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interactive GDPR 2016/0679 EN

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Article 2

Material scope

1.   This Regulation applies to the processing of personal_data wholly or partly by automated means and to the processing other than by automated means of personal_data which form part of a filing_system or are intended to form part of a filing_system.

2.   This Regulation does not apply to the processing of personal_data:

(a)

in the course of an activity which falls outside the scope of Union law;

(b)

by the Member States when carrying out activities which fall within the scope of Chapter 2 of Title V of the TEU;

(c)

by a natural person in the course of a purely personal or household activity;

(d)

by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security.

3.   For the processing of personal_data by the Union institutions, bodies, offices and agencies, Regulation (EC) No 45/2001 applies. Regulation (EC) No 45/2001 and other Union legal acts applicable to such processing of personal_data shall be adapted to the principles and rules of this Regulation in accordance with Article 98.

4.   This Regulation shall be without prejudice to the application of directive 2000/31/EC, in particular of the liability rules of intermediary service providers in Articles 12 to 15 of that directive.

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 21

Right to object

1.   The data subject shall have the right to object, on grounds relating to his or her particular situation, at any time to processing of personal_data concerning him or her which is based on point (e) or (f) of Article 6(1), including profiling based on those provisions. The controller shall no longer process the personal_data unless the controller demonstrates compelling legitimate grounds for the processing which override the interests, rights and freedoms of the data subject or for the establishment, exercise or defence of legal claims.

2.   Where personal_data are processed for direct marketing purposes, the data subject shall have the right to object at any time to processing of personal_data concerning him or her for such marketing, which includes profiling to the extent that it is related to such direct marketing.

3.   Where the data subject objects to processing for direct marketing purposes, the personal_data shall no longer be processed for such purposes.

4.   At the latest at the time of the first communication with the data subject, the right referred to in paragraphs 1 and 2 shall be explicitly brought to the attention of the data subject and shall be presented clearly and separately from any other information.

5.   In the context of the use of information_society_services, and notwithstanding directive 2002/58/EC, the data subject may exercise his or her right to object by automated means using technical specifications.

6.   Where personal_data are processed for scientific or historical research purposes or statistical purposes pursuant to Article 89(1), the data subject, on grounds relating to his or her particular situation, shall have the right to object to processing of personal_data concerning him or her, unless the processing is necessary for the performance of a task carried out for reasons of public interest.

Article 45

Transfers on the basis of an adequacy decision

1.   A transfer of personal_data to a third country or an international_organisation may take place where the Commission has decided that the third country, a territory or one or more specified sectors within that third country, or the international_organisation in question ensures an adequate level of protection. Such a transfer shall not require any specific authorisation.

2.   When assessing the adequacy of the level of protection, the Commission shall, in particular, take account of the following elements:

(a)

the rule of law, respect for human rights and fundamental freedoms, relevant legislation, both general and sectoral, including concerning public security, defence, national security and criminal law and the access of public authorities to personal_data, as well as the implementation of such legislation, data protection rules, professional rules and security measures, including rules for the onward transfer of personal_data to another third country or international_organisation which are complied with in that country or international_organisation, case-law, as well as effective and enforceable data subject rights and effective administrative and judicial redress for the data subjects whose personal_data are being transferred;

(b)

the existence and effective functioning of one or more independent supervisory authorities in the third country or to which an international_organisation is subject, with responsibility for ensuring and enforcing compliance with the data protection rules, including adequate enforcement powers, for assisting and advising the data subjects in exercising their rights and for cooperation with the supervisory authorities of the Member States; and

(c)

the international commitments the third country or international_organisation concerned has entered into, or other obligations arising from legally binding conventions or instruments as well as from its participation in multilateral or regional systems, in particular in relation to the protection of personal_data.

3.   The Commission, after assessing the adequacy of the level of protection, may decide, by means of implementing act, that a third country, a territory or one or more specified sectors within a third country, or an international_organisation ensures an adequate level of protection within the meaning of paragraph 2 of this Article. The implementing act shall provide for a mechanism for a periodic review, at least every four years, which shall take into account all relevant developments in the third country or international_organisation. The implementing act shall specify its territorial and sectoral application and, where applicable, identify the supervisory_authority or authorities referred to in point (b) of paragraph 2 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 93(2).

4.   The Commission shall, on an ongoing basis, monitor developments in third countries and international_organisations that could affect the functioning of decisions adopted pursuant to paragraph 3 of this Article and decisions adopted on the basis of Article 25(6) of directive 95/46/EC.

5.   The Commission shall, where available information reveals, in particular following the review referred to in paragraph 3 of this Article, that a third country, a territory or one or more specified sectors within a third country, or an international_organisation no longer ensures an adequate level of protection within the meaning of paragraph 2 of this Article, to the extent necessary, repeal, amend or suspend the decision referred to in paragraph 3 of this Article by means of implementing acts without retro-active effect. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2).

On duly justified imperative grounds of urgency, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 93(3).

6.   The Commission shall enter into consultations with the third country or international_organisation with a view to remedying the situation giving rise to the decision made pursuant to paragraph 5.

7.   A decision pursuant to paragraph 5 of this Article is without prejudice to transfers of personal_data to the third country, a territory or one or more specified sectors within that third country, or the international_organisation in question pursuant to Articles 46 to 49.

8.   The Commission shall publish in the Official Journal of the European Union and on its website a list of the third countries, territories and specified sectors within a third country and international_organisations for which it has decided that an adequate level of protection is or is no longer ensured.

9.   Decisions adopted by the Commission on the basis of Article 25(6) of directive 95/46/EC shall remain in force until amended, replaced or repealed by a Commission Decision adopted in accordance with paragraph 3 or 5 of this Article.

Article 46

Transfers subject to appropriate safeguards

1.   In the absence of a decision pursuant to Article 45(3), a controller or processor may transfer personal_data to a third country or an international_organisation only if the controller or processor has provided appropriate safeguards, and on condition that enforceable data subject rights and effective legal remedies for data subjects are available.

2.   The appropriate safeguards referred to in paragraph 1 may be provided for, without requiring any specific authorisation from a supervisory_authority, by:

(a)

a legally binding and enforceable instrument between public authorities or bodies;

(b)

binding_corporate_rules in accordance with Article 47;

(c)

standard data protection clauses adopted by the Commission in accordance with the examination procedure referred to in Article 93(2);

(d)

standard data protection clauses adopted by a supervisory_authority and approved by the Commission pursuant to the examination procedure referred to in Article 93(2);

(e)

an approved code of conduct pursuant to Article 40 together with binding and enforceable commitments of the controller or processor in the third country to apply the appropriate safeguards, including as regards data subjects' rights; or

(f)

an approved certification mechanism pursuant to Article 42 together with binding and enforceable commitments of the controller or processor in the third country to apply the appropriate safeguards, including as regards data subjects' rights.

3.   Subject to the authorisation from the competent supervisory_authority, the appropriate safeguards referred to in paragraph 1 may also be provided for, in particular, by:

(a)

contractual clauses between the controller or processor and the controller, processor or the recipient of the personal_data in the third country or international_organisation; or

(b)

provisions to be inserted into administrative arrangements between public authorities or bodies which include enforceable and effective data subject rights.

4.   The supervisory_authority shall apply the consistency mechanism referred to in Article 63 in the cases referred to in paragraph 3 of this Article.

5.   Authorisations by a Member State or supervisory_authority on the basis of Article 26(2) of directive 95/46/EC shall remain valid until amended, replaced or repealed, if necessary, by that supervisory_authority. Decisions adopted by the Commission on the basis of Article 26(4) of directive 95/46/EC shall remain in force until amended, replaced or repealed, if necessary, by a Commission Decision adopted in accordance with paragraph 2 of this Article.

Article 94

Repeal of directive 95/46/EC

1.   directive 95/46/EC is repealed with effect from 25 May 2018.

2.   References to the repealed directive shall be construed as references to this Regulation. References to the Working Party on the Protection of Individuals with regard to the Processing of Personal Data established by Article 29 of directive 95/46/EC shall be construed as references to the European Data Protection Board established by this Regulation.

Article 95

Relationship with directive 2002/58/EC

This Regulation shall not impose additional obligations on natural or legal persons in relation to processing in connection with the provision of publicly available electronic communications services in public communication networks in the Union in relation to matters for which they are subject to specific obligations with the same objective set out in directive 2002/58/EC.

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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