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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 8

Conditions under which data holders make data available to data recipients

1.   Where, in business-to-business relations, a data holder is obliged to make data available to a data recipient under Article 5 or under other applicable Union law or national legislation adopted in accordance with Union law, it shall agree with a data recipient the arrangements for making the data available and shall do so under fair, reasonable and non-discriminatory terms and conditions and in a transparent manner in accordance with this Chapter and Chapter IV.

2.   A contractual term concerning access to and the use of data, or liability and remedies for the breach or termination of data-related obligations, shall not be binding if it constitutes an unfair contractual term within the meaning of Article 13 or if, to the detriment of the user, it excludes the application of, derogates from or varies the effect of the user’s rights under Chapter II.

3.   A data holder shall not discriminate regarding the arrangements for making data available between comparable categories of data recipients, including partner enterprises or linked enterprises of the data holder when making data available. Where a data recipient considers that the conditions under which data has been made available to it are discriminatory, the data holder shall without undue delay provide the data recipient, upon its reasoned request, with information showing that there has been no discrimination.

4.   A data holder shall not make data available to a data recipient, including on an exclusive basis, unless requested to do so by the user under Chapter II.

5.   Data holders and data recipients shall not be required to provide any information beyond what is necessary to verify compliance with the contractual terms agreed for making data available or with their obligations under this Regulation or other applicable Union law or national legislation adopted in accordance with Union law.

6.   Unless otherwise provided for in Union law, including Article 4(6) and Article 5(9) of this Regulation, or by national legislation adopted in accordance with Union law, an obligation to make data available to a data recipient shall not oblige the disclosure of trade_secrets.

Article 10

Dispute settlement

1.   Users, data holders and data recipients shall have access to a dispute settlement body, certified in accordance with paragraph 5 of this Article, to settle disputes pursuant to Article 4(3) and (9) and Article 5(12) as well as disputes relating to the fair, reasonable and non-discriminatory terms and conditions for, and transparent manner of, making data available in accordance with this Chapter and Chapter IV.

2.   Dispute settlement bodies shall make the fees, or the mechanisms used to determine the fees, known to the parties concerned before those parties request a decision.

3.   For disputes referred to a dispute settlement body pursuant to Article 4(3) and (9) and Article 5(12), where the dispute settlement body decides a dispute in favour of the user or of the data recipient, the data holder shall bear all the fees charged by the dispute settlement body and shall reimburse that user or that data recipient for any other reasonable expenses that it has incurred in relation to the dispute settlement. If the dispute settlement body decides a dispute in favour of the data holder, the user or the data recipient shall not be required to reimburse any fees or other expenses that the data holder paid or is to pay in relation to the dispute settlement, unless the dispute settlement body finds that the user or the data recipient manifestly acted in bad faith.

4.   Customers and providers of data processing services shall have access to a dispute settlement body, certified in accordance with paragraph 5 of this Article, to settle disputes relating to breaches of the rights of customers and the obligations of providers of data processing services, in accordance with Articles 23 to 31.

5.   The Member State where the dispute settlement body is established shall, at the request of that body, certify that body where it has demonstrated that it meets all of the following conditions:

(a)

it is impartial and independent, and it is to issue its decisions in accordance with clear, non-discriminatory and fair rules of procedure;

(b)

it has the necessary expertise, in particular in relation to fair, reasonable and non-discriminatory terms and conditions, including compensation, and on making data available in a transparent manner, allowing the body to effectively determine those terms and conditions;

(c)

it is easily accessible through electronic communication technology;

(d)

it is capable of adopting its decisions in a swift, efficient and cost-effective manner in at least one official language of the Union.

6.   Member States shall notify to the Commission the dispute settlement bodies certified in accordance with paragraph 5. The Commission shall publish a list of those bodies on a dedicated website and keep it updated.

7.   A dispute settlement body shall refuse to deal with a request to resolve a dispute that has already been brought before another dispute settlement body or before a court or tribunal of a Member State.

8.   A dispute settlement body shall grant parties the possibility, within a reasonable period of time, to express their points of view on the matters those parties have brought before that body. In that context, each party to a dispute shall be provided with the submissions of the other party to their dispute and any statements made by experts. The parties shall be given the possibility to comment on those submissions and statements.

9.   A dispute settlement body shall adopt its decision on a matter referred to it within 90 days of receipt of a request pursuant to paragraphs 1 and 4. That decision shall be in writing or on a durable medium and shall be supported by a statement of reasons.

10.   Dispute settlement bodies shall draw up and make publicly available annual activity reports. Such annual reports shall include, in particular, the following general information:

(a)

an aggregation of the outcomes of disputes;

(b)

the average time taken to resolve disputes;

(c)

the most common reasons for disputes.

11.   In order to facilitate the exchange of information and best practices, a dispute settlement body may decide to include recommendations in the report referred to in paragraph 10 as to how problems can be avoided or resolved.

12.   The decision of a dispute settlement body shall be binding on the parties only if the parties have explicitly consented to its binding nature prior to the start of the dispute settlement proceedings.

13.   This Article does not affect the right of parties to seek an effective remedy before a court or tribunal of a Member State.

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 13

Unfair contractual terms unilaterally imposed on another enterprise

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

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

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

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

(a)

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

(b)

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

(c)

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

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

(a)

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

(b)

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

(c)

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

(d)

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

(e)

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

(f)

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

(g)

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

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

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

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

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

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

CHAPTER V

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

Article 15

Exceptional need to use data

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

(a)

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

(b)

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

(i)

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

(ii)

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

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

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

Article 25

Contractual terms concerning switching

1.   The rights of the customer and the obligations of the provider of data processing services in relation to switching between providers of such services or, where applicable, to an on-premises_ICT_infrastructure shall be clearly set out in a written contract. The provider of data processing services shall make that contract available to the customer prior to signing the contract in a way that allows the customer to store and reproduce the contract.

2.   Without prejudice to Directive (EU) 2019/770, the contract referred to in paragraph 1 of this Article shall include at least the following:

(a)

clauses allowing the customer, upon request, to switch to a data processing service offered by a different provider of data processing services or to port all exportable data and digital_assets to an on-premises_ICT_infrastructure, without undue delay and in any event not after the mandatory maximum transitional period of 30 calendar days, to be initiated after the maximum notice period referred to in point (d), during which the service contract remains applicable and during which the provider of data processing services shall:

(i)

provide reasonable assistance to the customer and third parties authorised by the customer in the switching process;

(ii)

act with due care to maintain business continuity, and continue the provision of the functions or services under the contract;

(iii)

provide clear information concerning known risks to continuity in the provision of the functions or services on the part of the source provider of data processing services;

(iv)

ensure that a high level of security is maintained throughout the switching process, in particular the security of the data during their transfer and the continued security of the data during the retrieval period specified in point (g), in accordance with applicable Union or national law;

(b)

an obligation of the provider of data processing services to support the customer’s exit strategy relevant to the contracted services, including by providing all relevant information;

(c)

a clause specifying that the contract shall be considered to be terminated and the customer shall be notified of the termination, in one of the following cases:

(i)

where applicable, upon the successful completion of the switching process;

(ii)

at the end of the maximum notice period referred to in paragraph (d), where the customer does not wish to switch but to erase its exportable data and digital_assets upon service termination;

(d)

a maximum notice period for initiation of the switching process, which shall not exceed two months;

(e)

an exhaustive specification of all categories of data and digital_assets that can be ported during the switching process, including, at a minimum, all exportable data;

(f)

an exhaustive specification of categories of data specific to the internal functioning of the provider’s data processing service that are to be exempted from the exportable data under point (e) of this paragraph where a risk of breach of trade_secrets of the provider exists, provided that such exemptions do not impede or delay the switching process provided for in Article 23;

(g)

a minimum period for data retrieval of at least 30 calendar days, starting after the termination of the transitional period that was agreed between the customer and the provider of data processing services, in accordance with point (a) of this paragraph and paragraph 4;

(h)

a clause guaranteeing full erasure of all exportable data and digital_assets generated directly by the customer, or relating to the customer directly, after the expiry of the retrieval period referred to in point (g) or after the expiry of an alternative agreed period at a date later than the date of expiry of the retrieval period referred to in point (g), provided that the switching process has been completed successfully;

(i)

switching charges, that may be imposed by providers of data processing services in accordance with Article 29.

3.   The contract referred to in paragraph 1 shall include clauses providing that the customer may notify the provider of data processing services of its decision to perform one or more of the following actions upon termination of the maximum notice period referred to in paragraph 2, point (d):

(a)

switch to a different provider of data processing services, in which case the customer shall provide the necessary details of that provider;

(b)

switch to an on-premises_ICT_infrastructure;

(c)

erase its exportable data and digital_assets.

4.   Where the mandatory maximum transitional period as provided for in paragraph 2, point (a) is technically unfeasible, the provider of data processing services shall notify the customer within 14 working days of the making of the switching request, and shall duly justify the technical unfeasibility and indicate an alternative transitional period, which shall not exceed seven months. In accordance with paragraph 1, service continuity shall be ensured throughout the alternative transitional period.

5.   Without prejudice to paragraph 4, the contract referred to in paragraph 1 shall include clauses providing the customer with the right to extend the transitional period once for a period that the customer considers more appropriate for its own purposes.

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)

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).

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 43

Databases containing certain data

The sui generis right provided for in Article 7 of Directive 96/9/EC shall not apply when data is obtained from or generated by a connected_product or related_service falling within the scope of this Regulation, in particular in relation to Articles 4 and 5 thereof.

CHAPTER XI

FINAL PROVISIONS

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 46

Committee procedure

1.   The Commission shall be assisted by the Committee established by Regulation (EU) 2022/868. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Article 49

Evaluation and review

1.   By 12 September 2028, the Commission shall carry out an evaluation of this Regulation and submit a report on its main findings to the European Parliament and to the Council, and to the European Economic and Social Committee. That evaluation shall assess, in particular:

(a)

situations to be considered to be situations of exceptional need for the purpose of Article 15 of this Regulation and the application of Chapter V of this Regulation in practice, in particular the experience in the application of Chapter V of this Regulation by public sector bodies, the Commission, the European Central Bank and Union_bodies; the number and outcome of the proceedings brought to the competent authority under Article 18(5) on the application of Chapter V of this Regulation, as reported by the competent authorities; the impact of other obligations laid down in Union or national law for the purposes of complying with requests for access to information; the impact of voluntary data-sharing mechanisms, such as those put in place by data altruism organisations recognised under Regulation (EU) 2022/868, on meeting the objectives of Chapter V of this Regulation, and the role of personal data in the context of Article 15 of this Regulation, including the evolution of privacy-enhancing technologies;

(b)

the impact of this Regulation on the use of data in the economy, including on data innovation, data monetisation practices and data intermediation services, as well as on data sharing within the common European data spaces;

(c)

the accessibility and use of different categories and types of data;

(d)

the exclusion of certain categories of enterprises as beneficiaries under Article 5;

(e)

the absence of any impact on intellectual property rights;

(f)

the impact on trade_secrets, including on the protection against their unlawful acquisition, use and disclosure, as well as the impact of the mechanism allowing the data holder to refuse the user’s request under Article 4(8) and Article 5(11), taking into account, to the extent possible, any revision of Directive (EU) 2016/943;

(g)

whether the list of unfair contractual terms referred to in Article 13 is up-to-date in light of new business practices and the rapid pace of market innovation;

(h)

changes in the contractual practices of providers of data processing services and whether this results in sufficient compliance with Article 25;

(i)

the diminution of charges imposed by providers of data processing services for the switching process, in line with the gradual withdrawal of switching charges pursuant to Article 29;

(j)

the interplay of this Regulation with other Union legal acts of relevance to the data economy;

(k)

the prevention of unlawful governmental access to non-personal data;

(l)

the efficacy of the enforcement regime required under Article 37;

(m)

the impact of this Regulation on SMEs with regard to their capacity to innovate and to the availability of data processing services for users in the Union and the burden of complying with new obligations.

2.   By 12 September 2028, the Commission shall carry out an evaluation of this Regulation and submit a report on its main findings to the European Parliament and to the Council, and to the European Economic and Social Committee. That evaluation shall assess the impact of Articles 23 to 31 and Articles 34 and 35, in particular regarding pricing and the diversity of data processing services offered within the Union, with a special focus on SME providers.

3.   Member States shall provide the Commission with the information necessary for the preparation of the reports referred to in paragraphs 1 and 2.

4.   On the basis of the reports referred to in paragraphs 1 and 2, the Commission may, where appropriate, submit a legislative proposal to the European Parliament and to the Council to amend this Regulation.


whereas









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