Data Act 2023/2854 EN

(c)	the making available of data by data holders to public sector bodies, the Commission, the European Central Bank and Union_bodies, where there is an exceptional need for those data for the performance of a specific task carried out in the public interest;

(d)	facilitating switching between data processing services;

(e)	introducing safeguards against unlawful third-party access to non-personal data; and

(f)	the development of interoperability standards for data to be accessed, transferred and used.

2. This Regulation covers personal and non-personal data, including the following types of data, in the following contexts:

(a)	Chapter II applies to data, with the exception of content, concerning the performance, use and environment of connected_products and related_services;

(b)	Chapter III applies to any private sector data that is subject to statutory data sharing obligations;

(c)	Chapter IV applies to any private sector data accessed and used on the basis of contract between enterprises;

(d)	Chapter V applies to any private sector data with a focus on non-personal data;

(e)	Chapter VI applies to any data and services processed by providers of data processing services;

(f)	Chapter VII applies to any non-personal data held in the Union by providers of data processing services.

3. This Regulation applies to:

(a)	manufacturers of connected_products placed on the market in the Union and providers of related_services, irrespective of the place of establishment of those manufacturers and providers;

(b)	users in the Union of connected_products or related_services as referred to in point (a);

(c)	data holders, irrespective of their place of establishment, that make data available to data recipients in the Union;

(d)	data recipients in the Union to whom data are made available;

(e)

public sector bodies, the Commission, the European Central Bank and Union_bodies that request data holders to make data available where there is an exceptional need for those data for the performance of a specific task carried out in the public interest and to the data holders that provide those data in response to such request;

(f)	providers of data processing services, irrespective of their place of establishment, providing such services to customers in the Union;

(g)	participants in data spaces and vendors of applications using smart_contracts and persons whose trade, business or profession involves the deployment of smart_contracts for others in the context of executing an agreement.

4. Where this Regulation refers to connected_products or related_services, such references are also understood to include virtual_assistants insofar as they interact with a connected_product or related_service.

5. This Regulation is without prejudice to Union and national law on the protection of personal data, privacy and confidentiality of communications and integrity of terminal equipment, which shall apply to personal data processed in connection with the rights and obligations laid down herein, in particular Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive 2002/58/EC, including the powers and competences of supervisory authorities and the rights of data subjects. Insofar as users are data subjects, the rights laid down in Chapter II of this Regulation shall complement the rights of access by data subjects and rights to data portability under Articles 15 and 20 of Regulation (EU) 2016/679. In the event of a conflict between this Regulation and Union law on the protection of personal data or privacy, or national legislation adopted in accordance with such Union law, the relevant Union or national law on the protection of personal data or privacy shall prevail.

6. This Regulation does not apply to or pre-empt voluntary arrangements for the exchange of data between private and public entities, in particular voluntary arrangements for data sharing.

This Regulation does not affect Union or national legal acts providing for the sharing of, access to and the use of data for the purpose of the prevention, investigation, detection or prosecution of criminal offences or for the execution of criminal penalties, or for customs and taxation purposes, in particular Regulations (EU) 2021/784, (EU) 2022/2065 and (EU) 2023/1543 and Directive (EU) 2023/1544, or international cooperation in that area. This Regulation does not apply to the collection or sharing of, access to or the use of data under Regulation (EU) 2015/847 and Directive (EU) 2015/849. This Regulation does not apply to areas that fall outside the scope of Union law and in any event does not affect the competences of the Member States concerning public security, defence or national security, regardless of the type of entity entrusted by the Member States to carry out tasks in relation to those competences, or their power to safeguard other essential State functions, including ensuring the territorial integrity of the State and the maintenance of law and order. This Regulation does not affect the competences of the Member States concerning customs and tax administration or the health and safety of citizens.

7. This Regulation complements the self-regulatory approach of Regulation (EU) 2018/1807 by adding generally applicable obligations on cloud switching.

8. This Regulation is without prejudice to Union and national legal acts providing for the protection of intellectual property rights, in particular Directives 2001/29/EC, 2004/48/EC and (EU) 2019/790.

9. This Regulation complements and is without prejudice to Union law which aims to promote the interests of consumers and ensure a high level of consumer protection, and to protect their health, safety and economic interests, in particular Directives 93/13/EEC, 2005/29/EC and 2011/83/EU.

10. This Regulation does not preclude the conclusion of voluntary lawful data sharing contracts, including contracts concluded on a reciprocal basis, which comply with the requirements laid down in this Regulation.

Article 4

The rights and obligations of users and data holders with regard to access, use and making available product data and related_service data

1. Where data cannot be directly accessed by the user from the connected_product or related_service, data holders shall make readily available data, as well as the relevant meta data necessary to interpret and use those data, accessible to the user without undue delay, of the same quality as is available to the data holder, easily, securely, free of charge, in a comprehensive, structured, commonly used and machine-readable format and, where relevant and technically feasible, continuously and in real-time. This shall be done on the basis of a simple request through electronic means where technically feasible.

2. Users and data holders may contractually restrict or prohibit accessing, using or further sharing data, if such processing could undermine security requirements of the connected_product, as laid down by Union or national law, resulting in a serious adverse effect on the health, safety or security of natural persons. Sectoral authorities may provide users and data holders with technical expertise in that context. Where the data holder refuses to share data pursuant to this Article, it shall notify the competent authority designated pursuant to Article 37.

3. Without prejudice to the user’s right to seek redress at any stage before a court or tribunal of a Member State, the user may, in relation to any dispute with the data holder concerning the contractual restrictions or prohibitions referred to in paragraph 2:

(a)	lodge, in accordance with Article 37(5), point (b), a complaint with the competent authority; or

(b)	agree with the data holder to refer the matter to a dispute settlement body in accordance with Article 10(1).

4. Data holders shall not make the exercise of choices or rights under this Article by the user unduly difficult, including by offering choices to the user in a non-neutral manner or by subverting or impairing the autonomy, decision-making or choices of the user via the structure, design, function or manner of operation of a user digital interface or a part thereof.

5. For the purpose of verifying whether a natural or legal person qualifies as a user for the purposes of paragraph 1, a data holder shall not require that person to provide any information beyond what is necessary. Data holders shall not keep any information, in particular log data, on the user’s access to the data requested beyond what is necessary for the sound execution of the user’s access request and for the security and maintenance of the data infrastructure.

6. Trade secrets shall be preserved and shall be disclosed only where the data holder and the user take all necessary measures prior to the disclosure to preserve their confidentiality in particular regarding third parties. The data holder or, where they are not the same person, the trade_secret holder shall identify the data which are protected as trade_secrets, including in the relevant meta data, and shall agree with the user proportionate technical and organisational measures necessary to preserve the confidentiality of the shared data, in particular in relation to third parties, such as model contractual terms, confidentiality agreements, strict access protocols, technical standards and the application of codes of conduct.

7. Where there is no agreement on the necessary measures referred to in paragraph 6, or if the user fails to implement the measures agreed pursuant to paragraph 6 or undermines the confidentiality of the trade_secrets, the data holder may withhold or, as the case may be, suspend the sharing of data identified as trade_secrets. The decision of the data holder shall be duly substantiated and provided in writing to the user without undue delay. In such cases, the data holder shall notify the competent authority designated pursuant to Article 37 that it has withheld or suspended data sharing and identify which measures have not been agreed or implemented and, where relevant, which trade_secrets have had their confidentiality undermined.

8. In exceptional circumstances, where the data holder who is a trade_secret holder is able to demonstrate that it is highly likely to suffer serious economic damage from the disclosure of trade_secrets, despite the technical and organisational measures taken by the user pursuant to paragraph 6 of this Article, that data holder may refuse on a case-by-case basis a request for access to the specific data in question. That demonstration shall be duly substantiated on the basis of objective elements, in particular the enforceability of trade_secrets protection in third countries, the nature and level of confidentiality of the data requested, and the uniqueness and novelty of the connected_product, and shall be provided in writing to the user without undue delay. Where the data holder refuses to share data pursuant to this paragraph, it shall notify the competent authority designated pursuant to Article 37.

9. Without prejudice to a user’s right to seek redress at any stage before a court or tribunal of a Member State, a user wishing to challenge a data holder’s decision to refuse or to withhold or suspend data sharing pursuant to paragraphs 7 and 8 may:

(a)	lodge, in accordance with Article 37(5), point (b), a complaint with the competent authority, which shall, without undue delay, decide whether and under which conditions data sharing is to start or resume; or

(b)	agree with the data holder to refer the matter to a dispute settlement body in accordance with Article 10(1).

10. The user shall not use the data obtained pursuant to a request referred to in paragraph 1 to develop a connected_product that competes with the connected_product from which the data originate, nor share the data with a third party with that intent and shall not use such data to derive insights about the economic situation, assets and production methods of the manufacturer or, where applicable the data holder.

11. The user shall not use coercive means or abuse gaps in the technical infrastructure of a data holder which is designed to protect the data in order to obtain access to data.

12. Where the user is not the data subject whose personal data is requested, any personal data generated by the use of a connected_product or related_service shall be made available by the data holder to the user only where there is a valid legal basis for processing under Article 6 of Regulation (EU) 2016/679 and, where relevant, the conditions of Article 9 of that Regulation and of Article 5(3) of Directive 2002/58/EC are fulfilled.

13. A data holder shall only use any readily available data that is non-personal data on the basis of a contract with the user. A data holder shall not use such data to derive insights about the economic situation, assets and production methods of, or the use by, the user in any other manner that could undermine the commercial position of that user on the markets in which the user is active.

14. Data holders shall not make available non-personal product data to third parties for commercial or non-commercial purposes other than the fulfilment of their contract with the user. Where relevant, data holders shall contractually bind third parties not to further share data received from them.

Article 5

Right of the user to share data with third parties

1. Upon request by a user, or by a party acting on behalf of a user, the data holder shall make available readily available data, as well as the relevant meta data necessary to interpret and use those data, to a third party without undue delay, of the same quality as is available to the data holder, easily, securely, free of charge to the user, in a comprehensive, structured, commonly used and machine-readable format and, where relevant and technically feasible, continuously and in real-time. The data shall be made available by the data holder to the third party in accordance with Articles 8 and 9.

2. Paragraph 1 shall not apply to readily available data in the context of the testing of new connected_products, substances or processes that are not yet placed on the market unless their use by a third party is contractually permitted.

3. Any undertaking designated as a gatekeeper, pursuant to Article 3 of Regulation (EU) 2022/1925, shall not be an eligible third party under this Article and therefore shall not:

(a)	solicit or commercially incentivise a user in any manner, including by providing monetary or any other compensation, to make data available to one of its services that the user has obtained pursuant to a request under Article 4(1);

(b)	solicit or commercially incentivise a user to request the data holder to make data available to one of its services pursuant to paragraph 1 of this Article;

(c)	receive data from a user that the user has obtained pursuant to a request under Article 4(1).

4. For the purpose of verifying whether a natural or legal person qualifies as a user or as a third party for the purposes of paragraph 1, the user or the third party shall not be required to provide any information beyond what is necessary. Data holders shall not keep any information on the third party’s access to the data requested beyond what is necessary for the sound execution of the third party’s access request and for the security and maintenance of the data infrastructure.

5. The third party shall not use coercive means or abuse gaps in the technical infrastructure of a data holder which is designed to protect the data in order to obtain access to data.

6. A data holder shall not use any readily available data to derive insights about the economic situation, assets and production methods of, or the use by, the third party in any other manner that could undermine the commercial position of the third party on the markets in which the third party is active, unless the third party has given permission to such use and has the technical possibility to easily withdraw that permission at any time.

7. Where the user is not the data subject whose personal data is requested, any personal data generated by the use of a connected_product or related_service shall be made available by the data holder to the third party only where there is a valid legal basis for processing under Article 6 of Regulation (EU) 2016/679 and, where relevant, the conditions of Article 9 of that Regulation and of Article 5(3) of Directive 2002/58/EC are fulfilled.

8. Any failure on the part of the data holder and the third party to agree on arrangements for transmitting the data shall not hinder, prevent or interfere with the exercise of the rights of the data subject under Regulation (EU) 2016/679 and, in particular, with the right to data portability under Article 20 of that Regulation.

9. Trade secrets shall be preserved and shall be disclosed to third parties only to the extent that such disclosure is strictly necessary to fulfil the purpose agreed between the user and the third party. The data holder or, where they are not the same person, the trade_secret holder shall identify the data which are protected as trade_secrets, including in the relevant meta data, and shall agree with the third party all proportionate technical and organisational measures necessary to preserve the confidentiality of the shared data, such as model contractual terms, confidentiality agreements, strict access protocols, technical standards and the application of codes of conduct.

10. Where there is no agreement on the necessary measures referred to in paragraph 9 of this Article or if the third party fails to implement the measures agreed pursuant to paragraph 9 of this Article or undermines the confidentiality of the trade_secrets, the data holder may withhold or, as the case may be, suspend the sharing of data identified as trade_secrets. The decision of the data holder shall be duly substantiated and provided in writing to the third party without undue delay. In such cases, the data holder shall notify the competent authority designated pursuant to Article 37 that it has withheld or suspended data sharing and identify which measures have not been agreed or implemented and, where relevant, which trade_secrets have had their confidentiality undermined.

11. In exceptional circumstances, where the data holder who is a trade_secret holder is able to demonstrate that it is highly likely to suffer serious economic damage from the disclosure of trade_secrets, despite the technical and organisational measures taken by the third party pursuant to paragraph 9 of this Article, that data holder may refuse on a case-by-case basis a request for access to the specific data in question. That demonstration shall be duly substantiated on the basis of objective elements, in particular the enforceability of trade_secrets protection in third countries, the nature and level of confidentiality of the data requested, and the uniqueness and novelty of the connected_product, and shall be provided in writing to the third party without undue delay. Where the data holder refuses to share data pursuant to this paragraph, it shall notify the competent authority designated pursuant to Article 37.

12. Without prejudice to the third party’s right to seek redress at any stage before a court or tribunal of a Member State, a third party wishing to challenge a data holder’s decision to refuse or to withhold or suspend data sharing pursuant to paragraphs 10 and 11 may:

(a)	lodge, in accordance with Article 37(5), point (b), a complaint with the competent authority, which shall, without undue delay, decide whether and under which conditions the data sharing is to start or resume; or

(b)	agree with the data holder to refer the matter to a dispute settlement body in accordance with Article 10(1).

13. The right referred to in paragraph 1 shall not adversely affect the rights of data subjects pursuant to the applicable Union and national law on the protection of personal data.

Article 6

Obligations of third parties receiving data at the request of the user

1. A third party shall process the data made available to it pursuant to Article 5 only for the purposes and under the conditions agreed with the user and subject to Union and national law on the protection of personal data including the rights of the data subject insofar as personal data are concerned. The third party shall erase the data when they are no longer necessary for the agreed purpose, unless otherwise agreed with the user in relation to non-personal data.

2. The third party shall not:

(a)

make the exercise of choices or rights under Article 5 and this Article by the user unduly difficult, including by offering choices to the user in a non-neutral manner, or by coercing, deceiving or manipulating the user, or by subverting or impairing the autonomy, decision-making or choices of the user, including by means of a user digital interface or a part thereof;

(b)	notwithstanding Article 22(2), points (a) and (c), of Regulation (EU) 2016/679, use the data it receives for the profiling, unless it is necessary to provide the service requested by the user;

(c)

make the data it receives available to another third party, unless the data is made available on the basis of a contract with the user, and provided that the other third party takes all necessary measures agreed between the data holder and the third party to preserve the confidentiality of trade_secrets;

(d)	make the data it receives available to an undertaking designated as a gatekeeper pursuant to Article 3 of Regulation (EU) 2022/1925;

(e)

use the data it receives to develop a product that competes with the connected_product from which the accessed data originate or share the data with another third party for that purpose; third parties shall also not use any non-personal product data or related_service data made available to them to derive insights about the economic situation, assets and production methods of, or use by, the data holder;

(f)	use the data it receives in a manner that has an adverse impact on the security of the connected_product or related_service;

(g)	disregard the specific measures agreed with a data holder or with the trade_secrets holder pursuant to Article 5(9) and undermine the confidentiality of trade_secrets;

(h)	prevent the user that is a consumer, including on the basis of a contract, from making the data it receives available to other parties.

Article 7

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

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

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

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

CHAPTER III

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

Article 11

Technical protection measures on the unauthorised use or disclosure of data

1. A data holder may apply appropriate technical protection measures, including smart_contracts and encryption, to prevent unauthorised access to data, including meta data, and to ensure compliance with Articles 4, 5, 6, 8 and 9, as well as with the agreed contractual terms for making data available. Such technical protection measures shall not discriminate between data recipients or hinder a user’s right to obtain a copy of, retrieve, use or access data, to provide data to third parties pursuant to Article 5 or any right of a third party under Union law or national legislation adopted in accordance with Union law. Users, third parties and data recipients shall not alter or remove such technical protection measures unless agreed by the data holder.

2. In the circumstances referred to in paragraph 3, the third party or data recipient shall comply, without undue delay, with the requests of the data holder and, where applicable and where they are not the same person, the trade_secret holder or the user:

(a)	to erase the data made available by the data holder and any copies thereof;

(b)

to end the production, offering or placing_on_the_market or use of goods, derivative data or services produced on the basis of knowledge obtained through such data, or the importation, export or storage of infringing goods for those purposes, and destroy any infringing goods, where there is a serious risk that the unlawful use of those data will cause significant harm to the data holder, the trade_secret holder or the user or where such a measure would not be disproportionate in light of the interests of the data holder, the trade_secret holder or the user;

(c)	to inform the user of the unauthorised use or disclosure of the data and of the measures taken to put an end to the unauthorised use or disclosure of the data;

(d)	to compensate the party suffering from the misuse or disclosure of such unlawfully accessed or used data.

3. Paragraph 2 shall apply where a third party or a data recipient has:

(a)	for the purposes of obtaining data, provided false information to a data holder, deployed deceptive or coercive means or abused gaps in the technical infrastructure of the data holder designed to protect the data;

(b)	used the data made available for unauthorised purposes, including the development of a competing connected_product within the meaning of Article 6(2), point (e);

(c)	unlawfully disclosed data to another party;

(d)	not maintained the technical and organisational measures agreed pursuant to Article 5(9); or

(e)	altered or removed technical protection measures applied by the data holder pursuant to paragraph 1 of this Article without the agreement of the data holder.

4. Paragraph 2 shall also apply where a user alters or removes technical protection measures applied by the data holder or does not maintain the technical and organisational measures taken by the user in agreement with the data holder or, where they are not the same person, the trade_secrets holder, in order to preserve trade_secrets, as well as in respect of any other party that receives the data from the user by means of an infringement of this Regulation.

5. Where the data recipient infringes Article 6(2), point (a) or (b), users shall have the same rights as data holders under paragraph 2 of this Article.

Article 19

Obligations of public sector bodies, the Commission, the European Central Bank and Union_bodies

1. A public_sector_body, the Commission, the European Central Bank or a Union body receiving data pursuant to a request made under Article 14 shall:

(a)	not use the data in a manner incompatible with the purpose for which they were requested;

(b)	have implemented technical and organisational measures that preserve the confidentiality and integrity of the requested data and the security of the data transfers, in particular personal data, and safeguard the rights and freedoms of data subjects;

(c)

erase the data as soon as they are no longer necessary for the stated purpose and inform the data holder and individuals or organisations that received the data pursuant to Article 21(1) without undue delay that the data have been erased, unless archiving of the data is required in accordance with Union or national law on public access to documents in the context of transparency obligations.

2. A public_sector_body, the Commission, the European Central Bank, a Union body or a third party receiving data under this Chapter shall not:

(a)	use the data or insights about the economic situation, assets and production or operation methods of the data holder to develop or enhance a connected_product or related_service that competes with the connected_product or related_service of the data holder;

(b)	share the data with another third party for any of the purposes referred to in point (a).

3. Disclosure of trade_secrets to a public_sector_body, the Commission, the European Central Bank or a Union body shall be required only to the extent that it is strictly necessary to achieve the purpose of a request under Article 15. In such a case, the data holder or, where they are not the same person, the trade_secret holder shall identify the data which are protected as trade_secrets, including in the relevant meta data. The public_sector_body, the Commission, the European Central Bank or the Union body shall, prior to the disclosure of trade_secrets, take all necessary and appropriate technical and organisational measures to preserve the confidentiality of the trade_secrets, including, as appropriate, the use of model contractual terms, technical standards and the application of codes of conduct.

4. A public_sector_body, the Commission, the European Central Bank or a Union body shall be responsible for the security of the data it receives.

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 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.

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 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.

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.

Article 50

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 12 September 2025.

The obligation resulting from Article 3(1) shall apply to connected_products and the services related to them placed on the market after 12 September 2026.

Chapter III shall apply in relation to obligations to make data available under Union law or national legislation adopted in accordance with Union law, which enters into force after 12 September 2025.

Chapter IV shall apply to contracts concluded after 12 September 2025.

Chapter IV shall apply from 12 September 2027 to contracts concluded on or before 12 September 2025 provided that they are:

(a)	of indefinite duration; or

(b)	due to expire at least 10 years from 11 January 2024.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 13 December 2023.

For the European Parliament

The President

R. METSOLA

For the Council

The President

P. NAVARRO RÍOS

(1) OJ C 402, 19.10.2022, p. 5.

(2) OJ C 365, 23.9.2022, p. 18.

(3) OJ C 375, 30.9.2022, p. 112.

(4) Position of the European Parliament of 9 November 2023 (not yet published in the Official Journal) and decision of the Council of 27 November 2023.

(5) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

(6) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

(7) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

(8) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).

(9) Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29).

(10) Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to- consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (‘Unfair Commercial Practices Directive’) (OJ L 149, 11.6.2005, p. 22).

(11) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64).

(12) Regulation (EU) 2021/784 of the European Parliament and of the Council of 29 April 2021 on addressing the dissemination of terrorist content online (OJ L 172, 17.5.2021, p. 79).

(13) Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1).

(14) Regulation (EU) 2023/1543 of the European Parliament and of the Council of 12 July 2023 on European Production Orders and European Preservation Orders for electronic evidence in criminal proceedings and for the execution of custodial sentences following criminal proceedings (OJ L 191, 28.7.2023, p. 118).

(15) Directive (EU) 2023/1544 of the European Parliament and of the Council of 12 July 2023 laying down harmonised rules on the designation of designated establishments and the appointment of legal representatives for the purpose of gathering electronic evidence in criminal proceedings (OJ L 191, 28.7.2023, p. 181).

(16) Regulation (EU) 2015/847 of the European Parliament and of the Council of 20 May 2015 on information accompanying transfers of funds and repealing Regulation (EC) No 1781/2006 (OJ L 141, 5.6.2015, p. 1).

(17) Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (OJ L 141, 5.6.2015, p. 73).

(18) Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (OJ L 151, 7.6.2019, p. 70).

(19) Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society (OJ L 167, 22.6.2001, p. 10).

(20) Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L 157, 30.4.2004, p. 45).

(21) Directive (EU) 2019/790 of the European Parliament and of the Council of 17 April 2019 on copyright and related rights in the Digital Single Market and amending Directives 96/9/EC and 2001/29/EC (OJ L 130, 17.5.2019, p. 92).

(22) Regulation (EU) 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance and amending Regulation (EU) 2018/1724 (Data Governance Act) (OJ L 152, 3.6.2022, p. 1).

(23) Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information ( trade_secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).

(24) Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer protection in the indication of the prices of products offered to consumers (OJ L 80, 18.3.1998, p. 27).

(25) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (‘Directive on electronic commerce’) (OJ L 178, 17.7.2000, p. 1).

(26) Regulation (EU) 2022/1925 of the European Parliament and of the Council of 14 September 2022 on contestable and fair markets in the digital sector and amending Directives (EU) 2019/1937 and (EU) 2020/1828 (Digital Markets Act) (OJ L 265, 12.10.2022, p. 1).

(27) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164).

(28) Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information (OJ L 172, 26.6.2019, p. 56).

(29) Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases (OJ L 77, 27.3.1996, p. 20).

(30) Regulation (EU) 2018/1807 of the European Parliament and of the Council of 14 November 2018 on a framework for the free flow of non-personal data in the European Union (OJ L 303, 28.11.2018, p. 59).

(31) Directive (EU) 2019/770 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the supply of digital content and digital services (OJ L 136, 22.5.2019, p. 1).

(32) Regulation (EU) 2022/2554 of the European Parliament and of the Council of 14 December 2022 on digital operational resilience for the financial sector and amending Regulations (EC) No 1060/2009, (EU) No 648/2012, (EU) No 600/2014, (EU) No 909/2014 and (EU) 2016/1011 (OJ L 333, 27.12.2022, p. 1).

(33) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).

(34) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).

(35) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).

(36) Regulation (EU) 2017/2394 of the European Parliament and of the Council of 12 December 2017 on cooperation between national authorities responsible for the enforcement of consumer protection laws and repealing Regulation (EC) No 2006/2004 (OJ L 345, 27.12.2017, p. 1).

(37) Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the protection of the collective interests of consumers and repealing Directive 2009/22/EC (OJ L 409, 4.12.2020, p. 1).

(38) OJ L 123, 12.5.2016, p. 1.

(39) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

ELI: http:// data.europa.eu/eli/reg/2023/2854/oj

ISSN 1977-0677 (electronic edition)

whereas

keyboard_tab Data Act 2023/2854 EN

Data Act 2023/2854 EN