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Digital Omnibus tracker

Data Act · Regulation (EU) 2023/2854

Article 1

Compare the available Commission, Council and Parliament texts and amendments affecting this article.

Article total: 24 parts · 3 Council drafts · 35 Parliament amendments

Removed wording is struck through; added or replacement wording is highlighted.

Institutional text

European Commission proposal

All Commission’s changes to Data Act

The wording proposed by the Commission at the start of this legislative file.

Full article with Commission changes

Article with proposed changes

Official consolidated text dated 13 December 2023, with all 13 Commission proposal changes affecting this article applied.

Removed by the proposal: Article 1(7).

Article 1

Subject matter and scope

  1. 1.

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

    1. (a)

      the making available of product data and related service data to the user of the connected product or related service;

    2. (b)

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

    3. (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;

    4. (d)

      facilitating switching between data processing services;

    5. (e)

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

    6. (ea)

      voluntary registration of data intermediation services;

    7. (eb)

      voluntary registration of entities which collect and process data made available for altruistic purposes;

    8. (ec)

      the establishment of a European Data Innovation Board;

    9. (ed)

      data localisation requirements and the availability of data to competent authorities;

    10. (ee)

      the re-use of certain data and documents held by public sector bodies or by certain public undertakings, and of research data.

    11. (f)

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

  2. 2.

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

    1. (a)

      Chapter II applies to data, with the exception of content, concerning the performance, use and environment of connected products and related services;

    2. (b)

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

    3. (c)

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

    4. (d)

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

    5. (e)

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

    6. (f)

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

    7. (g)

      Chapter VIIa applies to personal and non-personal data;

    8. (h)

      Chapter VIIb applies to any non-personal data;

    9. (i)

      Chapter VIIc applies to personal and non-personal data, namely the following:

      1. (i)

        documents held by public sector bodies of Member States as referred to in Article 32i(1), point (a) or by public undertakings as referred to in Article 32i(1), point (b);

      2. (ii)

        research data as referred to in Article 32i(1), point (c);

      3. (iii)

        certain categories of protected data as referred to in Article 32i(1), point (a).

  3. 3.

    This Regulation applies to:

    1. (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;

    2. (b)

      users in the Union of connected products or related services as referred to in point (a);

    3. (c)

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

    4. (d)

      data recipients in the Union to whom data are made available;

    5. (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;

    6. (f)

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

    7. (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. 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. 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. 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. 7.

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

  8. 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. 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. 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.

  11. 11.

    Chapter VIIb of this Regulation is without prejudice to laws, regulations, and administrative provisions that relate to the internal organisation of Member States and that allocate, among public authorities and bodies governed by public law, powers and responsibilities for the processing of data without contractual remuneration of private parties, as well as to laws, regulations, and administrative provisions of Member States that provide for the implementation of such powers and responsibilities.

  12. 12.

    Where sector-specific Union or national law requires public sector bodies, data intermediation services providers or recognised data altruism organisations to comply with specific additional technical, administrative or organisational requirements that relate to Chapters VIIa and VIIb, including through an authorisation or certification regime, those provisions of that sector-specific Union or national law shall also apply. Any such specific additional requirements shall be non-discriminatory, proportionate and objectively justified.

  13. 13.

    With regards to data and documents in scope of Section II of Chapter VIIc, Chapter VIIc of this Regulation does not affect the possibility for Member States to adopt more detailed or stricter rules, provided that those rules allow for more extensive re-use of data and documents.

Commission source wording and instructions

Article 1(1)(eb)

Commission proposal

(eb) voluntary registration of entities which collect and process data made available for altruistic purposes;

Article 1(1)(ed)

Commission proposal

(ed) data localisation requirements and the availability of data to competent authorities;

Article 1(1)(ee)

Commission proposal

(ee) the re-use of certain data and documents held by public sector bodies or by certain public undertakings, and of research data.

Article 1(2)(i)

Commission proposal

(i) Chapter VIIc applies to personal and non-personal data, namely the following: (i) documents held by public sector bodies of Member States as referred (1) to in Article 32i(1), point (a) or by public undertakings as referred (2) to in Article 32i(1), point (b); (ii) research data as referred to in Article 32i(1), point (c); (iii) certain categories of protected data as referred to in Article 32i(1), point (a).

Article 1(7)

Commission proposal

1. Article 1 is amended as follows: (a) in paragraph 1, the following points are inserted: ‘(ea) voluntary registration of data intermediation services; (eb) voluntary registration of entities which collect and process data made available for altruistic purposes; (ec) the establishment of a European Data Innovation Board; (ed) data localisation requirements and the availability of data to competent authorities; (ee) the re-use of certain data and documents held by public sector bodies or by certain public undertakings, and of research data.’; (b) in paragraph 2, the following points are added: ‘(g) Chapter VIIa applies to personal and non-personal data; (h) Chapter VIIb applies to any non-personal data; (i) Chapter VIIc applies to personal and non-personal data, namely the following: (i) documents held by public sector bodies of Member States as referred (1) to in Article 32i(1), point (a) or by public undertakings as referred (2) to in Article 32i(1), point (b); (ii) research data as referred to in Article 32i(1), point (c); (iii) certain categories of protected data as referred to in Article 32i(1), point (a).’ (c) in paragraph 3, point (g) is replaced by the following: ‘(g) participants in data spaces.’; (d) paragraph 7 is deleted. (e) the following paragraphs 11, 12 and 13 are added: ‘11. Chapter VIIb of this Regulation is without prejudice to laws, regulations, and administrative provisions that relate to the internal organisation of Member States and that allocate, among public authorities and bodies governed by public law, powers and responsibilities for the processing of data without contractual remuneration of private parties, as well as to laws, regulations, and administrative provisions of Member States that provide for the implementation of such powers and responsibilities. 12. Where sector-specific Union or national law requires public sector bodies, data intermediation services providers or recognised data altruism organisations to comply with specific additional technical, administrative or organisational requirements that relate to Chapters VIIa and VIIb, including through an authorisation or certification regime, those provisions of that sector-specific Union or national law shall also apply. Any such specific additional requirements shall be non-discriminatory, proportionate and objectively justified.’ 13. With regards to data and documents in scope of Section II of Chapter VIIc, Chapter VIIc of this Regulation does not affect the possibility for Member States to adopt more detailed or stricter rules, provided that those rules allow for more extensive re-use of data and documents.’

Article 1(11)

Commission proposal

11. Chapter VIIb of this Regulation is without prejudice to laws, regulations, and administrative provisions that relate to the internal organisation of Member States and that allocate, among public authorities and bodies governed by public law, powers and responsibilities for the processing of data without contractual remuneration of private parties, as well as to laws, regulations, and administrative provisions of Member States that provide for the implementation of such powers and responsibilities.

Article 1(12)

Commission proposal

12. Where sector-specific Union or national law requires public sector bodies, data intermediation services providers or recognised data altruism organisations to comply with specific additional technical, administrative or organisational requirements that relate to Chapters VIIa and VIIb, including through an authorisation or certification regime, those provisions of that sector-specific Union or national law shall also apply. Any such specific additional requirements shall be non-discriminatory, proportionate and objectively justified.

Article 1(13)

Commission proposal

13. With regards to data and documents in scope of Section II of Chapter VIIc, Chapter VIIc of this Regulation does not affect the possibility for Member States to adopt more detailed or stricter rules, provided that those rules allow for more extensive re-use of data and documents.

Institutional text

Council Presidency texts

Successive Presidency compromise texts. Their inclusion does not imply agreement or adoption.

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Article 1(1)(ee)

June Presidency compromise · 10 June

(ee) the re-use of certain data and documents held by public sector bodies or by certain public undertakings, and of research data.

Article 1(2)(g)

June Presidency compromise · 10 June

Exact provision wording unavailable within a wider Council operation

This provision forms part of a wider Council operation. Its wording is not available separately here; open the official source for the full passage.

Official source passage and amending instruction
1.

Article 1 is amended as follows:

(a)

in paragraph 1, the following points are inserted:

‘(ea)

voluntary registration of data intermediation services;

(eb)

voluntary registration of entities which collect and process data made available for altruistic purposes;

(ec)

the establishment of a European Data Innovation Board; (ed) data localisation requirements

(ee)

the re-use of certain data and documents held by public sector bodies or by certain public undertakings, and of research data.;’

(b)

in paragraph 2, the following points are added:

(h)

Chapter VIIb applies to any non-personal data;

(c)

in paragraph 3, point (g) is replaced by the following:

‘(g)

participants in data spaces.;

(ca)

in paragraph (5) the following subparagraph is added: ‘The rules set out in Chapters VIIa and VIIc do not create a legal basis for the processing of personal data.’’

(d)

paragraph 7 is deleted.

(e)

the following paragraphs 11, 12 and 13 are added:

‘11.

Chapter VIIb of this Regulation is without prejudice to laws, regulations, and administrative provisions that relate to the internal organisation of Member States and that allocate, among public authorities and bodies governed by public law, powers and responsibilities for the processing of data without contractual remuneration of private parties, as well as to laws, regulations, and administrative provisions of Member States that provide for the implementation of such powers and responsibilities.

12.

Where sector-specific Union or national law requires public sector bodies, data intermediation services providers or recognised data altruism organisations to comply with specific additional technical, administrative or organisational requirements that relate to Chapters VIIa and VIIb, including through an authorisation or certification regime, those provisions of that sector-specific Union or national law shall also apply. Any such specific additional requirements shall be non-discriminatory, proportionate and objectively justified.’

13.

With regards to data and documents in scope of Section II of Chapter VIIc, Chapter VIIc of this Regulation establishes a set of minimum rules governing the re-use and the practical arrangements for facilitating the reuse of data and documents and does not affect the possibility for Member States to adopt more detailed or stricter rules, provided that those rules allow for more extensive re-use of data and documents.’’

Article 1(2)(i)

June Presidency compromise · 10 June

Exact provision wording unavailable within a wider Council operation

This provision forms part of a wider Council operation. Its wording is not available separately here; open the official source for the full passage.

Official source passage and amending instruction
1.

Article 1 is amended as follows:

(a)

in paragraph 1, the following points are inserted:

‘(ea)

voluntary registration of data intermediation services;

(eb)

voluntary registration of entities which collect and process data made available for altruistic purposes;

(ec)

the establishment of a European Data Innovation Board; (ed) data localisation requirements

(ee)

the re-use of certain data and documents held by public sector bodies or by certain public undertakings, and of research data.;’

(b)

in paragraph 2, the following points are added:

(h)

Chapter VIIb applies to any non-personal data;

(c)

in paragraph 3, point (g) is replaced by the following:

‘(g)

participants in data spaces.;

(ca)

in paragraph (5) the following subparagraph is added: ‘The rules set out in Chapters VIIa and VIIc do not create a legal basis for the processing of personal data.’’

(d)

paragraph 7 is deleted.

(e)

the following paragraphs 11, 12 and 13 are added:

‘11.

Chapter VIIb of this Regulation is without prejudice to laws, regulations, and administrative provisions that relate to the internal organisation of Member States and that allocate, among public authorities and bodies governed by public law, powers and responsibilities for the processing of data without contractual remuneration of private parties, as well as to laws, regulations, and administrative provisions of Member States that provide for the implementation of such powers and responsibilities.

12.

Where sector-specific Union or national law requires public sector bodies, data intermediation services providers or recognised data altruism organisations to comply with specific additional technical, administrative or organisational requirements that relate to Chapters VIIa and VIIb, including through an authorisation or certification regime, those provisions of that sector-specific Union or national law shall also apply. Any such specific additional requirements shall be non-discriminatory, proportionate and objectively justified.’

13.

With regards to data and documents in scope of Section II of Chapter VIIc, Chapter VIIc of this Regulation establishes a set of minimum rules governing the re-use and the practical arrangements for facilitating the reuse of data and documents and does not affect the possibility for Member States to adopt more detailed or stricter rules, provided that those rules allow for more extensive re-use of data and documents.’’

Article 1(7)

June Presidency compromise · 10 June

The Council draft deletes this provision and supplies no replacement wording. Open the official source to read the instruction in context.

Official source passage and amending instruction
1.

Article 1 is amended as follows:

(a)

in paragraph 1, the following points are inserted:

‘(ea)

voluntary registration of data intermediation services;

(eb)

voluntary registration of entities which collect and process data made available for altruistic purposes;

(ec)

the establishment of a European Data Innovation Board; (ed) data localisation requirements

(ee)

the re-use of certain data and documents held by public sector bodies or by certain public undertakings, and of research data.;’

(b)

in paragraph 2, the following points are added:

(h)

Chapter VIIb applies to any non-personal data;

(c)

in paragraph 3, point (g) is replaced by the following:

‘(g)

participants in data spaces.;

(ca)

in paragraph (5) the following subparagraph is added: ‘The rules set out in Chapters VIIa and VIIc do not create a legal basis for the processing of personal data.’’

(d)

paragraph 7 is deleted.

(e)

the following paragraphs 11, 12 and 13 are added:

‘11.

Chapter VIIb of this Regulation is without prejudice to laws, regulations, and administrative provisions that relate to the internal organisation of Member States and that allocate, among public authorities and bodies governed by public law, powers and responsibilities for the processing of data without contractual remuneration of private parties, as well as to laws, regulations, and administrative provisions of Member States that provide for the implementation of such powers and responsibilities.

12.

Where sector-specific Union or national law requires public sector bodies, data intermediation services providers or recognised data altruism organisations to comply with specific additional technical, administrative or organisational requirements that relate to Chapters VIIa and VIIb, including through an authorisation or certification regime, those provisions of that sector-specific Union or national law shall also apply. Any such specific additional requirements shall be non-discriminatory, proportionate and objectively justified.’

13.

With regards to data and documents in scope of Section II of Chapter VIIc, Chapter VIIc of this Regulation establishes a set of minimum rules governing the re-use and the practical arrangements for facilitating the reuse of data and documents and does not affect the possibility for Member States to adopt more detailed or stricter rules, provided that those rules allow for more extensive re-use of data and documents.’’

Article 1(11)

June Presidency compromise · 10 June

11. Chapter VIIb of this Regulation is without prejudice to laws, regulations, and administrative provisions that relate to the internal organisation of Member States and that allocate, among public authorities and bodies governed by public law, powers and responsibilities for the processing of data without contractual remuneration of private parties, as well as to laws, regulations, and administrative provisions of Member States that provide for the implementation of such powers and responsibilities.

Article 1(12)

June Presidency compromise · 10 June

12. Where sector-specific Union or national law requires public sector bodies, data intermediation services providers or recognised data altruism organisations to comply with specific additional technical, administrative or organisational requirements that relate to Chapters VIIa and VIIb, including through an authorisation or certification regime, those provisions of that sector-specific Union or national law shall also apply. Any such specific additional requirements shall be non-discriminatory, proportionate and objectively justified.

Article 1(13)

June Presidency compromise · 10 June

Council wording reconstructed for this provision from the official operation

13.

With regards to data and documents in scope of Section II of Chapter VIIc, Chapter VIIc of this Regulation establishes a set of minimum rules governing the re-use and the practical arrangements for facilitating the reuse of data and documents and does not affect the possibility for Member States to adopt more detailed or stricter rules, provided that those rules allow for more extensive re-use of data and documents.

Competing proposals

European Parliament amendments

These are alternative tabled amendments. An amendment affecting several tracked parts appears once here, with each target identified.

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Political group at the amendment date where available; otherwise the current Parliament affiliation.

Remove proposed wording Amendment 13 JURI draft opinion · Brando Benifei (rapporteur)
(ea) voluntary registration of data intermediation services;
Justification

This amendment preserves a stronger and more reliable oversight framework for data intermediation services. Maintaining mandatory registration helps ensure transparency, accountability and effective supervision, particularly where sensitive or high-risk data processing activities are involved, and contributes to greater trust and legal certainty within the European data-sharing ecosystem.

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against:
Remove proposed wording Amendment 14 JURI draft opinion · Brando Benifei (rapporteur)
(eb) voluntary registration of entities which collect and process data made available for altruistic purposes;
Justification

This amendment preserves a stronger and more reliable oversight framework for data altruism organisations. Maintaining mandatory registration helps ensure transparency, accountability and effective supervision, particularly where sensitive or high-risk data processing activities are involved, and contributes to greater trust and legal certainty within the European data-sharing ecosystem.

Preview
against:
Remove proposed wording Amendment 140 · David Cormand JURI
Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1

Deletion marker printed in the source: deleted

Remove proposed wording Amendment 141 · Laurence Farreng JURI
Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point e a

Deletion marker printed in the source: deleted

Remove proposed wording Amendment 142 · David Cormand JURI
(eb) voluntary registration of entities which collect and process data made available for altruistic purposes;
Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1

Deletion marker printed in the source: deleted

Alternative wording Amendment 143 · Victor Negrescu JURI
(ee) the re-use of certain data and documents held by public sector bodies or by certain public undertakings, and of research data.; under open, transparent and non-discriminatory conditions, giving priority to open formats and standard licences where compatible with the protection of personal data, trade secrets and other legitimate interests.
Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1

Additional proposed wording Amendment 144 · Daniel Buda JURI
(12a)

The Commission shall publish guidance on the uniform application of these additional requirements to prevent fragmentation of the internal market.

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against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point e / Regulation (EU) 2023/2854 / Article 1 – paragraph 12 a (new)

Alternative wording Amendment 145 · Daniel Buda JURI
13. With regards to data and documents in scope of Section II of Chapter VIIc, Chapter VIIc of this Regulation does not affect the possibility for Member States to adopt more detailed or stricter rules, provided that those rules allow for more extensive re-use of data and documents, in a manner that is proportionate.’
Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point e / Regulation (EU) 2022/868 / Article 1 – paragraph 13

Alternative wording Amendment 192 · David Cormand on behalf of the Verts/ALE Group IMCO
Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point ea

Additional proposed wording Amendment 193 · David Cormand on behalf of the Verts/ALE Group IMCO
Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point ea a (new)

Additional proposed wording Amendment 194 · Virginie Joron IMCO
(eab)

voluntary registration of providers of data processing services on which the performance of a function of general interest or the continuity of an essential service in the Union depend and which are exposed to a unilateral suspension, obstacles to changing supplier or a transfer to a third country;

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against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point ea b (new)

Additional proposed wording Amendment 195 · Virginie Joron IMCO
(ebb)

voluntary registration of providers of data processing services that process sensitive data on the basis of a legitimate interest with a view to researching and developing innovative solutions and processes;

Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1– paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point ea c (new)

Additional proposed wording Amendment 196 · Virginie Joron IMCO
(ebc)

voluntary registration of providers of data processing services that process pseudonymised data using state-of-the-art methods to preserve and reinforce privacy, on the basis of Article 6(1)(f) of Regulation (EU) 2016/679;

Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point ea d (new)

Additional proposed wording Amendment 197 · Virginie Joron IMCO
Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point ea e (new)

Additional proposed wording Amendment 198 · Piotr Müller IMCO

(aa) in paragraph 2, point (a) is replaced by the following

(a)

Chapter II applies to data, with the exception of content, concerning the performance, use and environment of connected products and related services; Chapter II shall not apply where both the user and the data holder are enterprises;

Justification

Removes purely business-to-business dealings from the mandatory data-access obligations of Chapter II, cutting a broad and costly obligation where no consumer interest is at stake.

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against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point a a (new) / Regulation (EU) 2023/2854 / Article 1 – paragraph 2 – point a a (new)

Additional proposed wording Amendment 199 · Piotr Müller IMCO
(ia)

Chapter II shall apply on a voluntary basis to medical devices within the meaning of Regulation (EU) 2017/745, in vitro diagnostic medical devices within the meaning of Regulation (EU) 2017/746, electronic health record systems and related services;

Justification

Makes Chapter II voluntary for medical devices and electronic health records, removing a data-sharing mandate that conflicts with patient-safety and certification duties.

Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point b / Regulation (EU) 2023/2854 / Article 1 – paragraph 2 – point i a (new)

Remove proposed wording Amendment 527 · Elena Sancho Murillo, Marina Kaljurand, Brando Benifei, José Cepeda, Lina Gálvez, Francisco Assis, Alex Agius Saliba ITRE · LIBE
(ea) voluntary registration of data intermediation services;
Justification

This amendment preserves a stronger and more reliable oversight framework for data intermediation services. Maintaining mandatory registration helps ensure transparency, accountability and effective supervision, particularly where sensitive or high-risk data processing activities are involved, and contributes to greater trust and legal certainty within the European data-sharing ecosystem.

Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point ea

Deletion marker printed in the source: deleted

Alternative wording Amendment 528 · Damian Boeselager on behalf of the Verts/ALE Group ITRE · LIBE
(ea) voluntarynotification registrationand supervisory framework for the provision of data intermediation services;
Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point ea

Alternative wording Amendment 529 · João Oliveira ITRE · LIBE
(ea) voluntarymandatory registration of data intermediation services;
Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point ea

Additional proposed wording Amendment 530 · Julie Rechagneux, Mélanie Disdier, Aleksandar Nikolic, Pierre-Romain Thionnet, Alexandre Varaut, Fabrice Leggeri, Marion Maréchal, Christophe Bay ITRE · LIBE
(eaa)

voluntary registration of providers of data processing services that process pseudonymised data which have undergone state-of-the-art privacy-preserving and privacy-enhancing techniques on the basis of Article 6(1)(f) of Regulation (EU) 2016/679;

Justification

The debates surrounding the codification of the case-law of the Court of Justice on the concept of pseudonymised data have revealed an urgent need to clarify the legal status of this category of data. Such debates cannot be settled by a mere definition of personal data, but only through guidelines enabling economic operators to take all appropriate risk-mitigation measures so as to ensure their legal certainty and their due diligence. In order to produce guidelines informed by the best practices of data holders, this amendment establishes a voluntary registration scheme. This scheme will feed the work of the European Data Innovation Board, which, in cooperation with the European Data Protection Board and the Commission, will be able to issue such guidelines.

Preview
against:
Official source ↗
Source identification

Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – Paragraph 1 – point ea a (new)

Additional proposed wording Amendment 531 · Julie Rechagneux, Mélanie Disdier, Aleksandar Nikolic, Pierre-Romain Thionnet, Alexandre Varaut, Fabrice Leggeri, Marion Maréchal, Christophe Bay ITRE · LIBE
(eab)

voluntary registration of providers of data processing services that process high-value data sets or sensitive trade secrets;

Justification

For data processing services handling high-value or sensitive data — whether personal data, open public data or economic data (industrial data, trade secrets) — a voluntary registration scheme would allow operators to make themselves known to the European Data Innovation Board, to take part in its work and to share their best practices with operators subject to the same obligations.

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Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – Paragraph 1 – point ea b (new)

Additional proposed wording Amendment 532 · Julie Rechagneux, Mélanie Disdier, Aleksandar Nikolic, Pierre-Romain Thionnet, Alexandre Varaut, Fabrice Leggeri, Marion Maréchal, Christophe Bay ITRE · LIBE
(eac)

voluntary registration of providers of data processing services on which the performance of a function in the general interest or the continuity of an essential service in the Union depends, and which are exposed to unilateral suspension, switching obstacles or transfer to a third country;

Justification

The Regulation pays sustained attention to the risks arising from transfers — whether forced or voluntary — of sensitive data to third countries, and to the risk of disruption of digital services through unilateral measures of an extraterritorial nature. A voluntary registration scheme for providers on which the performance of a function in the general interest or the continuity of an essential service in the Union depends would enable such providers to make themselves known to the European Data Innovation Board and would inform the definition of protective measures against such extraterritorial reach.

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Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – Paragraph 1 – point ea c (new)

Additional proposed wording Amendment 533 · Julie Rechagneux, Mélanie Disdier, Aleksandar Nikolic, Pierre-Romain Thionnet, Alexandre Varaut, Fabrice Leggeri, Marion Maréchal, Christophe Bay ITRE · LIBE
(ead)

voluntary registration of providers of data processing services which process sensitive data on the basis of legitimate interest for the research and development of innovative solutions and processes;

Justification

The Regulation seeks to lift the ambiguity surrounding the status of pseudonymised data in order to make high-value datasets available for the research and development of innovative solutions and processes. A voluntary registration scheme for providers of data processing services which process sensitive data on the basis of legitimate interest, pursuant to Article 6(1)(f) of Regulation (EU) 2016/679, would allow these operators to make themselves known to the European Data Innovation Board and to share their practices as regards, in particular, the arrangements for obtaining consent where required and the measures taken to mitigate re-identification risks. This would inform the work of the Board and the development of guidelines enabling operators to secure their legal certainty and their due diligence.

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Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – Paragraph 1 – point ea d (new)

Remove proposed wording Amendment 534 · Elena Sancho Murillo, Marina Kaljurand, Brando Benifei, José Cepeda, Lina Gálvez, Francisco Assis, Alex Agius Saliba ITRE · LIBE
(eb) voluntary registration of entities which collect and process data made available for altruistic purposes;
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Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point eb

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Alternative wording Amendment 535 · Damian Boeselager on behalf of the Verts/ALE Group ITRE · LIBE
(eb) voluntarynotification registrationand supervisory framework of entities which collect and process data made available for altruistic purposes;
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Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point eb

Alternative wording Amendment 536 · João Oliveira ITRE · LIBE
(eb) voluntarymandatory registration of entities which collect and process data made available for altruistic purposes;
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Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point eb

Alternative wording Amendment 537 · Diana Iovanovici Şoşoacă ITRE · LIBE
(ee) (ee) the re-use of certain data and documents held by public sector bodies or by certain public undertakings, and of research data.’, under well-defined conditions of access and access periods, ensuring data protection and with potential penalties in the event of uncontrolled data leaks;
Justification

Data protection is key, especially access to this data and the persons who have access to this data.

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Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point ee

Alternative wording Amendment 538 · Elena Sancho Murillo, Marina Kaljurand, Brando Benifei, José Cepeda, Lina Gálvez, Francisco Assis, Alex Agius Saliba ITRE · LIBE
(ee) the re-use of certain data and documents held by public sector bodies or by certain public undertakings, and of research data. subject to safeguards;
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Header printed in the source: Article 1 – paragraph 1 – point 1 – point a / Regulation (EU) 2023/2854 / Article 1 – paragraph 1 – point ee

Alternative wording Amendment 540 · Elena Sancho Murillo, Marina Kaljurand, Brando Benifei, José Cepeda, Lina Gálvez, Francisco Assis, Alex Agius Saliba ITRE · LIBE
(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.;
Justification

Smart contracts are increasingly used as automated execution mechanisms for data-sharing arrangements, including triggering, authorising, restricting, or logging access to data and related services. Where deployed in connected products, digital ecosystems, or data spaces, such applications may determine or materially influence the conditions under which data are made available, accessed, or transferred between parties. In such cases, operators and deployers of smart contract-based systems function as technical intermediaries in the execution of data-sharing obligations under this Regulation and should therefore fall within its scope to ensure enforceability, transparency, and non-discriminatory access conditions.

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Header printed in the source: Article 1 – paragraph 1 – point 1 – point c / Regulation (EU) 2023/2854 / Article 1 – paragraph 3 – point g

Additional proposed wording Amendment 541 · Elena Sancho Murillo, Marina Kaljurand, Brando Benifei, José Cepeda, Lina Gálvez, Francisco Assis, Alex Agius Saliba ITRE · LIBE
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Header printed in the source: Article 1 – paragraph 1 – point 1 – point c a (new) / Regulation (EU) 2023/2854 / Article 1 – paragraph 5 – subparagraph (new)

Alternative wording Amendment 542 · Axel Voss ITRE · LIBE
(da) In Article 1, paragraph 8 is replaced by the following text:
8. This Regulation is without prejudice to Union and national legal acts providing for the protection of intellectual property rights and Trade Secrets, in particular Directives 2001/29/EC, 2004/48/EC, (EU) 2016/943 and (EU) 2019/790. It is also without prejudice to the achievement of the Union Cyber Resilience objectives, defined in particular by the NIS2 Directive and the Cyber Resilience Act."
Justification

The amendments ensure that Data Act access rights do not override trade secrets, IP or EU cybersecurity objectives. Industrial and IoT data can reveal know-how, algorithms, control logic, production methods or R&D results when combined, sequenced or analysed in bulk. Disclosure without the trade secret holder’s consent would weaken innovation, expose EU manufacturers to unfair competition and security risks, and reduce trust in data sharing, while preserving coherence with the Trade Secrets Directive, NIS2 and the Cyber Resilience Act.

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Header printed in the source: Article 1 – paragraph 1 – point 1 – point d a (new) / Regulation (EU) 2023/2854 / Article 1 – paragraph 8

Remove proposed wording Amendment 543 · Damian Boeselager on behalf of the Verts/ALE Group ITRE · LIBE
12. Where sector-specific Union or national law requires public sector bodies, data intermediation services providers or recognised data altruism organisations to comply with specific additional technical, administrative or organisational requirements that relate to Chapters VIIa and VIIb, including through an authorisation or certification regime, those provisions of that sector-specific Union or national law shall also apply. Any such specific additional requirements shall be non-discriminatory, proportionate and objectively justified.’
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Header printed in the source: Article 1 – paragraph 1 – point 1 – point e / Regulation (EU) 2023/2854 / Article 1 – paragraph 12

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Alternative wording Amendment 544 · Diana Iovanovici Şoşoacă ITRE · LIBE
(13) With regards to data and documents in scope of Section II of Chapter VIIc, Chapter VIIc of this Regulation does not affect the possibility for Member States to adopt more detailed or stricter rules, provided that those rules allow for more extensive re-use of data and documents, while respecting data protection and rapid response rules in the event of uncontrolled data leaks.’
Justification

Respect for data protection is crucial under all circumstances.

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Header printed in the source: Article 1 – paragraph 1 – point 1 – point e / Regulation (EU) 2023/2854 / Article 1 – paragraph 13

Additional proposed wording Amendment 545 · Aura Salla, Niels Flemming Hansen, Ana Miguel Pedro, Andrea Wechsler, Oliver Schenk, Christian Ehler ITRE · LIBE

(ea) Paragraph 14 is added, as follows

Chapters II and III of this Regulation shall not apply to:

(a)

data generated by medical devices and in vitro diagnostic medical devices as defined in Regulation (EU) 2017/745 and Regulation (EU) 2017/746 respectively, including accessories and software within the meaning of those Regulations;

(b)

data generated by or processed through electronic health record systems as defined in Article 2, point (2), of Regulation (EU) 2025/327;

(c)

data generated by or processed through related services within the meaning of Article 2, point (6), of this Regulation that are connected to the products referred to in points (a) and (b).

Manufacturers and providers of the products and services referred to in the first subparagraph may voluntarily comply with the obligations set out in Chapters II and III of this Regulation.

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Header printed in the source: Article 1 – paragraph 1 – point 1 – point e a (new) / Regulation (EU) 2023/2854 / Article 1 – paragraph 14

Additional proposed wording Amendment 616 · Henrik Dahl ITRE · LIBE
3a. Article 11 paragraph 1 is replaced by the following:
"A data holder may apply appropriate technical protection measures, including smart contracts and encryption, to prevent unauthorised access to data, including metadata, 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’suser'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, without prejudice to the right of a data holder to refuse access to specific data in accordance with Article 4(8) or 5(11). Users, third parties and data recipients shall not alter or remove such technical protection measures unless agreed by the data holder."
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The official header identifies Article 11(1), and the left column reproduces the official baseline wording of Article 11(1). The prior match to Article 1(11) was a numeric collision, not the amended-law target.

Header printed in the source: Article 1 – paragraph 1 – point 3 a (new) / Regulation (EU) 2023/2854 / Article 11 – paragraph 1