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 17

Requests for data to be made available

1. When requesting data pursuant to Article 14, a public_sector_body, the Commission, the European Central Bank or a Union body shall:

(a)	specify the data required, including the relevant meta data necessary to interpret and use those data;

(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;

(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;

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

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

(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;

(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;

(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;

(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;

(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.

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

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

(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;

(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;

(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;

(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;

(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;

(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;

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

(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.

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

3. 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.

4. 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.

5. 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.

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

Article 25

Contractual terms concerning switching

1. The rights of the customer and the obligations of the provider of data processing services in relation to switching between providers of such services or, where applicable, to an on-premises_ICT_infrastructure shall be clearly set out in a written contract. The provider of data processing services shall make that contract available to the customer prior to signing the contract in a way that allows the customer to store and reproduce the contract.

2. Without prejudice to Directive (EU) 2019/770, the contract referred to in paragraph 1 of this Article shall include at least the following:

(a)

clauses allowing the customer, upon request, to switch to a data processing service offered by a different provider of data processing services or to port all exportable data and digital_assets to an on-premises_ICT_infrastructure, without undue delay and in any event not after the mandatory maximum transitional period of 30 calendar days, to be initiated after the maximum notice period referred to in point (d), during which the service contract remains applicable and during which the provider of data processing services shall:

(i)	provide reasonable assistance to the customer and third parties authorised by the customer in the switching process;

(ii)	act with due care to maintain business continuity, and continue the provision of the functions or services under the contract;

(iii)

provide clear information concerning known risks to continuity in the provision of the functions or services on the part of the source provider of data processing services;

(iv)	ensure that a high level of security is maintained throughout the switching process, in particular the security of the data during their transfer and the continued security of the data during the retrieval period specified in point (g), in accordance with applicable Union or national law;

(b)	an obligation of the provider of data processing services to support the customer’s exit strategy relevant to the contracted services, including by providing all relevant information;

(c)

a clause specifying that the contract shall be considered to be terminated and the customer shall be notified of the termination, in one of the following cases:

(i)	where applicable, upon the successful completion of the switching process;

(ii)	at the end of the maximum notice period referred to in paragraph (d), where the customer does not wish to switch but to erase its exportable data and digital_assets upon service termination;

(d)	a maximum notice period for initiation of the switching process, which shall not exceed two months;

(e)	an exhaustive specification of all categories of data and digital_assets that can be ported during the switching process, including, at a minimum, all exportable data;

(f)

an exhaustive specification of categories of data specific to the internal functioning of the provider’s data processing service that are to be exempted from the exportable data under point (e) of this paragraph where a risk of breach of trade_secrets of the provider exists, provided that such exemptions do not impede or delay the switching process provided for in Article 23;

(g)	a minimum period for data retrieval of at least 30 calendar days, starting after the termination of the transitional period that was agreed between the customer and the provider of data processing services, in accordance with point (a) of this paragraph and paragraph 4;

(h)

a clause guaranteeing full erasure of all exportable data and digital_assets generated directly by the customer, or relating to the customer directly, after the expiry of the retrieval period referred to in point (g) or after the expiry of an alternative agreed period at a date later than the date of expiry of the retrieval period referred to in point (g), provided that the switching process has been completed successfully;

(i)	switching charges, that may be imposed by providers of data processing services in accordance with Article 29.

3. The contract referred to in paragraph 1 shall include clauses providing that the customer may notify the provider of data processing services of its decision to perform one or more of the following actions upon termination of the maximum notice period referred to in paragraph 2, point (d):

(a)	switch to a different provider of data processing services, in which case the customer shall provide the necessary details of that provider;

(b)	switch to an on-premises_ICT_infrastructure;

(c)	erase its exportable data and digital_assets.

4. Where the mandatory maximum transitional period as provided for in paragraph 2, point (a) is technically unfeasible, the provider of data processing services shall notify the customer within 14 working days of the making of the switching request, and shall duly justify the technical unfeasibility and indicate an alternative transitional period, which shall not exceed seven months. In accordance with paragraph 1, service continuity shall be ensured throughout the alternative transitional period.

5. Without prejudice to paragraph 4, the contract referred to in paragraph 1 shall include clauses providing the customer with the right to extend the transitional period once for a period that the customer considers more appropriate for its own purposes.

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 36

Essential requirements regarding smart_contracts for executing data sharing agreements

1. 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:

(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;

(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;

(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);

(d)	access control, to ensure that a smart_contract is protected through rigorous access control mechanisms at the governance and smart_contract layers; and

(e)	consistency, to ensure consistency with the terms of the data sharing agreement that the smart_contract executes.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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:

(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:

(i)	the request has not been accepted;

(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

(iii)

the harmonised_standards do not comply with the request; and

(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.

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

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

CHAPTER IX

IMPLEMENTATION AND ENFORCEMENT

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.

whereas

keyboard_tab Data Act 2023/2854 EN

Data Act 2023/2854 EN