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expand index establishment:

    CHAPTER I
    GENERAL PROVISIONS
  • 3 Article 1 Subject matter and scope

  • CHAPTER II
    BUSINESS TO CONSUMER AND BUSINESS TO BUSINESS DATA SHARING

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

    CHAPTER IV
    UNFAIR CONTRACTUAL TERMS RELATED TO DATA ACCESS AND USE BETWEEN ENTERPRISES

    CHAPTER V
    MAKING DATA AVAILABLE TO PUBLIC SECTOR BODIES, THE COMMISSION, THE EUROPEAN CENTRAL BANK AND UNION BODIES ON THE BASIS OF AN EXCEPTIONAL NEED

    CHAPTER VI
    SWITCHING BETWEEN DATA PROCESSING SERVICES

    CHAPTER VII
    UNLAWFUL INTERNATIONAL GOVERNMENTAL ACCESS AND TRANSFER OF NON-PERSONAL DATA

    CHAPTER VIII
    INTEROPERABILITY

    CHAPTER IX
    IMPLEMENTATION AND ENFORCEMENT
  • 1 Article 37 Competent authorities and data coordinators
  • 1 Article 38 Right to lodge a complaint

  • CHAPTER X
    SUI GENERIS RIGHT UNDER DIRECTIVE 96/9/EC

    CHAPTER XI
    FINAL PROVISIONS


whereas establishment:


definitions:


cloud tag: and the number of total unique words without stopwords is: 651

 

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 37

Competent authorities and data coordinators

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

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

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

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

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

4.   Without prejudice to paragraph 1 of this Article:

(a)

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

(b)

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

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

(a)

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

(b)

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

(c)

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

(d)

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

(e)

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

(f)

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

(g)

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

(h)

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

(i)

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

(j)

examining the requests for data made pursuant to Chapter V.

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

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

(a)

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

(b)

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

(c)

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

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

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

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

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

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

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

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

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

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

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

Article 38

Right to lodge a complaint

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

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

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

Article 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)



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