keyboard_tab Data Act 2023/2854 EN
BG CS DA DE EL EN ES ET FI FR GA HR HU IT LV LT MT NL PL PT RO SK SL SV print pdf
- 1 Article 2 Definitions
- 1 Article 10 Dispute settlement
- 1 Article 26 Information obligation of providers of data processing services
- 1 Article 33 Essential requirements regarding interoperability of data, of data sharing mechanisms and services, as well as of common European data spaces
- 1 Article 35 Interoperability of data processing services
- 1 Article 36 Essential requirements regarding smart contracts for executing data sharing agreements
- 1 Article 46 Committee procedure
CHAPTER I
GENERAL PROVISIONS
CHAPTER II
BUSINESS TO CONSUMER AND BUSINESS TO BUSINESS DATA SHARING
CHAPTER III
OBLIGATIONS FOR DATA HOLDERS OBLIGED TO MAKE DATA AVAILABLE PURSUANT TO UNION LAW
CHAPTER IV
UNFAIR CONTRACTUAL TERMS RELATED TO DATA ACCESS AND USE BETWEEN ENTERPRISES
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
CHAPTER VI
SWITCHING BETWEEN DATA PROCESSING SERVICES
CHAPTER VII
UNLAWFUL INTERNATIONAL GOVERNMENTAL ACCESS AND TRANSFER OF NON-PERSONAL DATA
CHAPTER VIII
INTEROPERABILITY
CHAPTER IX
IMPLEMENTATION AND ENFORCEMENT
CHAPTER X
SUI GENERIS RIGHT UNDER DIRECTIVE 96/9/EC
CHAPTER XI
FINAL PROVISIONS
- data
- metadata
- personal data
- non-personal data
- connected product
- related service
- processing
- data processing service
- same service type
- data intermediation service
- data subject
- user
- data holder
- data recipient
- product data
- related service data
- readily available data
- trade secret
- trade secret holder
- profiling
- making available on the market
- placing on the market
- consumer
- enterprise
- small enterprise
- microenterprise
- Union bodies
- public sector body
- public emergency
- customer
- virtual assistants
- digital assets
- on-premises ICT infrastructure
- switching
- data egress charges
- switching charges
- functional equivalence
- exportable data
- smart contract
- interoperability
- common specifications
- harmonised standard
- data 137
- shall 62
- means 52
- article 41
- processing 39
- requirements 35
- services 34
- paragraph 31
- commission 31
- regulation 30
- essential 26
- accordance 24
- dispute 24
- union 22
- interoperability 22
- referred 22
- european 21
- down 21
- settlement 21
- laid 20
- which 20
- service 20
- article 19
- implementing 19
- thereof 18
- body 18
- available 17
- acts 17
- relevant 16
- such 16
- harmonised_standards 16
- the 16
- request 14
- including 14
- access 13
- provider 13
- common 12
- harmonised_standard 11
- have 11
- point 11
- parties 11
- connected_product 11
- person 10
- user 10
- smart_contract 10
- business 10
- more 10
- customer 10
- parts 10
- portability 10
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
| (1) | ‘ data’ means any digital representation of acts, facts or information and any compilation of such acts, facts or information, including in the form of sound, visual or audio-visual recording; |
| (2) | ‘meta data’ means a structured description of the contents or the use of data facilitating the discovery or use of that data; |
| (3) | ‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679; |
| (4) | ‘non-personal data’ means data other than personal data; |
| (5) | ‘ connected_product’ means an item that obtains, generates or collects data concerning its use or environment and that is able to communicate product data via an electronic communications service, physical connection or on-device access, and whose primary function is not the storing, processing or transmission of data on behalf of any party other than the user; |
| (6) | ‘ related_service’ means a digital service, other than an electronic communications service, including software, which is connected with the product at the time of the purchase, rent or lease in such a way that its absence would prevent the connected_product from performing one or more of its functions, or which is subsequently connected to the product by the manufacturer or a third party to add to, update or adapt the functions of the connected_product; |
| (7) | ‘ processing’ means any operation or set of operations which is performed on data or on sets of data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination, or other means of making them available, alignment or combination, restriction, erasure or destruction; |
| (8) | ‘ data processing service’ means a digital service that is provided to a customer and that enables ubiquitous and on-demand network access to a shared pool of configurable, scalable and elastic computing resources of a centralised, distributed or highly distributed nature that can be rapidly provisioned and released with minimal management effort or service provider interaction; |
| (9) | ‘ same_service_type’ means a set of data processing services that share the same primary objective, data processing service model and main functionalities; |
| (10) | ‘ data intermediation service’ means data intermediation service as defined in Article 2, point (11), of Regulation (EU) 2022/868; |
| (11) | ‘ data subject’ means data subject as referred to in Article 4, point (1), of Regulation (EU) 2016/679; |
| (12) | ‘ user’ means a natural or legal person that owns a connected_product or to whom temporary rights to use that connected_product have been contractually transferred, or that receives related_services; |
| (13) | ‘ data holder’ means a natural or legal person that has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation adopted in accordance with Union law, to use and make available data, including, where contractually agreed, product data or related_service data which it has retrieved or generated during the provision of a related_service; |
| (14) | ‘ data recipient’ means a natural or legal person, acting for purposes which are related to that person’s trade, business, craft or profession, other than the user of a connected_product or related_service, to whom the data holder makes data available, including a third party following a request by the user to the data holder or in accordance with a legal obligation under Union law or national legislation adopted in accordance with Union law; |
| (15) | ‘product data’ means data generated by the use of a connected_product that the manufacturer designed to be retrievable, via an electronic communications service, physical connection or on-device access, by a user, data holder or a third party, including, where relevant, the manufacturer; |
| (16) | ‘ related_service data’ means data representing the digitisation of user actions or of events related to the connected_product, recorded intentionally by the user or generated as a by-product of the user’s action during the provision of a related_service by the provider; |
| (17) | ‘readily available data’ means product data and related_service data that a data holder lawfully obtains or can lawfully obtain from the connected_product or related_service, without disproportionate effort going beyond a simple operation; |
| (18) | ‘ trade_secret’ means trade_secret as defined in Article 2, point (1), of Directive (EU) 2016/943; |
| (19) | ‘ trade_secret holder’ means a trade_secret holder as defined in Article 2, point (2), of Directive (EU) 2016/943; |
| (20) | ‘ profiling’ means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679; |
| (21) | ‘ making_available_on_the_market’ means any supply of a connected_product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; |
| (22) | ‘ placing_on_the_market’ means the first making available of a connected_product on the Union market; |
| (23) | ‘ consumer’ means any natural person who is acting for purposes which are outside that person’s trade, business, craft or profession; |
| (24) | ‘ enterprise’ means a natural or legal person that, in relation to contracts and practices covered by this Regulation, is acting for purposes which are related to that person’s trade, business, craft or profession; |
| (25) | ‘small enterprise’ means a small enterprise as defined in Article 2(2) of the Annex to Recommendation 2003/361/EC; |
| (26) | ‘micro enterprise’ means a micro enterprise as defined in Article 2(3) of the Annex to Recommendation 2003/361/EC; |
| (27) | ‘ Union_bodies’ means the Union_bodies, offices and agencies set up by or pursuant to acts adopted on the basis of the Treaty on European Union, the TFEU or the Treaty establishing the European Atomic Energy Community; |
| (28) | ‘ public_sector_body’ means national, regional or local authorities of the Member States and bodies governed by public law of the Member States, or associations formed by one or more such authorities or one or more such bodies; |
| (29) | ‘ public_emergency’ means an exceptional situation, limited in time, such as a public health emergency, an emergency resulting from natural disasters, a human-induced major disaster, including a major cybersecurity incident, negatively affecting the population of the Union or the whole or part of a Member State, with a risk of serious and lasting repercussions for living conditions or economic stability, financial stability, or the substantial and immediate degradation of economic assets in the Union or the relevant Member State and which is determined or officially declared in accordance with the relevant procedures under Union or national law; |
| (30) | ‘ customer’ means a natural or legal person that has entered into a contractual relationship with a provider of data processing services with the objective of using one or more data processing services; |
| (31) | ‘ virtual_assistants’ means software that can process demands, tasks or questions including those based on audio, written input, gestures or motions, and that, based on those demands, tasks or questions, provides access to other services or controls the functions of connected_products; |
| (32) | ‘ digital_assets’ means elements in digital form, including applications, for which the customer has the right of use, independently from the contractual relationship with the data processing service it intends to switch from; |
| (33) | ‘ on-premises_ICT_infrastructure’ means ICT infrastructure and computing resources owned, rented or leased by the customer, located in the data centre of the customer itself and operated by the customer or by a third-party; |
| (34) | ‘ switching’ means the process involving a source provider of data processing services, a customer of a data processing service and, where relevant, a destination provider of data processing services, whereby the customer of a data processing service changes from using one data processing service to using another data processing service of the same_service_type, or other service, offered by a different provider of data processing services, or to an on-premises_ICT_infrastructure, including through extracting, transforming and uploading the data; |
| (35) | ‘ data egress charges’ means data transfer fees charged to customers for extracting their data through the network from the ICT infrastructure of a provider of data processing services to the system of a different provider or to on-premises_ICT_infrastructure; |
| (36) | ‘ switching charges’ means charges, other than standard service fees or early termination penalties, imposed by a provider of data processing services on a customer for the actions mandated by this Regulation for switching to the system of a different provider or to on-premises_ICT_infrastructure, including data egress charges; |
| (37) | ‘ functional_equivalence’ means re-establishing on the basis of the customer’s exportable data and digital_assets, a minimum level of functionality in the environment of a new data processing service of the same_service_type after the switching process, where the destination data processing service delivers a materially comparable outcome in response to the same input for shared features supplied to the customer under the contract; |
| (38) | ‘exportable data’, for the purpose of Articles 23 to 31 and Article 35, means the input and output data, including meta data, directly or indirectly generated, or cogenerated, by the customer’s use of the data processing service, excluding any assets or data protected by intellectual property rights, or constituting a trade_secret, of providers of data processing services or third parties; |
| (39) | ‘ smart_contract’ means a computer program used for the automated execution of an agreement or part thereof, using a sequence of electronic data records and ensuring their integrity and the accuracy of their chronological ordering; |
| (40) | ‘ interoperability’ means the ability of two or more data spaces or communication networks, systems, connected_products, applications, data processing services or components to exchange and use data in order to perform their functions; |
| (41) | open interoperability specification’ means a technical specification in the field of information and communication technologies which is performance oriented towards achieving interoperability between data processing services; |
| (42) | ‘ common_specifications’ means a document, other than a standard, containing technical solutions providing a means to comply with certain requirements and obligations established under this Regulation; |
| (43) | ‘ harmonised_standard’ means a harmonised_standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012. |
CHAPTER II
BUSINESS TO CONSUMER AND BUSINESS TO BUSINESS DATA SHARING
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 26
Information obligation of providers of data processing services
The provider of data processing services shall provide the customer with:
| (a) | information on available procedures for switching and porting to the data processing service, including information on available switching and porting methods and formats as well as restrictions and technical limitations which are known to the provider of data processing services; |
| (b) | a reference to an up-to-date online register hosted by the provider of data processing services, with details of all the data structures and data formats as well as the relevant standards and open interoperability specifications, in which the exportable data referred to in Article 25(2), point (e), are available. |
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:
|
| (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 35
Interoperability of data processing services
1. Open interoperability specifications and harmonised_standards for the interoperability of data processing services shall:
| (a) | achieve, where technically feasible, interoperability between different data processing services that cover the same_service_type; |
| (b) | enhance portability of digital_assets between different data processing services that cover the same_service_type; |
| (c) | facilitate, where technically feasible, functional_equivalence between different data processing services referred to in Article 30(1) that cover the same_service_type; |
| (d) | not have an adverse impact on the security and integrity of data processing services and data; |
| (e) | be designed in such a way so as to allow for technical advances and the inclusion of new functions and innovation in data processing services. |
2. Open interoperability specifications and harmonised_standards for the interoperability of data processing services shall adequately address:
| (a) | the cloud interoperability aspects of transport interoperability, syntactic interoperability, semantic data interoperability, behavioural interoperability and policy interoperability; |
| (b) | the cloud data portability aspects of data syntactic portability, data semantic portability and data policy portability; |
| (c) | the cloud application aspects of application syntactic portability, application instruction portability, application meta data portability, application behaviour portability and application policy portability. |
3. Open interoperability specifications shall comply with Annex II to Regulation (EU) No 1025/2012.
4. After taking into account relevant international and European standards and self-regulatory initiatives, the Commission may, in accordance with Article 10(1) 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 paragraphs 1 and 2 of this Article.
5. The Commission may, by means of implementing acts, adopt common_specifications based on open interoperability specifications covering all of the essential requirements laid down in paragraphs 1 and 2.
6. When preparing the draft implementing act referred to in paragraph 5 of this Article, the Commission shall take into account the views of the relevant competent authorities referred to in Article 37(5), point (h) and other relevant bodies or expert groups and shall duly consult all relevant stakeholders.
7. When a Member State considers that a common specification does not entirely satisfy the essential requirements laid down in paragraphs 1 and 2, 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.
8. For the purpose of Article 30(3), the Commission shall, by means of implementing acts, publish the references of harmonised_standards and common_specifications for the interoperability of data processing services in a central Union standards repository for the interoperability of data processing services.
9. The implementing acts referred to in this Article shall be adopted in accordance with the examination procedure referred to in Article 46(2).
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:
|
| (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 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.
whereas