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interactive GDPR 2016/0679 EN

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2016/0679 EN jump to: cercato: 'council' . Output generated live by software developed by IusOnDemand srl


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Article 4

Definitions

For the purposes of this Regulation:

(1)

personal_data’ means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person;

(2)

processing’ means any operation or set of operations which is performed on personal_data or on sets of personal_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 otherwise making available, alignment or combination, restriction, erasure or destruction;

(3)

‘restriction of processing’ means the marking of stored personal_data with the aim of limiting their processing in the future;

(4)

profiling’ means any form of automated processing of personal_data consisting of the use of personal_data to evaluate certain personal aspects relating to a natural person, in particular to analyse or predict aspects concerning that natural person's performance at work, economic situation, health, personal preferences, interests, reliability, behaviour, location or movements;

(5)

pseudonymisation’ means the processing of personal_data in such a manner that the personal_data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal_data are not attributed to an identified or identifiable natural person;

(6)

filing_system’ means any structured set of personal_data which are accessible according to specific criteria, whether centralised, decentralised or dispersed on a functional or geographical basis;

(7)

controller’ means the natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal_data; where the purposes and means of such processing are determined by Union or Member State law, the controller or the specific criteria for its nomination may be provided for by Union or Member State law;

(8)

processor’ means a natural or legal person, public authority, agency or other body which processes personal_data on behalf of the controller;

(9)

recipient’ means a natural or legal person, public authority, agency or another body, to which the personal_data are disclosed, whether a third_party or not. However, public authorities which may receive personal_data in the framework of a particular inquiry in accordance with Union or Member State law shall not be regarded as recipients; the processing of those data by those public authorities shall be in compliance with the applicable data protection rules according to the purposes of the processing;

(10)

third_party’ means a natural or legal person, public authority, agency or body other than the data subject, controller, processor and persons who, under the direct authority of the controller or processor, are authorised to process personal_data;

(11)

consent’ of the data subject means any freely given, specific, informed and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal_data relating to him or her;

(12)

personal_data breach’ means a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal_data transmitted, stored or otherwise processed;

(13)

genetic_data’ means personal_data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question;

(14)

biometric_data’ means personal_data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, which allow or confirm the unique identification of that natural person, such as facial images or dactyloscopic data;

(15)

data_concerning_health’ means personal_data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about his or her health status;

(16)

main_establishment’ means:

(a)

as regards a controller with establishments in more than one Member State, the place of its central administration in the Union, unless the decisions on the purposes and means of the processing of personal_data are taken in another establishment of the controller in the Union and the latter establishment has the power to have such decisions implemented, in which case the establishment having taken such decisions is to be considered to be the main_establishment;

(b)

as regards a processor with establishments in more than one Member State, the place of its central administration in the Union, or, if the processor has no central administration in the Union, the establishment of the processor in the Union where the main processing activities in the context of the activities of an establishment of the processor take place to the extent that the processor is subject to specific obligations under this Regulation;

(17)

representative’ means a natural or legal person established in the Union who, designated by the controller or processor in writing pursuant to Article 27, represents the controller or processor with regard to their respective obligations under this Regulation;

(18)

enterprise’ means a natural or legal person engaged in an economic activity, irrespective of its legal form, including partnerships or associations regularly engaged in an economic activity;

(19)

group_of_undertakings’ means a controlling undertaking and its controlled undertakings;

(20)

binding_corporate_rules’ means personal_data protection policies which are adhered to by a controller or processor established on the territory of a Member State for transfers or a set of transfers of personal_data to a controller or processor in one or more third countries within a group_of_undertakings, or group of enterprises engaged in a joint economic activity;

(21)

supervisory_authority’ means an independent public authority which is established by a Member State pursuant to Article 51;

(22)

supervisory_authority concerned’ means a supervisory_authority which is concerned by the processing of personal_data because:

(a)

the controller or processor is established on the territory of the Member State of that supervisory_authority;

(b)

data subjects residing in the Member State of that supervisory_authority are substantially affected or likely to be substantially affected by the processing; or

(c)

a complaint has been lodged with that supervisory_authority;

(23)

‘cross-border processing’ means either:

(a)

processing of personal_data which takes place in the context of the activities of establishments in more than one Member State of a controller or processor in the Union where the controller or processor is established in more than one Member State; or

(b)

processing of personal_data which takes place in the context of the activities of a single establishment of a controller or processor in the Union but which substantially affects or is likely to substantially affect data subjects in more than one Member State.

(24)

relevant_and_reasoned_objection’ means an objection to a draft decision as to whether there is an infringement of this Regulation, or whether envisaged action in relation to the controller or processor complies with this Regulation, which clearly demonstrates the significance of the risks posed by the draft decision as regards the fundamental rights and freedoms of data subjects and, where applicable, the free flow of personal_data within the Union;

(25)

information_society_service’ means a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the council (19);

(26)

international_organisation’ means an organisation and its subordinate bodies governed by public international law, or any other body which is set up by, or on the basis of, an agreement between two or more countries.

CHAPTER II

Principles

Article 43

Certification bodies

1.   Without prejudice to the tasks and powers of the competent supervisory_authority under Articles 57 and 58, certification bodies which have an appropriate level of expertise in relation to data protection shall, after informing the supervisory_authority in order to allow it to exercise its powers pursuant to point (h) of Article 58(2) where necessary, issue and renew certification. Member States shall ensure that those certification bodies are accredited by one or both of the following:

(a)

the supervisory_authority which is competent pursuant to Article 55 or 56;

(b)

the national accreditation body named in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the council (20) in accordance with EN-ISO/IEC 17065/2012 and with the additional requirements established by the supervisory_authority which is competent pursuant to Article 55 or 56.

2.   Certification bodies referred to in paragraph 1 shall be accredited in accordance with that paragraph only where they have:

(a)

demonstrated their independence and expertise in relation to the subject-matter of the certification to the satisfaction of the competent supervisory_authority;

(b)

undertaken to respect the criteria referred to in Article 42(5) and approved by the supervisory_authority which is competent pursuant to Article 55 or 56 or by the Board pursuant to Article 63;

(c)

established procedures for the issuing, periodic review and withdrawal of data protection certification, seals and marks;

(d)

established procedures and structures to handle complaints about infringements of the certification or the manner in which the certification has been, or is being, implemented by the controller or processor, and to make those procedures and structures transparent to data subjects and the public; and

(e)

demonstrated, to the satisfaction of the competent supervisory_authority, that their tasks and duties do not result in a conflict of interests.

3.   The accreditation of certification bodies as referred to in paragraphs 1 and 2 of this Article shall take place on the basis of criteria approved by the supervisory_authority which is competent pursuant to Article 55 or 56 or by the Board pursuant to Article 63. In the case of accreditation pursuant to point (b) of paragraph 1 of this Article, those requirements shall complement those envisaged in Regulation (EC) No 765/2008 and the technical rules that describe the methods and procedures of the certification bodies.

4.   The certification bodies referred to in paragraph 1 shall be responsible for the proper assessment leading to the certification or the withdrawal of such certification without prejudice to the responsibility of the controller or processor for compliance with this Regulation. The accreditation shall be issued for a maximum period of five years and may be renewed on the same conditions provided that the certification body meets the requirements set out in this Article.

5.   The certification bodies referred to in paragraph 1 shall provide the competent supervisory authorities with the reasons for granting or withdrawing the requested certification.

6.   The requirements referred to in paragraph 3 of this Article and the criteria referred to in Article 42(5) shall be made public by the supervisory_authority in an easily accessible form. The supervisory authorities shall also transmit those requirements and criteria to the Board. The Board shall collate all certification mechanisms and data protection seals in a register and shall make them publicly available by any appropriate means.

7.   Without prejudice to Chapter VIII, the competent supervisory_authority or the national accreditation body shall revoke an accreditation of a certification body pursuant to paragraph 1 of this Article where the conditions for the accreditation are not, or are no longer, met or where actions taken by a certification body infringe this Regulation.

8.   The Commission shall be empowered to adopt delegated acts in accordance with Article 92 for the purpose of specifying the requirements to be taken into account for the data protection certification mechanisms referred to in Article 42(1).

9.   The Commission may adopt implementing acts laying down technical standards for certification mechanisms and data protection seals and marks, and mechanisms to promote and recognise those certification mechanisms, seals and marks. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2).

CHAPTER V

Transfers of personal_data to third countries or international_organisations

Article 71

Reports

1.   The Board shall draw up an annual report regarding the protection of natural persons with regard to processing in the Union and, where relevant, in third countries and international_organisations. The report shall be made public and be transmitted to the European Parliament, to the council and to the Commission.

2.   The annual report shall include a review of the practical application of the guidelines, recommendations and best practices referred to in point (l) of Article 70(1) as well as of the binding decisions referred to in Article 65.

Article 76

Confidentiality

1.   The discussions of the Board shall be confidential where the Board deems it necessary, as provided for in its rules of procedure.

2.   Access to documents submitted to members of the Board, experts and representatives of third parties shall be governed by Regulation (EC) No 1049/2001 of the European Parliament and of the council (21).

CHAPTER VIII

Remedies, liability and penalties

Article 92

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 delegation of power referred to in Article 12(8) and Article 43(8) shall be conferred on the Commission for an indeterminate period of time from 24 May 2016.

3.   The delegation of power referred to in Article 12(8) and Article 43(8) may be revoked at any time by the European Parliament or by the council. A decision of revocation shall put an end to the delegation of power specified in that decision. It shall take effect the day following that of its publication 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.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the council.

5.   A delegated act adopted pursuant to Article 12(8) and Article 43(8) shall enter into force only if no objection has been expressed by either the European Parliament or the council within a period of three months of notification of that act to the European Parliament and 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 97

Commission reports

1.   By 25 May 2020 and every four years thereafter, the Commission shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the council. The reports shall be made public.

2.   In the context of the evaluations and reviews referred to in paragraph 1, the Commission shall examine, in particular, the application and functioning of:

(a)

Chapter V on the transfer of personal_data to third countries or international_organisations with particular regard to decisions adopted pursuant to Article 45(3) of this Regulation and decisions adopted on the basis of Article 25(6) of Directive 95/46/EC;

(b)

Chapter VII on cooperation and consistency.

3.   For the purpose of paragraph 1, the Commission may request information from Member States and supervisory authorities.

4.   In carrying out the evaluations and reviews referred to in paragraphs 1 and 2, the Commission shall take into account the positions and findings of the European Parliament, of the council, and of other relevant bodies or sources.

5.   The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into account of developments in information technology and in the light of the state of progress in the information society.

Article 99

Entry into force and application

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

2.   It shall apply from 25 May 2018.

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

Done at Brussels, 27 April 2016.

For the European Parliament

The President

M. SCHULZ

For the council

The President

J.A. HENNIS-PLASSCHAERT


(1)  OJ C 229, 31.7.2012, p. 90.

(2)  OJ C 391, 18.12.2012, p. 127.

(3)  Position of the European Parliament of 12 March 2014 (not yet published in the Official Journal) and position of the council at first reading of 8 April 2016 (not yet published in the Official Journal). Position of the European Parliament of 14 April 2016.

(4)  Directive 95/46/EC of the European Parliament and of the council of 24 October 1995 on the protection of individuals with regard to the processing of personal_data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).

(5)  Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (C(2003) 1422) (OJ L 124, 20.5.2003, p. 36).

(6)  Regulation (EC) No 45/2001 of the European Parliament and of the council of 18 December 2000 on the protection of individuals with regard to the processing of personal_data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).

(7)  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 prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and the free movement of such data and repealing council Framework Decision 2008/977/JHA (see page 89 of this Official Journal).

(8)  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).

(9)  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).

(10)  council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29).

(11)  Regulation (EC) No 1338/2008 of the European Parliament and of the council of 16 December 2008 on Community statistics on public health and health and safety at work (OJ L 354, 31.12.2008, p. 70).

(12)  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 Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

(13)  Regulation (EU) No 1215/2012 of the European Parliament and of the council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1).

(14)  Directive 2003/98/EC of the European Parliament and of the council of 17 November 2003 on the re-use of public sector information (OJ L 345, 31.12.2003, p. 90).

(15)  Regulation (EU) No 536/2014 of the European Parliament and of the council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).

(16)  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).

(17)  OJ C 192, 30.6.2012, p. 7.

(18)  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).

(19)  Directive (EU) 2015/1535 of the European Parliament and of the council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).

(20)  Regulation (EC) No 765/2008 of the European Parliament and of the council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).

(21)  Regulation (EC) No 1049/2001 of the European Parliament and of the council of 30 May 2001 regarding public access to European Parliament, council and Commission documents (OJ L 145, 31.5.2001, p. 43).


whereas

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