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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 13

Unfair contractual terms unilaterally imposed on another enterprise

1.   A contractual term concerning access to and the use of data or liability and remedies for the breach or the termination of data related obligations, which has been unilaterally imposed by an enterprise on another enterprise, shall not be binding on the latter enterprise if it is unfair.

2.   A contractual term which reflects mandatory provisions of Union law, or provisions of Union law which would apply if the contractual terms did not regulate the matter, shall not be considered to be unfair.

3.   A contractual term is unfair if it is of such a nature that its use grossly deviates from good commercial practice in data access and use, contrary to good faith and fair dealing.

4.   In particular, a contractual term shall be unfair for the purposes of paragraph 3, if its object or effect is to:

(a)

exclude or limit the liability of the party that unilaterally imposed the term for intentional acts or gross negligence;

(b)

exclude the remedies available to the party upon whom the term has been unilaterally imposed in the case of non-performance of contractual obligations, or the liability of the party that unilaterally imposed the term in the case of a breach of those obligations;

(c)

give the party that unilaterally imposed the term the exclusive right to determine whether the data supplied are in conformity with the contract or to interpret any contractual term.

5.   A contractual term shall be presumed to be unfair for the purposes of paragraph 3 if its object or effect is to:

(a)

inappropriately limit remedies in the case of non-performance of contractual obligations or liability in the case of a breach of those obligations, or extend the liability of the enterprise upon whom the term has been unilaterally imposed;

(b)

allow the party that unilaterally imposed the term to access and use the data of the other contracting party in a manner that is significantly detrimental to the legitimate interests of the other contracting party, in particular when such data contain commercially sensitive data or are protected by trade_secrets or by intellectual property rights;

(c)

prevent the party upon whom the term has been unilaterally imposed from using the data provided or generated by that party during the period of the contract, or to limit the use of such data to the extent that that party is not entitled to use, capture, access or control such data or exploit the value of such data in an adequate manner;

(d)

prevent the party upon whom the term has been unilaterally imposed from terminating the agreement within a reasonable period;

(e)

prevent the party upon whom the term has been unilaterally imposed from obtaining a copy of the data provided or generated by that party during the period of the contract or within a reasonable period after the termination thereof;

(f)

enable the party that unilaterally imposed the term to terminate the contract at unreasonably short notice, taking into consideration any reasonable possibility of the other contracting party to switch to an alternative and comparable service and the financial detriment caused by such termination, except where there are serious grounds for so doing;

(g)

enable the party that unilaterally imposed the term to substantially change the price specified in the contract or any other substantive condition related to the nature, format, quality or quantity of the data to be shared, where no valid reason and no right of the other party to terminate the contract in the case of such a change is specified in the contract.

Point (g) of the first subparagraph shall not affect terms by which the party that unilaterally imposed the term reserves the right to unilaterally change the terms of a contract of an indeterminate duration, provided that the contract specified a valid reason for such unilateral changes, that the party that unilaterally imposed the term is required to provide the other contracting party with reasonable notice of any such intended change, and that the other contracting party is free to terminate the contract at no cost in the case of a change.

6.   A contractual term shall be considered to be unilaterally imposed within the meaning of this Article if it has been supplied by one contracting party and the other contracting party has not been able to influence its content despite an attempt to negotiate it. The contracting party that supplied the contractual term bears the burden of proving that that term has not been unilaterally imposed. The contracting party that supplied the contested contractual term may not argue that the term is an unfair contractual term.

7.   Where the unfair contractual term is severable from the remaining terms of the contract, those remaining terms shall be binding.

8.   This Article does not apply to contractual terms defining the main subject matter of the contract or to the adequacy of the price, as against the data supplied in exchange.

9.   The parties to a contract covered by paragraph 1 shall not exclude the application of this Article, derogate from it, or vary its effects.

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

Article 14

Obligation to make data available on the basis of an exceptional need

Where a public_sector_body, the Commission, the European Central Bank or a Union body demonstrates an exceptional need, as set out in Article 15, to use certain data, including the relevant meta data necessary to interpret and use those data, to carry out its statutory duties in the public interest, data holders that are legal persons, other than public sectors bodies, which hold those data shall make them available upon a duly reasoned request.

Article 15

Exceptional need to use data

1.   An exceptional need to use certain data within the meaning of this Chapter shall be limited in time and scope and shall be considered to exist only in any of the following circumstances:

(a)

where the data requested is necessary to respond to a public_emergency and the public_sector_body, the Commission, the European Central Bank or the Union body is unable to obtain such data by alternative means in a timely and effective manner under equivalent conditions;

(b)

in circumstances not covered by point (a) and only insofar as non-personal data is concerned, where:

(i)

a public_sector_body, the Commission, the European Central Bank or a Union body is acting on the basis of Union or national law and has identified specific data, the lack of which prevents it from fulfilling a specific task carried out in the public interest, that has been explicitly provided for by law, such as the production of official statistics or the mitigation of or recovery from a public_emergency; and

(ii)

the public_sector_body, the Commission, the European Central Bank or the Union body has exhausted all other means at its disposal to obtain such data, including purchase of non-personal data on the market by offering market rates, or by relying on existing obligations to make data available or the adoption of new legislative measures which could guarantee the timely availability of the data.

2.   Paragraph 1, point (b), shall not apply to micro enterprises and small enterprises.

3.   The obligation to demonstrate that the public_sector_body was unable to obtain non-personal data by purchasing them on the market shall not apply where the specific task carried out in the public interest is the production of official statistics and where the purchase of such data is not allowed by national law.

Article 17

Requests for data to be made available

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

(a)

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

(b)

demonstrate that the conditions necessary for the existence of an exceptional need as referred to in Article 15 for the purpose of which the data are requested are met;

(c)

explain the purpose of the request, the intended use of the data requested, including, where applicable, by a third party in accordance with paragraph 4 of this Article, the duration of that use, and, where relevant, how the processing of personal data is to address the exceptional need;

(d)

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

(e)

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

(f)

specify any other public sector bodies or the Commission, European Central Bank or Union_bodies and the third parties with which the data requested is expected to be shared with;

(g)

where personal data are requested, specify any technical and organisational measures necessary and proportionate to implement data protection principles and necessary safeguards, such as pseudonymisation, and whether anonymisation can be applied by the data holder before making the data available;

(h)

state the legal provision allocating to the requesting public_sector_body, the Commission, the European Central Bank or the Union body the specific task carried out in the public interest relevant for requesting the data;

(i)

specify the deadline by which the data are to be made available and the deadline referred to in Article 18(2) by which the data holder may decline or seek modification of the request;

(j)

make its best efforts to avoid compliance with the data request resulting in the data holders’ liability for infringement of Union or national law.

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

(a)

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

(b)

be specific regarding the type of data requested and correspond to data which the data holder has control over at the time of the request;

(c)

be proportionate to the exceptional need and duly justified, regarding the granularity and volume of the data requested and frequency of access of the data requested;

(d)

respect the legitimate aims of the data holder, committing to ensuring the protection of trade_secrets in accordance with Article 19(3), and the cost and effort required to make the data available;

(e)

concern non-personal data, and only if this is demonstrated to be insufficient to respond to the exceptional need to use data, in accordance with Article 15(1), point (a), request personal data in pseudonymised form and establish the technical and organisational measures that are to be taken to protect the data;

(f)

inform the data holder of the penalties that are to be imposed pursuant to Article 40 by the competent authority designated pursuant to Article 37 in the event of non-compliance with the request;

(g)

where the request is made by a public_sector_body, be transmitted to the data coordinator referred to in Article 37 of the Member State where the requesting public_sector_body is established, who shall make the request publicly available online without undue delay unless the data coordinator considers that such publication would create a risk for public security;

(h)

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

(i)

where personal data are requested, be notified without undue delay to the supervisory authority responsible for monitoring the application of Regulation (EU) 2016/679 in the Member State where the public_sector_body is established.

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

3.   A public_sector_body, the Commission, the European Central Bank or a Union body shall not make data obtained pursuant to this Chapter available for reuse as defined in Article 2, point (2), of Regulation (EU) 2022/868 or Article 2, point (11), of Directive (EU) 2019/1024. Regulation (EU) 2022/868 and Directive (EU) 2019/1024 shall not apply to the data held by public sector bodies obtained pursuant to this Chapter.

4.   Paragraph 3 of this Article does not preclude a public_sector_body, the Commission, the European Central Bank or a Union body to exchange data obtained pursuant to this Chapter with another public_sector_body or the Commission, the European Central Bank or a Union body in view of completing the tasks referred to in Article 15, as specified in the request in accordance with paragraph 1, point (f), of this Article or to make the data available to a third party where it has delegated, by means of a publicly available agreement, technical inspections or other functions to that third party. The obligations on public sector bodies pursuant to Article 19, in particular safeguards to preserve the confidentiality of trade_secrets, shall apply also to such third parties. Where a public_sector_body, the Commission, the European Central Bank or a Union body transmits or makes data available under this paragraph, it shall notify the data holder from whom the data was received without undue delay.

5.   Where the data holder considers that its rights under this Chapter have been infringed by the transmission or making available of data, it may lodge a complaint with the competent authority designated pursuant to Article 37 of the Member State where the data holder is established.

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

Article 18

Compliance with requests for data

1.   A data holder receiving a request to make data available under this Chapter shall make the data available to the requesting public_sector_body, the Commission, the European Central Bank or a Union body without undue delay, taking into account necessary technical, organisational and legal measures.

2.   Without prejudice to specific needs regarding the availability of data defined in Union or national law, a data holder may decline or seek the modification of a request to make data available under this Chapter without undue delay and, in any event, no later than five working days after the receipt of a request for the data necessary to respond to a public_emergency and without undue delay and, in any event, no later than 30 working days after the receipt of such a request in other cases of an exceptional need, on any of the following grounds:

(a)

the data holder does not have control over the data requested;

(b)

a similar request for the same purpose has been previously submitted by another public_sector_body or the Commission, the European Central Bank or a Union body and the data holder has not been notified of the erasure of the data pursuant to Article 19(1), point (c);

(c)

the request does not meet the conditions laid down in Article 17(1) and (2).

3.   If the data holder decides to decline the request or to seek its modification in accordance with paragraph 2, point (b), it shall indicate the identity of the public_sector_body or the Commission, the European Central Bank or the Union body that previously submitted a request for the same purpose.

4.   Where the data requested includes personal data, the data holder shall properly anonymise the data, unless the compliance with the request to make data available to a public_sector_body, the Commission, the European Central Bank or a Union body requires the disclosure of personal data. In such cases, the data holder shall pseudonymise the data.

5.   Where the public_sector_body, the Commission, the European Central Bank or the Union body wishes to challenge a data holder’s refusal to provide the data requested, or where the data holder wishes to challenge the request and the matter cannot be resolved by an appropriate modification of the request, the matter shall be referred to the competent authority designated pursuant to Article 37 of the Member State where the data holder is established.

Article 20

Compensation in cases of an exceptional need

1.   Data holders other than micro enterprises and small enterprises shall make available data necessary to respond to a public_emergency pursuant to Article 15(1), point (a), free of charge. The public_sector_body, the Commission, the European Central Bank or the Union body that has received data shall provide public acknowledgement to the data holder if requested by the data holder.

2.   The data holder shall be entitled to fair compensation for making data available in compliance with a request made pursuant to Article 15(1), point (b). Such compensation shall cover the technical and organisational costs incurred to comply with the request including, where applicable, the costs of anonymisation, pseudonymisation, aggregation and of technical adaptation, and a reasonable margin. Upon request of the public_sector_body, the Commission, the European Central Bank or the Union body, the data holder shall provide information on the basis for the calculation of the costs and the reasonable margin.

3.   Paragraph 2 shall also apply where a micro enterprise and small enterprise claims compensation for making data available.

4.   Data holders shall not be entitled to compensation for making data available in compliance with a request made pursuant to Article 15(1), point (b), where the specific task carried out in the public interest is the production of official statistics and where the purchase of data is not allowed by national law. Member States shall notify the Commission where the purchase of data for the production of official statistics is not allowed by national law.

5.   Where the public_sector_body, the Commission, the European Central Bank or the Union body disagrees with the level of compensation requested by the data holder, they may lodge a complaint with the competent authority designated pursuant to Article 37 of the Member State where the data holder is established.

Article 21

Sharing of data obtained in the context of an exceptional need with research organisations or statistical bodies

1.   A public_sector_body, the Commission, the European Central Bank or a Union body shall be entitled to share data received under this Chapter:

(a)

with individuals or organisations in view of carrying out scientific research or analytics compatible with the purpose for which the data was requested; or

(b)

with national statistical institutes and Eurostat for the production of official statistics.

2.   Individuals or organisations receiving the data pursuant to paragraph 1 shall act on a not-for-profit basis or in the context of a public-interest mission recognised in Union or national law. They shall not include organisations upon which commercial undertakings have a significant influence which is likely to result in preferential access to the results of the research.

3.   Individuals or organisations receiving the data pursuant to paragraph 1 of this Article shall comply with the same obligations that are applicable to the public sector bodies, the Commission, the European Central Bank or Union_bodies pursuant to Article 17(3) and Article 19.

4.   Notwithstanding Article 19(1), point (c), individuals or organisations receiving the data pursuant to paragraph 1 of this Article may keep the data received for the purpose for which the data was requested for up to six months following erasure of the data by the public sector bodies, the Commission, the European Central Bank and Union_bodies.

5.   Where a public_sector_body, the Commission, the European Central Bank or a Union body intends to transmit or make data available under paragraph 1 of this Article, it shall notify without undue delay the data holder from whom the data was received, stating the identity and contact details of the organisation or the individual receiving the data, the purpose of the transmission or making available of the data, the period for which the data is to be used and the technical protection and organisational measures taken, including where personal data or trade_secrets are involved. Where the data holder disagrees with the transmission or making available of data, it may lodge a complaint with the competent authority designated pursuant to Article 37 of the Member State where the data holder is established.

Article 22

Mutual assistance and cross-border cooperation

1.   Public sector bodies, the Commission, the European Central Bank and Union_bodies shall cooperate and assist one another, to implement this Chapter in a consistent manner.

2.   Any data exchanged in the context of assistance requested and provided pursuant to paragraph 1 shall not be used in a manner incompatible with the purpose for which they were requested.

3.   Where a public_sector_body intends to request data from a data holder established in another Member State, it shall first notify the competent authority designated pursuant to Article 37 in that Member State of that intention. This requirement shall also apply to requests by the Commission, the European Central Bank and Union_bodies. The request shall be examined by the competent authority of the Member State where the data holder is established.

4.   After having examined the request in light of the requirements laid down in Article 17, the relevant competent authority shall, without undue delay, take one of the following actions:

(a)

transmit the request to the data holder and, if applicable, advise the requesting public_sector_body, the Commission, the European Central Bank or the Union body of the need, if any, to cooperate with public sector bodies of the Member State in which the data holder is established with the aim of reducing the administrative burden on the data holder in complying with the request;

(b)

reject the request on duly substantiated grounds in accordance with this Chapter.

The requesting public_sector_body, the Commission, the European Central Bank and the Union body shall take into account the advice of and the grounds provided by the relevant competent authority pursuant to the first subparagraph before taking any further action such as resubmitting the request, if applicable.

CHAPTER VI

SWITCHING BETWEEN DATA PROCESSING SERVICES

Article 31

Specific regime for certain data processing services

1.   The obligations laid down in Article 23, point (d), Article 29 and Article 30(1) and (3) shall not apply to data processing services of which the majority of main features has been custom-built to accommodate the specific needs of an individual customer or where all components have been developed for the purposes of an individual customer, and where those data processing services are not offered at broad commercial scale via the service catalogue of the provider of data processing services.

2.   The obligations laid down in this Chapter shall not apply to data processing services provided as a non-production version for testing and evaluation purposes and for a limited period of time.

3.   Prior to the conclusion of a contract on the provision of the data processing services referred to in this Article, the provider of data processing services shall inform the prospective customer of the obligations of this Chapter that do not apply.

CHAPTER VII

UNLAWFUL INTERNATIONAL GOVERNMENTAL ACCESS AND TRANSFER OF NON-PERSONAL DATA

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 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.


whereas









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