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037 Article 37

Cité d’après 32023R2854, eng, le libellé original du 2023-12-13 (la date de l’acte dans le paquet Formex de l’éditeur).

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.

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Article 37 of Regulation (EU) 2023/2854, as at 13 December 2023
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Article 37 of Regulation (EU) 2023/2854, as at 13 December 2023
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CELEX: 32023R2854

Wording: the original wording of 2023-12-13

Published in: the Official Journal reference is not held by this index.

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50 articles cités ; détenus sans texte : 0.

Sommaire
  1. Page 1 : Article 1 à Article 32
  2. Page 2 : Article 33 à Article 50

Page 2 sur 2 : Article 33 à Article 50.

  1. 033 Article 33

    Article 33 Essential requirements regarding interoperability of data, of data sharing mechanisms and services, as well as of common European data spaces 1. Participants in data spaces that offer data or data services to other participants shall comply with the following essential requirements to facilitate the interoperability of data, of data sharing mechanisms and services, as well as of common European data spaces which are purpose- or sector-specific or cross-sectoral interoperable frameworks for common standards and practices to share or jointly process data for, inter alia, the development of new products and services, scientific research or civil society initiatives: (a) the dataset content, use restrictions, licences, data collection methodology, data quality and uncertainty shall be sufficiently described, where applicable, in a machine-readable format, to allow the recipient to find, access and use the data; (b) the data structures, data formats, vocabularies, classification schemes, taxonomies and code lists, where available, shall be described in a publicly available and consistent manner; (c) the technical means to access the data, such as application programming interfaces, and their terms of use and quality of service shall be sufficiently described to enable automatic access and transmission of data between parties, including continuously, in bulk download or in real-time in a machine-readable format where that is technically feasible and does not hamper the good functioning of the connected product; (d) where applicable, the means to enable the interoperability of tools for automating the execution of data sharing agreements, such as smart contracts shall be provided. The requirements can have a generic nature or concern specific sectors, while taking fully into account the interrelation with requirements arising from other Union or national law. 2. The Commission is empowered to adopt delegated acts, in accordance with Article 45 of this Regulation to supplement this Regulation by further specifying the essential requirements laid down in paragraph 1 of this Article, in relation to those requirements that, by their nature, cannot produce the intended effect unless they are further specified in binding Union legal acts and in order to properly reflect technological and market developments. The Commission shall when adopting delegated acts take into account the advice of the EDIB in accordance with Article 42, point (c)(iii). 3. The participants in data spaces that offer data or data services to other participants in data spaces which meet the harmonised standards or parts thereof, the references of which are published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such harmonised standards or parts thereof. 4. 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. 5. 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). 6. Before preparing a draft implementing act referred to in paragraph 5 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 5 of this Article have been fulfilled. 7. When preparing the draft implementing act referred to in paragraph 5, the Commission shall take into account the advice of the EDIB and views of other relevant bodies or expert groups and shall duly consult all relevant stakeholders. 8. The participants in data spaces that offer data or data services to other participants in data spaces that meet the common specifications established by implementing acts referred to in paragraph 5 or parts thereof shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such common specifications or parts thereof. 9. Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. Where the reference of a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 5 of this Article, or parts thereof which cover the same essential requirements as those covered by that harmonised standard. 10. 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. 11. The Commission may adopt guidelines taking into account the proposal of the EDIB in accordance with Article 30, point (h), of Regulation (EU) 2022/868 laying down interoperable frameworks for common standards and practices for the functioning of common European data spaces.

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  2. 034 Article 34

    Article 34 Interoperability for the purposes of in-parallel use of data processing services 1. The requirements laid down in Article 23, Article 24, Article 25(2), points (a)(ii), (a)(iv), (e) and (f) and Article 30(2) to (5) shall also apply mutatis mutandis to providers of data processing services to facilitate interoperability for the purposes of in-parallel use of data processing services. 2. Where a data processing service is being used in parallel with another data processing service, the providers of data processing services may impose data egress charges, but only for the purpose of passing on egress costs incurred, without exceeding such costs.

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  3. 035 Article 35

    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 metadata 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).

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  4. 036 Article 36

    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.

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  5. 037 Article 37

    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.

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  6. 038 Article 38

    Article 38 Right to lodge a complaint 1. Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint, individually or, where relevant, collectively, with the relevant competent authority in the Member State of their habitual residence, place of work or establishment if they consider that their rights under this Regulation have been infringed. The data coordinator shall, upon request, provide all the necessary information to natural and legal persons for the lodging of their complaints with the appropriate competent authority. 2. The competent authority with which the complaint has been lodged shall inform the complainant, in accordance with national law, of the progress of the proceedings and of the decision taken. 3. Competent authorities shall cooperate to handle and resolve complaints effectively and in a timely manner, including by exchanging all relevant information by electronic means, without undue delay. This cooperation shall not affect the cooperation mechanisms provided for by Chapters VI and VII of Regulation (EU) 2016/679 and by Regulation (EU) 2017/2394.

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  7. 039 Article 39

    Article 39 Right to an effective judicial remedy 1. Notwithstanding any administrative or other non-judicial remedy, any affected natural and legal person shall have the right to an effective judicial remedy with regard to legally binding decisions taken by competent authorities. 2. Where a competent authority fails to act on a complaint, any affected natural and legal person shall, in accordance with national law, either have the right to an effective judicial remedy or access to review by an impartial body with the appropriate expertise. 3. Proceedings pursuant to this Article shall be brought before the courts or tribunals of the Member State of the competent authority against which the judicial remedy is sought individually or, where relevant, collectively by the representatives of one or more natural or legal persons.

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  8. 040 Article 40

    Article 40 Penalties 1. Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. 2. Member States shall by 12 September 2025 notify the Commission of those rules and measures and shall notify it without delay of any subsequent amendment affecting them. The Commission shall regularly update and maintain an easily accessible public register of those measures. 3. Member States shall take into account the recommendations of the EDIB and the following non-exhaustive criteria for the imposition of penalties for infringements of this Regulation: (a) the nature, gravity, scale and duration of the infringement; (b) any action taken by the infringing party to mitigate or remedy the damage caused by the infringement; (c) any previous infringements by the infringing party; (d) the financial benefits gained or losses avoided by the infringing party due to the infringement, insofar as such benefits or losses can be reliably established; (e) any other aggravating or mitigating factor applicable to the circumstances of the case; (f) infringing party’s annual turnover in the preceding financial year in the Union. 4. For infringements of the obligations laid down in Chapter II, III and V of this Regulation, the supervisory authorities responsible for monitoring the application of Regulation (EU) 2016/679 may within their scope of competence impose administrative fines in accordance with Article 83 of Regulation (EU) 2016/679 and up to the amount referred to in Article 83(5) of that Regulation. 5. For infringements of the obligations laid down in Chapter V of this Regulation, the European Data Protection Supervisor may impose within its scope of competence administrative fines in accordance with Article 66 of Regulation (EU) 2018/1725 up to the amount referred to in Article 66(3) of that Regulation.

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  9. 041 Article 41

    Article 41 Model contractual terms and standard contractual clauses The Commission, before 12 September 2025, shall develop and recommend non-binding model contractual terms on data access and use, including terms on reasonable compensation and the protection of trade secrets, and non-binding standard contractual clauses for cloud computing contracts to assist parties in drafting and negotiating contracts with fair, reasonable and non-discriminatory contractual rights and obligations.

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  10. 042 Article 42

    Article 42 Role of the EDIB The EDIB established by the Commission as an expert group pursuant to Article 29 of Regulation (EU) 2022/868, in which competent authorities shall be represented, shall support the consistent application of this Regulation by: (a) advising and assisting the Commission with regard to developing consistent practice of competent authorities in the enforcement of Chapters II, III, V and VII; (b) facilitating cooperation between competent authorities through capacity-building and the exchange of information, in particular by establishing methods for the efficient exchange of information relating to the enforcement of the rights and obligations under Chapters II, III and V in cross-border cases, including coordination with regard to the setting of penalties; (c) advising and assisting the Commission with regard to: (i) whether to request the drafting of harmonised standards referred to in Article 33(4), Article 35(4) and Article 36(5); (ii) the preparation of the implementing acts referred to in Article 33(5), Article 35(5) and (8) and Article 36(6); (iii) the preparation of the delegated acts referred to in Article 29(7) and Article 33(2); and (iv) the adoption of the guidelines laying down interoperable frameworks for common standards and practices for the functioning of common European data spaces referred to in Article 33(11).

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  11. 043 Article 43

    Article 43 Databases containing certain data The sui generis right provided for in Article 7 of Directive 96/9/EC shall not apply when data is obtained from or generated by a connected product or related service falling within the scope of this Regulation, in particular in relation to Articles 4 and 5 thereof.

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  12. 044 Article 44

    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.

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  13. 045 Article 45

    Article 45 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 29(7) and Article 33(2) shall be conferred on the Commission for an indeterminate period of time from 11 January 2024. 3. The delegation of power referred to in Article 29(7) and Article 33(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 29(7) or Article 33(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.

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  14. 046 Article 46

    Article 46 Committee procedure 1. The Commission shall be assisted by the Committee established by Regulation (EU) 2022/868. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

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  15. 047 Article 47

    Article 47 Amendment to Regulation (EU) 2017/2394 In the Annex to Regulation (EU) 2017/2394 the following point is added: ‘29. Regulation (EU) 2023/2854 of the European Parliament and of the Council of 13 December 2023 on harmonised rules on fair access to and use of data and amending Regulation (EU) 2017/2394 and Directive (EU) 2020/1828 (Data Act) (OJ L, 2023/2854, 22.12.2023, ELI: http://data.europa.eu/eli/reg/2023/2854/oj).’

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  16. 048 Article 48

    Article 48 Amendment to Directive (EU) 2020/1828 In Annex I to Directive (EU) 2020/1828 the following point is added: ‘68. Regulation (EU) 2023/2854 of the European Parliament and of the Council of 13 December 2023 on harmonised rules on fair access to and use of data and amending Regulation (EU) 2017/2394 and Directive (EU) 2020/1828 (Data Act) (OJ L, 2023/2854, 22.12.2023, ELI: http://data.europa.eu/eli/reg/2023/2854/oj). ’

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  17. 049 Article 49

    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.

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  18. 050 Article 50

    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.

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