interactive GDPR 2016/0679 EN

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 6

Lawfulness of processing

1. Processing shall be lawful only if and to the extent that at least one of the following applies:

(a)	the data subject has given consent to the processing of his or her personal_data for one or more specific purposes;

(b)	processing is necessary for the performance of a contract to which the data subject is party or in order to take steps at the request of the data subject prior to entering into a contract;

(c)	processing is necessary for compliance with a legal obligation to which the controller is subject;

(d)	processing is necessary in order to protect the vital interests of the data subject or of another natural person;

(e)	processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

(f)

processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third_party, except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal_data, in particular where the data subject is a child.

Point (f) of the first subparagraph shall not apply to processing carried out by public authorities in the performance of their tasks.

2. Member States may maintain or introduce more specific provisions to adapt the application of the rules of this Regulation with regard to processing for compliance with points (c) and (e) of paragraph 1 by determining more precisely specific requirements for the processing and other measures to ensure lawful and fair processing including for other specific processing situations as provided for in Chapter IX.

3. The basis for the processing referred to in point (c) and (e) of paragraph 1 shall be laid down by:

(a)	Union law; or

(b)	Member State law to which the controller is subject.

The purpose of the processing shall be determined in that legal basis or, as regards the processing referred to in point (e) of paragraph 1, shall be necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. That legal basis may contain specific provisions to adapt the application of rules of this Regulation, inter alia: the general conditions governing the lawfulness of processing by the controller; the types of data which are subject to the processing; the data subjects concerned; the entities to, and the purposes for which, the personal_data may be disclosed; the purpose limitation; storage periods; and processing operations and processing procedures, including measures to ensure lawful and fair processing such as those for other specific processing situations as provided for in Chapter IX. The Union or the Member State law shall meet an objective of public interest and be proportionate to the legitimate aim pursued.

4. Where the processing for a purpose other than that for which the personal_data have been collected is not based on the data subject's consent or on a Union or Member State law which constitutes a necessary and proportionate measure in a democratic society to safeguard the objectives referred to in Article 23(1), the controller shall, in order to ascertain whether processing for another purpose is compatible with the purpose for which the personal_data are initially collected, take into account, inter alia:

(a)	any link between the purposes for which the personal_data have been collected and the purposes of the intended further processing;

(b)	the context in which the personal_data have been collected, in particular regarding the relationship between data subjects and the controller;

(c)	the nature of the personal_data, in particular whether special categories of personal_data are processed, pursuant to Article 9, or whether personal_data related to criminal convictions and offences are processed, pursuant to Article 10;

(d)	the possible consequences of the intended further processing for data subjects;

(e)	the existence of appropriate safeguards, which may include encryption or pseudonymisation.

Article 27

Representatives of controllers or processors not established in the Union

1. Where Article 3(2) applies, the controller or the processor shall designate in writing a representative in the Union.

2. The obligation laid down in paragraph 1 of this Article shall not apply to:

(a)

processing which is occasional, does not include, on a large scale, processing of special categories of data as referred to in Article 9(1) or processing of personal_data relating to criminal convictions and offences referred to in Article 10, and is unlikely to result in a risk to the rights and freedoms of natural persons, taking into account the nature, context, scope and purposes of the processing; or

(b)	a public authority or body.

3. The representative shall be established in one of the Member States where the data subjects, whose personal_data are processed in relation to the offering of goods or services to them, or whose behaviour is monitored, are.

4. The representative shall be mandated by the controller or processor to be addressed in addition to or instead of the controller or the processor by, in particular, supervisory authorities and data subjects, on all issues related to processing, for the purposes of ensuring compliance with this Regulation.

5. The designation of a representative by the controller or processor shall be without prejudice to legal actions which could be initiated against the controller or the processor themselves.

Article 37

Designation of the data protection officer

1. The controller and the processor shall designate a data protection officer in any case where:

(a)	the processing is carried out by a public authority or body, except for courts acting in their judicial capacity;

(b)	the core activities of the controller or the processor consist of processing operations which, by virtue of their nature, their scope and/or their purposes, require regular and systematic monitoring of data subjects on a large scale; or

(c)	the core activities of the controller or the processor consist of processing on a large scale of special categories of data pursuant to Article 9 and personal_data relating to criminal convictions and offences referred to in Article 10.

2. A group_of_undertakings may appoint a single data protection officer provided that a data protection officer is easily accessible from each establishment.

3. Where the controller or the processor is a public authority or body, a single data protection officer may be designated for several such authorities or bodies, taking account of their organisational structure and size.

4. In cases other than those referred to in paragraph 1, the controller or processor or associations and other bodies representing categories of controllers or processors may or, where required by Union or Member State law shall, designate a data protection officer. The data protection officer may act for such associations and other bodies representing controllers or processors.

5. The data protection officer shall be designated on the basis of professional qualities and, in particular, expert knowledge of data protection law and practices and the ability to fulfil the tasks referred to in Article 39.

6. The data protection officer may be a staff member of the controller or processor, or fulfil the tasks on the basis of a service contract.

7. The controller or the processor shall publish the contact details of the data protection officer and communicate them to the supervisory_authority.

Article 40

Codes of conduct

1. The Member States, the supervisory authorities, the Board and the Commission shall encourage the drawing up of codes of conduct intended to contribute to the proper application of this Regulation, taking account of the specific features of the various processing sectors and the specific needs of micro, small and medium-sized enterprises.

2. Associations and other bodies representing categories of controllers or processors may prepare codes of conduct, or amend or extend such codes, for the purpose of specifying the application of this Regulation, such as with regard to:

(a)	fair and transparent processing;

(b)	the legitimate interests pursued by controllers in specific contexts;

(c)	the collection of personal_data;

(d)	the pseudonymisation of personal_data;

(e)	the information provided to the public and to data subjects;

(f)	the exercise of the rights of data subjects;

(g)	the information provided to, and the protection of, children, and the manner in which the consent of the holders of parental responsibility over children is to be obtained;

(h)	the measures and procedures referred to in Articles 24 and 25 and the measures to ensure security of processing referred to in Article 32;

(i)	the notification of personal_data breaches to supervisory authorities and the communication of such personal_data breaches to data subjects;

(j)	the transfer of personal_data to third countries or international_organisations; or

(k)	out-of-court proceedings and other dispute resolution procedures for resolving disputes between controllers and data subjects with regard to processing, without prejudice to the rights of data subjects pursuant to Articles 77 and 79.

3. In addition to adherence by controllers or processors subject to this Regulation, codes of conduct approved pursuant to paragraph 5 of this Article and having general validity pursuant to paragraph 9 of this Article may also be adhered to by controllers or processors that are not subject to this Regulation pursuant to Article 3 in order to provide appropriate safeguards within the framework of personal_data transfers to third countries or international_organisations under the terms referred to in point (e) of Article 46(2). Such controllers or processors shall make binding and enforceable commitments, via contractual or other legally binding instruments, to apply those appropriate safeguards including with regard to the rights of data subjects.

4. A code of conduct referred to in paragraph 2 of this Article shall contain mechanisms which enable the body referred to in Article 41(1) to carry out the mandatory monitoring of compliance with its provisions by the controllers or processors which undertake to apply it, without prejudice to the tasks and powers of supervisory authorities competent pursuant to Article 55 or 56.

5. Associations and other bodies referred to in paragraph 2 of this Article which intend to prepare a code of conduct or to amend or extend an existing code shall submit the draft code, amendment or extension to the supervisory_authority which is competent pursuant to Article 55. The supervisory_authority shall provide an opinion on whether the draft code, amendment or extension complies with this Regulation and shall approve that draft code, amendment or extension if it finds that it provides sufficient appropriate safeguards.

6. Where the draft code, or amendment or extension is approved in accordance with paragraph 5, and where the code of conduct concerned does not relate to processing activities in several Member States, the supervisory_authority shall register and publish the code.

7. Where a draft code of conduct relates to processing activities in several Member States, the supervisory_authority which is competent pursuant to Article 55 shall, before approving the draft code, amendment or extension, submit it in the procedure referred to in Article 63 to the Board which shall provide an opinion on whether the draft code, amendment or extension complies with this Regulation or, in the situation referred to in paragraph 3 of this Article, provides appropriate safeguards.

8. Where the opinion referred to in paragraph 7 confirms that the draft code, amendment or extension complies with this Regulation, or, in the situation referred to in paragraph 3, provides appropriate safeguards, the Board shall submit its opinion to the Commission.

9. The Commission may, by way of implementing acts, decide that the approved code of conduct, amendment or extension submitted to it pursuant to paragraph 8 of this Article have general validity within the Union. Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 93(2).

10. The Commission shall ensure appropriate publicity for the approved codes which have been decided as having general validity in accordance with paragraph 9.

11. The Board shall collate all approved codes of conduct, amendments and extensions in a register and shall make them publicly available by way of appropriate means.

Article 41

Monitoring of approved codes of conduct

1. Without prejudice to the tasks and powers of the competent supervisory_authority under Articles 57 and 58, the monitoring of compliance with a code of conduct pursuant to Article 40 may be carried out by a body which has an appropriate level of expertise in relation to the subject-matter of the code and is accredited for that purpose by the competent supervisory_authority.

2. A body as referred to in paragraph 1 may be accredited to monitor compliance with a code of conduct where that body has:

(a)	demonstrated its independence and expertise in relation to the subject-matter of the code to the satisfaction of the competent supervisory_authority;

(b)	established procedures which allow it to assess the eligibility of controllers and processors concerned to apply the code, to monitor their compliance with its provisions and to periodically review its operation;

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

(d)	demonstrated to the satisfaction of the competent supervisory_authority that its tasks and duties do not result in a conflict of interests.

3. The competent supervisory_authority shall submit the draft criteria for accreditation of a body as referred to in paragraph 1 of this Article to the Board pursuant to the consistency mechanism referred to in Article 63.

4. Without prejudice to the tasks and powers of the competent supervisory_authority and the provisions of Chapter VIII, a body as referred to in paragraph 1 of this Article shall, subject to appropriate safeguards, take appropriate action in cases of infringement of the code by a controller or processor, including suspension or exclusion of the controller or processor concerned from the code. It shall inform the competent supervisory_authority of such actions and the reasons for taking them.

5. The competent supervisory_authority shall revoke the accreditation of a body as referred to in paragraph 1 if the conditions for accreditation are not, or are no longer, met or where actions taken by the body infringe this Regulation.

6. This Article shall not apply to processing carried out by public authorities and bodies.

Article 42

Certification

1. The Member States, the supervisory authorities, the Board and the Commission shall encourage, in particular at Union level, the establishment of data protection certification mechanisms and of data protection seals and marks, for the purpose of demonstrating compliance with this Regulation of processing operations by controllers and processors. The specific needs of micro, small and medium-sized enterprises shall be taken into account.

2. In addition to adherence by controllers or processors subject to this Regulation, data protection certification mechanisms, seals or marks approved pursuant to paragraph 5 of this Article may be established for the purpose of demonstrating the existence of appropriate safeguards provided by controllers or processors that are not subject to this Regulation pursuant to Article 3 within the framework of personal_data transfers to third countries or international_organisations under the terms referred to in point (f) of Article 46(2). Such controllers or processors shall make binding and enforceable commitments, via contractual or other legally binding instruments, to apply those appropriate safeguards, including with regard to the rights of data subjects.

3. The certification shall be voluntary and available via a process that is transparent.

4. A certification pursuant to this Article does not reduce the responsibility of the controller or the processor for compliance with this Regulation and is without prejudice to the tasks and powers of the supervisory authorities which are competent pursuant to Article 55 or 56.

5. A certification pursuant to this Article shall be issued by the certification bodies referred to in Article 43 or by the competent supervisory_authority, on the basis of criteria approved by that competent supervisory_authority pursuant to Article 58(3) or by the Board pursuant to Article 63. Where the criteria are approved by the Board, this may result in a common certification, the European Data Protection Seal.

6. The controller or processor which submits its processing to the certification mechanism shall provide the certification body referred to in Article 43, or where applicable, the competent supervisory_authority, with all information and access to its processing activities which are necessary to conduct the certification procedure.

7. Certification shall be issued to a controller or processor for a maximum period of three years and may be renewed, under the same conditions, provided that the relevant requirements continue to be met. Certification shall be withdrawn, as applicable, by the certification bodies referred to in Article 43 or by the competent supervisory_authority where the requirements for the certification are not or are no longer met.

8. The Board shall collate all certification mechanisms and data protection seals and marks in a register and shall make them publicly available by any appropriate means.

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 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 47

Binding corporate rules

1. The competent supervisory_authority shall approve binding_corporate_rules in accordance with the consistency mechanism set out in Article 63, provided that they:

(a)	are legally binding and apply to and are enforced by every member concerned of the group_of_undertakings, or group of enterprises engaged in a joint economic activity, including their employees;

(b)	expressly confer enforceable rights on data subjects with regard to the processing of their personal_data; and

(c)	fulfil the requirements laid down in paragraph 2.

2. The binding_corporate_rules referred to in paragraph 1 shall specify at least:

(a)	the structure and contact details of the group_of_undertakings, or group of enterprises engaged in a joint economic activity and of each of its members;

(b)	the data transfers or set of transfers, including the categories of personal_data, the type of processing and its purposes, the type of data subjects affected and the identification of the third country or countries in question;

(c)	their legally binding nature, both internally and externally;

(d)

the application of the general data protection principles, in particular purpose limitation, data minimisation, limited storage periods, data quality, data protection by design and by default, legal basis for processing, processing of special categories of personal_data, measures to ensure data security, and the requirements in respect of onward transfers to bodies not bound by the binding_corporate_rules;

(e)

the rights of data subjects in regard to processing and the means to exercise those rights, including the right not to be subject to decisions based solely on automated processing, including profiling in accordance with Article 22, the right to lodge a complaint with the competent supervisory_authority and before the competent courts of the Member States in accordance with Article 79, and to obtain redress and, where appropriate, compensation for a breach of the binding_corporate_rules;

(f)

the acceptance by the controller or processor established on the territory of a Member State of liability for any breaches of the binding_corporate_rules by any member concerned not established in the Union; the controller or the processor shall be exempt from that liability, in whole or in part, only if it proves that that member is not responsible for the event giving rise to the damage;

(g)	how the information on the binding_corporate_rules, in particular on the provisions referred to in points (d), (e) and (f) of this paragraph is provided to the data subjects in addition to Articles 13 and 14;

(h)

the tasks of any data protection officer designated in accordance with Article 37 or any other person or entity in charge of the monitoring compliance with the binding_corporate_rules within the group_of_undertakings, or group of enterprises engaged in a joint economic activity, as well as monitoring training and complaint-handling;

(i)	the complaint procedures;

(j)

the mechanisms within the group_of_undertakings, or group of enterprises engaged in a joint economic activity for ensuring the verification of compliance with the binding_corporate_rules. Such mechanisms shall include data protection audits and methods for ensuring corrective actions to protect the rights of the data subject. Results of such verification should be communicated to the person or entity referred to in point (h) and to the board of the controlling undertaking of a group_of_undertakings, or of the group of enterprises engaged in a joint economic activity, and should be available upon request to the competent supervisory_authority;

(k)	the mechanisms for reporting and recording changes to the rules and reporting those changes to the supervisory_authority;

(l)

the cooperation mechanism with the supervisory_authority to ensure compliance by any member of the group_of_undertakings, or group of enterprises engaged in a joint economic activity, in particular by making available to the supervisory_authority the results of verifications of the measures referred to in point (j);

(m)

the mechanisms for reporting to the competent supervisory_authority any legal requirements to which a member of the group_of_undertakings, or group of enterprises engaged in a joint economic activity is subject in a third country which are likely to have a substantial adverse effect on the guarantees provided by the binding_corporate_rules; and

(n)	the appropriate data protection training to personnel having permanent or regular access to personal_data.

3. The Commission may specify the format and procedures for the exchange of information between controllers, processors and supervisory authorities for binding_corporate_rules within the meaning of this Article. Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 93(2).

Article 49

Derogations for specific situations

1. In the absence of an adequacy decision pursuant to Article 45(3), or of appropriate safeguards pursuant to Article 46, including binding_corporate_rules, a transfer or a set of transfers of personal_data to a third country or an international_organisation shall take place only on one of the following conditions:

(a)	the data subject has explicitly consented to the proposed transfer, after having been informed of the possible risks of such transfers for the data subject due to the absence of an adequacy decision and appropriate safeguards;

(b)	the transfer is necessary for the performance of a contract between the data subject and the controller or the implementation of pre-contractual measures taken at the data subject's request;

(c)	the transfer is necessary for the conclusion or performance of a contract concluded in the interest of the data subject between the controller and another natural or legal person;

(d)	the transfer is necessary for important reasons of public interest;

(e)	the transfer is necessary for the establishment, exercise or defence of legal claims;

(f)	the transfer is necessary in order to protect the vital interests of the data subject or of other persons, where the data subject is physically or legally incapable of giving consent;

(g)

the transfer is made from a register which according to Union or Member State law is intended to provide information to the public and which is open to consultation either by the public in general or by any person who can demonstrate a legitimate interest, but only to the extent that the conditions laid down by Union or Member State law for consultation are fulfilled in the particular case.

Where a transfer could not be based on a provision in Article 45 or 46, including the provisions on binding_corporate_rules, and none of the derogations for a specific situation referred to in the first subparagraph of this paragraph is applicable, a transfer to a third country or an international_organisation may take place only if the transfer is not repetitive, concerns only a limited number of data subjects, is necessary for the purposes of compelling legitimate interests pursued by the controller which are not overridden by the interests or rights and freedoms of the data subject, and the controller has assessed all the circumstances surrounding the data transfer and has on the basis of that assessment provided suitable safeguards with regard to the protection of personal_data. The controller shall inform the supervisory_authority of the transfer. The controller shall, in addition to providing the information referred to in Articles 13 and 14, inform the data subject of the transfer and on the compelling legitimate interests pursued.

2. A transfer pursuant to point (g) of the first subparagraph of paragraph 1 shall not involve the entirety of the personal_data or entire categories of the personal_data contained in the register. Where the register is intended for consultation by persons having a legitimate interest, the transfer shall be made only at the request of those persons or if they are to be the recipients.

3. Points (a), (b) and (c) of the first subparagraph of paragraph 1 and the second subparagraph thereof shall not apply to activities carried out by public authorities in the exercise of their public powers.

4. The public interest referred to in point (d) of the first subparagraph of paragraph 1 shall be recognised in Union law or in the law of the Member State to which the controller is subject.

5. In the absence of an adequacy decision, Union or Member State law may, for important reasons of public interest, expressly set limits to the transfer of specific categories of personal_data to a third country or an international_organisation. Member States shall notify such provisions to the Commission.

6. The controller or processor shall document the assessment as well as the suitable safeguards referred to in the second subparagraph of paragraph 1 of this Article in the records referred to in Article 30.

Article 50

International cooperation for the protection of personal_data

In relation to third countries and international_organisations, the Commission and supervisory authorities shall take appropriate steps to:

(a)	develop international cooperation mechanisms to facilitate the effective enforcement of legislation for the protection of personal_data;

(b)

provide international mutual assistance in the enforcement of legislation for the protection of personal_data, including through notification, complaint referral, investigative assistance and information exchange, subject to appropriate safeguards for the protection of personal_data and other fundamental rights and freedoms;

(c)	engage relevant stakeholders in discussion and activities aimed at furthering international cooperation in the enforcement of legislation for the protection of personal_data;

(d)	promote the exchange and documentation of personal_data protection legislation and practice, including on jurisdictional conflicts with third countries.

CHAPTER VI

Independent supervisory authorities

Section 1

Independent status

Article 51

Supervisory authority

1. Each Member State shall provide for one or more independent public authorities to be responsible for monitoring the application of this Regulation, in order to protect the fundamental rights and freedoms of natural persons in relation to processing and to facilitate the free flow of personal_data within the Union (‘ supervisory_authority’).

2. Each supervisory_authority shall contribute to the consistent application of this Regulation throughout the Union. For that purpose, the supervisory authorities shall cooperate with each other and the Commission in accordance with Chapter VII.

3. Where more than one supervisory_authority is established in a Member State, that Member State shall designate the supervisory_authority which is to represent those authorities in the Board and shall set out the mechanism to ensure compliance by the other authorities with the rules relating to the consistency mechanism referred to in Article 63.

4. Each Member State shall notify to the Commission the provisions of its law which it adopts pursuant to this Chapter, by 25 May 2018 and, without delay, any subsequent amendment affecting them.

Article 53

General conditions for the members of the supervisory_authority

1. Member States shall provide for each member of their supervisory authorities to be appointed by means of a transparent procedure by:

—	their parliament;

—	their government;

—	their head of State; or

—	an independent body entrusted with the appointment under Member State law.

2. Each member shall have the qualifications, experience and skills, in particular in the area of the protection of personal_data, required to perform its duties and exercise its powers.

3. The duties of a member shall end in the event of the expiry of the term of office, resignation or compulsory retirement, in accordance with the law of the Member State concerned.

4. A member shall be dismissed only in cases of serious misconduct or if the member no longer fulfils the conditions required for the performance of the duties.

Article 55

Competence

1. Each supervisory_authority shall be competent for the performance of the tasks assigned to and the exercise of the powers conferred on it in accordance with this Regulation on the territory of its own Member State.

2. Where processing is carried out by public authorities or private bodies acting on the basis of point (c) or (e) of Article 6(1), the supervisory_authority of the Member State concerned shall be competent. In such cases Article 56 does not apply.

3. Supervisory authorities shall not be competent to supervise processing operations of courts acting in their judicial capacity.

Article 57

Tasks

1. Without prejudice to other tasks set out under this Regulation, each supervisory_authority shall on its territory:

(a)	monitor and enforce the application of this Regulation;

(b)	promote public awareness and understanding of the risks, rules, safeguards and rights in relation to processing. Activities addressed specifically to children shall receive specific attention;

(c)	advise, in accordance with Member State law, the national parliament, the government, and other institutions and bodies on legislative and administrative measures relating to the protection of natural persons' rights and freedoms with regard to processing;

(d)	promote the awareness of controllers and processors of their obligations under this Regulation;

(e)	upon request, provide information to any data subject concerning the exercise of their rights under this Regulation and, if appropriate, cooperate with the supervisory authorities in other Member States to that end;

(f)

handle complaints lodged by a data subject, or by a body, organisation or association in accordance with Article 80, and investigate, to the extent appropriate, the subject matter of the complaint and inform the complainant of the progress and the outcome of the investigation within a reasonable period, in particular if further investigation or coordination with another supervisory_authority is necessary;

(g)	cooperate with, including sharing information and provide mutual assistance to, other supervisory authorities with a view to ensuring the consistency of application and enforcement of this Regulation;

(h)	conduct investigations on the application of this Regulation, including on the basis of information received from another supervisory_authority or other public authority;

(i)	monitor relevant developments, insofar as they have an impact on the protection of personal_data, in particular the development of information and communication technologies and commercial practices;

(j)	adopt standard contractual clauses referred to in Article 28(8) and in point (d) of Article 46(2);

(k)	establish and maintain a list in relation to the requirement for data protection impact assessment pursuant to Article 35(4);

(l)	give advice on the processing operations referred to in Article 36(2);

(m)	encourage the drawing up of codes of conduct pursuant to Article 40(1) and provide an opinion and approve such codes of conduct which provide sufficient safeguards, pursuant to Article 40(5);

(n)	encourage the establishment of data protection certification mechanisms and of data protection seals and marks pursuant to Article 42(1), and approve the criteria of certification pursuant to Article 42(5);

(o)	where applicable, carry out a periodic review of certifications issued in accordance with Article 42(7);

(p)	draft and publish the criteria for accreditation of a body for monitoring codes of conduct pursuant to Article 41 and of a certification body pursuant to Article 43;

(q)	conduct the accreditation of a body for monitoring codes of conduct pursuant to Article 41 and of a certification body pursuant to Article 43;

(r)	authorise contractual clauses and provisions referred to in Article 46(3);

(s)	approve binding_corporate_rules pursuant to Article 47;

(t)	contribute to the activities of the Board;

(u)	keep internal records of infringements of this Regulation and of measures taken in accordance with Article 58(2); and

(v)	fulfil any other tasks related to the protection of personal_data.

2. Each supervisory_authority shall facilitate the submission of complaints referred to in point (f) of paragraph 1 by measures such as a complaint submission form which can also be completed electronically, without excluding other means of communication.

3. The performance of the tasks of each supervisory_authority shall be free of charge for the data subject and, where applicable, for the data protection officer.

4. Where requests are manifestly unfounded or excessive, in particular because of their repetitive character, the supervisory_authority may charge a reasonable fee based on administrative costs, or refuse to act on the request. The supervisory_authority shall bear the burden of demonstrating the manifestly unfounded or excessive character of the request.

Article 58

Powers

1. Each supervisory_authority shall have all of the following investigative powers:

(a)	to order the controller and the processor, and, where applicable, the controller's or the processor's representative to provide any information it requires for the performance of its tasks;

(b)	to carry out investigations in the form of data protection audits;

(c)	to carry out a review on certifications issued pursuant to Article 42(7);

(d)	to notify the controller or the processor of an alleged infringement of this Regulation;

(e)	to obtain, from the controller and the processor, access to all personal_data and to all information necessary for the performance of its tasks;

(f)	to obtain access to any premises of the controller and the processor, including to any data processing equipment and means, in accordance with Union or Member State procedural law.

2. Each supervisory_authority shall have all of the following corrective powers:

(a)	to issue warnings to a controller or processor that intended processing operations are likely to infringe provisions of this Regulation;

(b)	to issue reprimands to a controller or a processor where processing operations have infringed provisions of this Regulation;

(c)	to order the controller or the processor to comply with the data subject's requests to exercise his or her rights pursuant to this Regulation;

(d)	to order the controller or processor to bring processing operations into compliance with the provisions of this Regulation, where appropriate, in a specified manner and within a specified period;

(e)	to order the controller to communicate a personal_data breach to the data subject;

(f)	to impose a temporary or definitive limitation including a ban on processing;

(g)	to order the rectification or erasure of personal_data or restriction of processing pursuant to Articles 16, 17 and 18 and the notification of such actions to recipients to whom the personal_data have been disclosed pursuant to Article 17(2) and Article 19;

(h)	to withdraw a certification or to order the certification body to withdraw a certification issued pursuant to Articles 42 and 43, or to order the certification body not to issue certification if the requirements for the certification are not or are no longer met;

(i)	to impose an administrative fine pursuant to Article 83, in addition to, or instead of measures referred to in this paragraph, depending on the circumstances of each individual case;

(j)	to order the suspension of data flows to a recipient in a third country or to an international_organisation.

3. Each supervisory_authority shall have all of the following authorisation and advisory powers:

(a)	to advise the controller in accordance with the prior consultation procedure referred to in Article 36;

(b)	to issue, on its own initiative or on request, opinions to the national parliament, the Member State government or, in accordance with Member State law, to other institutions and bodies as well as to the public on any issue related to the protection of personal_data;

(c)	to authorise processing referred to in Article 36(5), if the law of the Member State requires such prior authorisation;

(d)	to issue an opinion and approve draft codes of conduct pursuant to Article 40(5);

(e)	to accredit certification bodies pursuant to Article 43;

(f)	to issue certifications and approve criteria of certification in accordance with Article 42(5);

(g)	to adopt standard data protection clauses referred to in Article 28(8) and in point (d) of Article 46(2);

(h)	to authorise contractual clauses referred to in point (a) of Article 46(3);

(i)	to authorise administrative arrangements referred to in point (b) of Article 46(3);

(j)	to approve binding_corporate_rules pursuant to Article 47.

4. The exercise of the powers conferred on the supervisory_authority pursuant to this Article shall be subject to appropriate safeguards, including effective judicial remedy and due process, set out in Union and Member State law in accordance with the Charter.

5. Each Member State shall provide by law that its supervisory_authority shall have the power to bring infringements of this Regulation to the attention of the judicial authorities and where appropriate, to commence or engage otherwise in legal proceedings, in order to enforce the provisions of this Regulation.

6. Each Member State may provide by law that its supervisory_authority shall have additional powers to those referred to in paragraphs 1, 2 and 3. The exercise of those powers shall not impair the effective operation of Chapter VII.

Article 59

Activity reports

Each supervisory_authority shall draw up an annual report on its activities, which may include a list of types of infringement notified and types of measures taken in accordance with Article 58(2). Those reports shall be transmitted to the national parliament, the government and other authorities as designated by Member State law. They shall be made available to the public, to the Commission and to the Board.

CHAPTER VII

Cooperation and consistency

Section 1

Cooperation

Article 60

Cooperation between the lead supervisory_authority and the other supervisory authorities concerned

1. The lead supervisory_authority shall cooperate with the other supervisory authorities concerned in accordance with this Article in an endeavour to reach consensus. The lead supervisory_authority and the supervisory authorities concerned shall exchange all relevant information with each other.

2. The lead supervisory_authority may request at any time other supervisory authorities concerned to provide mutual assistance pursuant to Article 61 and may conduct joint operations pursuant to Article 62, in particular for carrying out investigations or for monitoring the implementation of a measure concerning a controller or processor established in another Member State.

3. The lead supervisory_authority shall, without delay, communicate the relevant information on the matter to the other supervisory authorities concerned. It shall without delay submit a draft decision to the other supervisory authorities concerned for their opinion and take due account of their views.

4. Where any of the other supervisory authorities concerned within a period of four weeks after having been consulted in accordance with paragraph 3 of this Article, expresses a relevant_and_reasoned_objection to the draft decision, the lead supervisory_authority shall, if it does not follow the relevant_and_reasoned_objection or is of the opinion that the objection is not relevant or reasoned, submit the matter to the consistency mechanism referred to in Article 63.

5. Where the lead supervisory_authority intends to follow the relevant_and_reasoned_objection made, it shall submit to the other supervisory authorities concerned a revised draft decision for their opinion. That revised draft decision shall be subject to the procedure referred to in paragraph 4 within a period of two weeks.

6. Where none of the other supervisory authorities concerned has objected to the draft decision submitted by the lead supervisory_authority within the period referred to in paragraphs 4 and 5, the lead supervisory_authority and the supervisory authorities concerned shall be deemed to be in agreement with that draft decision and shall be bound by it.

7. The lead supervisory_authority shall adopt and notify the decision to the main_establishment or single establishment of the controller or processor, as the case may be and inform the other supervisory authorities concerned and the Board of the decision in question, including a summary of the relevant facts and grounds. The supervisory_authority with which a complaint has been lodged shall inform the complainant on the decision.

8. By derogation from paragraph 7, where a complaint is dismissed or rejected, the supervisory_authority with which the complaint was lodged shall adopt the decision and notify it to the complainant and shall inform the controller thereof.

9. Where the lead supervisory_authority and the supervisory authorities concerned agree to dismiss or reject parts of a complaint and to act on other parts of that complaint, a separate decision shall be adopted for each of those parts of the matter. The lead supervisory_authority shall adopt the decision for the part concerning actions in relation to the controller, shall notify it to the main_establishment or single establishment of the controller or processor on the territory of its Member State and shall inform the complainant thereof, while the supervisory_authority of the complainant shall adopt the decision for the part concerning dismissal or rejection of that complaint, and shall notify it to that complainant and shall inform the controller or processor thereof.

10. After being notified of the decision of the lead supervisory_authority pursuant to paragraphs 7 and 9, the controller or processor shall take the necessary measures to ensure compliance with the decision as regards processing activities in the context of all its establishments in the Union. The controller or processor shall notify the measures taken for complying with the decision to the lead supervisory_authority, which shall inform the other supervisory authorities concerned.

11. Where, in exceptional circumstances, a supervisory_authority concerned has reasons to consider that there is an urgent need to act in order to protect the interests of data subjects, the urgency procedure referred to in Article 66 shall apply.

12. The lead supervisory_authority and the other supervisory authorities concerned shall supply the information required under this Article to each other by electronic means, using a standardised format.

Article 61

Mutual assistance

1. Supervisory authorities shall provide each other with relevant information and mutual assistance in order to implement and apply this Regulation in a consistent manner, and shall put in place measures for effective cooperation with one another. Mutual assistance shall cover, in particular, information requests and supervisory measures, such as requests to carry out prior authorisations and consultations, inspections and investigations.

2. Each supervisory_authority shall take all appropriate measures required to reply to a request of another supervisory_authority without undue delay and no later than one month after receiving the request. Such measures may include, in particular, the transmission of relevant information on the conduct of an investigation.

3. Requests for assistance shall contain all the necessary information, including the purpose of and reasons for the request. Information exchanged shall be used only for the purpose for which it was requested.

4. The requested supervisory_authority shall not refuse to comply with the request unless:

(a)	it is not competent for the subject-matter of the request or for the measures it is requested to execute; or

(b)	compliance with the request would infringe this Regulation or Union or Member State law to which the supervisory_authority receiving the request is subject.

5. The requested supervisory_authority shall inform the requesting supervisory_authority of the results or, as the case may be, of the progress of the measures taken in order to respond to the request. The requested supervisory_authority shall provide reasons for any refusal to comply with a request pursuant to paragraph 4.

6. Requested supervisory authorities shall, as a rule, supply the information requested by other supervisory authorities by electronic means, using a standardised format.

7. Requested supervisory authorities shall not charge a fee for any action taken by them pursuant to a request for mutual assistance. Supervisory authorities may agree on rules to indemnify each other for specific expenditure arising from the provision of mutual assistance in exceptional circumstances.

8. Where a supervisory_authority does not provide the information referred to in paragraph 5 of this Article within one month of receiving the request of another supervisory_authority, the requesting supervisory_authority may adopt a provisional measure on the territory of its Member State in accordance with Article 55(1). In that case, the urgent need to act under Article 66(1) shall be presumed to be met and require an urgent binding decision from the Board pursuant to Article 66(2).

9. The Commission may, by means of implementing acts, specify the format and procedures for mutual assistance referred to in this Article and the arrangements for the exchange of information by electronic means between supervisory authorities, and between supervisory authorities and the Board, in particular the standardised format referred to in paragraph 6 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2).

Article 62

Joint operations of supervisory authorities

1. The supervisory authorities shall, where appropriate, conduct joint operations including joint investigations and joint enforcement measures in which members or staff of the supervisory authorities of other Member States are involved.

2. Where the controller or processor has establishments in several Member States or where a significant number of data subjects in more than one Member State are likely to be substantially affected by processing operations, a supervisory_authority of each of those Member States shall have the right to participate in joint operations. The supervisory_authority which is competent pursuant to Article 56(1) or (4) shall invite the supervisory_authority of each of those Member States to take part in the joint operations and shall respond without delay to the request of a supervisory_authority to participate.

3. A supervisory_authority may, in accordance with Member State law, and with the seconding supervisory_authority's authorisation, confer powers, including investigative powers on the seconding supervisory_authority's members or staff involved in joint operations or, in so far as the law of the Member State of the host supervisory_authority permits, allow the seconding supervisory_authority's members or staff to exercise their investigative powers in accordance with the law of the Member State of the seconding supervisory_authority. Such investigative powers may be exercised only under the guidance and in the presence of members or staff of the host supervisory_authority. The seconding supervisory_authority's members or staff shall be subject to the Member State law of the host supervisory_authority.

4. Where, in accordance with paragraph 1, staff of a seconding supervisory_authority operate in another Member State, the Member State of the host supervisory_authority shall assume responsibility for their actions, including liability, for any damage caused by them during their operations, in accordance with the law of the Member State in whose territory they are operating.

5. The Member State in whose territory the damage was caused shall make good such damage under the conditions applicable to damage caused by its own staff. The Member State of the seconding supervisory_authority whose staff has caused damage to any person in the territory of another Member State shall reimburse that other Member State in full any sums it has paid to the persons entitled on their behalf.

6. Without prejudice to the exercise of its rights vis-à-vis third parties and with the exception of paragraph 5, each Member State shall refrain, in the case provided for in paragraph 1, from requesting reimbursement from another Member State in relation to damage referred to in paragraph 4.

7. Where a joint operation is intended and a supervisory_authority does not, within one month, comply with the obligation laid down in the second sentence of paragraph 2 of this Article, the other supervisory authorities may adopt a provisional measure on the territory of its Member State in accordance with Article 55. In that case, the urgent need to act under Article 66(1) shall be presumed to be met and require an opinion or an urgent binding decision from the Board pursuant to Article 66(2).

Section 2

Consistency

Article 63

Consistency mechanism

In order to contribute to the consistent application of this Regulation throughout the Union, the supervisory authorities shall cooperate with each other and, where relevant, with the Commission, through the consistency mechanism as set out in this Section.

Article 64

Opinion of the Board

1. The Board shall issue an opinion where a competent supervisory_authority intends to adopt any of the measures below. To that end, the competent supervisory_authority shall communicate the draft decision to the Board, when it:

(a)	aims to adopt a list of the processing operations subject to the requirement for a data protection impact assessment pursuant to Article 35(4);

(b)	concerns a matter pursuant to Article 40(7) whether a draft code of conduct or an amendment or extension to a code of conduct complies with this Regulation;

(c)	aims to approve the criteria for accreditation of a body pursuant to Article 41(3) or a certification body pursuant to Article 43(3);

(d)	aims to determine standard data protection clauses referred to in point (d) of Article 46(2) and in Article 28(8);

(e)	aims to authorise contractual clauses referred to in point (a) of Article 46(3); or

(f)	aims to approve binding_corporate_rules within the meaning of Article 47.

2. Any supervisory_authority, the Chair of the Board or the Commission may request that any matter of general application or producing effects in more than one Member State be examined by the Board with a view to obtaining an opinion, in particular where a competent supervisory_authority does not comply with the obligations for mutual assistance in accordance with Article 61 or for joint operations in accordance with Article 62.

3. In the cases referred to in paragraphs 1 and 2, the Board shall issue an opinion on the matter submitted to it provided that it has not already issued an opinion on the same matter. That opinion shall be adopted within eight weeks by simple majority of the members of the Board. That period may be extended by a further six weeks, taking into account the complexity of the subject matter. Regarding the draft decision referred to in paragraph 1 circulated to the members of the Board in accordance with paragraph 5, a member which has not objected within a reasonable period indicated by the Chair, shall be deemed to be in agreement with the draft decision.

4. Supervisory authorities and the Commission shall, without undue delay, communicate by electronic means to the Board, using a standardised format any relevant information, including as the case may be a summary of the facts, the draft decision, the grounds which make the enactment of such measure necessary, and the views of other supervisory authorities concerned.

5. The Chair of the Board shall, without undue, delay inform by electronic means:

(a)	the members of the Board and the Commission of any relevant information which has been communicated to it using a standardised format. The secretariat of the Board shall, where necessary, provide translations of relevant information; and

(b)	the supervisory_authority referred to, as the case may be, in paragraphs 1 and 2, and the Commission of the opinion and make it public.

6. The competent supervisory_authority shall not adopt its draft decision referred to in paragraph 1 within the period referred to in paragraph 3.

7. The supervisory_authority referred to in paragraph 1 shall take utmost account of the opinion of the Board and shall, within two weeks after receiving the opinion, communicate to the Chair of the Board by electronic means whether it will maintain or amend its draft decision and, if any, the amended draft decision, using a standardised format.

8. Where the supervisory_authority concerned informs the Chair of the Board within the period referred to in paragraph 7 of this Article that it does not intend to follow the opinion of the Board, in whole or in part, providing the relevant grounds, Article 65(1) shall apply.

Article 65

Dispute resolution by the Board

1. In order to ensure the correct and consistent application of this Regulation in individual cases, the Board shall adopt a binding decision in the following cases:

(a)

where, in a case referred to in Article 60(4), a supervisory_authority concerned has raised a relevant_and_reasoned_objection to a draft decision of the lead authority or the lead authority has rejected such an objection as being not relevant or reasoned. The binding decision shall concern all the matters which are the subject of the relevant_and_reasoned_objection, in particular whether there is an infringement of this Regulation;

(b)	where there are conflicting views on which of the supervisory authorities concerned is competent for the main_establishment;

(c)

where a competent supervisory_authority does not request the opinion of the Board in the cases referred to in Article 64(1), or does not follow the opinion of the Board issued under Article 64. In that case, any supervisory_authority concerned or the Commission may communicate the matter to the Board.

2. The decision referred to in paragraph 1 shall be adopted within one month from the referral of the subject-matter by a two-thirds majority of the members of the Board. That period may be extended by a further month on account of the complexity of the subject-matter. The decision referred to in paragraph 1 shall be reasoned and addressed to the lead supervisory_authority and all the supervisory authorities concerned and binding on them.

3. Where the Board has been unable to adopt a decision within the periods referred to in paragraph 2, it shall adopt its decision within two weeks following the expiration of the second month referred to in paragraph 2 by a simple majority of the members of the Board. Where the members of the Board are split, the decision shall by adopted by the vote of its Chair.

4. The supervisory authorities concerned shall not adopt a decision on the subject matter submitted to the Board under paragraph 1 during the periods referred to in paragraphs 2 and 3.

5. The Chair of the Board shall notify, without undue delay, the decision referred to in paragraph 1 to the supervisory authorities concerned. It shall inform the Commission thereof. The decision shall be published on the website of the Board without delay after the supervisory_authority has notified the final decision referred to in paragraph 6.

6. The lead supervisory_authority or, as the case may be, the supervisory_authority with which the complaint has been lodged shall adopt its final decision on the basis of the decision referred to in paragraph 1 of this Article, without undue delay and at the latest by one month after the Board has notified its decision. The lead supervisory_authority or, as the case may be, the supervisory_authority with which the complaint has been lodged, shall inform the Board of the date when its final decision is notified respectively to the controller or the processor and to the data subject. The final decision of the supervisory authorities concerned shall be adopted under the terms of Article 60(7), (8) and (9). The final decision shall refer to the decision referred to in paragraph 1 of this Article and shall specify that the decision referred to in that paragraph will be published on the website of the Board in accordance with paragraph 5 of this Article. The final decision shall attach the decision referred to in paragraph 1 of this Article.

Article 66

Urgency procedure

1. In exceptional circumstances, where a supervisory_authority concerned considers that there is an urgent need to act in order to protect the rights and freedoms of data subjects, it may, by way of derogation from the consistency mechanism referred to in Articles 63, 64 and 65 or the procedure referred to in Article 60, immediately adopt provisional measures intended to produce legal effects on its own territory with a specified period of validity which shall not exceed three months. The supervisory_authority shall, without delay, communicate those measures and the reasons for adopting them to the other supervisory authorities concerned, to the Board and to the Commission.

2. Where a supervisory_authority has taken a measure pursuant to paragraph 1 and considers that final measures need urgently be adopted, it may request an urgent opinion or an urgent binding decision from the Board, giving reasons for requesting such opinion or decision.

3. Any supervisory_authority may request an urgent opinion or an urgent binding decision, as the case may be, from the Board where a competent supervisory_authority has not taken an appropriate measure in a situation where there is an urgent need to act, in order to protect the rights and freedoms of data subjects, giving reasons for requesting such opinion or decision, including for the urgent need to act.

4. By derogation from Article 64(3) and Article 65(2), an urgent opinion or an urgent binding decision referred to in paragraphs 2 and 3 of this Article shall be adopted within two weeks by simple majority of the members of the Board.

Article 67

Exchange of information

The Commission may adopt implementing acts of general scope in order to specify the arrangements for the exchange of information by electronic means between supervisory authorities, and between supervisory authorities and the Board, in particular the standardised format referred to in Article 64.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2).

Section 3

European data protection board

Article 70

Tasks of the Board

1. The Board shall ensure the consistent application of this Regulation. To that end, the Board shall, on its own initiative or, where relevant, at the request of the Commission, in particular:

(a)	monitor and ensure the correct application of this Regulation in the cases provided for in Articles 64 and 65 without prejudice to the tasks of national supervisory authorities;

(b)	advise the Commission on any issue related to the protection of personal_data in the Union, including on any proposed amendment of this Regulation;

(c)	advise the Commission on the format and procedures for the exchange of information between controllers, processors and supervisory authorities for binding_corporate_rules;

(d)	issue guidelines, recommendations, and best practices on procedures for erasing links, copies or replications of personal_data from publicly available communication services as referred to in Article 17(2);

(e)	examine, on its own initiative, on request of one of its members or on request of the Commission, any question covering the application of this Regulation and issue guidelines, recommendations and best practices in order to encourage consistent application of this Regulation;

(f)	issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for further specifying the criteria and conditions for decisions based on profiling pursuant to Article 22(2);

(g)

issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for establishing the personal_data breaches and determining the undue delay referred to in Article 33(1) and (2) and for the particular circumstances in which a controller or a processor is required to notify the personal_data breach;

(h)	issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph as to the circumstances in which a personal_data breach is likely to result in a high risk to the rights and freedoms of the natural persons referred to in Article 34(1).

(i)

issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for the purpose of further specifying the criteria and requirements for personal_data transfers based on binding_corporate_rules adhered to by controllers and binding_corporate_rules adhered to by processors and on further necessary requirements to ensure the protection of personal_data of the data subjects concerned referred to in Article 47;

(j)	issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for the purpose of further specifying the criteria and requirements for the personal_data transfers on the basis of Article 49(1);

(k)	draw up guidelines for supervisory authorities concerning the application of measures referred to in Article 58(1), (2) and (3) and the setting of administrative fines pursuant to Article 83;

(l)	review the practical application of the guidelines, recommendations and best practices referred to in points (e) and (f);

(m)	issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for establishing common procedures for reporting by natural persons of infringements of this Regulation pursuant to Article 54(2);

(n)	encourage the drawing-up of codes of conduct and the establishment of data protection certification mechanisms and data protection seals and marks pursuant to Articles 40 and 42;

(o)	carry out the accreditation of certification bodies and its periodic review pursuant to Article 43 and maintain a public register of accredited bodies pursuant to Article 43(6) and of the accredited controllers or processors established in third countries pursuant to Article 42(7);

(p)	specify the requirements referred to in Article 43(3) with a view to the accreditation of certification bodies under Article 42;

(q)	provide the Commission with an opinion on the certification requirements referred to in Article 43(8);

(r)	provide the Commission with an opinion on the icons referred to in Article 12(7);

(s)

provide the Commission with an opinion for the assessment of the adequacy of the level of protection in a third country or international_organisation, including for the assessment whether a third country, a territory or one or more specified sectors within that third country, or an international_organisation no longer ensures an adequate level of protection. To that end, the Commission shall provide the Board with all necessary documentation, including correspondence with the government of the third country, with regard to that third country, territory or specified sector, or with the international_organisation.

(t)	issue opinions on draft decisions of supervisory authorities pursuant to the consistency mechanism referred to in Article 64(1), on matters submitted pursuant to Article 64(2) and to issue binding decisions pursuant to Article 65, including in cases referred to in Article 66;

(u)	promote the cooperation and the effective bilateral and multilateral exchange of information and best practices between the supervisory authorities;

(v)	promote common training programmes and facilitate personnel exchanges between the supervisory authorities and, where appropriate, with the supervisory authorities of third countries or with international_organisations;

(w)	promote the exchange of knowledge and documentation on data protection legislation and practice with data protection supervisory authorities worldwide.

(x)	issue opinions on codes of conduct drawn up at Union level pursuant to Article 40(9); and

(y)	maintain a publicly accessible electronic register of decisions taken by supervisory authorities and courts on issues handled in the consistency mechanism.

2. Where the Commission requests advice from the Board, it may indicate a time limit, taking into account the urgency of the matter.

3. The Board shall forward its opinions, guidelines, recommendations, and best practices to the Commission and to the committee referred to in Article 93 and make them public.

4. The Board shall, where appropriate, consult interested parties and give them the opportunity to comment within a reasonable period. The Board shall, without prejudice to Article 76, make the results of the consultation procedure publicly available.

Article 74

Tasks of the Chair

1. The Chair shall have the following tasks:

(a)	to convene the meetings of the Board and prepare its agenda;

(b)	to notify decisions adopted by the Board pursuant to Article 65 to the lead supervisory_authority and the supervisory authorities concerned;

(c)	to ensure the timely performance of the tasks of the Board, in particular in relation to the consistency mechanism referred to in Article 63.

2. The Board shall lay down the allocation of tasks between the Chair and the deputy chairs in its rules of procedure.

Article 75

Secretariat

1. The Board shall have a secretariat, which shall be provided by the European Data Protection Supervisor.

2. The secretariat shall perform its tasks exclusively under the instructions of the Chair of the Board.

3. The staff of the European Data Protection Supervisor involved in carrying out the tasks conferred on the Board by this Regulation shall be subject to separate reporting lines from the staff involved in carrying out tasks conferred on the European Data Protection Supervisor.

4. Where appropriate, the Board and the European Data Protection Supervisor shall establish and publish a Memorandum of Understanding implementing this Article, determining the terms of their cooperation, and applicable to the staff of the European Data Protection Supervisor involved in carrying out the tasks conferred on the Board by this Regulation.

5. The secretariat shall provide analytical, administrative and logistical support to the Board.

6. The secretariat shall be responsible in particular for:

(a)	the day-to-day business of the Board;

(b)	communication between the members of the Board, its Chair and the Commission;

(c)	communication with other institutions and the public;

(d)	the use of electronic means for the internal and external communication;

(e)	the translation of relevant information;

(f)	the preparation and follow-up of the meetings of the Board;

(g)	the preparation, drafting and publication of opinions, decisions on the settlement of disputes between supervisory authorities and other texts adopted by the Board.

Article 83

General conditions for imposing administrative fines

1. Each supervisory_authority shall ensure that the imposition of administrative fines pursuant to this Article in respect of infringements of this Regulation referred to in paragraphs 4, 5 and 6 shall in each individual case be effective, proportionate and dissuasive.

2. Administrative fines shall, depending on the circumstances of each individual case, be imposed in addition to, or instead of, measures referred to in points (a) to (h) and (j) of Article 58(2). When deciding whether to impose an administrative fine and deciding on the amount of the administrative fine in each individual case due regard shall be given to the following:

(a)	the nature, gravity and duration of the infringement taking into account the nature scope or purpose of the processing concerned as well as the number of data subjects affected and the level of damage suffered by them;

(b)	the intentional or negligent character of the infringement;

(c)	any action taken by the controller or processor to mitigate the damage suffered by data subjects;

(d)	the degree of responsibility of the controller or processor taking into account technical and organisational measures implemented by them pursuant to Articles 25 and 32;

(e)	any relevant previous infringements by the controller or processor;

(f)	the degree of cooperation with the supervisory_authority, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;

(g)	the categories of personal_data affected by the infringement;

(h)	the manner in which the infringement became known to the supervisory_authority, in particular whether, and if so to what extent, the controller or processor notified the infringement;

(i)	where measures referred to in Article 58(2) have previously been ordered against the controller or processor concerned with regard to the same subject-matter, compliance with those measures;

(j)	adherence to approved codes of conduct pursuant to Article 40 or approved certification mechanisms pursuant to Article 42; and

(k)	any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained, or losses avoided, directly or indirectly, from the infringement.

3. If a controller or processor intentionally or negligently, for the same or linked processing operations, infringes several provisions of this Regulation, the total amount of the administrative fine shall not exceed the amount specified for the gravest infringement.

4. Infringements of the following provisions shall, in accordance with paragraph 2, be subject to administrative fines up to 10 000 000 EUR, or in the case of an undertaking, up to 2 % of the total worldwide annual turnover of the preceding financial year, whichever is higher:

(a)	the obligations of the controller and the processor pursuant to Articles 8, 11, 25 to 39 and 42 and 43;

(b)	the obligations of the certification body pursuant to Articles 42 and 43;

(c)	the obligations of the monitoring body pursuant to Article 41(4).

5. Infringements of the following provisions shall, in accordance with paragraph 2, be subject to administrative fines up to 20 000 000 EUR, or in the case of an undertaking, up to 4 % of the total worldwide annual turnover of the preceding financial year, whichever is higher:

(a)	the basic principles for processing, including conditions for consent, pursuant to Articles 5, 6, 7 and 9;

(b)	the data subjects' rights pursuant to Articles 12 to 22;

(c)	the transfers of personal_data to a recipient in a third country or an international_organisation pursuant to Articles 44 to 49;

(d)	any obligations pursuant to Member State law adopted under Chapter IX;

(e)	non-compliance with an order or a temporary or definitive limitation on processing or the suspension of data flows by the supervisory_authority pursuant to Article 58(2) or failure to provide access in violation of Article 58(1).

6. Non-compliance with an order by the supervisory_authority as referred to in Article 58(2) shall, in accordance with paragraph 2 of this Article, be subject to administrative fines up to 20 000 000 EUR, or in the case of an undertaking, up to 4 % of the total worldwide annual turnover of the preceding financial year, whichever is higher.

7. Without prejudice to the corrective powers of supervisory authorities pursuant to Article 58(2), each Member State may lay down the rules on whether and to what extent administrative fines may be imposed on public authorities and bodies established in that Member State.

8. The exercise by the supervisory_authority of its powers under this Article shall be subject to appropriate procedural safeguards in accordance with Union and Member State law, including effective judicial remedy and due process.

9. Where the legal system of the Member State does not provide for administrative fines, this Article may be applied in such a manner that the fine is initiated by the competent supervisory_authority and imposed by competent national courts, while ensuring that those legal remedies are effective and have an equivalent effect to the administrative fines imposed by supervisory authorities. In any event, the fines imposed shall be effective, proportionate and dissuasive. Those Member States shall notify to the Commission the provisions of their laws which they adopt pursuant to this paragraph by 25 May 2018 and, without delay, any subsequent amendment law or amendment affecting them.

Article 85

Processing and freedom of expression and information

1. Member States shall by law reconcile the right to the protection of personal_data pursuant to this Regulation with the right to freedom of expression and information, including processing for journalistic purposes and the purposes of academic, artistic or literary expression.

2. For processing carried out for journalistic purposes or the purpose of academic artistic or literary expression, Member States shall provide for exemptions or derogations from Chapter II (principles), Chapter III (rights of the data subject), Chapter IV ( controller and processor), Chapter V (transfer of personal_data to third countries or international_organisations), Chapter VI (independent supervisory authorities), Chapter VII (cooperation and consistency) and Chapter IX (specific data processing situations) if they are necessary to reconcile the right to the protection of personal_data with the freedom of expression and information.

3. Each Member State shall notify to the Commission the provisions of its law which it has adopted pursuant to paragraph 2 and, without delay, any subsequent amendment law or amendment affecting them.

Article 90

Obligations of secrecy

1. Member States may adopt specific rules to set out the powers of the supervisory authorities laid down in points (e) and (f) of Article 58(1) in relation to controllers or processors that are subject, under Union or Member State law or rules established by national competent bodies, to an obligation of professional secrecy or other equivalent obligations of secrecy where this is necessary and proportionate to reconcile the right of the protection of personal_data with the obligation of secrecy. Those rules shall apply only with regard to personal_data which the controller or processor has received as a result of or has obtained in an activity covered by that obligation of secrecy.

2. Each Member State shall notify to the Commission the rules adopted pursuant to paragraph 1, by 25 May 2018 and, without delay, any subsequent amendment affecting them.

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

(5) The economic and social integration resulting from the functioning of the internal market has led to a substantial increase in cross-border flows of personal_data.
The exchange of personal_data between public and private actors, including natural persons, associations and undertakings across the Union has increased.
National authorities in the Member States are being called upon by Union law to cooperate and exchange personal_data so as to be able to perform their duties or carry out tasks on behalf of an authority in another Member State.

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(6) Rapid technological developments and globalisation have brought new challenges for the protection of personal_data.
The scale of the collection and sharing of personal_data has increased significantly.
Technology allows both private companies and public authorities to make use of personal_data on an unprecedented scale in order to pursue their activities.
Natural persons increasingly make personal information available publicly and globally.
Technology has transformed both the economy and social life, and should further facilitate the free flow of personal_data within the Union and the transfer to third countries and international_organisations, while ensuring a high level of the protection of personal_data.

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(7) Those developments require a strong and more coherent data protection framework in the Union, backed by strong enforcement, given the importance of creating the trust that will allow the digital economy to develop across the internal market.
Natural persons should have control of their own personal_data.
Legal and practical certainty for natural persons, economic operators and public authorities should be enhanced.

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(9) The objectives and principles of Directive 95/46/EC remain sound, but it has not prevented fragmentation in the implementation of data protection across the Union, legal uncertainty or a widespread public perception that there are significant risks to the protection of natural persons, in particular with regard to online activity.
Differences in the level of protection of the rights and freedoms of natural persons, in particular the right to the protection of personal_data, with regard to the processing of personal_data in the Member States may prevent the free flow of personal_data throughout the Union.
Those differences may therefore constitute an obstacle to the pursuit of economic activities at the level of the Union, distort competition and impede authorities in the discharge of their responsibilities under Union law.
Such a difference in levels of protection is due to the existence of differences in the implementation and application of Directive 95/46/EC.

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(13) In order to ensure a consistent level of protection for natural persons throughout the Union and to prevent divergences hampering the free movement of personal_data within the internal market, a Regulation is necessary to provide legal certainty and transparency for economic operators, including micro, small and medium-sized enterprises, and to provide natural persons in all Member States with the same level of legally enforceable rights and obligations and responsibilities for controllers and processors, to ensure consistent monitoring of the processing of personal_data, and equivalent sanctions in all Member States as well as effective cooperation between the supervisory authorities of different Member States.
The proper functioning of the internal market requires that the free movement of personal_data within the Union is not restricted or prohibited for reasons connected with the protection of natural persons with regard to the processing of personal_data.
To take account of the specific situation of micro, small and medium-sized enterprises, this Regulation includes a derogation for organisations with fewer than 250 employees with regard to record-keeping.
In addition, the Union institutions and bodies, and Member States and their supervisory authorities, are encouraged to take account of the specific needs of micro, small and medium-sized enterprises in the application of this Regulation.
The notion of micro, small and medium-sized enterprises should draw from Article 2 of the Annex to Commission Recommendation 2003/361/EC (5).

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(19) 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, including the safeguarding against and the prevention of threats to public security and the free movement of such data, is the subject of a specific Union legal act.
This Regulation should not, therefore, apply to processing activities for those purposes.
However, personal_data processed by public authorities under this Regulation should, when used for those purposes, be governed by a more specific Union legal act, namely Directive (EU) 2016/680 of the European Parliament and of the Council (7).
Member States may entrust competent authorities within the meaning of Directive (EU) 2016/680 with tasks which are not necessarily carried out for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and prevention of threats to public security, so that the processing of personal_data for those other purposes, in so far as it is within the scope of Union law, falls within the scope of this Regulation.

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(20) While this Regulation applies, inter alia, to the activities of courts and other judicial authorities, Union or Member State law could specify the processing operations and processing procedures in relation to the processing of personal_data by courts and other judicial authorities.
The competence of the supervisory authorities should not cover the processing of personal_data when courts are acting in their judicial capacity, in order to safeguard the independence of the judiciary in the performance of its judicial tasks, including decision-making.
It should be possible to entrust supervision of such data processing operations to specific bodies within the judicial system of the Member State, which should, in particular ensure compliance with the rules of this Regulation, enhance awareness among members of the judiciary of their obligations under this Regulation and handle complaints in relation to such data processing operations.

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(31) Public authorities to which personal_data are disclosed in accordance with a legal obligation for the exercise of their official mission, such as tax and customs authorities, financial investigation units, independent administrative authorities, or financial market authorities responsible for the regulation and supervision of securities markets should not be regarded as recipients if they receive personal_data which are necessary to carry out a particular inquiry in the general interest, in accordance with Union or Member State law.
The requests for disclosure sent by the public authorities should always be in writing, reasoned and occasional and should not concern the entirety of a filing_system or lead to the interconnection of filing_systems.
The processing of personal_data by those public authorities should comply with the applicable data-protection rules according to the purposes of the processing.

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(36) The main_establishment of a controller in the Union should be 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, in which case that other establishment should be considered to be the main_establishment.
The main_establishment of a controller in the Union should be determined according to objective criteria and should imply the effective and real exercise of management activities determining the main decisions as to the purposes and means of processing through stable arrangements.
That criterion should not depend on whether the processing of personal_data is carried out at that location.
The presence and use of technical means and technologies for processing personal_data or processing activities do not, in themselves, constitute a main_establishment and are therefore not determining criteria for a main_establishment.
The main_establishment of the processor should be the place of its central administration in the Union or, if it has no central administration in the Union, the place where the main processing activities take place in the Union.
In cases involving both the controller and the processor, the competent lead supervisory_authority should remain the supervisory_authority of the Member State where the controller has its main_establishment, but the supervisory_authority of the processor should be considered to be a supervisory_authority concerned and that supervisory_authority should participate in the cooperation procedure provided for by this Regulation.
In any case, the supervisory authorities of the Member State or Member States where the processor has one or more establishments should not be considered to be supervisory authorities concerned where the draft decision concerns only the controller.
Where the processing is carried out by a group_of_undertakings, the main_establishment of the controlling undertaking should be considered to be the main_establishment of the group_of_undertakings, except where the purposes and means of processing are determined by another undertaking.

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(47) The legitimate interests of a controller, including those of a controller to which the personal_data may be disclosed, or of a third_party, may provide a legal basis for processing, provided that the interests or the fundamental rights and freedoms of the data subject are not overriding, taking into consideration the reasonable expectations of data subjects based on their relationship with the controller.
Such legitimate interest could exist for example where there is a relevant and appropriate relationship between the data subject and the controller in situations such as where the data subject is a client or in the service of the controller.
At any rate the existence of a legitimate interest would need careful assessment including whether a data subject can reasonably expect at the time and in the context of the collection of the personal_data that processing for that purpose may take place.
The interests and fundamental rights of the data subject could in particular override the interest of the data controller where personal_data are processed in circumstances where data subjects do not reasonably expect further processing.
Given that it is for the legislator to provide by law for the legal basis for public authorities to process personal_data, that legal basis should not apply to the processing by public authorities in the performance of their tasks.
The processing of personal_data strictly necessary for the purposes of preventing fraud also constitutes a legitimate interest of the data controller concerned.
The processing of personal_data for direct marketing purposes may be regarded as carried out for a legitimate interest.

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(49) The processing of personal_data to the extent strictly necessary and proportionate for the purposes of ensuring network and information security, i.e.
the ability of a network or an information system to resist, at a given level of confidence, accidental events or unlawful or malicious actions that compromise the availability, authenticity, integrity and confidentiality of stored or transmitted personal_data, and the security of the related services offered by, or accessible via, those networks and systems, by public authorities, by computer emergency response teams (CERTs), computer security incident response teams (CSIRTs), by providers of electronic communications networks and services and by providers of security technologies and services, constitutes a legitimate interest of the data controller concerned.
This could, for example, include preventing unauthorised access to electronic communications networks and malicious code distribution and stopping ‘denial of service’ attacks and damage to computer and electronic communication systems.

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(53) Special categories of personal_data which merit higher protection should be processed for health-related purposes only where necessary to achieve those purposes for the benefit of natural persons and society as a whole, in particular in the context of the management of health or social care services and systems, including processing by the management and central national health authorities of such data for the purpose of quality control, management information and the general national and local supervision of the health or social care system, and ensuring continuity of health or social care and cross-border healthcare or health security, monitoring and alert purposes, or for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes, based on Union or Member State law which has to meet an objective of public interest, as well as for studies conducted in the public interest in the area of public health.
Therefore, this Regulation should provide for harmonised conditions for the processing of special categories of personal_data concerning health, in respect of specific needs, in particular where the processing of such data is carried out for certain health-related purposes by persons subject to a legal obligation of professional secrecy.
Union or Member State law should provide for specific and suitable measures so as to protect the fundamental rights and the personal_data of natural persons.
Member States should be allowed to maintain or introduce further conditions, including limitations, with regard to the processing of genetic_data, biometric_data or data_concerning_health.
However, this should not hamper the free flow of personal_data within the Union when those conditions apply to cross-border processing of such data.

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(55) Moreover, the processing of personal_data by official authorities for the purpose of achieving the aims, laid down by constitutional law or by international public law, of officially recognised religious associations, is carried out on grounds of public interest.

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(79) The protection of the rights and freedoms of data subjects as well as the responsibility and liability of controllers and processors, also in relation to the monitoring by and measures of supervisory authorities, requires a clear allocation of the responsibilities under this Regulation, including where a controller determines the purposes and means of the processing jointly with other controllers or where a processing operation is carried out on behalf of a controller.

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(80) Where a controller or a processor not established in the Union is processing personal_data of data subjects who are in the Union whose processing activities are related to the offering of goods or services, irrespective of whether a payment of the data subject is required, to such data subjects in the Union, or to the monitoring of their behaviour as far as their behaviour takes place within the Union, the controller or the processor should designate a representative, unless the processing is occasional, does not include processing, on a large scale, of special categories of personal_data or the processing of personal_data relating to criminal convictions and offences, and is unlikely to result in a risk to the rights and freedoms of natural persons, taking into account the nature, context, scope and purposes of the processing or if the controller is a public authority or body.
The representative should act on behalf of the controller or the processor and may be addressed by any supervisory_authority.
The representative should be explicitly designated by a written mandate of the controller or of the processor to act on its behalf with regard to its obligations under this Regulation.
The designation of such a representative does not affect the responsibility or liability of the controller or of the processor under this Regulation.
Such a representative should perform its tasks according to the mandate received from the controller or processor, including cooperating with the competent supervisory authorities with regard to any action taken to ensure compliance with this Regulation.
The designated representative should be subject to enforcement proceedings in the event of non-compliance by the controller or processor.

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(86) The controller should communicate to the data subject a personal_data breach, without undue delay, where that personal_data breach is likely to result in a high risk to the rights and freedoms of the natural person in order to allow him or her to take the necessary precautions.
The communication should describe the nature of the personal_data breach as well as recommendations for the natural person concerned to mitigate potential adverse effects.
Such communications to data subjects should be made as soon as reasonably feasible and in close cooperation with the supervisory_authority, respecting guidance provided by it or by other relevant authorities such as law-enforcement authorities.
For example, the need to mitigate an immediate risk of damage would call for prompt communication with data subjects whereas the need to implement appropriate measures against continuing or similar personal_data breaches may justify more time for communication.

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(88) In setting detailed rules concerning the format and procedures applicable to the notification of personal_data breaches, due consideration should be given to the circumstances of that breach, including whether or not personal_data had been protected by appropriate technical protection measures, effectively limiting the likelihood of identity fraud or other forms of misuse.
Moreover, such rules and procedures should take into account the legitimate interests of law-enforcement authorities where early disclosure could unnecessarily hamper the investigation of the circumstances of a personal_data breach.

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(89) Directive 95/46/EC provided for a general obligation to notify the processing of personal_data to the supervisory authorities.
While that obligation produces administrative and financial burdens, it did not in all cases contribute to improving the protection of personal_data.
Such indiscriminate general notification obligations should therefore be abolished, and replaced by effective procedures and mechanisms which focus instead on those types of processing operations which are likely to result in a high risk to the rights and freedoms of natural persons by virtue of their nature, scope, context and purposes.
Such types of processing operations may be those which in, particular, involve using new technologies, or are of a new kind and where no data protection impact assessment has been carried out before by the controller, or where they become necessary in the light of the time that has elapsed since the initial processing.

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(92) There are circumstances under which it may be reasonable and economical for the subject of a data protection impact assessment to be broader than a single project, for example where public authorities or bodies intend to establish a common application or processing platform or where several controllers plan to introduce a common application or processing environment across an industry sector or segment or for a widely used horizontal activity.

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(97) Where the processing is carried out by a public authority, except for courts or independent judicial authorities when acting in their judicial capacity, where, in the private sector, processing is carried out by a controller whose core activities consist of processing operations that require regular and systematic monitoring of the data subjects on a large scale, or where the core activities of the controller or the processor consist of processing on a large scale of special categories of personal_data and data relating to criminal convictions and offences, a person with expert knowledge of data protection law and practices should assist the controller or processor to monitor internal compliance with this Regulation.
In the private sector, the core activities of a controller relate to its primary activities and do not relate to the processing of personal_data as ancillary activities.
The necessary level of expert knowledge should be determined in particular according to the data processing operations carried out and the protection required for the personal_data processed by the controller or the processor.
Such data protection officers, whether or not they are an employee of the controller, should be in a position to perform their duties and tasks in an independent manner.

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(104) In line with the fundamental values on which the Union is founded, in particular the protection of human rights, the Commission should, in its assessment of the third country, or of a territory or specified sector within a third country, take into account how a particular third country respects the rule of law, access to justice as well as international human rights norms and standards and its general and sectoral law, including legislation concerning public security, defence and national security as well as public order and criminal law.
The adoption of an adequacy decision with regard to a territory or a specified sector in a third country should take into account clear and objective criteria, such as specific processing activities and the scope of applicable legal standards and legislation in force in the third country.
The third country should offer guarantees ensuring an adequate level of protection essentially equivalent to that ensured within the Union, in particular where personal_data are processed in one or several specific sectors.
In particular, the third country should ensure effective independent data protection supervision and should provide for cooperation mechanisms with the Member States' data protection authorities, and the data subjects should be provided with effective and enforceable rights and effective administrative and judicial redress.

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(108) In the absence of an adequacy decision, the controller or processor should take measures to compensate for the lack of data protection in a third country by way of appropriate safeguards for the data subject.
Such appropriate safeguards may consist of making use of binding_corporate_rules, standard data protection clauses adopted by the Commission, standard data protection clauses adopted by a supervisory_authority or contractual clauses authorised by a supervisory_authority.
Those safeguards should ensure compliance with data protection requirements and the rights of the data subjects appropriate to processing within the Union, including the availability of enforceable data subject rights and of effective legal remedies, including to obtain effective administrative or judicial redress and to claim compensation, in the Union or in a third country.
They should relate in particular to compliance with the general principles relating to personal_data processing, the principles of data protection by design and by default.
Transfers may also be carried out by public authorities or bodies with public authorities or bodies in third countries or with international_organisations with corresponding duties or functions, including on the basis of provisions to be inserted into administrative arrangements, such as a memorandum of understanding, providing for enforceable and effective rights for data subjects.
Authorisation by the competent supervisory_authority should be obtained when the safeguards are provided for in administrative arrangements that are not legally binding.

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(112) Those derogations should in particular apply to data transfers required and necessary for important reasons of public interest, for example in cases of international data exchange between competition authorities, tax or customs administrations, between financial supervisory authorities, between services competent for social security matters, or for public health, for example in the case of contact tracing for contagious diseases or in order to reduce and/or eliminate doping in sport.
A transfer of personal_data should also be regarded as lawful where it is necessary to protect an interest which is essential for the data subject's or another person's vital interests, including physical integrity or life, if the data subject is incapable of giving consent.
In the absence of an adequacy decision, Union or Member State law may, for important reasons of public interest, expressly set limits to the transfer of specific categories of data to a third country or an international_organisation.
Member States should notify such provisions to the Commission.
Any transfer to an international humanitarian organisation of personal_data of a data subject who is physically or legally incapable of giving consent, with a view to accomplishing a task incumbent under the Geneva Conventions or to complying with international humanitarian law applicable in armed conflicts, could be considered to be necessary for an important reason of public interest or because it is in the vital interest of the data subject.

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(115) Some third countries adopt laws, regulations and other legal acts which purport to directly regulate the processing activities of natural and legal persons under the jurisdiction of the Member States.
This may include judgments of courts or tribunals or decisions of administrative authorities in third countries requiring a controller or processor to transfer or disclose personal_data, and which are not based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or a Member State.
The extraterritorial application of those laws, regulations and other legal acts may be in breach of international law and may impede the attainment of the protection of natural persons ensured in the Union by this Regulation.
Transfers should only be allowed where the conditions of this Regulation for a transfer to third countries are met.
This may be the case, inter alia, where disclosure is necessary for an important ground of public interest recognised in Union or Member State law to which the controller is subject.

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(116) When personal_data moves across borders outside the Union it may put at increased risk the ability of natural persons to exercise data protection rights in particular to protect themselves from the unlawful use or disclosure of that information.
At the same time, supervisory authorities may find that they are unable to pursue complaints or conduct investigations relating to the activities outside their borders.
Their efforts to work together in the cross-border context may also be hampered by insufficient preventative or remedial powers, inconsistent legal regimes, and practical obstacles like resource constraints.
Therefore, there is a need to promote closer cooperation among data protection supervisory authorities to help them exchange information and carry out investigations with their international counterparts.
For the purposes of developing international cooperation mechanisms to facilitate and provide international mutual assistance for the enforcement of legislation for the protection of personal_data, the Commission and the supervisory authorities should exchange information and cooperate in activities related to the exercise of their powers with competent authorities in third countries, based on reciprocity and in accordance with this Regulation.

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(117) The establishment of supervisory authorities in Member States, empowered to perform their tasks and exercise their powers with complete independence, is an essential component of the protection of natural persons with regard to the processing of their personal_data.
Member States should be able to establish more than one supervisory_authority, to reflect their constitutional, organisational and administrative structure.

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(118) The independence of supervisory authorities should not mean that the supervisory authorities cannot be subject to control or monitoring mechanisms regarding their financial expenditure or to judicial review.

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(119) Where a Member State establishes several supervisory authorities, it should establish by law mechanisms for ensuring the effective participation of those supervisory authorities in the consistency mechanism.
That Member State should in particular designate the supervisory_authority which functions as a single contact point for the effective participation of those authorities in the mechanism, to ensure swift and smooth cooperation with other supervisory authorities, the Board and the Commission.

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(120) Each supervisory_authority should be provided with the financial and human resources, premises and infrastructure necessary for the effective performance of their tasks, including those related to mutual assistance and cooperation with other supervisory authorities throughout the Union.
Each supervisory_authority should have a separate, public annual budget, which may be part of the overall state or national budget.

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(122) Each supervisory_authority should be competent on the territory of its own Member State to exercise the powers and to perform the tasks conferred on it in accordance with this Regulation.
This should cover in particular the processing in the context of the activities of an establishment of the controller or processor on the territory of its own Member State, the processing of personal_data carried out by public authorities or private bodies acting in the public interest, processing affecting data subjects on its territory or processing carried out by a controller or processor not established in the Union when targeting data subjects residing on its territory.
This should include handling complaints lodged by a data subject, conducting investigations on the application of this Regulation and promoting public awareness of the risks, rules, safeguards and rights in relation to the processing of personal_data.

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(123) The supervisory authorities should monitor the application of the provisions pursuant to this Regulation and contribute to its consistent application throughout the Union, in order to protect natural persons in relation to the processing of their personal_data and to facilitate the free flow of personal_data within the internal market.
For that purpose, the supervisory authorities should cooperate with each other and with the Commission, without the need for any agreement between Member States on the provision of mutual assistance or on such cooperation.

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(124) Where the processing of personal_data takes place in the context of the activities of an establishment of a controller or a processor in the Union and the controller or processor is established in more than one Member State, or where processing taking place in the context of the activities of a single establishment of a controller or processor in the Union substantially affects or is likely to substantially affect data subjects in more than one Member State, the supervisory_authority for the main_establishment of the controller or processor or for the single establishment of the controller or processor should act as lead authority.
It should cooperate with the other authorities concerned, because the controller or processor has an establishment on the territory of their Member State, because data subjects residing on their territory are substantially affected, or because a complaint has been lodged with them.
Also where a data subject not residing in that Member State has lodged a complaint, the supervisory_authority with which such complaint has been lodged should also be a supervisory_authority concerned.
Within its tasks to issue guidelines on any question covering the application of this Regulation, the Board should be able to issue guidelines in particular on the criteria to be taken into account in order to ascertain whether the processing in question substantially affects data subjects in more than one Member State and on what constitutes a relevant_and_reasoned_objection.

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(125) The lead authority should be competent to adopt binding decisions regarding measures applying the powers conferred on it in accordance with this Regulation.
In its capacity as lead authority, the supervisory_authority should closely involve and coordinate the supervisory authorities concerned in the decision-making process.
Where the decision is to reject the complaint by the data subject in whole or in part, that decision should be adopted by the supervisory_authority with which the complaint has been lodged.

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(126) The decision should be agreed jointly by the lead supervisory_authority and the supervisory authorities concerned and should be directed towards the main or single establishment of the controller or processor and be binding on the controller and processor.
The controller or processor should take the necessary measures to ensure compliance with this Regulation and the implementation of the decision notified by the lead supervisory_authority to the main_establishment of the controller or processor as regards the processing activities in the Union.

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(127) Each supervisory_authority not acting as the lead supervisory_authority should be competent to handle local cases where the controller or processor is established in more than one Member State, but the subject matter of the specific processing concerns only processing carried out in a single Member State and involves only data subjects in that single Member State, for example, where the subject matter concerns the processing of employees' personal_data in the specific employment context of a Member State.
In such cases, the supervisory_authority should inform the lead supervisory_authority without delay about the matter.
After being informed, the lead supervisory_authority should decide, whether it will handle the case pursuant to the provision on cooperation between the lead supervisory_authority and other supervisory authorities concerned (‘one-stop-shop mechanism’), or whether the supervisory_authority which informed it should handle the case at local level.
When deciding whether it will handle the case, the lead supervisory_authority should take into account whether there is an establishment of the controller or processor in the Member State of the supervisory_authority which informed it in order to ensure effective enforcement of a decision vis-à-vis the controller or processor.
Where the lead supervisory_authority decides to handle the case, the supervisory_authority which informed it should have the possibility to submit a draft for a decision, of which the lead supervisory_authority should take utmost account when preparing its draft decision in that one-stop-shop mechanism.

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(128) The rules on the lead supervisory_authority and the one-stop-shop mechanism should not apply where the processing is carried out by public authorities or private bodies in the public interest.
In such cases the only supervisory_authority competent to exercise the powers conferred to it in accordance with this Regulation should be the supervisory_authority of the Member State where the public authority or private body is established.

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(129) In order to ensure consistent monitoring and enforcement of this Regulation throughout the Union, the supervisory authorities should have in each Member State the same tasks and effective powers, including powers of investigation, corrective powers and sanctions, and authorisation and advisory powers, in particular in cases of complaints from natural persons, and without prejudice to the powers of prosecutorial authorities under Member State law, to bring infringements of this Regulation to the attention of the judicial authorities and engage in legal proceedings.
Such powers should also include the power to impose a temporary or definitive limitation, including a ban, on processing.
Member States may specify other tasks related to the protection of personal_data under this Regulation.
The powers of supervisory authorities should be exercised in accordance with appropriate procedural safeguards set out in Union and Member State law, impartially, fairly and within a reasonable time.
In particular each measure should be appropriate, necessary and proportionate in view of ensuring compliance with this Regulation, taking into account the circumstances of each individual case, respect the right of every person to be heard before any individual measure which would affect him or her adversely is taken and avoid superfluous costs and excessive inconveniences for the persons concerned.
Investigatory powers as regards access to premises should be exercised in accordance with specific requirements in Member State procedural law, such as the requirement to obtain a prior judicial authorisation.
Each legally binding measure of the supervisory_authority should be in writing, be clear and unambiguous, indicate the supervisory_authority which has issued the measure, the date of issue of the measure, bear the signature of the head, or a member of the supervisory_authority authorised by him or her, give the reasons for the measure, and refer to the right of an effective remedy.
This should not preclude additional requirements pursuant to Member State procedural law.
The adoption of a legally binding decision implies that it may give rise to judicial review in the Member State of the supervisory_authority that adopted the decision.

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(132) Awareness-raising activities by supervisory authorities addressed to the public should include specific measures directed at controllers and processors, including micro, small and medium-sized enterprises, as well as natural persons in particular in the educational context.

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(133) The supervisory authorities should assist each other in performing their tasks and provide mutual assistance, so as to ensure the consistent application and enforcement of this Regulation in the internal market.
A supervisory_authority requesting mutual assistance may adopt a provisional measure if it receives no response to a request for mutual assistance within one month of the receipt of that request by the other supervisory_authority.

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(134) Each supervisory_authority should, where appropriate, participate in joint operations with other supervisory authorities.
The requested supervisory_authority should be obliged to respond to the request within a specified time period.

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(135) In order to ensure the consistent application of this Regulation throughout the Union, a consistency mechanism for cooperation between the supervisory authorities should be established.
That mechanism should in particular apply where a supervisory_authority intends to adopt a measure intended to produce legal effects as regards processing operations which substantially affect a significant number of data subjects in several Member States.
It should also apply where any supervisory_authority concerned or the Commission requests that such matter should be handled in the consistency mechanism.
That mechanism should be without prejudice to any measures that the Commission may take in the exercise of its powers under the Treaties.

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(136) In applying the consistency mechanism, the Board should, within a determined period of time, issue an opinion, if a majority of its members so decides or if so requested by any supervisory_authority concerned or the Commission.
The Board should also be empowered to adopt legally binding decisions where there are disputes between supervisory authorities.
For that purpose, it should issue, in principle by a two-thirds majority of its members, legally binding decisions in clearly specified cases where there are conflicting views among supervisory authorities, in particular in the cooperation mechanism between the lead supervisory_authority and supervisory authorities concerned on the merits of the case, in particular whether there is an infringement of this Regulation.

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(138) The application of such mechanism should be a condition for the lawfulness of a measure intended to produce legal effects by a supervisory_authority in those cases where its application is mandatory.
In other cases of cross-border relevance, the cooperation mechanism between the lead supervisory_authority and supervisory authorities concerned should be applied and mutual assistance and joint operations might be carried out between the supervisory authorities concerned on a bilateral or multilateral basis without triggering the consistency mechanism.

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(139) In order to promote the consistent application of this Regulation, the Board should be set up as an independent body of the Union.
To fulfil its objectives, the Board should have legal personality.
The Board should be represented by its Chair.
It should replace the Working Party on the Protection of Individuals with Regard to the Processing of Personal Data established by Directive 95/46/EC.
It should consist of the head of a supervisory_authority of each Member State and the European Data Protection Supervisor or their respective representatives.
The Commission should participate in the Board's activities without voting rights and the European Data Protection Supervisor should have specific voting rights.
The Board should contribute to the consistent application of this Regulation throughout the Union, including by advising the Commission, in particular on the level of protection in third countries or international_organisations, and promoting cooperation of the supervisory authorities throughout the Union.
The Board should act independently when performing its tasks.

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(143) Any natural or legal person has the right to bring an action for annulment of decisions of the Board before the Court of Justice under the conditions provided for in Article 263 TFEU.
As addressees of such decisions, the supervisory authorities concerned which wish to challenge them have to bring action within two months of being notified of them, in accordance with Article 263 TFEU.
Where decisions of the Board are of direct and individual concern to a controller, processor or complainant, the latter may bring an action for annulment against those decisions within two months of their publication on the website of the Board, in accordance with Article 263 TFEU.
Without prejudice to this right under Article 263 TFEU, each natural or legal person should have an effective judicial remedy before the competent national court against a decision of a supervisory_authority which produces legal effects concerning that person.
Such a decision concerns in particular the exercise of investigative, corrective and authorisation powers by the supervisory_authority or the dismissal or rejection of complaints.
However, the right to an effective judicial remedy does not encompass measures taken by supervisory authorities which are not legally binding, such as opinions issued by or advice provided by the supervisory_authority.
Proceedings against a supervisory_authority should be brought before the courts of the Member State where the supervisory_authority is established and should be conducted in accordance with that Member State's procedural law.
Those courts should exercise full jurisdiction, which should include jurisdiction to examine all questions of fact and law relevant to the dispute before them.

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(150) In order to strengthen and harmonise administrative penalties for infringements of this Regulation, each supervisory_authority should have the power to impose administrative fines.
This Regulation should indicate infringements and the upper limit and criteria for setting the related administrative fines, which should be determined by the competent supervisory_authority in each individual case, taking into account all relevant circumstances of the specific situation, with due regard in particular to the nature, gravity and duration of the infringement and of its consequences and the measures taken to ensure compliance with the obligations under this Regulation and to prevent or mitigate the consequences of the infringement.
Where administrative fines are imposed on an undertaking, an undertaking should be understood to be an undertaking in accordance with Articles 101 and 102 TFEU for those purposes.
Where administrative fines are imposed on persons that are not an undertaking, the supervisory_authority should take account of the general level of income in the Member State as well as the economic situation of the person in considering the appropriate amount of the fine.
The consistency mechanism may also be used to promote a consistent application of administrative fines.
It should be for the Member States to determine whether and to which extent public authorities should be subject to administrative fines.
Imposing an administrative fine or giving a warning does not affect the application of other powers of the supervisory authorities or of other penalties under this Regulation.

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(151) The legal systems of Denmark and Estonia do not allow for administrative fines as set out in this Regulation.
The rules on administrative fines may be applied in such a manner that in Denmark the fine is imposed by competent national courts as a criminal penalty and in Estonia the fine is imposed by the supervisory_authority in the framework of a misdemeanour procedure, provided that such an application of the rules in those Member States has an equivalent effect to administrative fines imposed by supervisory authorities.
Therefore the competent national courts should take into account the recommendation by the supervisory_authority initiating the fine.
In any event, the fines imposed should be effective, proportionate and dissuasive.

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(153) Member States law should reconcile the rules governing freedom of expression and information, including journalistic, academic, artistic and or literary expression with the right to the protection of personal_data pursuant to this Regulation.
The processing of personal_data solely for journalistic purposes, or for the purposes of academic, artistic or literary expression should be subject to derogations or exemptions from certain provisions of this Regulation if necessary to reconcile the right to the protection of personal_data with the right to freedom of expression and information, as enshrined in Article 11 of the Charter.
This should apply in particular to the processing of personal_data in the audiovisual field and in news archives and press libraries.
Therefore, Member States should adopt legislative measures which lay down the exemptions and derogations necessary for the purpose of balancing those fundamental rights.
Member States should adopt such exemptions and derogations on general principles, the rights of the data subject, the controller and the processor, the transfer of personal_data to third countries or international_organisations, the independent supervisory authorities, cooperation and consistency, and specific data- processing situations.
Where such exemptions or derogations differ from one Member State to another, the law of the Member State to which the controller is subject should apply.
In order to take account of the importance of the right to freedom of expression in every democratic society, it is necessary to interpret notions relating to that freedom, such as journalism, broadly.

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(154) This Regulation allows the principle of public access to official documents to be taken into account when applying this Regulation.
Public access to official documents may be considered to be in the public interest.
Personal data in documents held by a public authority or a public body should be able to be publicly disclosed by that authority or body if the disclosure is provided for by Union or Member State law to which the public authority or public body is subject.
Such laws should reconcile public access to official documents and the reuse of public sector information with the right to the protection of personal_data and may therefore provide for the necessary reconciliation with the right to the protection of personal_data pursuant to this Regulation.
The reference to public authorities and bodies should in that context include all authorities or other bodies covered by Member State law on public access to documents.
Directive 2003/98/EC of the European Parliament and of the Council (14) leaves intact and in no way affects the level of protection of natural persons with regard to the processing of personal_data under the provisions of Union and Member State law, and in particular does not alter the obligations and rights set out in this Regulation.
In particular, that Directive should not apply to documents to which access is excluded or restricted by virtue of the access regimes on the grounds of protection of personal_data, and parts of documents accessible by virtue of those regimes which contain personal_data the re-use of which has been provided for by law as being incompatible with the law concerning the protection of natural persons with regard to the processing of personal_data.

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(158) Where personal_data are processed for archiving purposes, this Regulation should also apply to that processing, bearing in mind that this Regulation should not apply to deceased persons.
Public authorities or public or private bodies that hold records of public interest should be services which, pursuant to Union or Member State law, have a legal obligation to acquire, preserve, appraise, arrange, describe, communicate, promote, disseminate and provide access to records of enduring value for general public interest.
Member States should also be authorised to provide for the further processing of personal_data for archiving purposes, for example with a view to providing specific information related to the political behaviour under former totalitarian state regimes, genocide, crimes against humanity, in particular the Holocaust, or war crimes.

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(163) The confidential information which the Union and national statistical authorities collect for the production of official European and official national statistics should be protected.
European statistics should be developed, produced and disseminated in accordance with the statistical principles as set out in Article 338(2) TFEU, while national statistics should also comply with Member State law.
Regulation (EC) No 223/2009 of the European Parliament and of the Council (16) provides further specifications on statistical confidentiality for European statistics.

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(164) As regards the powers of the supervisory authorities to obtain from the controller or processor access to personal_data and access to their premises, Member States may adopt by law, within the limits of this Regulation, specific rules in order to safeguard the professional or other equivalent secrecy obligations, in so far as necessary to reconcile the right to the protection of personal_data with an obligation of professional secrecy.
This is without prejudice to existing Member State obligations to adopt rules on professional secrecy where required by Union law.

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(168) The examination procedure should be used for the adoption of implementing acts on standard contractual clauses between controllers and processors and between processors; codes of conduct; technical standards and mechanisms for certification; the adequate level of protection afforded by a third country, a territory or a specified sector within that third country, or an international_organisation; standard protection clauses; formats and procedures for the exchange of information by electronic means between controllers, processors and supervisory authorities for binding_corporate_rules; mutual assistance; and arrangements for the exchange of information by electronic means between supervisory authorities, and between supervisory authorities and the Board.

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(171) Directive 95/46/EC should be repealed by this Regulation.
Processing already under way on the date of application of this Regulation should be brought into conformity with this Regulation within the period of two years after which this Regulation enters into force.
Where processing is based on consent pursuant to Directive 95/46/EC, it is not necessary for the data subject to give his or her consent again if the manner in which the consent has been given is in line with the conditions of this Regulation, so as to allow the controller to continue such processing after the date of application of this Regulation.
Commission decisions adopted and authorisations by supervisory authorities based on Directive 95/46/EC remain in force until amended, replaced or repealed.

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