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2022/0868 EN cercato: 'application' . 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 8

Single information points

1.   Member States shall ensure that all relevant information concerning the application of Articles 5 and 6 is available and easily accessible through a single information point. Member States shall establish a new body or designate an existing body or structure as the single information point. The single information point may be linked to sectoral, regional or local information points. The functions of the single information point may be automated provided that the public_sector_body ensures adequate support.

2.   The single information point shall be competent to receive enquiries or requests for the re-use of the categories of data referred to in Article 3(1) and shall transmit them, where possible and appropriate by automated means, to the competent public sector bodies, or the competent bodies referred to in Article 7(1), where relevant. The single information point shall make available by electronic means a searchable asset list containing an overview of all available data resources including, where relevant, those data resources that are available at sectoral, regional or local information points, with relevant information describing the available data, including at least the data format and size and the conditions for their  re-use.

3.   The single information point may establish a separate, simplified and well-documented information channel for SMEs and start-ups, addressing their needs and capabilities in requesting the re-use of the categories of data referred to in Article 3(1).

4.   The Commission shall establish a European single access point offering a searchable electronic register of data available in the national single information points and further information on how to request data via those national single information points.

Article 19

Registration of recognised data altruism organisations

1.   An entity which meets the requirements of Article 18 may submit an application for registration in the public national register of recognised data altruism organisations in the Member State in which it is established.

2.   An entity which meets the requirements of Article 18 and has establishments in more than one Member State may submit an application for registration in the public national register of recognised data altruism organisations in the Member State in which it has its main_establishment.

3.   An entity which meets the requirements of Article 18 but which is not established in the Union shall designate a legal_representative in one of the Member States in which the data altruism services are offered.

For the purpose of ensuring compliance with this Regulation, the legal_representative shall be mandated by the entity to be addressed in addition to or instead of it by competent authorities for the registration of data altruism organisations or data subjects and data holders, with regard to all issues related to that entity. The legal_representative shall cooperate with and comprehensively demonstrate to the competent authorities for the registration of data altruism organisations, upon request, the actions taken and provisions put in place by the entity to ensure compliance with this Regulation.

The entity shall be deemed to be under the jurisdiction of the Member State in which the legal_representative is located. Such an entity may submit an application for registration in the public national register of recognised data altruism organisations in that Member State. The designation of a legal_representative by the entity shall be without prejudice to any legal actions which could be initiated against the entity.

4.   applications for registration referred to in paragraphs 1, 2 and 3 shall contain the following information:

(a)

the name of the entity;

(b)

the entity’s legal status, form and, where the entity is registered in a public national register, registration number;

(c)

the statutes of the entity, where appropriate;

(d)

the entity’s sources of income;

(e)

the address of the entity’s main_establishment in the Union, if any, and, where applicable, any secondary branch in another Member State or that of the legal_representative;

(f)

a public website where complete and up-to-date information on the entity and the activities can be found, including as a minimum the information referred to in points (a), (b), (d), (e) and (h);

(g)

the entity’s contact persons and contact details;

(h)

the objectives of general interest it intends to promote when collecting data;

(i)

the nature of the data that the entity intends to control or process, and, in the case of personal data, an indication of the categories of personal data;

(j)

any other documents which demonstrate that the requirements of Article 18 are met.

5.   Where the entity has submitted all necessary information pursuant to paragraph 4 and after the competent authority for the registration of data altruism organisations has evaluated the application for registration and found that the entity complies with the requirements of Article 18, it shall register the entity in the public national register of recognised data altruism organisations within 12 weeks after the receipt of the application for registration. The registration shall be valid in all Member States.

The competent authority for the registration of data altruism organisations shall notify the Commission of any registration. The Commission shall include that registration in the public Union register of recognised data altruism organisations.

6.   The information referred to in paragraph 4, points (a), (b), (f), (g) and (h), shall be published in the relevant public national register of recognised data altruism organisations.

7.   A recognised data altruism organisation shall notify the relevant competent authority for the registration of data altruism organisations of any changes to the information provided pursuant to paragraph 4 within 14 days of the date of the change.

The competent authority for the registration of data altruism organisations shall notify the Commission of each such notification by electronic means without delay. Based on such a notification, the Commission shall update the public Union register of recognised data altruism organisations without delay.

Article 30

Tasks of the European Data Innovation Board

The European Data Innovation Board shall have the following tasks:

(a)

to advise and assist the Commission with regard to developing a consistent practice of public sector bodies and competent bodies referred to in Article 7(1) in handling requests for the re-use of the categories of data referred to in Article 3(1);

(b)

to advise and assist the Commission with regard to developing a consistent practice for data altruism across the Union;

(c)

to advise and assist the Commission with regard to developing a consistent practice of the competent authorities for data intermediation services and the competent authorities for the registration of data altruism organisations in the application of requirements applicable to data intermediation services providers and recognised data altruism organisations;

(d)

to advise and assist the Commission with regard to developing consistent guidelines on how to best protect, in the context of this Regulation, commercially sensitive non-personal data, in particular trade secrets, but also non-personal data representing content protected by intellectual property rights from unlawful access that risks intellectual property theft or industrial espionage;

(e)

to advise and assist the Commission with regard to developing consistent guidelines for cybersecurity requirements for the exchange and storage of data;

(f)

to advise the Commission, in particular taking into account the input from standardisation organisations, on the prioritisation of cross-sector standards to be used and developed for data use and cross-sector data sharing between emerging common European data spaces, cross-sectoral comparison and exchange of best practices with regard to sectoral requirements for security and access procedures, taking into account sector-specific standardisation activities, in particular clarifying and distinguishing which standards and practices are cross-sectoral and which are sectoral;

(g)

to assist the Commission, in particular taking into account the input from standardisation organisations, in addressing fragmentation of the internal market and the data economy in the internal market by enhancing cross-border, cross-sector interoperability of data as well as data sharing services between different sectors and domains, building on existing European, international or national standards, inter alia with the aim of encouraging the creation of common European data spaces;

(h)

to propose guidelines for common European data spaces, namely purpose- or sector-specific or cross-sectoral interoperable frameworks of 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, such common standards and practices taking into account existing standards, complying with the competition rules and ensuring non-discriminatory access to all participants, for the purpose of facilitating data sharing in the Union and reaping the potential of existing and future data spaces, addressing, inter alia:

(i)

cross-sectoral standards to be used and developed for data use and cross-sector data sharing, cross-sectoral comparison and exchange of best practices with regard to sectoral requirements for security and access procedures, taking into account sector-specific standardisation activities, in particular clarifying and distinguishing which standards and practices are cross-sectoral and which are sectoral;

(ii)

requirements to counter barriers to market entry and to avoid lock-in effects, for the purpose of ensuring fair competition and interoperability;

(iii)

adequate protection for lawful data transfers to third countries, including safeguards against any transfers prohibited by Union law;

(iv)

adequate and non-discriminatory representation of relevant stakeholders in the governance of common European data spaces;

(v)

adherence to cybersecurity requirements in accordance with Union law;

(i)

to facilitate cooperation between Member States with regard to setting harmonised conditions allowing for the re-use of the categories of data referred to in Article 3(1) held by public sector bodies across the internal market;

(j)

to facilitate cooperation between competent authorities for data intermediation services and competent authorities for the registration of data altruism organisations through capacity-building and the exchange of information, in particular by establishing methods for the efficient exchange of information relating to the notification procedure for data intermediation services providers and the registration and monitoring of recognised data altruism organisations, including coordination with regard to the setting of fees or penalties, as well as facilitate cooperation between competent authorities for data intermediation services and competent authorities for the registration of data altruism organisations with regard to international access and transfer of data;

(k)

to advise and assist the Commission with regard to evaluating whether the implementing acts referred to in Article 5(11) and (12) are to be adopted;

(l)

to advise and assist the Commission with regard to developing the European data altruism consent form in accordance with Article 25(1);

(m)

to advise the Commission on improving the international regulatory environment for non-personal data, including standardisation.

CHAPTER VII

International access and transfer

Article 35

Evaluation and review

By 24 September 2025, 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 as well as to the European Economic and Social Committee. The report shall be accompanied, where necessary, by legislative proposals.

The report shall assess, in particular:

(a)

the application and functioning of the rules on penalties laid down by the Member States pursuant to Article 34;

(b)

the level of compliance of the legal_representatives of data intermediation services providers and recognised data altruism organisations that are not established in the Union with this Regulation and the level of enforceability of penalties imposed on those providers and organisations;

(c)

the type of data altruism organisations registered under Chapter IV and an overview of the objectives of general interests for which data are shared in view of establishing clear criteria in that respect.

Member States shall provide the Commission with the information necessary for the preparation of that report.

Article 36

Amendment to Regulation (EU) 2018/1724

In the table in Annex II to Regulation (EU) 2018/1724, the entry ‘Starting, running and closing a business’ is replaced by the following:

Life events

Procedures

Expected output subject to an assessment of the application by the competent authority in accordance with national law, where relevant

Starting, running and closing a business

Notification of business activity, permission for exercising a business activity, changes of business activity and the termination of a business activity not involving insolvency or liquidation procedures, excluding the initial registration of a business activity with the business register and excluding procedures concerning the constitution of or any subsequent filing by companies or firms within the meaning of the second paragraph of Article 54 TFEU

Confirmation of the receipt of notification or change, or of the request for permission for business activity

 

Registration of an employer (a natural person) with compulsory pension and insurance schemes

Confirmation of registration or social security registration number

Registration of employees with compulsory pension and insurance schemes

Confirmation of registration or social security registration number

Submitting a corporate tax declaration

Confirmation of the receipt of the declaration

Notification to the social security schemes of the end of contract with an employee, excluding procedures for the collective termination of employee contracts

Confirmation of the receipt of the notification

Payment of social contributions for employees

Receipt or other form of confirmation of payment of social contributions for employees

Notification of a data intermediation services provider

Confirmation of the receipt of notification

Registration as a data altruism organisation recognised in the Union

Confirmation of the registration

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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