interactive GDPR 2016/0679 EN

(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 21

Right to object

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

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

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

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

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

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

Article 23

Restrictions

1. Union or Member State law to which the data controller or processor is subject may restrict by way of a legislative measure the scope of the obligations and rights provided for in Articles 12 to 22 and Article 34, as well as Article 5 in so far as its provisions correspond to the rights and obligations provided for in Articles 12 to 22, when such a restriction respects the essence of the fundamental rights and freedoms and is a necessary and proportionate measure in a democratic society to safeguard:

(a)	national security;

(b)

defence;

(c)	public security;

(d)	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;

(e)	other important objectives of general public interest of the Union or of a Member State, in particular an important economic or financial interest of the Union or of a Member State, including monetary, budgetary and taxation a matters, public health and social security;

(f)	the protection of judicial independence and judicial proceedings;

(g)	the prevention, investigation, detection and prosecution of breaches of ethics for regulated professions;

(h)	a monitoring, inspection or regulatory function connected, even occasionally, to the exercise of official authority in the cases referred to in points (a) to (e) and (g);

(i)	the protection of the data subject or the rights and freedoms of others;

(j)	the enforcement of civil law claims.

2. In particular, any legislative measure referred to in paragraph 1 shall contain specific provisions at least, where relevant, as to:

(a)	the purposes of the processing or categories of processing;

(b)	the categories of personal_data;

(c)	the scope of the restrictions introduced;

(d)	the safeguards to prevent abuse or unlawful access or transfer;

(e)	the specification of the controller or categories of controllers;

(f)	the storage periods and the applicable safeguards taking into account the nature, scope and purposes of the processing or categories of processing;

(g)	the risks to the rights and freedoms of data subjects; and

(h)	the right of data subjects to be informed about the restriction, unless that may be prejudicial to the purpose of the restriction.

CHAPTER IV

Controller and processor

Section 1

General obligations

Article 28

Processor

1. Where processing is to be carried out on behalf of a controller, the controller shall use only processors providing sufficient guarantees to implement appropriate technical and organisational measures in such a manner that processing will meet the requirements of this Regulation and ensure the protection of the rights of the data subject.

2. The processor shall not engage another processor without prior specific or general written authorisation of the controller. In the case of general written authorisation, the processor shall inform the controller of any intended changes concerning the addition or replacement of other processors, thereby giving the controller the opportunity to object to such changes.

3. Processing by a processor shall be governed by a contract or other legal act under Union or Member State law, that is binding on the processor with regard to the controller and that sets out the subject-matter and duration of the processing, the nature and purpose of the processing, the type of personal_data and categories of data subjects and the obligations and rights of the controller. That contract or other legal act shall stipulate, in particular, that the processor:

(a)

processes the personal_data only on documented instructions from the controller, including with regard to transfers of personal_data to a third country or an international_organisation, unless required to do so by Union or Member State law to which the processor is subject; in such a case, the processor shall inform the controller of that legal requirement before processing, unless that law prohibits such information on important grounds of public interest;

(b)	ensures that persons authorised to process the personal_data have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality;

(c)	takes all measures required pursuant to Article 32;

(d)	respects the conditions referred to in paragraphs 2 and 4 for engaging another processor;

(e)	taking into account the nature of the processing, assists the controller by appropriate technical and organisational measures, insofar as this is possible, for the fulfilment of the controller's obligation to respond to requests for exercising the data subject's rights laid down in Chapter III;

(f)	assists the controller in ensuring compliance with the obligations pursuant to Articles 32 to 36 taking into account the nature of processing and the information available to the processor;

(g)	at the choice of the controller, deletes or returns all the personal_data to the controller after the end of the provision of services relating to processing, and deletes existing copies unless Union or Member State law requires storage of the personal_data;

(h)	makes available to the controller all information necessary to demonstrate compliance with the obligations laid down in this Article and allow for and contribute to audits, including inspections, conducted by the controller or another auditor mandated by the controller.

With regard to point (h) of the first subparagraph, the processor shall immediately inform the controller if, in its opinion, an instruction infringes this Regulation or other Union or Member State data protection provisions.

4. Where a processor engages another processor for carrying out specific processing activities on behalf of the controller, the same data protection obligations as set out in the contract or other legal act between the controller and the processor as referred to in paragraph 3 shall be imposed on that other processor by way of a contract or other legal act under Union or Member State law, in particular providing sufficient guarantees to implement appropriate technical and organisational measures in such a manner that the processing will meet the requirements of this Regulation. Where that other processor fails to fulfil its data protection obligations, the initial processor shall remain fully liable to the controller for the performance of that other processor's obligations.

5. Adherence of a processor to an approved code of conduct as referred to in Article 40 or an approved certification mechanism as referred to in Article 42 may be used as an element by which to demonstrate sufficient guarantees as referred to in paragraphs 1 and 4 of this Article.

6. Without prejudice to an individual contract between the controller and the processor, the contract or the other legal act referred to in paragraphs 3 and 4 of this Article may be based, in whole or in part, on standard contractual clauses referred to in paragraphs 7 and 8 of this Article, including when they are part of a certification granted to the controller or processor pursuant to Articles 42 and 43.

7. The Commission may lay down standard contractual clauses for the matters referred to in paragraph 3 and 4 of this Article and in accordance with the examination procedure referred to in Article 93(2).

8. A supervisory_authority may adopt standard contractual clauses for the matters referred to in paragraph 3 and 4 of this Article and in accordance with the consistency mechanism referred to in Article 63.

9. The contract or the other legal act referred to in paragraphs 3 and 4 shall be in writing, including in electronic form.

10. Without prejudice to Articles 82, 83 and 84, if a processor infringes this Regulation by determining the purposes and means of processing, the processor shall be considered to be a controller in respect of that processing.

Article 39

Tasks of the data protection officer

1. The data protection officer shall have at least the following tasks:

(a)	to inform and advise the controller or the processor and the employees who carry out processing of their obligations pursuant to this Regulation and to other Union or Member State data protection provisions;

(b)

to monitor compliance with this Regulation, with other Union or Member State data protection provisions and with the policies of the controller or processor in relation to the protection of personal_data, including the assignment of responsibilities, awareness-raising and training of staff involved in processing operations, and the related audits;

(c)	to provide advice where requested as regards the data protection impact assessment and monitor its performance pursuant to Article 35;

(d)	to cooperate with the supervisory_authority;

(e)	to act as the contact point for the supervisory_authority on issues relating to processing, including the prior consultation referred to in Article 36, and to consult, where appropriate, with regard to any other matter.

2. The data protection officer shall in the performance of his or her tasks have due regard to the risk associated with processing operations, taking into account the nature, scope, context and purposes of processing.

Section 5

Codes of conduct and certification

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 44

General principle for transfers

Any transfer of personal_data which are undergoing processing or are intended for processing after transfer to a third country or to an international_organisation shall take place only if, subject to the other provisions of this Regulation, the conditions laid down in this Chapter are complied with by the controller and processor, including for onward transfers of personal_data from the third country or an international_organisation to another third country or to another international_organisation. All provisions in this Chapter shall be applied in order to ensure that the level of protection of natural persons guaranteed by this Regulation is not undermined.

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 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 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 68

European Data Protection Board

1. The European Data Protection Board (the ‘Board’) is hereby established as a body of the Union and shall have legal personality.

2. The Board shall be represented by its Chair.

3. The Board shall be composed of the head of one supervisory_authority of each Member State and of the European Data Protection Supervisor, or their respective representatives.

4. Where in a Member State more than one supervisory_authority is responsible for monitoring the application of the provisions pursuant to this Regulation, a joint representative shall be appointed in accordance with that Member State's law.

5. The Commission shall have the right to participate in the activities and meetings of the Board without voting right. The Commission shall designate a representative. The Chair of the Board shall communicate to the Commission the activities of the Board.

6. In the cases referred to in Article 65, the European Data Protection Supervisor shall have voting rights only on decisions which concern principles and rules applicable to the Union institutions, bodies, offices and agencies which correspond in substance to those of this Regulation.

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 84

Penalties

1. Member States shall lay down the rules on other penalties applicable to infringements of this Regulation in particular for infringements which are not subject to administrative fines pursuant to Article 83, and shall take all measures necessary to ensure that they are implemented. Such penalties shall be effective, proportionate and dissuasive.

2. Each Member State shall notify to the Commission the provisions of its law which it adopts pursuant to paragraph 1, by 25 May 2018 and, without delay, any subsequent amendment affecting them.

CHAPTER IX

provisions relating to specific processing situations

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 88

Processing in the context of employment

1. Member States may, by law or by collective agreements, provide for more specific rules to ensure the protection of the rights and freedoms in respect of the processing of employees' personal_data in the employment context, in particular for the purposes of the recruitment, the performance of the contract of employment, including discharge of obligations laid down by law or by collective agreements, management, planning and organisation of work, equality and diversity in the workplace, health and safety at work, protection of employer's or customer's property and for the purposes of the exercise and enjoyment, on an individual or collective basis, of rights and benefits related to employment, and for the purpose of the termination of the employment relationship.

2. Those rules shall include suitable and specific measures to safeguard the data subject's human dignity, legitimate interests and fundamental rights, with particular regard to the transparency of processing, the transfer of personal_data within a group_of_undertakings, or a group of enterprises engaged in a joint economic activity and monitoring systems at the work place.

3. Each Member State shall notify to the Commission those provisions of its law which it adopts pursuant to paragraph 1, by 25 May 2018 and, without delay, any subsequent amendment affecting them.

Article 93

Committee procedure

1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

CHAPTER XI

Final provisions

whereas

(8) Where this Regulation provides for specifications or restrictions of its rules by Member State law, Member States may, as far as necessary for coherence and for making the national provisions comprehensible to the persons to whom they apply, incorporate elements of this Regulation into their national law.

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(10) In order to ensure a consistent and high level of protection of natural persons and to remove the obstacles to flows of personal_data within the Union, the level of protection of the rights and freedoms of natural persons with regard to the processing of such data should be equivalent in all Member States.
Consistent and homogenous application of the rules for the protection of the fundamental rights and freedoms of natural persons with regard to the processing of personal_data should be ensured throughout the Union.
Regarding the processing of personal_data for compliance with a legal obligation, for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller, Member States should be allowed to maintain or introduce national provisions to further specify the application of the rules of this Regulation.
In conjunction with the general and horizontal law on data protection implementing Directive 95/46/EC, Member States have several sector-specific laws in areas that need more specific provisions.
This Regulation also provides a margin of manoeuvre for Member States to specify its rules, including for the processing of special categories of personal_data (‘sensitive data’).
To that extent, this Regulation does not exclude Member State law that sets out the circumstances for specific processing situations, including determining more precisely the conditions under which the processing of personal_data is lawful.

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(51) Personal data which are, by their nature, particularly sensitive in relation to fundamental rights and freedoms merit specific protection as the context of their processing could create significant risks to the fundamental rights and freedoms.
Those personal_data should include personal_data revealing racial or ethnic origin, whereby the use of the term ‘racial origin’ in this Regulation does not imply an acceptance by the Union of theories which attempt to determine the existence of separate human races.
The processing of photographs should not systematically be considered to be processing of special categories of personal_data as they are covered by the definition of biometric_data only when processed through a specific technical means allowing the unique identification or authentication of a natural person.
Such personal_data should not be processed, unless processing is allowed in specific cases set out in this Regulation, taking into account that Member States law may lay down specific provisions on data protection in order to adapt the application of the rules of this Regulation for compliance with a legal obligation or for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.
In addition to the specific requirements for such processing, the general principles and other rules of this Regulation should apply, in particular as regards the conditions for lawful processing.
Derogations from the general prohibition for processing such special categories of personal_data should be explicitly provided, inter alia, where the data subject gives his or her explicit consent or in respect of specific needs in particular where the processing is carried out in the course of legitimate activities by certain associations or foundations the purpose of which is to permit the exercise of fundamental freedoms.

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(101) Flows of personal_data to and from countries outside the Union and international_organisations are necessary for the expansion of international trade and international cooperation.
The increase in such flows has raised new challenges and concerns with regard to the protection of personal_data.
However, when personal_data are transferred from the Union to controllers, processors or other recipients in third countries or to international_organisations, the level of protection of natural persons ensured in the Union by this Regulation should not be undermined, including in cases of onward transfers of personal_data from the third country or international_organisation to controllers, processors in the same or another third country or international_organisation.
In any event, transfers to third countries and international_organisations may only be carried out in full compliance with this Regulation.
A transfer could take place only if, subject to the other provisions of this Regulation, the conditions laid down in the provisions of this Regulation relating to the transfer of personal_data to third countries or international_organisations are complied with by the controller or processor.

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(102) This Regulation is without prejudice to international agreements concluded between the Union and third countries regulating the transfer of personal_data including appropriate safeguards for the data subjects.
Member States may conclude international agreements which involve the transfer of personal_data to third countries or international_organisations, as far as such agreements do not affect this Regulation or any other provisions of Union law and include an appropriate level of protection for the fundamental rights of the data subjects.

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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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(111) provisions should be made for the possibility for transfers in certain circumstances where the data subject has given his or her explicit consent, where the transfer is occasional and necessary in relation to a contract or a legal claim, regardless of whether in a judicial procedure or whether in an administrative or any out-of-court procedure, including procedures before regulatory bodies.
Provision should also be made for the possibility for transfers where important grounds of public interest laid down by Union or Member State law so require or where the transfer is made from a register established by law and intended for consultation by the public or persons having a legitimate interest.
In the latter case, such a transfer should not involve the entirety of the personal_data or entire categories of the data contained in the register and, when the register is intended for consultation by persons having a legitimate interest, the transfer should be made only at the request of those persons or, if they are to be the recipients, taking into full account the interests and fundamental rights of the data subject.

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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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(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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(130) Where the supervisory_authority with which the complaint has been lodged is not the lead supervisory_authority, the lead supervisory_authority should closely cooperate with the supervisory_authority with which the complaint has been lodged in accordance with the provisions on cooperation and consistency laid down in this Regulation.
In such cases, the lead supervisory_authority should, when taking measures intended to produce legal effects, including the imposition of administrative fines, take utmost account of the view of the supervisory_authority with which the complaint has been lodged and which should remain competent to carry out any investigation on the territory of its own Member State in liaison with the competent supervisory_authority.

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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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(161) For the purpose of consenting to the participation in scientific research activities in clinical trials, the relevant provisions of Regulation (EU) No 536/2014 of the European Parliament and of the Council (15) should apply.

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