Data Act 2023/2854 EN

(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;

(d)	facilitating switching between data processing services;

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

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

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

(a)	Chapter II applies to data, with the exception of content, concerning the performance, use and environment of connected_products and related_services;

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

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

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

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

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

3. This Regulation applies to:

(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;

(b)	users in the Union of connected_products or related_services as referred to in point (a);

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

(d)	data recipients in the Union to whom data are made available;

(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;

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

(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.

4. 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.

5. 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.

6. 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.

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

8. 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.

9. 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.

10. 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.

Article 2

Definitions

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

(1)	‘ 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;

(2)	‘meta data’ means a structured description of the contents or the use of data facilitating the discovery or use of that data;

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

(4)	‘non-personal data’ means data other than personal data;

(5)

‘ 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;

(6)

‘ 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;

(7)

‘ 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;

(8)

‘ 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;

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

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

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

(12)	‘ 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;

(13)

‘ 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;

(14)

‘ 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;

(15)	‘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;

(16)	‘ 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;

(17)	‘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;

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

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

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

(21)	‘ 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;

(22)	‘ placing_on_the_market’ means the first making available of a connected_product on the Union market;

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

(24)	‘ 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;

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

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

(27)	‘ 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;

(28)	‘ 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;

(29)

‘ 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;

(30)	‘ 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;

(31)	‘ 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;

(32)	‘ 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;

(33)	‘ 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;

(34)

‘ 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;

(35)	‘ 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;

(36)

‘ 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;

(37)

‘ 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;

(38)

‘exportable data’, for the purpose of Articles 23 to 31 and Article 35, means the input and output data, including meta data, 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;

(39)	‘ 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;

(40)	‘ 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;

(41)	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;

(42)	‘ 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;

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

CHAPTER II

BUSINESS TO CONSUMER AND BUSINESS TO BUSINESS DATA SHARING

Article 4

The rights and obligations of users and data holders with regard to access, use and making available product data and related_service data

1. 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 meta data 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.

2. 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.

3. 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:

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

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

4. 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.

5. 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.

6. 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 meta data, 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.

7. 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.

8. 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.

9. 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:

(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

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

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

Article 35

Interoperability of data processing services

1. Open interoperability specifications and harmonised_standards for the interoperability of data processing services shall:

(a)	achieve, where technically feasible, interoperability between different data processing services that cover the same_service_type;

(b)	enhance portability of digital_assets between different data processing services that cover the same_service_type;

(c)	facilitate, where technically feasible, functional_equivalence between different data processing services referred to in Article 30(1) that cover the same_service_type;

(d)	not have an adverse impact on the security and integrity of data processing services and data;

(e)	be designed in such a way so as to allow for technical advances and the inclusion of new functions and innovation in data processing services.

2. Open interoperability specifications and harmonised_standards for the interoperability of data processing services shall adequately address:

(a)	the cloud interoperability aspects of transport interoperability, syntactic interoperability, semantic data interoperability, behavioural interoperability and policy interoperability;

(b)	the cloud data portability aspects of data syntactic portability, data semantic portability and data policy portability;

(c)	the cloud application aspects of application syntactic portability, application instruction portability, application meta data portability, application behaviour portability and application policy portability.

3. Open interoperability specifications shall comply with Annex II to Regulation (EU) No 1025/2012.

4. After taking into account relevant international and European standards and self-regulatory initiatives, the Commission may, in accordance with Article 10(1) 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 paragraphs 1 and 2 of this Article.

5. The Commission may, by means of implementing acts, adopt common_specifications based on open interoperability specifications covering all of the essential requirements laid down in paragraphs 1 and 2.

6. When preparing the draft implementing act referred to in paragraph 5 of this Article, the Commission shall take into account the views of the relevant competent authorities referred to in Article 37(5), point (h) and other relevant bodies or expert groups and shall duly consult all relevant stakeholders.

7. When a Member State considers that a common specification does not entirely satisfy the essential requirements laid down in paragraphs 1 and 2, 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.

8. For the purpose of Article 30(3), the Commission shall, by means of implementing acts, publish the references of harmonised_standards and common_specifications for the interoperability of data processing services in a central Union standards repository for the interoperability of data processing services.

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

Article 37

Competent authorities and data coordinators

1. 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.

2. 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.

3. 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.

4. Without prejudice to paragraph 1 of this Article:

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

(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.

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

(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;

(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;

(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;

(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;

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

(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;

(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;

(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;

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

(j)	examining the requests for data made pursuant to Chapter V.

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.

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

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

(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;

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

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

Article 38

Right to lodge a complaint

1. 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.

2. 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.

3. 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.

Article 39

Right to an effective judicial remedy

1. 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.

2. 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.

3. 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.

Article 40

Penalties

1. 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.

2. 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.

3. 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:

(a)	the nature, gravity, scale and duration of the infringement;

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

(c)	any previous infringements by the infringing party;

(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;

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

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

4. 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.

5. 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.

Article 42

Role of the EDIB

The EDIB established by the Commission as an expert group pursuant to Article 29 of Regulation (EU) 2022/868, in which competent authorities shall be represented, shall support the consistent application of this Regulation by:

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

(b)

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;

(c)

advising and assisting the Commission with regard to:

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

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

(iii)

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

(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).

CHAPTER X

SUI GENERIS RIGHT UNDER DIRECTIVE 96/9/EC

Article 49

Evaluation and review

1. 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:

(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;

(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;

(c)	the accessibility and use of different categories and types of data;

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

(e)	the absence of any impact on intellectual property rights;

(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;

(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;

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

(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;

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

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

(l)	the efficacy of the enforcement regime required under Article 37;

(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.

2. 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.

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

4. 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.

Article 50

Entry into force and application

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

It shall apply from 12 September 2025.

The obligation resulting from Article 3(1) shall apply to connected_products and the services related to them placed on the market after 12 September 2026.

Chapter III shall apply in relation to obligations to make data available under Union law or national legislation adopted in accordance with Union law, which enters into force after 12 September 2025.

Chapter IV shall apply to contracts concluded after 12 September 2025.

Chapter IV shall apply from 12 September 2027 to contracts concluded on or before 12 September 2025 provided that they are:

(a)	of indefinite duration; or

(b)	due to expire at least 10 years from 11 January 2024.

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

Done at Strasbourg, 13 December 2023.

For the European Parliament

The President

R. METSOLA

For the Council

The President

P. NAVARRO RÍOS

(1) OJ C 402, 19.10.2022, p. 5.

(2) OJ C 365, 23.9.2022, p. 18.

(3) OJ C 375, 30.9.2022, p. 112.

(4) Position of the European Parliament of 9 November 2023 (not yet published in the Official Journal) and decision of the Council of 27 November 2023.

(5) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

(6) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

(7) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

(8) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).

(9) Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29).

(10) Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to- consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (‘Unfair Commercial Practices Directive’) (OJ L 149, 11.6.2005, p. 22).

(11) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64).

(12) Regulation (EU) 2021/784 of the European Parliament and of the Council of 29 April 2021 on addressing the dissemination of terrorist content online (OJ L 172, 17.5.2021, p. 79).

(13) Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1).

(14) Regulation (EU) 2023/1543 of the European Parliament and of the Council of 12 July 2023 on European Production Orders and European Preservation Orders for electronic evidence in criminal proceedings and for the execution of custodial sentences following criminal proceedings (OJ L 191, 28.7.2023, p. 118).

(15) Directive (EU) 2023/1544 of the European Parliament and of the Council of 12 July 2023 laying down harmonised rules on the designation of designated establishments and the appointment of legal representatives for the purpose of gathering electronic evidence in criminal proceedings (OJ L 191, 28.7.2023, p. 181).

(16) Regulation (EU) 2015/847 of the European Parliament and of the Council of 20 May 2015 on information accompanying transfers of funds and repealing Regulation (EC) No 1781/2006 (OJ L 141, 5.6.2015, p. 1).

(17) Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (OJ L 141, 5.6.2015, p. 73).

(18) Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (OJ L 151, 7.6.2019, p. 70).

(19) Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society (OJ L 167, 22.6.2001, p. 10).

(20) Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L 157, 30.4.2004, p. 45).

(21) Directive (EU) 2019/790 of the European Parliament and of the Council of 17 April 2019 on copyright and related rights in the Digital Single Market and amending Directives 96/9/EC and 2001/29/EC (OJ L 130, 17.5.2019, p. 92).

(22) Regulation (EU) 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance and amending Regulation (EU) 2018/1724 (Data Governance Act) (OJ L 152, 3.6.2022, p. 1).

(23) Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information ( trade_secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).

(24) Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer protection in the indication of the prices of products offered to consumers (OJ L 80, 18.3.1998, p. 27).

(25) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (‘Directive on electronic commerce’) (OJ L 178, 17.7.2000, p. 1).

(26) Regulation (EU) 2022/1925 of the European Parliament and of the Council of 14 September 2022 on contestable and fair markets in the digital sector and amending Directives (EU) 2019/1937 and (EU) 2020/1828 (Digital Markets Act) (OJ L 265, 12.10.2022, p. 1).

(27) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164).

(28) Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information (OJ L 172, 26.6.2019, p. 56).

(29) Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases (OJ L 77, 27.3.1996, p. 20).

(30) Regulation (EU) 2018/1807 of the European Parliament and of the Council of 14 November 2018 on a framework for the free flow of non-personal data in the European Union (OJ L 303, 28.11.2018, p. 59).

(31) Directive (EU) 2019/770 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the supply of digital content and digital services (OJ L 136, 22.5.2019, p. 1).

(32) Regulation (EU) 2022/2554 of the European Parliament and of the Council of 14 December 2022 on digital operational resilience for the financial sector and amending Regulations (EC) No 1060/2009, (EU) No 648/2012, (EU) No 600/2014, (EU) No 909/2014 and (EU) 2016/1011 (OJ L 333, 27.12.2022, p. 1).

(33) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).

(34) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).

(35) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).

(36) Regulation (EU) 2017/2394 of the European Parliament and of the Council of 12 December 2017 on cooperation between national authorities responsible for the enforcement of consumer protection laws and repealing Regulation (EC) No 2006/2004 (OJ L 345, 27.12.2017, p. 1).

(37) Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the protection of the collective interests of consumers and repealing Directive 2009/22/EC (OJ L 409, 4.12.2020, p. 1).

(38) OJ L 123, 12.5.2016, p. 1.

(39) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

ELI: http:// data.europa.eu/eli/reg/2023/2854/oj

ISSN 1977-0677 (electronic edition)

whereas

keyboard_tab Data Act 2023/2854 EN

Data Act 2023/2854 EN