interactive GDPR 2016/0679 EN

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Article 2

Material scope

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

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

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

(b)	by the Member states when carrying out activities which fall within the scope of Chapter 2 of Title V of the TEU;

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

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

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

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

Article 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 8

Conditions applicable to child's consent in relation to information_society_services

1. Where point (a) of Article 6(1) applies, in relation to the offer of information_society_services directly to a child, the processing of the personal_data of a child shall be lawful where the child is at least 16 years old. Where the child is below the age of 16 years, such processing shall be lawful only if and to the extent that consent is given or authorised by the holder of parental responsibility over the child.

Member states may provide by law for a lower age for those purposes provided that such lower age is not below 13 years.

2. The controller shall make reasonable efforts to verify in such cases that consent is given or authorised by the holder of parental responsibility over the child, taking into consideration available technology.

3. Paragraph 1 shall not affect the general contract law of Member states such as the rules on the validity, formation or effect of a contract in relation to a child.

Article 9

Processing of special categories of personal_data

1. Processing of personal_data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic_data, biometric_data for the purpose of uniquely identifying a natural person, data_concerning_health or data concerning a natural person's sex life or sexual orientation shall be prohibited.

2. Paragraph 1 shall not apply if one of the following applies:

(a)	the data subject has given explicit consent to the processing of those personal_data for one or more specified purposes, except where Union or Member State law provide that the prohibition referred to in paragraph 1 may not be lifted by the data subject;

(b)

processing is necessary for the purposes of carrying out the obligations and exercising specific rights of the controller or of the data subject in the field of employment and social security and social protection law in so far as it is authorised by Union or Member State law or a collective agreement pursuant to Member State law providing for appropriate safeguards for the fundamental rights and the interests of the data subject;

(c)	processing is necessary to protect the vital interests of the data subject or of another natural person where the data subject is physically or legally incapable of giving consent;

(d)

processing is carried out in the course of its legitimate activities with appropriate safeguards by a foundation, association or any other not-for-profit body with a political, philosophical, religious or trade union aim and on condition that the processing relates solely to the members or to former members of the body or to persons who have regular contact with it in connection with its purposes and that the personal_data are not disclosed outside that body without the consent of the data subjects;

(e)	processing relates to personal_data which are manifestly made public by the data subject;

(f)	processing is necessary for the establishment, exercise or defence of legal claims or whenever courts are acting in their judicial capacity;

(g)

processing is necessary for reasons of substantial public interest, on the basis of Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject;

(h)

processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3;

(i)

processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy;

(j)

processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

3. Personal data referred to in paragraph 1 may be processed for the purposes referred to in point (h) of paragraph 2 when those data are processed by or under the responsibility of a professional subject to the obligation of professional secrecy under Union or Member State law or rules established by national competent bodies or by another person also subject to an obligation of secrecy under Union or Member State law or rules established by national competent bodies.

4. Member states may maintain or introduce further conditions, including limitations, with regard to the processing of genetic_data, biometric_data or data_concerning_health.

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 35

Data protection impact assessment

1. Where a type of processing in particular using new technologies, and taking into account the nature, scope, context and purposes of the processing, is likely to result in a high risk to the rights and freedoms of natural persons, the controller shall, prior to the processing, carry out an assessment of the impact of the envisaged processing operations on the protection of personal_data. A single assessment may address a set of similar processing operations that present similar high risks.

2. The controller shall seek the advice of the data protection officer, where designated, when carrying out a data protection impact assessment.

3. A data protection impact assessment referred to in paragraph 1 shall in particular be required in the case of:

(a)	a systematic and extensive evaluation of personal aspects relating to natural persons which is based on automated processing, including profiling, and on which decisions are based that produce legal effects concerning the natural person or similarly significantly affect the natural person;

(b)	processing on a large scale of special categories of data referred to in Article 9(1), or of personal_data relating to criminal convictions and offences referred to in Article 10; or

(c)	a systematic monitoring of a publicly accessible area on a large scale.

4. The supervisory_authority shall establish and make public a list of the kind of processing operations which are subject to the requirement for a data protection impact assessment pursuant to paragraph 1. The supervisory_authority shall communicate those lists to the Board referred to in Article 68.

5. The supervisory_authority may also establish and make public a list of the kind of processing operations for which no data protection impact assessment is required. The supervisory_authority shall communicate those lists to the Board.

6. Prior to the adoption of the lists referred to in paragraphs 4 and 5, the competent supervisory_authority shall apply the consistency mechanism referred to in Article 63 where such lists involve processing activities which are related to the offering of goods or services to data subjects or to the monitoring of their behaviour in several Member states, or may substantially affect the free movement of personal_data within the Union.

7. The assessment shall contain at least:

(a)	a systematic description of the envisaged processing operations and the purposes of the processing, including, where applicable, the legitimate interest pursued by the controller;

(b)	an assessment of the necessity and proportionality of the processing operations in relation to the purposes;

(c)	an assessment of the risks to the rights and freedoms of data subjects referred to in paragraph 1; and

(d)	the measures envisaged to address the risks, including safeguards, security measures and mechanisms to ensure the protection of personal_data and to demonstrate compliance with this Regulation taking into account the rights and legitimate interests of data subjects and other persons concerned.

8. Compliance with approved codes of conduct referred to in Article 40 by the relevant controllers or processors shall be taken into due account in assessing the impact of the processing operations performed by such controllers or processors, in particular for the purposes of a data protection impact assessment.

9. Where appropriate, the controller shall seek the views of data subjects or their representatives on the intended processing, without prejudice to the protection of commercial or public interests or the security of processing operations.

10. Where processing pursuant to point (c) or (e) of Article 6(1) has a legal basis in Union law or in the law of the Member State to which the controller is subject, that law regulates the specific processing operation or set of operations in question, and a data protection impact assessment has already been carried out as part of a general impact assessment in the context of the adoption of that legal basis, paragraphs 1 to 7 shall not apply unless Member states deem it to be necessary to carry out such an assessment prior to processing activities.

11. Where necessary, the controller shall carry out a review to assess if processing is performed in accordance with the data protection impact assessment at least when there is a change of the risk represented by processing operations.

Article 36

Prior consultation

1. The controller shall consult the supervisory_authority prior to processing where a data protection impact assessment under Article 35 indicates that the processing would result in a high risk in the absence of measures taken by the controller to mitigate the risk.

2. Where the supervisory_authority is of the opinion that the intended processing referred to in paragraph 1 would infringe this Regulation, in particular where the controller has insufficiently identified or mitigated the risk, the supervisory_authority shall, within period of up to eight weeks of receipt of the request for consultation, provide written advice to the controller and, where applicable to the processor, and may use any of its powers referred to in Article 58. That period may be extended by six weeks, taking into account the complexity of the intended processing. The supervisory_authority shall inform the controller and, where applicable, the processor, of any such extension within one month of receipt of the request for consultation together with the reasons for the delay. Those periods may be suspended until the supervisory_authority has obtained information it has requested for the purposes of the consultation.

3. When consulting the supervisory_authority pursuant to paragraph 1, the controller shall provide the supervisory_authority with:

(a)	where applicable, the respective responsibilities of the controller, joint controllers and processors involved in the processing, in particular for processing within a group_of_undertakings;

(b)	the purposes and means of the intended processing;

(c)	the measures and safeguards provided to protect the rights and freedoms of data subjects pursuant to this Regulation;

(d)	where applicable, the contact details of the data protection officer;

(e)	the data protection impact assessment provided for in Article 35; and

(f)	any other information requested by the supervisory_authority.

4. Member states shall consult the supervisory_authority during the preparation of a proposal for a legislative measure to be adopted by a national parliament, or of a regulatory measure based on such a legislative measure, which relates to processing.

5. Notwithstanding paragraph 1, Member State law may require controllers to consult with, and obtain prior authorisation from, the supervisory_authority in relation to processing by a controller for the performance of a task carried out by the controller in the public interest, including processing in relation to social protection and public health.

Section 4

Data protection officer

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 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 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 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 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 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 80

Representation of data subjects

1. The data subject shall have the right to mandate a not-for-profit body, organisation or association which has been properly constituted in accordance with the law of a Member State, has statutory objectives which are in the public interest, and is active in the field of the protection of data subjects' rights and freedoms with regard to the protection of their personal_data to lodge the complaint on his or her behalf, to exercise the rights referred to in Articles 77, 78 and 79 on his or her behalf, and to exercise the right to receive compensation referred to in Article 82 on his or her behalf where provided for by Member State law.

2. Member states may provide that any body, organisation or association referred to in paragraph 1 of this Article, independently of a data subject's mandate, has the right to lodge, in that Member State, a complaint with the supervisory_authority which is competent pursuant to Article 77 and to exercise the rights referred to in Articles 78 and 79 if it considers that the rights of a data subject under this Regulation have been infringed as a result of the processing.

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 87

Processing of the national identification number

Member states may further determine the specific conditions for the processing of a national identification number or any other identifier of general application. In that case the national identification number or any other identifier of general application shall be used only under appropriate safeguards for the rights and freedoms of the data subject pursuant to this Regulation.

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 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 96

Relationship with previously concluded Agreements

International agreements involving the transfer of personal_data to third countries or international_organisations which were concluded by Member states prior to 24 May 2016, and which comply with Union law as applicable prior to that date, shall remain in force until amended, replaced or revoked.

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

(3) Directive 95/46/EC of the European Parliament and of the Council (4) seeks to harmonise the protection of fundamental rights and freedoms of natural persons in respect of processing activities and to ensure the free flow of personal_data between Member states.

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(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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(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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(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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(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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(11) Effective protection of personal_data throughout the Union requires the strengthening and setting out in detail of the rights of data subjects and the obligations of those who process and determine the processing of personal_data, as well as equivalent powers for monitoring and ensuring compliance with the rules for the protection of personal_data and equivalent sanctions for infringements in the Member states.

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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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(16) This Regulation does not apply to issues of protection of fundamental rights and freedoms or the free flow of personal_data related to activities which fall outside the scope of Union law, such as activities concerning national security.
This Regulation does not apply to the processing of personal_data by the Member states when carrying out activities in relation to the common foreign and security policy of the Union.

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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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(21) This Regulation is without prejudice to the application of Directive 2000/31/EC of the European Parliament and of the Council (8), in particular of the liability rules of intermediary service providers in Articles 12 to 15 of that Directive.
That Directive seeks to contribute to the proper functioning of the internal market by ensuring the free movement of information_society_services between Member states.

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(23) In order to ensure that natural persons are not deprived of the protection to which they are entitled under this Regulation, the processing of personal_data of data subjects who are in the Union by a controller or a processor not established in the Union should be subject to this Regulation where the processing activities are related to offering goods or services to such data subjects irrespective of whether connected to a payment.
In order to determine whether such a controller or processor is offering goods or services to data subjects who are in the Union, it should be ascertained whether it is apparent that the controller or processor envisages offering services to data subjects in one or more Member states in the Union.
Whereas the mere accessibility of the controller's, processor's or an intermediary's website in the Union, of an email address or of other contact details, or the use of a language generally used in the third country where the controller is established, is insufficient to ascertain such intention, factors such as the use of a language or a currency generally used in one or more Member states with the possibility of ordering goods and services in that other language, or the mentioning of customers or users who are in the Union, may make it apparent that the controller envisages offering goods or services to data subjects in the Union.

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(27) This Regulation does not apply to the personal_data of deceased persons.
Member states may provide for rules regarding the processing of personal_data of deceased persons.

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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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(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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(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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(93) In the context of the adoption of the Member State law on which the performance of the tasks of the public authority or public body is based and which regulates the specific processing operation or set of operations in question, Member states may deem it necessary to carry out such assessment prior to the processing activities.

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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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(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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(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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(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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(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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(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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(131) Where another supervisory_authority should act as a lead supervisory_authority for the processing activities of the controller or processor but the concrete subject matter of a complaint or the possible infringement concerns only processing activities of the controller or processor in the Member State where the complaint has been lodged or the possible infringement detected and the matter does not substantially affect or is not likely to substantially affect data subjects in other Member states, the supervisory_authority receiving a complaint or detecting or being informed otherwise of situations that entail possible infringements of this Regulation should seek an amicable settlement with the controller and, if this proves unsuccessful, exercise its full range of powers.
This should include: specific processing carried out in the territory of the Member State of the supervisory_authority or with regard to data subjects on the territory of that Member State; processing that is carried out in the context of an offer of goods or services specifically aimed at data subjects in the territory of the Member State of the supervisory_authority; or processing that has to be assessed taking into account relevant legal obligations under Member State law.

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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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(145) For proceedings against a controller or processor, the plaintiff should have the choice to bring the action before the courts of the Member states where the controller or processor has an establishment or where the data subject resides, unless the controller is a public authority of a Member State acting in the exercise of its public powers.

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(149) Member states should be able to lay down the rules on criminal penalties for infringements of this Regulation, including for infringements of national rules adopted pursuant to and within the limits of this Regulation.
Those criminal penalties may also allow for the deprivation of the profits obtained through infringements of this Regulation.
However, the imposition of criminal penalties for infringements of such national rules and of administrative penalties should not lead to a breach of the principle of ne bis in idem, as interpreted by the Court of Justice.

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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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(152) Where this Regulation does not harmonise administrative penalties or where necessary in other cases, for example in cases of serious infringements of this Regulation, Member states should implement a system which provides for effective, proportionate and dissuasive penalties.
The nature of such penalties, criminal or administrative, should be determined by Member State law.

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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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(156) The processing of personal_data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes should be subject to appropriate safeguards for the rights and freedoms of the data subject pursuant to this Regulation.
Those safeguards should ensure that technical and organisational measures are in place in order to ensure, in particular, the principle of data minimisation.
The further processing of personal_data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes is to be carried out when the controller has assessed the feasibility to fulfil those purposes by processing data which do not permit or no longer permit the identification of data subjects, provided that appropriate safeguards exist (such as, for instance, pseudonymisation of the data).
Member states should provide for appropriate safeguards for the processing of personal_data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes.
Member states should be authorised to provide, under specific conditions and subject to appropriate safeguards for data subjects, specifications and derogations with regard to the information requirements and rights to rectification, to erasure, to be forgotten, to restriction of processing, to data portability, and to object when processing personal_data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes.
The conditions and safeguards in question may entail specific procedures for data subjects to exercise those rights if this is appropriate in the light of the purposes sought by the specific processing along with technical and organisational measures aimed at minimising the processing of personal_data in pursuance of the proportionality and necessity principles.
The processing of personal_data for scientific purposes should also comply with other relevant legislation such as on clinical trials.

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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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(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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(165) This Regulation respects and does not prejudice the status under existing constitutional law of churches and religious associations or communities in the Member states, as recognised in Article 17 TFEU.

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(170) Since the objective of this Regulation, namely to ensure an equivalent level of protection of natural persons and the free flow of personal_data throughout the Union, cannot be sufficiently achieved by the Member states and can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU).
In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

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