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Article 1

Subject matter and scope

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

(a)

the making available of product data and related_service data to the user of the connected_product or related_service;

(b)

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

(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 7

Scope of business-to- consumer and business-to-business data sharing obligations

1.   The obligations of this Chapter shall not apply to data generated through the use of connected_products manufactured or designed or related_services provided by a micro enterprise or a small enterprise, provided that that enterprise does not have a partner enterprise or a linked enterprise within the meaning of Article 3 of the Annex to Recommendation 2003/361/EC that does not qualify as a micro enterprise or a small enterprise and where the micro enterprise and small enterprise is not subcontracted to manufacture or design a connected_product or to provide a related_service.

The same shall apply to data generated through the use of connected_products manufactured by or related_services provided by an enterprise that has qualified as a medium-sized enterprise under Article 2 of the Annex to Recommendation 2003/361/EC for less than one year and to connected_products for one year after the date on which they were placed on the market by a medium-sized enterprise.

2.   Any contractual term which, to the detriment of the user, excludes the application of, derogates from or varies the effect of the user’s rights under this Chapter shall not be binding on the user.

CHAPTER III

OBLIGATIONS FOR DATA HOLDERS OBLIGED TO MAKE DATA AVAILABLE PURSUANT TO UNION LAW

Article 8

Conditions under which data holders make data available to data recipients

1.   Where, in business-to-business relations, a data holder is obliged to make data available to a data recipient under Article 5 or under other applicable Union law or national legislation adopted in accordance with Union law, it shall agree with a data recipient the arrangements for making the data available and shall do so under fair, reasonable and non-discriminatory terms and conditions and in a transparent manner in accordance with this Chapter and Chapter IV.

2.   A contractual term concerning access to and the use of data, or liability and remedies for the breach or termination of data-related obligations, shall not be binding if it constitutes an unfair contractual term within the meaning of Article 13 or if, to the detriment of the user, it excludes the application of, derogates from or varies the effect of the user’s rights under Chapter II.

3.   A data holder shall not discriminate regarding the arrangements for making data available between comparable categories of data recipients, including partner enterprises or linked enterprises of the data holder when making data available. Where a data recipient considers that the conditions under which data has been made available to it are discriminatory, the data holder shall without undue delay provide the data recipient, upon its reasoned request, with information showing that there has been no discrimination.

4.   A data holder shall not make data available to a data recipient, including on an exclusive basis, unless requested to do so by the user under Chapter II.

5.   Data holders and data recipients shall not be required to provide any information beyond what is necessary to verify compliance with the contractual terms agreed for making data available or with their obligations under this Regulation or other applicable Union law or national legislation adopted in accordance with Union law.

6.   Unless otherwise provided for in Union law, including Article 4(6) and Article 5(9) of this Regulation, or by national legislation adopted in accordance with Union law, an obligation to make data available to a data recipient shall not oblige the disclosure of trade_secrets.

Article 9

Compensation for making data available

1.   Any compensation agreed upon between a data holder and a data recipient for making data available in business-to-business relations shall be non- discriminatory and reasonable and may include a margin.

2.   When agreeing on any compensation, the data holder and the data recipient shall take into account in particular:

(a)

costs incurred in making the data available, including, in particular, the costs necessary for the formatting of data, dissemination via electronic means and storage;

(b)

investments in the collection and production of data, where applicable, taking into account whether other parties contributed to obtaining, generating or collecting the data in question.

3.   The compensation referred to in paragraph 1 may also depend on the volume, format and nature of the data.

4.   Where the data recipient is an SME or a not-for-profit research organisation and where such a data recipient does not have partner enterprises or linked enterprises that do not qualify as SMEs, any compensation agreed shall not exceed the costs referred to in paragraph 2, point (a).

5.   The Commission shall adopt guidelines on the calculation of reasonable compensation, taking into account the advice of the European Data Innovation Board (EDIB) referred to in Article 42.

6.   This Article shall not preclude other Union law or national legislation adopted in accordance with Union law from excluding compensation for making data available or providing for lower compensation.

7.   The data holder shall provide the data recipient with information setting out the basis for the calculation of the compensation in sufficient detail so that the data recipient can assess whether the requirements of paragraphs 1 to 4 are met.

Article 12

Scope of obligations for data holders obliged pursuant to Union law to make data available

1.   This Chapter shall apply where, in business-to-business relations, a data holder is obliged under Article 5 or under applicable Union law or national legislation adopted in accordance with Union law, to make data available to a data recipient.

2.   A contractual term in a data sharing agreement which, to the detriment of one party, or, where applicable, to the detriment of the user, excludes the application of this Chapter, derogates from it, or varies its effect, shall not be binding on that party.

CHAPTER IV

UNFAIR CONTRACTUAL TERMS RELATED TO DATA ACCESS AND USE BETWEEN ENTERPRISES

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 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 44

Other Union legal acts governing rights and obligations on data access and use

1.   The specific obligations for the making available of data between businesses, between businesses and consumers, and on exceptional basis between businesses and public bodies, in Union legal acts that entered into force on or before 11 January 2024, and delegated or implementing acts pursuant thereto, shall remain unaffected.

2.   This Regulation is without prejudice to Union law specifying, in light of the needs of a sector, a common European data space, or an area of public interest, further requirements, in particular in relation to:

(a)

technical aspects of data access;

(b)

limits on the rights of data holders to access or use certain data provided by users;

(c)

aspects going beyond data access and use.

3.   This Regulation, with the exception of Chapter V, is without prejudice to Union and national law providing for access to and authorising the use of data for scientific research purposes.

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









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