Data Act 2023/2854 EN

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2023/2854 EN cercato: 'edib' . Output generated live by software developed by IusOnDemand srl

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Article 9

Compensation for making data available

1. Any compensation agreed upon between a data holder and a data recipient for making data available in business-to-business relations shall be non- discriminatory and reasonable and may include a margin.

2. When agreeing on any compensation, the data holder and the data recipient shall take into account in particular:

(a)	costs incurred in making the data available, including, in particular, the costs necessary for the formatting of data, dissemination via electronic means and storage;

(b)	investments in the collection and production of data, where applicable, taking into account whether other parties contributed to obtaining, generating or collecting the data in question.

3. The compensation referred to in paragraph 1 may also depend on the volume, format and nature of the data.

4. Where the data recipient is an SME or a not-for-profit research organisation and where such a data recipient does not have partner enterprises or linked enterprises that do not qualify as SMEs, any compensation agreed shall not exceed the costs referred to in paragraph 2, point (a).

5. The Commission shall adopt guidelines on the calculation of reasonable compensation, taking into account the advice of the European Data Innovation Board (edib) referred to in Article 42.

6. This Article shall not preclude other Union law or national legislation adopted in accordance with Union law from excluding compensation for making data available or providing for lower compensation.

7. The data holder shall provide the data recipient with information setting out the basis for the calculation of the compensation in sufficient detail so that the data recipient can assess whether the requirements of paragraphs 1 to 4 are met.

Article 32

International governmental access and transfer

1. Providers of data processing services shall take all adequate technical, organisational and legal measures, including contracts, in order to prevent international and third-country governmental access and transfer of non-personal data held in the Union where such transfer or access would create a conflict with Union law or with the national law of the relevant Member State, without prejudice to paragraph 2 or 3.

2. Any decision or judgment of a third-country court or tribunal and any decision of a third-country administrative authority requiring a provider of data processing services to transfer or give access to non-personal data falling within the scope of this Regulation held in the Union shall be recognised or enforceable in any manner only if based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union, or any such agreement between the requesting third country and a Member State.

3. In the absence of an international agreement as referred to in paragraph 2, where a provider of data processing services is the addressee of a decision or judgment of a third-country court or tribunal or a decision of a third-country administrative authority to transfer or give access to non-personal data falling within the scope of this Regulation held in the Union and compliance with such a decision would risk putting the addressee in conflict with Union law or with the national law of the relevant Member State, transfer to or access to such data by that third-country authority shall take place only where:

(a)	the third-country system requires the reasons and proportionality of such a decision or judgment to be set out and requires such a decision or judgment to be specific in character, for instance by establishing a sufficient link to certain suspected persons or infringements;

(b)	the reasoned objection of the addressee is subject to a review by a competent third-country court or tribunal; and

(c)

the competent third-country court or tribunal issuing the decision or judgment or reviewing the decision of an administrative authority is empowered under the law of that third country to take duly into account the relevant legal interests of the provider of the data protected by Union law or by the national law of the relevant Member State.

The addressee of the decision or judgment may ask the opinion of the relevant national body or authority competent for international cooperation in legal matters, in order to determine whether the conditions laid down in the first subparagraph are met, in particular when it considers that the decision may relate to trade_secrets and other commercially sensitive data as well as to content protected by intellectual property rights or the transfer may lead to re-identification. The relevant national body or authority may consult the Commission. If the addressee considers that the decision or judgment may impinge on the national security or defence interests of the Union or its Member States, it shall ask the opinion of the relevant national body or authority in order to determine whether the data requested concerns national security or defence interests of the Union or its Member States. If the addressee has not received a reply within one month, or if the opinion of such body or authority concludes that the conditions laid down in the first subparagraph are not met, the addressee may reject the request for transfer or access, to non-personal data, on those grounds.

The edib referred to in Article 42 shall advise and assist the Commission in developing guidelines on the assessment of whether the conditions laid down in the first subparagraph of this paragraph are met.

4. If the conditions laid down in paragraph 2 or 3 are met, the provider of data processing services shall provide the minimum amount of data permissible in response to a request, on the basis of the reasonable interpretation of that request by the provider or relevant national body or authority referred to in paragraph 3, second subparagraph.

5. The provider of data processing services shall inform the customer about the existence of a request of a third-country authority to access its data before complying with that request, except where the request serves law enforcement purposes and for as long as this is necessary to preserve the effectiveness of the law enforcement activity.

CHAPTER VIII

INTEROPERABILITY

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 36

Essential requirements regarding smart_contracts for executing data sharing agreements

1. The vendor of an application using smart_contracts or, in the absence thereof, the person whose trade, business or profession involves the deployment of smart_contracts for others in the context of executing an agreement or part of it, to make data available shall ensure that those smart_contracts comply with the following essential requirements of:

(a)	robustness and access control, to ensure that the smart_contract has been designed to offer access control mechanisms and a very high degree of robustness to avoid functional errors and to withstand manipulation by third parties;

(b)

safe termination and interruption, to ensure that a mechanism exists to terminate the continued execution of transactions and that the smart_contract includes internal functions which can reset or instruct the contract to stop or interrupt the operation, in particular to avoid future accidental executions;

(c)	data archiving and continuity, to ensure, in circumstances in which a smart_contract must be terminated or deactivated, there is a possibility to archive the transactional data, smart_contract logic and code in order to keep the record of operations performed on the data in the past (auditability);

(d)	access control, to ensure that a smart_contract is protected through rigorous access control mechanisms at the governance and smart_contract layers; and

(e)	consistency, to ensure consistency with the terms of the data sharing agreement that the smart_contract executes.

2. The vendor of a smart_contract or, in the absence thereof, the person whose trade, business or profession involves the deployment of smart_contracts for others in the context of executing an agreement or part of it, to make data available shall perform a conformity assessment with a view to fulfilling the essential requirements laid down in paragraph 1 and, on the fulfilment of those requirements, issue an EU declaration of conformity.

3. By drawing up the EU declaration of conformity, the vendor of an application using smart_contracts or, in the absence thereof, the person whose trade, business or profession involves the deployment of smart_contracts for others in the context of executing an agreement or part of it, to make data available shall be responsible for compliance with the essential requirements laid down in paragraph 1.

4. A smart_contract that meets the harmonised_standards or the relevant parts thereof, the references of which are published in the Official Journal of the European Union, shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such harmonised_standards or parts thereof.

5. The Commission shall, pursuant to Article 10 of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised_standards that satisfy the essential requirements laid down in paragraph 1 of this Article.

6. The Commission may, by means of implementing acts, adopt common_specifications covering any or all of the essential requirements laid down in paragraph 1 where the following conditions have been fulfilled:

(a)

(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)

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(2).

7. Before preparing a draft implementing act referred to in paragraph 6 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 6 of this Article have been fulfilled.

8. When preparing the draft implementing act referred to in paragraph 6, the Commission shall take into account the advice of the edib and views of other relevant bodies or expert groups and shall duly consult all relevant stakeholders.

9. The vendor of a smart_contract or, in the absence thereof, the person whose trade, business or profession involves the deployment of smart_contracts for others in the context of executing an agreement or part of it, to make data available that meet the common_specifications established by implementing acts referred to in paragraph 6 or parts thereof shall be presumed to be in conformity with the essential requirements laid down in paragraph 1 to the extent that those requirements are covered by such common_specifications or parts thereof.

10. Where a harmonised_standard is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess the harmonised_standard in accordance with Regulation (EU) No 1025/2012. Where the reference of a harmonised_standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 6 of this Article, or parts thereof which cover the same essential requirements as those covered by that harmonised_standard.

11. When a Member State considers that a common specification does not entirely satisfy the essential requirements laid down in paragraph 1, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.

CHAPTER IX

IMPLEMENTATION AND ENFORCEMENT

Article 37

Competent authorities and data coordinators

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

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

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

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

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

4. Without prejudice to paragraph 1 of this Article:

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

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

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

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

(b)

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

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

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

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

(f)

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

(g)

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

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

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

(j)	examining the requests for data made pursuant to Chapter V.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Article 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 42

Role of the edib

The edib established by the Commission as an expert group pursuant to Article 29 of Regulation (EU) 2022/868, in which competent authorities shall be represented, shall support the consistent application of this Regulation by:

(a)	advising and assisting the Commission with regard to developing consistent practice of competent authorities in the enforcement of Chapters II, III, V and VII;

(b)

facilitating cooperation between competent authorities through capacity-building and the exchange of information, in particular by establishing methods for the efficient exchange of information relating to the enforcement of the rights and obligations under Chapters II, III and V in cross-border cases, including coordination with regard to the setting of penalties;

(c)

advising and assisting the Commission with regard to:

(i)	whether to request the drafting of harmonised_standards referred to in Article 33(4), Article 35(4) and Article 36(5);

(ii)	the preparation of the implementing acts referred to in Article 33(5), Article 35(5) and (8) and Article 36(6);

(iii)

the preparation of the delegated acts referred to in Article 29(7) and Article 33(2); and

(iv)	the adoption of the guidelines laying down interoperable frameworks for common standards and practices for the functioning of common European data spaces referred to in Article 33(11).

CHAPTER X

SUI GENERIS RIGHT UNDER DIRECTIVE 96/9/EC

whereas

keyboard_tab Data Act 2023/2854 EN

Data Act 2023/2854 EN