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2022/0868 EN cercato: 'power' . Output generated live by software developed by IusOnDemand srl


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Article 1

Subject matter and scope

1.   This Regulation lays down:

(a)

conditions for the re-use, within the Union, of certain categories of data held by public sector bodies;

(b)

a notification and supervisory framework for the provision of data intermediation services;

(c)

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

(d)

a framework for the establishment of a European Data Innovation Board.

2.   This Regulation does not create any obligation on public sector bodies to allow the re-use of data, nor does it release public sector bodies from their confidentiality obligations under Union or national law.

This Regulation is without prejudice to:

(a)

specific provisions in Union or national law regarding the access to or re-use of certain categories of data, in particular with regard to the granting of access to and disclosure of official documents; and

(b)

the obligations of public sector bodies under Union or national law to allow the re-use of data or to requirements related to processing of non-personal data.

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

3.   Union and national law on the protection of personal data shall apply to any personal data processed in connection with this Regulation. In particular, this Regulation is without prejudice to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directives 2002/58/EC and (EU) 2016/680, including with regard to the powers and competences of supervisory authorities. In the event of a conflict between this Regulation and Union law on the protection of personal data or national law adopted in accordance with such Union law, the relevant Union or national law on the protection of personal data shall prevail. This Regulation does not create a legal basis for the processing of personal data, nor does it affect any of the rights and obligations set out in Regulations (EU) 2016/679 or (EU) 2018/1725 or Directives 2002/58/EC or (EU) 2016/680.

4.   This Regulation is without prejudice to the application of competition law.

5.   This Regulation is without prejudice to the competences of the Member States with regard to their activities concerning public security, defence and national security.

Article 7

Competent bodies

1.   For the purpose of carrying out the tasks referred to in this Article, each Member State shall designate one or more competent bodies, which may be competent for particular sectors, to assist the public sector bodies which grant or refuse access for the re-use of the categories of data referred to in Article 3(1). Member States may either establish one or more new competent bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions laid down in this Regulation.

2.   The competent bodies may be empowered to grant access for the re-use of the categories of data referred to in Article 3(1) pursuant to Union or national law which provides for such access to be granted. Where they grant or refuse access for the re-use, Articles 4, 5, 6 and 9 shall apply to those competent bodies.

3.   The competent bodies shall have adequate legal, financial, technical and human resources to carry out the tasks assigned to them, including the necessary technical knowledge to be able to comply with relevant Union or national law concerning the access regimes for the categories of data referred to in Article 3(1).

4.   The assistance provided for in paragraph 1 shall include, where necessary:

(a)

providing technical support by making available a secure processing environment for providing access for the re-use of data;

(b)

providing guidance and technical support on how to best structure and store data to make that data easily accessible;

(c)

providing technical support for pseudonymisation and ensuring data processing in a manner that effectively preserves the privacy, confidentiality, integrity and accessibility of the information contained in the data for which re-use is allowed, including techniques for the anonymisation, generalisation, suppression and randomisation of personal data or other state-of-the-art privacy-preserving methods, and the deletion of commercially confidential information, including trade secrets or content protected by intellectual property rights;

(d)

assisting the public sector bodies, where relevant, to provide support to re-users in requesting consent for re-use from data subjects or permission from data holders in line with their specific decisions, including on the jurisdiction in which the data processing is intended to take place and assisting the public sector bodies in establishing technical mechanisms that allow the transmission of requests for consent or permission from re-users, where practically feasible;

(e)

providing public sector bodies with assistance in assessing the adequacy of contractual commitments made by a re-user pursuant to Article 5(10).

5.   Each Member State shall notify the Commission of the identity of the competent bodies designated pursuant to paragraph 1 by 24 September 2023. Each Member State shall also notify the Commission of any subsequent change to the identity of those competent bodies.

Article 13

Competent authorities for data intermediation services

1.   Each Member State shall designate one or more competent authorities to carry out the tasks related to the notification procedure for data intermediation services and shall notify the Commission of the identity of those competent authorities by 24 September 2023. Each Member State shall also notify the Commission of any subsequent change to the identity of those competent authorities.

2.   The competent authorities for data intermediation services shall comply with the requirements set out in Article 26.

3.   The powers of the competent authorities for data intermediation services are without prejudice to the powers of the data protection authorities, national competition authorities, authorities in charge of cybersecurity and other relevant sectoral authorities. In accordance with their respective competences under Union and national law, those authorities shall establish strong cooperation and exchange information as is necessary for the exercise of their tasks in relation to data intermediation services providers, and shall aim to achieve consistency in the decisions taken in applying this Regulation.

Article 14

Monitoring of compliance

1.   The competent authorities for data intermediation services shall monitor and supervise compliance of data intermediation services providers with the requirements of this Chapter. The competent authorities for data intermediation services may also monitor and supervise the compliance of data intermediation services providers, on the basis of a request by a natural or legal person.

2.   The competent authorities for data intermediation services shall have the power to request from data intermediation services providers or their legal_representatives all the information that is necessary to verify compliance with the requirements of this Chapter. Any request for information shall be proportionate to the performance of the task and shall be reasoned.

3.   Where the competent authority for data intermediation services finds that a data intermediation services provider does not comply with one or more of the requirements of this Chapter, it shall notify that data intermediation services provider of those findings and give it the opportunity to state its views, within 30 days of the receipt of the notification.

4.   The competent authority for data intermediation services shall have the power to require the cessation of the infringement referred to in paragraph 3 within a reasonable time limit or immediately in the case of a serious infringement and shall take appropriate and proportionate measures with the aim of ensuring compliance. In that regard, the competent authority for data intermediation services shall have the power, where appropriate:

(a)

to impose, through administrative procedures, dissuasive financial penalties, which may include periodic penalties and penalties with retroactive effect, to initiate legal proceedings for the imposition of fines, or both;

(b)

to require a postponement of the commencement or a suspension of the provision of the data intermediation service until any changes to the conditions requested by the competent authority for data intermediation services have been made; or

(c)

to require the cessation of the provision of the data intermediation service in the event that serious or repeated infringements have not been remedied despite prior notification in accordance with paragraph 3.

The competent authority for data intermediation services shall request the Commission to remove the data intermediation services provider from the register of data intermediation services providers once it has ordered the cessation of the provision of the data intermediation service in accordance with the first subparagraph, point (c).

If a data intermediation services provider remedies infringements, that data intermediation services provider shall re-notify the competent authority for data intermediation services. The competent authority for data intermediation services shall notify the Commission of each new re-notification.

5.   Where a data intermediation services provider that is not established in the Union fails to designate a legal_representative or the legal_representative fails, upon request of the competent authority for data intermediation services, to provide the necessary information that comprehensively demonstrates compliance with this Regulation, the competent authority for data intermediation services shall have the power to postpone the commencement of or to suspend the provision of the data intermediation service until the legal_representative is designated or the necessary information is provided.

6.   The competent authorities for data intermediation services shall notify the data intermediation services provider concerned of the measures imposed pursuant to paragraphs 4 and 5 and the reasons on which they are based, as well as the necessary steps to be taken to rectify the relevant shortcomings, without delay, and shall stipulate a reasonable period, which shall not be longer than 30 days, for the data intermediation services provider to comply with those measures.

7.   If a data intermediation services provider has its main_establishment or its legal_representative in a Member State but provides services in other Member States, the competent authority for data intermediation services of the Member State of the main_establishment or where the legal_representative is located and the competent authorities for data intermediation services of those other Member States shall cooperate and assist each other. Such assistance and cooperation may cover information exchanges between the competent authorities for data intermediation services concerned for the purposes of their tasks under this Regulation and reasoned requests to take the measures referred to in this Article.

Where a competent authority for data intermediation services in one Member State requests assistance from a competent authority for data intermediation services in another Member State, it shall submit a reasoned request. The competent authority for data intermediation services shall, upon such a request, provide a response without delay and within a timeframe proportionate to the urgency of the request.

Any information exchanged in the context of assistance requested and provided under this paragraph shall be used only in respect of the matter for which it was requested.

Article 24

Monitoring of compliance

1.   The competent authorities for the registration of data altruism organisations shall monitor and supervise compliance of recognised data altruism organisations with the requirements laid down in this Chapter. The competent authority for the registration of data altruism organisations may also monitor and supervise the compliance of such recognised data altruism organisations, on the basis of a request by a natural or legal person.

2.   The competent authorities for the registration of data altruism organisations shall have the power to request information from recognised data altruism organisations that is necessary to verify compliance with the requirements of this Chapter. Any request for information shall be proportionate to the performance of the task and shall be reasoned.

3.   Where the competent authority for the registration of data altruism organisations finds that a recognised data altruism organisation does not comply with one or more of the requirements of this Chapter, it shall notify the recognised data altruism organisation of those findings and give it the opportunity to state its views within 30 days of the receipt of the notification.

4.   The competent authority for the registration of data altruism organisations shall have the power to require the cessation of the infringement referred to in paragraph 3 either immediately or within a reasonable time limit and shall take appropriate and proportionate measures with the aim of ensuring compliance.

5.   If a recognised data altruism organisation does not comply with one or more of the requirements of this Chapter even after having been notified in accordance with paragraph 3 by the competent authority for the registration of data altruism organisations, that recognised data altruism organisation shall:

(a)

lose its right to use the label ‘ data altruism organisation recognised in the Union’ in any written and spoken communication;

(b)

be removed from the relevant public national register of recognised data altruism organisations and the public Union register of recognised data altruism organisations.

Any decision revoking the right to use the label ‘ data altruism organisation recognised in the Union’ under the first subparagraph, point (a), shall be made public by the competent authority for the registration of data altruism organisations.

6.   If a recognised data altruism organisation has its main_establishment or its legal_representative in a Member State but is active in other Member States, the competent authority for the registration of data altruism organisations of the Member State of the main_establishment or where the legal_representative is located and the competent authorities for the registration of data altruism organisations of those other Member States shall cooperate and assist each other. Such assistance and cooperation may cover information exchanges between the competent authorities for the registration of data altruism organisations concerned for the purposes of their tasks under this Regulation and reasoned requests to take the measures referred to in this Article.

Where a competent authority for the registration of data altruism organisations in one Member State requests assistance from a competent authority for the registration of data altruism organisations in another Member State, it shall submit a reasoned request. The competent authority for the registration of data altruism organisations shall, upon such a request, provide a response without delay and within a timeframe proportionate to the urgency of the request.

Any information exchanged in the context of assistance requested and provided under this paragraph shall be used only in respect of the matter for which it was requested.

Article 31

International access and transfer

1.   The public_sector_body, the natural or legal person to which the right to re-use data was granted under Chapter II, the data intermediation services provider or the recognised data altruism organisation shall take all reasonable technical, legal and organisational measures, including contractual arrangements, in order to prevent international transfer or governmental access to non-personal data held in the Union where such transfer or access would create a conflict with Union law or 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 public_sector_body, a natural or legal person to which the right to re-use data was granted under Chapter II, a data intermediation services provider or recognised data altruism organisation to transfer or give access to non-personal data 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 of this Article, where a public_sector_body, a natural or legal person to which the right to re-use data was granted under Chapter II, a data intermediation services provider or recognised data altruism organisation 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 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 under Union law or the national law of the relevant Member State.

4.   If the conditions laid down in paragraph 2 or 3 are met, the public_sector_body, the natural or legal person to which the right to re-use data was granted under Chapter II, the data intermediation services provider or the recognised data altruism organisation shall provide the minimum amount of data permissible in response to a request, based on a reasonable interpretation of the request.

5.   The public_sector_body, the natural or legal person to which the right to re-use data was granted under Chapter II, the data intermediation services provider and the recognised data altruism organisation shall inform the data holder about the existence of a request of a third-country administrative 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

Delegation and committee procedure

Article 32

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 5(13) and Article 22(1) shall be conferred on the Commission for an indeterminate period of time from 23 June 2022.

3.   The delegation of power referred to in Article 5(13) and Article 22(1) 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 5(13) or Article 22(1) 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 38

Entry into force and application

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

It shall apply from 24 September 2023.

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

Done at Brussels, 30 May 2022.

For the European Parliament

The President

R. METSOLA

For the Council

The President

B. LE MAIRE


(1)  OJ C 286, 16.7.2021, p. 38.

(2)  Position of the European Parliament of 6 April 2022 (not yet published in the Official Journal) and decision of the Council of 16 May 2022.

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

(4)  Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

(5)  Regulation (EU) 2019/1239 of the European Parliament and of the Council of 20 June 2019 establishing a European Maritime Single Window environment and repealing Directive 2010/65/EU (OJ L 198, 25.7.2019, p. 64).

(6)  Regulation (EU) 2020/1056 of the European Parliament and of the Council of 15 July 2020 on electronic freight transport information (OJ L 249, 31.7.2020, p. 33).

(7)  Directive 2010/40/EU of the European Parliament and of the Council of 7 July 2010 on the framework for the deployment of Intelligent Transport Systems in the field of road transport and for interfaces with other modes of transport (OJ L 207, 6.8.2010, p. 1).

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

(9)  Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).

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

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

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

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

(14)  Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1).

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

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

(17)  Directive (EU) 2017/1132 of the European Parliament and of the Council of 14 June 2017 relating to certain aspects of company law (OJ L 169, 30.6.2017, p. 46).

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

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

(20)  Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security, and amending Directives 2004/17/EC and 2004/18/EC (OJ L 216, 20.8.2009, p. 76).

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

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

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

(24)  Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89).

(25)  Commission Regulation (EU) No 557/2013 of 17 June 2013 implementing Regulation (EC) No 223/2009 of the European Parliament and of the Council on European Statistics as regards access to confidential data for scientific purposes and repealing Commission Regulation (EC) No 831/2002 (OJ L 164, 18.6.2013, p. 16).

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

(27)  Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84).

(28)  Directive (EU) 2015/2366 of the European Parliament and of the Council of 25 November 2015 on payment services in the internal market, amending Directives 2002/65/EC, 2009/110/EC and 2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC (OJ L 337, 23.12.2015, p. 35).

(29)  Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1).

(30)  OJ L 123, 12.5.2016, p. 1.

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

(32)  Directive (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the accessibility of the websites and mobile applications of public sector bodies (OJ L 327, 2.12.2016, p. 1).

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



whereas









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