arising from other Union or national law.

1. (a)

   the dataset content, use restrictions, licences, data collection methodology, data quality and uncertainty shall be sufficiently described, where applicable, in a machine-readable format, to allow the recipient to find, access and use the data;

2. (b)

   the data structures, data formats, vocabularies, classification schemes, taxonomies and code lists, where available, shall be described in a publicly available and consistent manner;

3. (c)

   the technical means to access the data, such as application programming interfaces, and their terms of use and quality of service shall be sufficiently described to enable automatic access and transmission of data between parties, including continuously, in bulk download or in real-time in a machine-readable format where that is technically feasible and does not hamper the good functioning of the connected product;

4. (d)

   where applicable, the means to enable the interoperability of tools for automating the execution of data sharing agreements shall be provided.

The participants in data spaces that offer data or data services to other participants in data spaces which meet the harmonised standards or parts thereof, the references of which are published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such harmonised standards or parts thereof.

The Commission shall, pursuant to Article 10 of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards that satisfy the essential requirements laid down in paragraph 1 of this Article.

The Commission may, by means of implementing acts, adopt common specifications covering any or all of the essential requirements laid down in paragraph 1 where the following conditions have been fulfilled:

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(2).

1. (a)

   the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard that satisfies the essential requirements laid down in paragraph 1 of this Article and:

   1. (i)

      the request has not been accepted;

   2. (ii)

      the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or

   3. (iii)

      the harmonised standards do not comply with the request; and

2. (b)

   no reference to harmonised standards covering the relevant essential requirements laid down in paragraph 1 of this Article is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period.

Before preparing a draft implementing act referred to in paragraph 5 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 5 of this Article have been fulfilled.

When preparing the draft implementing act referred to in paragraph 5, the Commission shall take into account the advice of the EDIB and views of other relevant bodies or expert groups and shall duly consult all relevant stakeholders.

The participants in data spaces that offer data or data services to other participants in data spaces that meet the common specifications established by implementing acts referred to in paragraph 5 or parts thereof shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such common specifications or parts thereof.

Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. Where the reference of a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 5 of this Article, or parts thereof which cover the same essential requirements as those covered by that harmonised standard.

When a Member State considers that a common specification does not entirely satisfy the essential requirements laid down in paragraph 1, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.

The Commission may adopt guidelines taking into account the proposal of the EDIB in accordance with Article 30, point (h), of Regulation (EU) 2022/868 laying down interoperable frameworks for common standards and practices for the functioning of common European data spaces.

The vendor of an application using smart contracts or, in the absence thereof, the person whose trade, business or profession involves the deployment of smart contracts for others in the context of executing an agreement or part of it, to make data available shall ensure that those smart contracts comply with the following essential requirements of:

1. (a)

   robustness and access control, to ensure that the smart contract has been designed to offer access control mechanisms and a very high degree of robustness to avoid functional errors and to withstand manipulation by third parties;

2. (b)

   safe termination and interruption, to ensure that a mechanism exists to terminate the continued execution of transactions and that the smart contract includes internal functions which can reset or instruct the contract to stop or interrupt the operation, in particular to avoid future accidental executions;

3. (c)

   data archiving and continuity, to ensure, in circumstances in which a smart contract must be terminated or deactivated, there is a possibility to archive the transactional data, smart contract logic and code in order to keep the record of operations performed on the data in the past (auditability);

4. (d)

   access control, to ensure that a smart contract is protected through rigorous access control mechanisms at the governance and smart contract layers; and

5. (e)

   consistency, to ensure consistency with the terms of the data sharing agreement that the smart contract executes.

The vendor of a smart contract or, in the absence thereof, the person whose trade, business or profession involves the deployment of smart contracts for others in the context of executing an agreement or part of it, to make data available shall perform a conformity assessment with a view to fulfilling the essential requirements laid down in paragraph 1 and, on the fulfilment of those requirements, issue an EU declaration of conformity.

By drawing up the EU declaration of conformity, the vendor of an application using smart contracts or, in the absence thereof, the person whose trade, business or profession involves the deployment of smart contracts for others in the context of executing an agreement or part of it, to make data available shall be responsible for compliance with the essential requirements laid down in paragraph 1.

A smart contract that meets the harmonised standards or the relevant parts thereof, the references of which are published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such harmonised standards or parts thereof.

The Commission shall, pursuant to Article 10 of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards that satisfy the essential requirements laid down in paragraph 1 of this Article.

The Commission may, by means of implementing acts, adopt common specifications covering any or all of the essential requirements laid down in paragraph 1 where the following conditions have been fulfilled:

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(2).

1. (a)

   the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard that satisfies the essential requirements laid down in paragraph 1 of this Article and:

   1. (i)

      the request has not been accepted;

   2. (ii)

      the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or

   3. (iii)

      the harmonised standards do not comply with the request; and

2. (b)

   no reference to harmonised standards covering the relevant essential requirements laid down in paragraph 1 of this Article is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period.

Before preparing a draft implementing act referred to in paragraph 6 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 6 of this Article have been fulfilled.

When preparing the draft implementing act referred to in paragraph 6, the Commission shall take into account the advice of the EDIB and views of other relevant bodies or expert groups and shall duly consult all relevant stakeholders.

The vendor of a smart contract or, in the absence thereof, the person whose trade, business or profession involves the deployment of smart contracts for others in the context of executing an agreement or part of it, to make data available that meet the common specifications established by implementing acts referred to in paragraph 6 or parts thereof shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such common specifications or parts thereof.

Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. Where the reference of a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 6 of this Article, or parts thereof which cover the same essential requirements as those covered by that harmonised standard.

When a Member State considers that a common specification does not entirely satisfy the essential requirements laid down in paragraph 1, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.

Each Member State shall designate one or more competent authorities to be responsible for the application and enforcement of this Regulation (competent authorities). Member States may establish one or more new authorities or rely on existing authorities.

Where a Member State designates more than one competent authority, it shall designate a data coordinator from among them to facilitate cooperation between the competent authorities and to assist entities within the scope of this Regulation on all matters related to its application and enforcement. Competent authorities shall, in the exercise of the tasks and powers assigned to them under paragraph 5, cooperate with each other.

The supervisory authorities responsible for monitoring the application of Regulation (EU) 2016/679 shall be responsible for monitoring the application of this Regulation insofar as the protection of personal data is concerned. Chapters VI and VII of Regulation (EU) 2016/679 shall apply mutatis mutandis.

The European Data Protection Supervisor shall be responsible for monitoring the application of this Regulation insofar as it concerns the Commission, the European Central Bank or Union bodies. Where relevant, Article 62 of Regulation (EU) 2018/1725 shall apply mutatis mutandis.

The tasks and powers of the supervisory authorities referred to in this paragraph shall be exercised with regard to the processing of personal data.

Without prejudice to paragraph 1 of this Article:

1. (a)

   for specific sectoral data access and use issues related to the application of this Regulation, the competence of sectoral authorities shall be respected;

2. (b)

   the competent authority responsible for the application and enforcement of Articles 23 to 31 and Articles 34 and 35 shall have experience in the field of data and electronic communications services.

Member States shall ensure that the tasks and powers of the competent authorities are clearly defined and include:

Where designated, the data coordinator shall facilitate the cooperation referred to in points (f), (g) and (h) of the first subparagraph and shall assist the competent authorities upon their request.

1. (a)

   promoting data literacy and awareness among users and entities falling within the scope of this Regulation of the rights and obligations under this Regulation;

2. (b)

   handling complaints arising from alleged infringements of this Regulation, including in relation to trade secrets, and investigating, to the extent appropriate, the subject matter of complaints and regularly informing complainants, where relevant in accordance with national law, of the progress and the outcome of the investigation within a reasonable period, in particular if further investigation or coordination with another competent authority is necessary;

3. (c)

   conducting investigations into matters that concern the application of this Regulation, including on the basis of information received from another competent authority or other public authority;

4. (d)

   imposing effective, proportionate and dissuasive financial penalties which may include periodic penalties and penalties with retroactive effect, or initiating legal proceedings for the imposition of fines;

5. (e)

   monitoring technological and relevant commercial developments of relevance for the making available and use of data;

6. (f)

   cooperating with competent authorities of other Member States and, where relevant, with the Commission or the EDIB, to ensure the consistent and efficient application of this Regulation, including the exchange of all relevant information by electronic means, without undue delay, including regarding paragraph 10 of this Article;

7. (g)

   cooperating with the relevant competent authorities responsible for the implementation of other Union or national legal acts, including with authorities competent in the field of data and electronic communication services, with the supervisory authority responsible for monitoring the application of Regulation (EU) 2016/679 or with sectoral authorities to ensure that this Regulation is enforced consistently with other Union and national law;

8. (h)

   cooperating with the relevant competent authorities to ensure that Articles 23 to 31 and Articles 34 and 35 are enforced consistently with other Union law and self-regulation applicable to providers of data processing services;

9. (i)

   ensuring that switching charges are withdrawn in accordance with Article 29;

10. (j)

    examining the requests for data made pursuant to Chapter V.

The data coordinator, where such competent authority has been designated, shall:

1. (a)

   act as the single point of contact for all issues related to the application of this Regulation;

2. (b)

   ensure the online public availability of requests to make data available made by public sector bodies in the case of exceptional need under Chapter V and promote voluntary data sharing agreements between public sector bodies and data holders;

3. (c)

   inform the Commission, on an annual basis, of the refusals notified under Article 4(2) and (8) and Article 5(11).

Member States shall notify the Commission of the names of the competent authorities and of their tasks and powers and, where applicable, the name of the data coordinator. The Commission shall maintain a public register of those authorities.

When carrying out their tasks and exercising their powers in accordance with this Regulation, competent authorities shall remain impartial and free from any external influence, whether direct or indirect, and shall neither seek nor take instructions for individual cases from any other public authority or any private party.

Member States shall ensure that the competent authorities are provided with sufficient human and technical resources and relevant expertise to effectively carry out their tasks in accordance with this Regulation.

Entities falling within the scope of this Regulation shall be subject to the competence of the Member State where the entity is established. Where the entity is established in more than one Member State, it shall be considered to be under the competence of the Member State in which it has its main establishment, that is, where the entity has its head office or registered office from which the principal financial functions and operational control are exercised.

Any entity falling within the scope of this Regulation that makes connected products available or offers services in the Union, and which is not established in the Union, shall designate a legal representative in one of the Member States.

For the purpose of ensuring compliance with this Regulation, a legal representative shall be mandated by an entity falling within the scope of this Regulation that makes connected products available or offers services in the Union to be addressed in addition to or instead of it by competent authorities with regard to all issues related to that entity. That legal representative shall cooperate with and comprehensively demonstrate to the competent authorities, upon request, the actions taken and provisions put in place by the entity falling within the scope of this Regulation that makes connected products available or offers services in the Union to ensure compliance with this Regulation.

An entity falling within the scope of this Regulation that makes connected products available or offers services in the Union, shall be considered to be under the competence of the Member State in which its legal representative is located. The designation of a legal representative by such an entity shall be without prejudice to the liability of, and any legal action that could be initiated against, such an entity. Until such time as an entity designates a legal representative in accordance with this Article, it shall be under the competence of all Member States, where applicable, for the purposes of ensuring the application and enforcement of this Regulation. Any competent authority may exercise its competence, including by imposing effective, proportionate and dissuasive penalties, provided that the entity is not subject to enforcement proceedings under this Regulation regarding the same facts by another competent authority.

Competent authorities shall have the power to request from users, data holders, or data recipients, or their legal representatives, falling under the competence of their Member State all information necessary to verify compliance with this Regulation. Any request for information shall be proportionate to the performance of the underlying task and shall be reasoned.

Where a competent authority in one Member State requests assistance or enforcement measures from a competent authority in another Member State, it shall submit a reasoned request. A competent authority shall, upon receiving such a request, provide a response, detailing the actions that have been taken or which are intended to be taken, without undue delay.

Competent authorities shall respect the principles of confidentiality and of professional and commercial secrecy and shall protect personal data in accordance with Union or national law. Any information exchanged in the context of a request for assistance and provided pursuant to this Article shall be used only in respect of the matter for which it was requested.

Where a Member State designates more than one competent authority, it shall designate a data coordinator from among them to facilitate cooperation between the competent authorities and to assist entities within the scope of this Regulation on all matters related to its application and enforcement. Competent authorities shall, in the exercise of the tasks and powers assigned to them under paragraph 5, cooperate with each other.

Without prejudice to paragraph 1 of this Article:

1. (a)

   for specific sectoral data access and use issues related to the application of this Regulation, the competence of sectoral authorities shall be respected;

2. (b)

   the competent authority responsible for the application and enforcement of Articles 23 to 31 and Articles 34 and 35 shall have experience in the field of data and electronic communications services.

Member States shall ensure that the tasks and powers of the competent authorities are clearly defined and include:

Where designated, the data coordinator shall facilitate the cooperation referred to in points (f), (g) and (h) of the first subparagraph and shall assist the competent authorities upon their request.

1. (a)

   promoting data literacy and awareness among users and entities falling within the scope of this Regulation of the rights and obligations under this Regulation;

2. (b)

   handling complaints arising from alleged infringements of this Regulation, including in relation to trade secrets, and investigating, to the extent appropriate, the subject matter of complaints and regularly informing complainants, where relevant in accordance with national law, of the progress and the outcome of the investigation within a reasonable period, in particular if further investigation or coordination with another competent authority is necessary;

3. (c)

   conducting investigations into matters that concern the application of this Regulation, including on the basis of information received from another competent authority or other public authority;

4. (d)

   imposing effective, proportionate and dissuasive financial penalties which may include periodic penalties and penalties with retroactive effect, or initiating legal proceedings for the imposition of fines;

5. (e)

   monitoring technological and relevant commercial developments of relevance for the making available and use of data;

6. (f)

   cooperating with competent authorities of other Member States and, where relevant, with the Commission, or the EDIB, or BEREC, to ensure the consistent and efficient application of this Regulation, including the exchange of all relevant information by electronic means, without undue delay, including regarding paragraph 10 of this Article

7. (g)

   cooperating with the relevant competent authorities responsible for the implementation of other Union or national legal acts, including with authorities competent in the field of data and electronic communication services, with the supervisory authority responsible for monitoring the application of Regulation (EU) 2016/679 or with sectoral authorities to ensure that this Regulation is enforced consistently with other Union and national law, including the exchange of all relevant information

8. (h)

   cooperating with the relevant competent authorities to ensure that Articles 23 to 31 and Articles 34 and 35 are enforced consistently with other Union law and self-regulation applicable to providers of data processing services;

9. (i)

   ensuring that switching charges are withdrawn in accordance with Article 29;

10. (j)

    examining the requests for data made pursuant to Chapter V.

The data coordinator, where such competent authority has been designated, shall:

1. (a)

   act as the single point of contact for all issues related to the application of this Regulation;

2. (b)

   ensure the online public availability of requests to make data available made by public sector bodies in the case of exceptional need under Chapter V and promote voluntary data sharing agreements between public sector bodies and data holders;

3. (c)

   inform the Commission, on an annual basis, of the refusals notified under Article 4(2) and (8) and Article 5(11).

Member States shall notify the Commission of the names of the competent authorities and of their tasks and powers and, where applicable, the name of the data coordinator. The Commission shall maintain a public register of those authorities.

When carrying out their tasks and exercising their powers in accordance with this Regulation, competent authorities shall remain impartial and free from any external influence, whether direct or indirect, and shall neither seek nor take instructions for individual cases from any other public authority or any private party.

Member States shall ensure that the competent authorities are provided with sufficient human and technical resources and relevant expertise to effectively carry out their tasks in accordance with this Regulation.

Entities falling within the scope of this Regulation shall be subject to the competence of the Member State where the entity is established. Where the entity is established in more than one Member State, it shall be considered to be under the competence of the Member State in which it has its main establishment, that is, where the entity has its head office or registered office from which the principal financial functions and operational control are exercised.

Any entity falling within the scope of this Regulation that makes connected products available or offers services in the Union, and which is not established in the Union, shall designate a legal representative in one of the Member States.

For the purpose of ensuring compliance with this Regulation, a legal representative shall be mandated by an entity falling within the scope of this Regulation that makes connected products available or offers services in the Union to be addressed in addition to or instead of it by competent authorities with regard to all issues related to that entity. That legal representative shall cooperate with and comprehensively demonstrate to the competent authorities, upon request, the actions taken and provisions put in place by the entity falling within the scope of this Regulation that makes connected products available or offers services in the Union to ensure compliance with this Regulation.

An entity falling within the scope of this Regulation that makes connected products available or offers services in the Union, shall be considered to be under the competence of the Member State in which its legal representative is located. The designation of a legal representative by such an entity shall be without prejudice to the liability of, and any legal action that could be initiated against, such an entity. Until such time as an entity designates a legal representative in accordance with this Article, it shall be under the competence of all Member States, where applicable, for the purposes of ensuring the application and enforcement of this Regulation. Any competent authority may exercise its competence, including by imposing effective, proportionate and dissuasive penalties, provided that the entity is not subject to enforcement proceedings under this Regulation regarding the same facts by another competent authority.

Competent authorities shall have the power to request from users, data holders, or data recipients, or their legal representatives, falling under the competence of their Member State all information necessary to verify compliance with this Regulation. Any request for information shall be proportionate to the performance of the underlying task and shall be reasoned.

Where a competent authority in one Member State requests assistance or enforcement measures from a competent authority in another Member State, it shall submit a reasoned request. A competent authority shall, upon receiving such a request, provide a response, detailing the actions that have been taken or which are intended to be taken, without undue delay.

Competent authorities shall respect the principles of confidentiality and of professional and commercial secrecy and shall protect personal data in accordance with Union or national law. Any information exchanged in the context of a request for assistance and provided pursuant to this Article shall be used only in respect of the matter for which it was requested.

Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint, individually or, where relevant, collectively, with the relevant competent authority in the Member State of their habitual residence, place of work or establishment if they consider that their rights under this Regulation have been infringed. The data coordinator shall, upon request, provide all the necessary information to natural and legal persons for the lodging of their complaints with the appropriate competent authority.

The competent authority with which the complaint has been lodged shall inform the complainant, in accordance with national law, of the progress of the proceedings and of the decision taken.

Competent authorities shall cooperate to handle and resolve complaints effectively and in a timely manner, including by exchanging all relevant information by electronic means, without undue delay. This cooperation shall not affect the cooperation mechanisms provided for by Chapters VI and VII of Regulation (EU) 2016/679 and by Regulation (EU) 2017/2394.

Notwithstanding any administrative or other non-judicial remedy, any affected natural and legal person shall have the right to an effective judicial remedy with regard to legally binding decisions taken by competent authorities.

Where a competent authority fails to act on a complaint, any affected natural and legal person 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.

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

Notwithstanding any administrative or other non-judicial remedy, any affected natural and legal person shall have the right to an effective judicial remedy with regard to legally binding decisions taken by competent authorities.

Where a competent authority fails to act on a complaint, any affected natural and legal person 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.

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

Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.

Member States shall by 12 September 2025 notify the Commission of those rules and measures and shall notify it without delay of any subsequent amendment affecting them. The Commission shall regularly update and maintain an easily accessible public register of those measures.

Member States shall take into account the recommendations of the EDIB and the following non-exhaustive criteria for the imposition of penalties for infringements of this Regulation:

1. (a)

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

2. (b)

   any action taken by the infringing party to mitigate or remedy the damage caused by the infringement;

3. (c)

   any previous infringements by the infringing party;

4. (d)

   the financial benefits gained or losses avoided by the infringing party due to the infringement, insofar as such benefits or losses can be reliably established;

5. (e)

   any other aggravating or mitigating factor applicable to the circumstances of the case;

6. (f)

   infringing party’s annual turnover in the preceding financial year in the Union.

For infringements of the obligations laid down in Chapter II, III and V of this Regulation, the supervisory authorities responsible for monitoring the application of Regulation (EU) 2016/679 may within their scope of competence impose administrative fines in accordance with Article 83 of Regulation (EU) 2016/679 and up to the amount referred to in Article 83(5) of that Regulation.

For infringements of the obligations laid down in Chapter V of this Regulation, the European Data Protection Supervisor may impose within its scope of competence administrative fines in accordance with Article 66 of Regulation (EU) 2018/1725 up to the amount referred to in Article 66(3) of that Regulation.

Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.

Member States shall by 12 September 2025 notify the Commission of those rules and measures and shall notify it without delay of any subsequent amendment affecting them. The Commission shall regularly update and maintain an easily accessible public register of those measures.

Member States shall take into account the recommendations of the EDIB and the following non-exhaustive criteria for the imposition of penalties for infringements of this Regulation:

1. (a)

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

2. (b)

   any action taken by the infringing party to mitigate or remedy the damage caused by the infringement;

3. (c)

   any previous infringements by the infringing party;

4. (d)

   the financial benefits gained or losses avoided by the infringing party due to the infringement, insofar as such benefits or losses can be reliably established;

5. (e)

   any other aggravating or mitigating factor applicable to the circumstances of the case;

6. (f)

   infringing party’s annual turnover in the preceding financial year in the Union.

For infringements of the obligations laid down in Chapter II, III and V of this Regulation, the supervisory authorities responsible for monitoring the application of Regulation (EU) 2016/679 may within their scope of competence impose administrative fines in accordance with Article 83 of Regulation (EU) 2016/679 and up to the amount referred to in Article 83(5) of that Regulation.

For infringements of the obligations laid down in Chapter V of this Regulation, the European Data Protection Supervisor may impose within its scope of competence administrative fines in accordance with Article 66 of Regulation (EU) 2018/1725 up to the amount referred to in Article 66(3) of that Regulation.

advising and assisting the Commission with regard to developing consistent practice of competent authorities in the enforcement of Chapters II, III, V and VII;

facilitating cooperation between competent authorities through capacity-building and the exchange of information, in particular by establishing methods for the efficient exchange of information relating to the enforcement of the rights and obligations under Chapters II, III and V in cross-border cases, including coordination with regard to the setting of penalties;

advising and assisting the Commission with regard to:

1. (i)

   whether to request the drafting of harmonised standards referred to in Article 33(4), Article 35(4) and Article 36(5);

2. (ii)

   the preparation of the implementing acts referred to in Article 33(5), Article 35(5) and (8) and Article 36(6);

3. (iii)

   the preparation of the delegated acts referred to in Article 29(7) and Article 33(2); and

4. (iv)

   the adoption of the guidelines laying down interoperable frameworks for common standards and practices for the functioning of common European data spaces referred to in Article 33(11).

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 29(7) and Article 33(2) shall be conferred on the Commission for an indeterminate period of time from 11 January 2024.

The delegation of power referred to in Article 29(7) and Article 33(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of 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 29(7) or Article 33(2) 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 power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

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.

The Commission shall be assisted by the Committee established by Regulation (EU) 2022/868. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

Where reference is made to this paragraph, Article 5 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.

By 12 September 2028, the Commission shall carry out an evaluation of this Regulation and submit a report on its main findings to the European Parliament and to the Council, and to the European Economic and Social Committee. That evaluation shall assess, in particular:

1. (a)

   situations to be considered to be situations of exceptional need for the purpose of Article 15 of this Regulation and the application of Chapter V of this Regulation in practice, in particular the experience in the application of Chapter V of this Regulation by public sector bodies, the Commission, the European Central Bank and Union bodies; the number and outcome of the proceedings brought to the competent authority under Article 18(5) on the application of Chapter V of this Regulation, as reported by the competent authorities; the impact of other obligations laid down in Union or national law for the purposes of complying with requests for access to information; the impact of voluntary data-sharing mechanisms, such as those put in place by data altruism organisations recognised under Regulation (EU) 2022/868, on meeting the objectives of Chapter V of this Regulation, and the role of personal data in the context of Article 15 of this Regulation, including the evolution of privacy-enhancing technologies;

2. (b)

   the impact of this Regulation on the use of data in the economy, including on data innovation, data monetisation practices and data intermediation services, as well as on data sharing within the common European data spaces;

3. (c)

   the accessibility and use of different categories and types of data;

4. (d)

   the exclusion of certain categories of enterprises as beneficiaries under Article 5;

5. (e)

   the absence of any impact on intellectual property rights;

6. (f)

   the impact on trade secrets, including on the protection against their unlawful acquisition, use and disclosure, as well as the impact of the mechanism allowing the data holder to refuse the user’s request under Article 4(8) and Article 5(11), taking into account, to the extent possible, any revision of Directive (EU) 2016/943;

7. (g)

   whether the list of unfair contractual terms referred to in Article 13 is up-to-date in light of new business practices and the rapid pace of market innovation;

8. (h)

   changes in the contractual practices of providers of data processing services and whether this results in sufficient compliance with Article 25;

9. (i)

   the diminution of charges imposed by providers of data processing services for the switching process, in line with the gradual withdrawal of switching charges pursuant to Article 29;

10. (j)

    the interplay of this Regulation with other Union legal acts of relevance to the data economy;

11. (k)

    the prevention of unlawful governmental access to non-personal data;

12. (l)

    the efficacy of the enforcement regime required under Article 37;

13. (m)

    the impact of this Regulation on SMEs with regard to their capacity to innovate and to the availability of data processing services for users in the Union and the burden of complying with new obligations.

By 12 September 2028, the Commission shall carry out an evaluation of this Regulation and submit a report on its main findings to the European Parliament and to the Council, and to the European Economic and Social Committee. That evaluation shall assess the impact of Articles 23 to 31 and Articles 34 and 35, in particular regarding pricing and the diversity of data processing services offered within the Union, with a special focus on SME providers.

Member States shall provide the Commission with the information necessary for the preparation of the reports referred to in paragraphs 1 and 2.

On the basis of the reports referred to in paragraphs 1 and 2, the Commission may, where appropriate, submit a legislative proposal to the European Parliament and to the Council to amend this Regulation.