REGULATION (EU) 2018/1725 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 23 October 2018

on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 16(2) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1) The protection of natural persons in relation to the processing of personal data is a fundamental right. Article 8(1) of the Charter of Fundamental Rights of the European Union (the ‘Charter’) and Article 16(1) of the Treaty on the Functioning of the European Union (TFEU) provide that everyone has the right to the protection of personal data concerning him or her. This right is also guaranteed under Article 8 of the European Convention for the Protection of Human Rights and Fundamental Freedoms.

(2) Regulation (EC) No 45/2001 of the European Parliament and of the Council (3) provides natural persons with legally enforceable rights, specifies the data processing obligations of controllers within the Community institutions and bodies, and creates an independent supervisory authority, the European Data Protection Supervisor, responsible for monitoring the processing of personal data by the Union institutions and bodies. However, it does not apply to the processing of personal data in the course of an activity of Union institutions and bodies which fall outside the scope of Union law.

(3) Regulation (EU) 2016/679 of the European Parliament and of the Council (4) and Directive (EU) 2016/680 of the European Parliament and of the Council (5) were adopted on 27 April 2016. While the Regulation lays down general rules to protect natural persons with regard to the processing of personal data and to ensure the free movement of personal data within the Union, the Directive lays down the specific rules to protect natural persons with regard to the processing of personal data and to ensure the free movement of personal data within the Union in the fields of judicial cooperation in criminal matters and police cooperation.

(4) Regulation (EU) 2016/679 provides for the adaptation of Regulation (EC) No 45/2001 in order to ensure a strong and coherent data protection framework in the Union and to allow its application in parallel with Regulation (EU) 2016/679.

(5) It is in the interest of a coherent approach to personal data protection throughout the Union, and of the free movement of personal data within the Union, to align as far as possible the data protection rules for Union institutions, bodies, offices and agencies with the data protection rules adopted for the public sector in the Member States. Whenever the provisions of this Regulation follow the same principles as the provisions of Regulation (EU) 2016/679, those two sets of provisions should, under the case law of the Court of Justice of the European Union (the ‘Court of Justice’), be interpreted homogeneously, in particular because the scheme of this Regulation should be understood as equivalent to the scheme of Regulation (EU) 2016/679.

(6) Persons whose personal data are processed by Union institutions and bodies in any context whatsoever, for example, because they are employed by those institutions and bodies, should be protected. This Regulation should not apply to the processing of personal data of deceased persons. This Regulation does not cover the processing of personal data which concerns legal persons and in particular undertakings established as legal persons, including the name and the form of the legal person and the contact details of the legal person.

(7) In order to prevent creating a serious risk of circumvention, the protection of natural persons should be technologically neutral and should not depend on the techniques used.

(8) This Regulation should apply to the processing of personal data by all Union institutions, bodies, offices and agencies. It should apply 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. Files or sets of files, as well as their cover pages, which are not structured according to specific criteria should not fall within the scope of this Regulation.

(9) In Declaration No 21 on the protection of personal data in the fields of judicial cooperation in criminal matters and police cooperation, annexed to the final act of the intergovernmental conference which adopted the Treaty of Lisbon, the conference acknowledged that specific rules on the protection of personal data and on the free movement of personal data in the fields of judicial cooperation in criminal matters and police cooperation based on Article 16 TFEU could prove necessary because of the specific nature of those fields. A distinct Chapter of this Regulation containing general rules should therefore apply to the processing of operational personal data, such as personal data processed for the purposes of a criminal investigation by Union bodies, offices or agencies when carrying out activities in the fields of judicial cooperation in criminal matters and police cooperation.

(10) Directive (EU) 2016/680 sets out harmonised rules for the protection and the free movement of personal data processed for the purposes of the prevention, investigation, detection or prosecution of criminal offences or execution of criminal penalties, including the safeguarding against and the prevention of threats to public security. In order to ensure the same level of protection for natural persons through legally enforceable rights throughout the Union and to prevent divergences hampering the exchange of personal data between Union bodies, offices or agencies when carrying out activities which fall within the scope of Chapter 4 or Chapter 5 of Title V of Part Three TFEU and competent authorities, the rules for the protection and the free movement of operational personal data processed by such Union bodies, offices or agencies should be consistent with Directive (EU) 2016/680.

(11) The general rules of the Chapter of this Regulation on the processing of operational personal data should apply without prejudice to the specific rules applicable to the processing of operational personal data by Union bodies, offices and agencies when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of Title V of Part Three TFEU. Such specific rules should be regarded as lex specialis to the provisions in the Chapter of this Regulation on the processing of operational personal data (lex specialis derogat legi generali). In order to reduce legal fragmentation, specific data protection rules applicable to the processing of operational personal data by Union bodies, offices or agencies when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of Title V of Part Three TFEU should be consistent with the principles underpinning the Chapter of this Regulation on the processing of operational personal data, as well as with the provisions of this Regulation relating to independent supervision, remedies, liability and penalties.

(12) The Chapter of this Regulation on the processing of operational personal data should apply to Union bodies, offices and agencies when carrying out activities which fall within the scope of Chapter 4 or Chapter 5 of Title V of Part Three TFEU, whether they exercise such activities as their main or ancillary tasks, for the purposes of the prevention, detection, investigation or prosecution of criminal offences. However, it should not apply to Europol or to the European Public Prosecutor’s Office until the legal acts establishing Europol and the European Public Prosecutor’s Office are amended with a view to rendering the Chapter of this Regulation on the processing of operational personal data, as adapted, applicable to them.

(13) The Commission should conduct a review of this Regulation, in particular the Chapter of this Regulation on the processing of operational personal data. The Commission should also conduct a review of other legal acts adopted on the basis of the Treaties which regulate the processing of operational personal data by Union bodies, offices or agencies when carrying out activities which fall within the scope of Chapter 4 or Chapter 5 of Title V of Part Three TFEU. After such a review, in order to ensure uniform and consistent protection of natural persons with regard to the processing of personal data, the Commission should be able to make any appropriate legislative proposals, including any necessary adaptations of the Chapter of this Regulation on the processing of operational personal data, with a view to applying it to Europol and to the European Public Prosecutor’s Office. The adaptations should take into account provisions relating to independent supervision, remedies, liability and penalties.

(14) The processing of administrative personal data, such as staff data, by Union bodies, offices or agencies carrying out activities which fall within the scope of Chapter 4 or Chapter 5 of Title V of Part Three TFEU should be covered by this Regulation.

(15) This Regulation should apply to the processing of personal data by Union institutions, bodies, offices or agencies carrying out activities which fall within the scope of Chapter 2 of Title V of the Treaty on European Union (TEU). This Regulation should not apply to the processing of personal data by missions referred to in Articles 42(1), 43 and 44 TEU, which implement the common security and defence policy. Where appropriate, relevant proposals should be put forward to further regulate the processing of personal data in the field of the common security and defence policy.

(16) The principles of data protection should apply to any information concerning an identified or identifiable natural person. Personal data which have undergone pseudonymisation, which could be attributed to a natural person by the use of additional information, should be considered to be information on an identifiable natural person. To determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used, such as singling out, either by the controller or by another person, to identify the natural person directly or indirectly. To ascertain whether means are reasonably likely to be used to identify the natural person, account should be taken of all objective factors, such as the costs of and the amount of time required for identification, taking into consideration the available technology at the time of the processing and technological developments. The principles of data protection should therefore not apply to anonymous information, namely information which does not relate to an identified or identifiable natural person or to personal data rendered anonymous in such a manner that the data subject is not or no longer identifiable. This Regulation does not therefore concern the processing of such anonymous information, including for statistical or research purposes.

(17) The application of pseudonymisation to personal data can reduce the risks to the data subjects concerned and help controllers and processors to meet their data protection obligations. The explicit introduction of ‘pseudonymisation’ in this Regulation is not intended to preclude any other measures of data protection.

(18) Natural persons may be associated with online identifiers provided by their devices, applications, tools and protocols, such as internet protocol addresses, cookie identifiers or other identifiers such as radio frequency identification tags. This may leave traces which, in particular when combined with unique identifiers and other information received by the servers, may be used to create profiles of the natural persons and identify them.

(19) Consent should be given by a clear affirmative act establishing a freely given, specific, informed and unambiguous indication of the data subject’s agreement to the processing of personal data relating to him or her, such as by a written statement, including by electronic means, or an oral statement. This could include ticking a box when visiting an internet website, choosing technical settings for information society services or another statement or conduct which clearly indicates in this context the data subject’s acceptance of the proposed processing of his or her personal data. Silence, pre-ticked boxes or inactivity should not therefore constitute consent. Consent should cover all processing activities carried out for the same purpose or purposes. When the processing has multiple purposes, consent should be given for all of them. If the data subject’s consent is to be given following a request by electronic means, the request must be clear, concise and not unnecessarily disruptive to the use of the service for which it is provided. At the same time, the data subject should have the right to withdraw consent at any time without affecting the lawfulness of processing based on consent before its withdrawal. In order to ensure that consent is freely given, consent should not provide a valid legal ground for the processing of personal data in a specific case where there is a clear imbalance between the data subject and the controller and it is therefore unlikely that consent was freely given in all the circumstances of that specific situation. It is often not possible to fully identify the purpose of personal data processing for scientific research purposes at the time of data collection. Therefore, data subjects should be allowed to give their consent to certain areas of scientific research when in keeping with recognised ethical standards for scientific research. Data subjects should have an opportunity to give their consent only to certain areas of research or parts of research projects to the extent allowed by the intended purpose.

(20) Any processing of personal data should be lawful and fair. It should be transparent to natural persons that personal data concerning them are collected, used, consulted or otherwise processed and to what extent the personal data are or will be processed. The principle of transparency requires that any information and communication relating to the processing of those personal data be easily accessible and easy to understand, and that clear and plain language be used. That principle concerns, in particular, information to the data subjects on the identity of the controller and the purposes of the processing and further information to ensure fair and transparent processing in respect of the natural persons concerned and their right to obtain confirmation and communication of personal data concerning them which are being processed. Natural persons should be made aware of risks, rules, safeguards and rights in relation to the processing of personal data and how to exercise their rights in relation to such processing. In particular, the specific purposes for which personal data are processed should be explicit and legitimate and determined at the time of the collection of the personal data. The personal data should be adequate, relevant and limited to what is necessary for the purposes for which they are processed. This requires, in particular, ensuring that the period for which the personal data are stored is limited to a strict minimum. Personal data should be processed only if the purpose of the processing could not reasonably be fulfilled by other means. In order to ensure that the personal data are not kept longer than necessary, time limits should be established by the controller for erasure or for a periodic review. Every reasonable step should be taken to ensure that personal data which are inaccurate are rectified or deleted. Personal data should be processed in a manner that ensures appropriate security and confidentiality of the personal data, including for preventing unauthorised access to or use of personal data and the equipment used for the processing and for preventing its unauthorised disclosure when it is transmitted.

(21) In accordance with the principle of accountability, where Union institutions and bodies transmit personal data within the same Union institution or body and the recipient is not part of the controller, or to other Union institutions or bodies, they should verify whether such personal data are required for the legitimate performance of tasks within the competence of the recipient. In particular, following a recipient’s request for transmission of personal data, the controller should verify the existence of a relevant ground for lawfully processing personal data and the competence of the recipient. The controller should also make a provisional evaluation of the necessity of the transmission of the data. If doubts arise as to this necessity, the controller should seek further information from the recipient. The recipient should ensure that the necessity of the transmission of the data can be subsequently verified.

(22) In order for processing to be lawful, personal data should be processed on the basis of the necessity for the performance of a task carried out in the public interest by Union institutions and bodies or in the exercise of their official authority, the necessity for compliance with a legal obligation to which the controller is subject or some other legitimate basis under this Regulation, including the consent of the data subject concerned, the necessity 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. Processing of personal data for the performance of tasks carried out in the public interest by the Union institutions and bodies includes the processing of personal data necessary for the management and functioning of those institutions and bodies. The processing of personal data should also be regarded to be lawful where it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person. Processing of personal data based on the vital interest of another natural person should in principle take place only where the processing cannot be manifestly based on another legal basis. Some types of processing may serve both important grounds of public interest and the vital interests of the data subject, as for instance when processing is necessary for humanitarian purposes, including for monitoring epidemics and their spread, or in situations of humanitarian emergencies, in particular in situations of natural and man-made disasters.

(23) The Union law referred to in this Regulation should be clear and precise and its application should be foreseeable to persons subject to it, in accordance with the requirements set out in the Charter and the European Convention for the Protection of Human Rights and Fundamental Freedoms.

(24) The internal rules referred to in this Regulation should be clear and precise acts of general application intended to produce legal effects vis-à-vis data subjects. They should be adopted at the highest level of management of the Union institutions and bodies, within their competencies and in matters relating to their operation. They should be published in the Official Journal of the European Union. The application of those rules should be foreseeable to persons subject to them in accordance with the requirements set out in the Charter and the European Convention for the Protection of Human Rights and Freedoms. Internal rules may take the form of decisions, in particular when adopted by Union institutions.

(25) The processing of personal data for purposes other than those for which the personal data were initially collected should be allowed only where the processing is compatible with the purposes for which the personal data were initially collected. In such a case, no legal basis separate from that which allowed the collection of the personal data is required. If the 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, Union law may determine and specify the tasks and purposes for which the further processing should be regarded as compatible and lawful. Further processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes should be considered to be compatible lawful processing operations. The legal basis provided by Union law for the processing of personal data may also provide a legal basis for further processing. In order to ascertain whether a purpose of further processing is compatible with the purpose for which the personal data are initially collected, the controller, after having met all the requirements for the lawfulness of the original processing, should take into account, inter alia: any link between those purposes and the purposes of the intended further processing; the context in which the personal data have been collected, in particular the reasonable expectations of data subjects based on their relationship with the controller as to their further use; the nature of the personal data; the consequences of the intended further processing for data subjects; and the existence of appropriate safeguards in both the original and intended further processing operations.

(26) Where processing is based on the data subject’s consent, the controller should be able to demonstrate that the data subject has given consent to the processing operation. In particular in the context of a written declaration on another matter, safeguards should ensure that the data subject is aware of the fact that and the extent to which consent is given. In accordance with Council Directive 93/13/EEC (6), a declaration of consent pre-formulated by the controller should be provided in an intelligible and easily accessible form, using clear and plain language and it should not contain unfair terms. For consent to be informed, the data subject should be aware at least of the identity of the controller and the purposes of the processing for which the personal data are intended. Consent should not be regarded as freely given if the data subject has no genuine or free choice or is unable to refuse or withdraw consent without detriment.

(27) Children merit specific protection with regard to their personal data, as they may be less aware of the risks, consequences and safeguards concerned and their rights in relation to the processing of personal data. Such specific protection should, in particular, apply to creating personality profiles and to the collection of personal data with regard to children when services are offered directly to a child on websites of Union institutions and bodies, such as interpersonal communication services or online selling of tickets, and the processing of personal data is based on consent.

(28) When recipients established in the Union other than Union institutions and bodies would like to have personal data transmitted to them by Union institutions and bodies, those recipients should demonstrate that it is necessary to have the data transmitted to these recipients either for the performance of their task carried out in the public interest or in the exercise of official authority vested in them. Alternatively, those recipients should demonstrate that the transmission is necessary for a specific purpose in the public interest and the controller should establish whether there is any reason to assume that the data subject’s legitimate interests might be prejudiced. In such cases, the controller should demonstrably weigh the various competing interests in order to assess the proportionality of the requested transmission of personal data. The specific purpose in the public interest could relate to the transparency of Union institutions and bodies. Furthermore, Union institutions and bodies should demonstrate such necessity when they themselves initiate a transmission, in compliance with the principle of transparency and good administration. The requirements laid down in this Regulation for transmissions to recipients established in the Union other than Union institutions and bodies should be understood as supplementary to the conditions for lawful processing.

(29) 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. Such personal data should not be processed unless the specific conditions set out in this Regulation are met. 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. In addition to the specific requirements for processing of sensitive data, 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.

(30) 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. 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 law should provide for specific and suitable measures so as to protect fundamental rights and the personal data of natural persons.

(31) The processing of special categories of personal data may be necessary for reasons of public interest in the areas of public health without consent of the data subject. Such processing should be subject to suitable and specific measures so as to protect the rights and freedoms of natural persons. In that context, ‘public health’ should be interpreted as defined in Regulation (EC) No 1338/2008 of the European Parliament and of the Council (7), namely all elements related to health, namely health status, including morbidity and disability, the determinants having an effect on that health status, healthcare needs, resources allocated to healthcare, the provision of, and universal access to, healthcare as well as healthcare expenditure and financing, and the causes of mortality. Such processing of data concerning health for reasons of public interest should not result in personal data being processed for other purposes.

(32) If the personal data processed by a controller do not permit the controller to identify a natural person, the data controller should not be obliged to acquire additional information in order to identify the data subject for the sole purpose of complying with any provision of this Regulation. However, the controller should not refuse to take additional information provided by the data subject in order to support the exercise of his or her rights. Identification should include the digital identification of a data subject, for example through an authentication mechanism such as the same credentials, used by the data subject to log in to the online service offered by the data controller.

(33) 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). Union institutions and bodies 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 in Union law, which may include internal rules adopted by Union institutions and bodies in matters relating to their operation.

(34) Modalities should be provided for facilitating the exercise of the data subject’s rights under this Regulation, including mechanisms to request and, if applicable, obtain, free of charge, in particular, access to and rectification or erasure of personal data and the exercise of the right to object. The controller should also provide means for requests to be made electronically, especially where personal data are processed by electronic means. The controller should be obliged to respond to requests from the data subject without undue delay and at the latest within one month and to give reasons where the controller does not intend to comply with any such requests.

(35) The principles of fair and transparent processing require that the data subject be informed of the existence of the processing operation and its purposes. The controller should provide the data subject with any further information necessary to ensure fair and transparent processing taking into account the specific circumstances and context in which the personal data are processed. Furthermore, the data subject should be informed of the existence of profiling and the consequences of such profiling. Where the personal data are collected from the data subject, the data subject should also be informed whether he or she is obliged to provide the personal data and of the consequences, where he or she does not provide such data. That information may be provided in combination with standardised icons in order to give in an easily visible, intelligible and clearly legible manner, a meaningful overview of the intended processing. Where the icons are presented electronically, they should be machine-readable.

(36) The information in relation to the processing of personal data relating to the data subject should be given to him or her at the time of collection from the data subject, or, where the personal data are obtained from another source, within a reasonable period, depending on the circumstances of the case. Where personal data can be legitimately disclosed to another recipient, the data subject should be informed when the personal data are first disclosed to the recipient. Where the controller intends to process the personal data for a purpose other than that for which they were collected, the controller should provide the data subject prior to that further processing with information on that other purpose and other necessary information. Where the origin of the personal data cannot be provided to the data subject because various sources have been used, general information should be provided.

(37) A data subject should have the right of access to personal data which have been collected concerning him or her, and to exercise that right easily and at reasonable intervals, in order to be aware of, and verify, the lawfulness of the processing. This includes the right for data subjects to have access to data concerning their health, for example the data in their medical records containing information such as diagnoses, examination results, assessments by treating physicians and any treatment or interventions provided. Every data subject should therefore have the right to know and obtain communication in particular with regard to the purposes for which the personal data are processed, where possible the period for which the personal data are processed, the recipients of the personal data, the logic involved in any automatic personal data processing and, at least when based on profiling, the consequences of such processing. That right should not adversely affect the rights or freedoms of others, including trade secrets or intellectual property and in particular the copyright protecting the software. However, the result of those considerations should not be a refusal to provide all information to the data subject. Where the controller processes a large quantity of information concerning the data subject, the controller should be able to request that, before the information is delivered, the data subject specify the information or processing activities to which the request relates.

(38) A data subject should have the right to have personal data concerning him or her rectified and a ‘right to be forgotten’ where the retention of such data infringes this Regulation or Union law to which the controller is subject. A data subject should have the right to have his or her personal data erased and no longer processed where the personal data are no longer necessary in relation to the purposes for which they are collected or otherwise processed, where a data subject has withdrawn his or her consent or objects to the processing of personal data concerning him or her, or where the processing of his or her personal data does not otherwise comply with this Regulation. That right is relevant in particular where the data subject has given his or her consent as a child and is not fully aware of the risks involved by the processing, and later wants to remove such personal data, especially on the internet. The data subject should be able to exercise that right notwithstanding the fact that he or she is no longer a child. However, the further retention of the personal data should be lawful where it is necessary, for exercising the right of freedom of expression and information, 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, on the grounds of public interest in the area of public health, for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes, or for the establishment, exercise or defence of legal claims.

(39) To strengthen the right to be forgotten in the online environment, the right to erasure should also be extended in such a way that a controller who has made the personal data public should be obliged to inform the controllers which are processing such personal data to erase any links to, or copies or replications of those personal data. In doing so, that controller should take reasonable steps, taking into account available technology and the means available to the controller, including technical measures, to inform the controllers which are processing the personal data of the data subject’s request.

(40) Methods by which to restrict the processing of personal data could include, inter alia, temporarily moving the selected data to another processing system, making the selected personal data unavailable to users, or temporarily removing published data from a website. In automated filing systems, the restriction of processing should in principle be ensured by technical means in such a manner that the personal data are not subject to further processing operations and cannot be changed. The fact that the processing of personal data is restricted should be clearly indicated in the system.

(41) To further strengthen the control over his or her own data, where the processing of personal data is carried out by automated means, the data subject should also be allowed to receive personal data concerning him or her which he or she has provided to a controller in a structured, commonly used, machine-readable and interoperable format, and to transmit it to another controller. Data controllers should be encouraged to develop interoperable formats that enable data portability. That right should apply where the data subject provided the personal data on the basis of his or her consent or the processing is necessary for the performance of a contract. It should therefore not apply where the processing of the personal data is necessary for compliance with a legal obligation to which the controller is subject or for the performance of a task carried out in the public interest or in the exercise of an official authority vested in the controller. The data subject’s right to transmit or receive personal data concerning him or her should not create an obligation for the controllers to adopt or maintain processing systems which are technically compatible. Where, in a certain set of personal data, more than one data subject is concerned, the right to receive the personal data should be without prejudice to the rights and freedoms of other data subjects in accordance with this Regulation. Furthermore, that right should not prejudice the right of the data subject to obtain the erasure of personal data and the limitations of that right as set out in this Regulation and should, in particular, not imply the erasure of personal data concerning the data subject which have been provided by him or her for the performance of a contract to the extent that and for as long as the personal data are necessary for the performance of that contract. Where technically feasible, the data subject should have the right to have the personal data transmitted directly from one controller to another.

(42) Where personal data might lawfully be processed because 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, a data subject should, nevertheless, be entitled to object to the processing of any personal data relating to his or her particular situation. It should be for the controller to demonstrate that its compelling legitimate interest overrides the interests or the fundamental rights and freedoms of the data subject.

(43) The data subject should have the right not to be subject to a decision, which may include a measure, evaluating personal aspects relating to him or her which is based solely on automated processing and which produces legal effects concerning him or her or similarly significantly affects him or her, such as e-recruiting practices without any human intervention. Such processing includes ‘profiling’ that consists of any form of automated processing of personal data evaluating the personal aspects relating to a natural person, in particular to analyse or predict aspects concerning the data subject’s performance at work, economic situation, health, personal preferences or interests, reliability or behaviour, location or movements, where it produces legal effects concerning him or her or similarly significantly affects him or her. However, decision-making based on such processing, including profiling, should be allowed where expressly authorised by Union law. In any case, such processing should be subject to suitable safeguards, which should include specific information to the data subject and the right to obtain human intervention, to express his or her point of view, to obtain an explanation of the decision reached after such assessment and to challenge the decision. Such measure should not concern a child. In order to ensure fair and transparent processing in respect of the data subject, taking into account the specific circumstances and context in which the personal data are processed, the controller should use appropriate mathematical or statistical procedures for the profiling, implement technical and organisational measures appropriate to ensure, in particular, that factors which result in inaccuracies in personal data are corrected and the risk of errors is minimised, secure personal data in a manner that takes account of the potential risks involved for the interests and rights of the data subject. and prevent, inter alia, discriminatory effects on natural persons on the basis of racial or ethnic origin, political opinion, religion or beliefs, trade union membership, genetic or health status or sexual orientation, or processing that results in measures having such an effect. Automated decision-making and profiling based on special categories of personal data should be allowed only under specific conditions.

(44) Legal acts adopted on the basis of the Treaties or internal rules adopted by Union institutions and bodies in matters relating to their operation may impose restrictions concerning specific principles and the rights of information, access to and rectification or erasure of personal data, the right to data portability, confidentiality of electronic communications data as well as the communication of a personal data breach to a data subject and certain related obligations of the controllers, as far as necessary and proportionate in a democratic society to safeguard public security and for the prevention, investigation and prosecution of criminal offences or the execution of criminal penalties. This includes safeguarding against and the prevention of threats to public security, protection of human life especially in response to natural or manmade disasters, internal security of Union institutions and bodies, other important objectives of general public interest of the Union or of a Member State, in particular the objectives of the Common Foreign and Security Policy of the Union or an important economic or financial interest of the Union or of a Member State, and keeping of public registers for reasons of general public interest or the protection of the data subject or the rights and freedoms of others, including social protection, public health and humanitarian purposes.

(45) The responsibility and liability of the controller for any processing of personal data carried out by the controller or on the controller’s behalf should be established. In particular, the controller should be obliged to implement appropriate and effective measures and be able to demonstrate the compliance of processing activities with this Regulation, including the effectiveness of the measures. Those measures should take into account the nature, scope, context and purposes of the processing and the risk to the rights and freedoms of natural persons.

(46) The risk to the rights and freedoms of natural persons, of varying likelihood and severity, may result from personal data processing which could lead to physical, material or non-material damage, in particular: where the processing may give rise to discrimination, identity theft or fraud, financial loss, damage to the reputation, loss of confidentiality of personal data protected by professional secrecy, unauthorised reversal of pseudonymisation, or any other significant economic or social disadvantage; where data subjects might be deprived of their rights and freedoms or prevented from exercising control over their personal data; where personal data are processed which reveal racial or ethnic origin, political opinions, religion or philosophical beliefs, trade union membership, and the processing of genetic data, data concerning health or data concerning sex life or criminal convictions and offences or related security measures; where personal aspects are evaluated, in particular analysing or predicting aspects concerning performance at work, economic situation, health, personal preferences or interests, reliability or behaviour, location or movements, in order to create or use personal profiles; where personal data of vulnerable natural persons, in particular of children, are processed; or where processing involves a large amount of personal data and affects a large number of data subjects.

(47) The likelihood and severity of the risk to the rights and freedoms of the data subject should be determined by reference to the nature, scope, context and purposes of the processing. Risk should be evaluated on the basis of an objective assessment, by which it is established whether data processing operations involve a risk or a high risk.

(48) The protection of the rights and freedoms of natural persons with regard to the processing of personal data require that appropriate technical and organisational measures be taken to ensure that the requirements of this Regulation are met. In order to be able to demonstrate compliance with this Regulation, the controller should adopt internal policies and implement measures which meet in particular the principles of data protection by design and data protection by default. Such measures could consist, inter alia, of minimising the processing of personal data, pseudonymising personal data as soon as possible, transparency with regard to the functions and processing of personal data, enabling the data subject to monitor the data processing, enabling the controller to create and improve security features. The principles of data protection by design and by default should also be taken into consideration in the context of public tenders.

(49) Regulation (EU) 2016/679 provides for controllers to demonstrate compliance by adherence to approved certification mechanisms. Likewise, Union institutions and bodies should be able to demonstrate compliance with this Regulation by obtaining certification in accordance with Article 42 of Regulation (EU) 2016/679.

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

(51) To ensure compliance with the requirements of this Regulation in respect of the processing to be carried out by the processor on behalf of the controller, when entrusting a processor with processing activities, the controller should use only processors providing sufficient guarantees, in particular in terms of expert knowledge, reliability and resources, to implement technical and organisational measures which meet the requirements of this Regulation, including for the security of processing. The adherence of processors other than Union institutions and bodies to an approved code of conduct or an approved certification mechanism can be used as an element to demonstrate compliance with the obligations of the controller. The carrying-out of processing by a processor other than a Union institution or body should be governed by a contract, or, in case of Union institutions and bodies acting as processors, by a contract or other legal act under Union law, binding the processor to the controller, setting out the subject matter and duration of the processing, the nature and purposes of the processing, the type of personal data and categories of data subjects, taking into account the specific tasks and responsibilities of the processor in the context of the processing to be carried out and the risk to the rights and freedoms of the data subject. The controller and processor should be able to choose to use an individual contract or standard contractual clauses which are adopted either directly by the Commission or by the European Data Protection Supervisor and then adopted by the Commission. After the completion of the processing on behalf of the controller, the processor should, at the choice of the controller, return or delete the personal data, unless there is a requirement to store that personal data under Union or Member State law to which the processor is subject.

(52) In order to demonstrate compliance with this Regulation, controllers should maintain records of processing activities under their responsibility and processors should maintain records of categories of processing activities under their responsibility. Union institutions and bodies should be obliged to cooperate with the European Data Protection Supervisor and make their records available to it on request, so that they might serve for monitoring those processing operations. Unless it is not appropriate taking into account the size of a Union institution or body, Union institutions and bodies should be able to establish a central register of records of their processing activities. For reasons of transparency, they should also be able to make such a register public.

(53) In order to maintain security and to prevent processing in infringement of this Regulation, the controller or processor should evaluate the risks inherent in the processing and implement measures to mitigate those risks, such as encryption. Those measures should ensure an appropriate level of security, including confidentiality, taking into account the state of the art and the costs of implementation in relation to the risks and the nature of the personal data to be protected. In assessing data security risk, consideration should be given to the risks that are presented by personal data processing, such as accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed which may in particular lead to physical, material or non-material damage.

(54) Union institutions and bodies should ensure the confidentiality of electronic communications provided for by Article 7 of the Charter. In particular, Union institutions and bodies should ensure the security of their electronic communications networks. They should protect the information related to the terminal equipment of users accessing their publicly available websites and mobile applications, in accordance with the Directive 2002/58/EC of the European Parliament and of the Council (8). They should also protect the personal data stored in directories of users.

(55) A personal data breach could, if not addressed in an appropriate and timely manner, result in physical, material or non-material damage to natural persons. Therefore, as soon as the controller becomes aware that a personal data breach has occurred, the controller should notify that personal data breach to the European Data Protection Supervisor without undue delay and, where feasible, not later than 72 hours after having become aware of it, unless the controller is able to demonstrate, in accordance with the accountability principle, that the personal data breach is unlikely to result in a risk to the rights and freedoms of natural persons. Where such notification cannot be achieved within 72 hours, it should be accompanied by the reasons for the delay and information can be provided in phases without further undue delay. Where such delay is justified, less sensitive or less specific information on the breach should be released as early as possible, rather than fully resolving the underlying incident before notifying.

(56) The controller should communicate to the data subject a personal data breach, without undue delay, where that personal data breach is likely to result in a high risk to the rights and freedoms of the natural person in order to allow him or her to take the necessary precautions. The communication should describe the nature of the personal data breach as well as recommendations for the natural person concerned to mitigate potential adverse effects. Such communications to data subjects should be made as soon as reasonably feasible and in close cooperation with the European Data Protection Supervisor, respecting guidance provided by it or by other relevant authorities such as law-enforcement authorities.

(57) Regulation (EC) No 45/2001 provides for a general obligation on a controller to notify the processing of personal data to the data protection officer. Unless it is not appropriate taking into account the size of the Union institution or body, the data protection officer is to keep a register of notified processing operations. Besides this general obligation, effective procedures and mechanisms should be put in place to monitor processing operations that are likely to result in a high risk to the rights and freedoms of natural persons by virtue of their nature, scope, context and purposes. Such procedures should, in particular, also be in place where types of processing operations involve using new technologies, or are of a new kind in relation to which no data protection impact assessment has been carried out before by the controller, or where they become necessary in the light of the time that has elapsed since the initial processing. In such cases, a data protection impact assessment should be carried out by the controller prior to the processing in order to assess the particular likelihood and severity of the high risk, taking into account the nature, scope, context and purposes of the processing and the sources of the risk. That impact assessment should include, in particular, the measures, safeguards and mechanisms envisaged for mitigating that risk, ensuring the protection of personal data and demonstrating compliance with this Regulation.

(58) Where a data protection impact assessment indicates that the processing would, in the absence of safeguards, security measures and mechanisms to mitigate the risk, result in a high risk to the rights and freedoms of natural persons and the controller is of the opinion that the risk cannot be mitigated by reasonable means in terms of available technologies and costs of implementation, the European Data Protection Supervisor should be consulted prior to the start of processing activities. Such high risk is likely to result from certain types of processing and the extent and frequency of processing, which could result also in a realisation of damage or interference with the rights and freedoms of the natural person. The European Data Protection Supervisor should respond to the request for consultation within a specified period. However, the absence of a reaction of the European Data Protection Supervisor within that period should be without prejudice to any intervention of the European Data Protection Supervisor in accordance with his or her tasks and powers laid down in this Regulation, including the power to prohibit processing operations. As part of that consultation process, it should be possible to submit the outcome of a data protection impact assessment carried out with regard to the processing at issue to the European Data Protection Supervisor, in particular the measures envisaged to mitigate the risk to the rights and freedoms of natural persons.

(59) The European Data Protection Supervisor should be informed of administrative measures and consulted on internal rules adopted by Union institutions and bodies in matters relating to their operation when they provide for the processing of personal data, lay down conditions for restricting the rights of data subjects or provide appropriate safeguards for data subject rights, in order to ensure that the intended processing complies with this Regulation, in particular as regards mitigating the risks involved for the data subject.

(60) Regulation (EU) 2016/679 established the European Data Protection Board as an independent body of the Union with legal personality. The Board should contribute to the consistent application of Regulation (EU) 2016/679 and Directive (EU) 2016/680 throughout the Union, including by advising the Commission. At the same time, the European Data Protection Supervisor should continue to exercise his or her supervisory and advisory functions in respect of all Union institutions and bodies, on his or her own initiative or upon request. In order to ensure consistency of data protection rules throughout the Union, when preparing proposals or recommendations, the Commission should endeavour to consult the European Data Protection Supervisor. A consultation by the Commission should be obligatory following the adoption of legislative acts or during the preparation of delegated acts and implementing acts as defined in Article 289, 290 and 291 TFEU and following the adoption of recommendations and proposals relating to agreements with third countries and international organisations as provided for in Article 218 TFEU which have an impact on the right to protection of personal data. In such cases, the Commission should be obliged to consult the European Data Protection Supervisor, except where the Regulation (EU) 2016/679 provides for mandatory consultation of the European Data Protection Board, for example on adequacy decisions or delegated acts on standardised icons and requirements for certification mechanisms. Where the act in question is of particular importance for the protection of rights and freedoms of natural persons with regard to the processing of personal data, the Commission should be able, in addition, to consult the European Data Protection Board. In those cases, the European Data Protection Supervisor should, as a member of the European Data Protection Board, coordinate his or her work with the latter with a view to issuing a joint opinion. The European Data Protection Supervisor, and where applicable, the European Data Protection Board should provide their written advice within eight weeks. That time-frame should be shorter in urgent cases or where otherwise appropriate, for example when the Commission is preparing delegated and implementing acts.

(61) In accordance with Article 75 of Regulation (EU) 2016/679, the European Data Protection Supervisor should provide the secretariat of the European Data Protection Board.

(62) In all Union institutions and bodies a data protection officer should ensure that the provisions of this Regulation are applied and should advise controllers and processors on fulfilling their obligations. That officer should be a person with expert knowledge of data protection law and practices, which should be determined in particular according to the data processing operations carried out by the controller or the processor and the protection required for the personal data involved. Such data protection officers should be in a position to perform their duties and tasks in an independent manner.

(63) When personal data are transferred from the Union institutions and bodies to controllers, processors or other recipients in third countries or to international organisations, the level of protection of natural persons ensured in the Union by this Regulation should be guaranteed. The same guarantees should apply in cases of onward transfers of personal data from the third country or international organisation to controllers, processors in the same or another third country or international organisation. In any event, transfers to third countries and international organisations may only be carried out in full compliance with this Regulation and respecting the fundamental rights and freedoms enshrined in the Charter. A transfer could take place only if, subject to the other provisions of this Regulation, the conditions laid down in the provisions of this Regulation relating to the transfer of personal data to third countries or international organisations are complied with by the controller or processor.

(64) The Commission can decide, under Article 45 of Regulation (EU) 2016/679 or under Article 36 of Directive (EU) 2016/680, that a third country, a territory or specified sector within a third country or an international organisation offers an adequate level of data protection. In such cases, transfers of personal data to that third country or international organisation by a Union institution or body can take place without the need to obtain any further authorisation.

(65) In the absence of an adequacy decision, the controller or processor should take measures to compensate for the lack of data protection in a third country by way of appropriate safeguards for the data subject. Such appropriate safeguards can consist of making use of standard data protection clauses adopted by the Commission, standard data protection clauses adopted by the European Data Protection Supervisor or contractual clauses authorised by the European Data Protection Supervisor. Where the processor is not a Union institution or body those appropriate safeguards can also consist of binding corporate rules, codes of conduct and certification mechanisms used for international transfers under Regulation (EU) 2016/679. Those safeguards should ensure compliance with data protection requirements and the rights of the data subjects appropriate to processing within the Union, including the availability of enforceable data subject rights and of effective legal remedies, including to obtain effective administrative or judicial redress and to claim compensation, in the Union or in a third country. They should relate in particular to compliance with the general principles relating to personal data processing, the principles of data protection by design and by default. Transfers may also be carried out by Union institutions and bodies to public authorities or bodies in third countries or to international organisations with corresponding duties or functions, including on the basis of provisions to be inserted into administrative arrangements, such as a memorandum of understanding, providing for enforceable and effective rights for data subjects. Authorisation by the European Data Protection Supervisor should be obtained when the safeguards are provided for in administrative arrangements that are not legally binding.

(66) The possibility for the controller or processor to use standard data-protection clauses adopted by the Commission or by the European Data Protection Supervisor should prevent controllers or processors neither from including the standard data-protection clauses in a wider contract, such as a contract between the processor and another processor, nor from adding other clauses or additional safeguards provided that they do not contradict, directly or indirectly, the standard contractual clauses adopted by the Commission or by the European Data Protection Supervisor or prejudice the fundamental rights or freedoms of the data subjects. Controllers and processors should be encouraged to provide additional safeguards via contractual commitments that supplement standard data-protection clauses.

(67) Some third countries adopt laws, regulations and other legal acts which purport to directly regulate the processing activities of Union institutions and bodies. 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 in force between the requesting third country and the Union. 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 law.

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

(69) 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 Union institutions and bodies and competition authorities, tax or customs administrations, financial supervisory authorities and 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 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. 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.

(70) In any case, where the Commission has taken no decision on the adequate level of data protection in a third country, the controller or processor should make use of solutions that provide data subjects with enforceable and effective rights as regards the processing of their data in the Union once those data have been transferred so that that they will continue to benefit from fundamental rights and safeguards.

(71) When personal data moves across borders outside the Union it may put at increased risk the ability of natural persons to exercise data protection rights, in particular to protect themselves from the unlawful use or disclosure of that information. At the same time, national supervisory authorities and the European Data Protection Supervisor can be unable to pursue complaints or conduct investigations relating to the activities outside their jurisdiction. Their efforts to work together in the cross-border context can also be hampered by insufficient preventive or remedial powers, inconsistent legal regimes, and practical obstacles like resource constraints. Therefore, closer cooperation between the European Data Protection Supervisor and national supervisory authorities should be promoted to help the exchange of information with their international counterparts.

(72) The establishment in Regulation (EC) No 45/2001 of the European Data Protection Supervisor, who is empowered to perform his or her tasks and exercise his or her powers with complete independence, is an essential component of the protection of natural persons with regard to the processing of their personal data. This Regulation should further strengthen and clarify his or her role and independence. The European Data Protection Supervisor should be a person whose independence is beyond doubt and who is acknowledged as having the experience and skills required to perform the duties of European Data Protection Supervisor, for example because he or she has belonged to one of the supervisory authorities established under Article 51 of Regulation (EU) 2016/679.

(73) In order to ensure consistent monitoring and enforcement of data protection rules throughout the Union, the European Data Protection Supervisor should have the same tasks and effective powers as the national supervisory authorities, including powers of investigation, corrective powers and sanctions, and authorisation and advisory powers, in particular in cases of complaints from natural persons, powers to bring infringements of this Regulation to the attention of the Court of Justice and powers to engage in legal proceedings in accordance with the primary law. Such powers should also include the power to impose a temporary or definitive limitation, including a ban, on processing. In order to avoid superfluous costs and excessive inconveniencies for the persons concerned who might be adversely affected, each measure of the European Data Protection Supervisor should be appropriate, necessary and proportionate in view of ensuring compliance with this Regulation, should take into account the circumstances of each individual case and respect the right of every person to be heard before any individual measure concerned is taken. Each legally binding measure of the European Data Protection Supervisor should be in writing, be clear and unambiguous, indicate the date of issue of the measure, bear the signature of the European Data Protection Supervisor, give the reasons for the measure, and refer to the right to an effective remedy.

(74) The supervisory competence of the European Data Protection Supervisor should not cover the processing of personal data by the Court of Justice when acting in its judicial capacity, in order to safeguard the independence of the Court in the performance of its judicial tasks, including decision-making. For such processing operations, the Court should establish independent supervision, in accordance with Article 8(3) of the Charter, for example through an internal mechanism.

(75) The decisions of the European Data Protection Supervisor regarding exemptions, guarantees, authorisations and conditions relating to data processing operations, as defined in this Regulation, should be published in the activities report. Independently of the publication of an annual activities report, the European Data Protection Supervisor can publish reports on specific subjects.

(76) The European Data Protection Supervisor should comply with Regulation (EC) No 1049/2001 of the European Parliament and of the Council (9).

(77) The national supervisory authorities monitor the application of Regulation (EU) 2016/679 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. In order to increase consistency in the application of data protection rules applicable in Member States and of data protection rules applicable to Union institutions and bodies, the European Data Protection Supervisor should cooperate effectively with the national supervisory authorities.

(78) In certain instances, Union law provides for a model of coordinated supervision, shared between the European Data Protection Supervisor and the national supervisory authorities. The European Data Protection Supervisor is also the supervisory authority of Europol and for these purposes, a specific model of cooperation with the national supervisory authorities has been established through a cooperation board with an advisory function. In order to improve the effective supervision and enforcement of substantive data protection rules, a single, coherent model of coordinated supervision should be introduced in the Union. The Commission should therefore make legislative proposals where appropriate with a view to amending Union legal acts providing for a model of coordinated supervision, in order to align them with the coordinated supervision model of this Regulation. The European Data Protection Board should serve as a single forum for ensuring effective coordinated supervision in all areas.

(79) Every data subject should have the right to lodge a complaint with the European Data Protection Supervisor, and the right to an effective judicial remedy before the Court of Justice in accordance with the Treaties, if the data subject considers that his or her rights under this Regulation are infringed or where the European Data Protection Supervisor does not act on a complaint, partially or wholly rejects or dismisses a complaint or does not act where such action is necessary to protect the rights of the data subject. The investigation following a complaint should be carried out, subject to judicial review, to the extent that is appropriate in the specific case. The European Data Protection Supervisor should inform the data subject of the progress and the outcome of the complaint within a reasonable period. If the case requires further coordination with a national supervisory authority, intermediate information should be given to the data subject. In order to facilitate the submission of complaints, the European Data Protection Supervisor should take measures such as providing a complaint submission form which can also be completed electronically, without excluding other means of communication.

(80) Any person who has suffered material or non-material damage as a result of an infringement of this Regulation should have the right to receive compensation from the controller or processor for the damage suffered, subject to the conditions provided for in the Treaties.

(81) In order to strengthen the supervisory role of the European Data Protection Supervisor and the effective enforcement of this Regulation, the European Data Protection Supervisor should, as a sanction of last resort, have the power to impose administrative fines. The fines should aim at sanctioning the Union institution or body — rather than individuals — for non-compliance with this Regulation, to deter future violations of this Regulation and to foster a culture of personal data protection within the Union institutions and bodies. This Regulation should indicate the infringements subject to administrative fines and the upper limits and criteria for setting the associated fines. The European Data Protection Supervisor should determine the amount of the fine in each individual case, by taking into account all relevant circumstances of the specific situation, with due regard to the nature, gravity and duration of the infringement, 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. When imposing an administrative fine on a Union institution or body, the European Data Protection Supervisor should consider the proportionality of amount of the fine. The administrative procedure for the imposition of fines on Union institutions and bodies should respect the general principles of Union law as interpreted by the Court of Justice.

(82) Where a data subject considers that his or her rights under this Regulation are infringed, he or she should have the right to mandate a not-for-profit body, organisation or association which is constituted in accordance with Union law or 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 personal data to lodge a complaint on his or her behalf with the European Data Protection Supervisor. Such a body, organisation or association should also be able to exercise the right to a judicial remedy on behalf of data subjects or exercise the right to receive compensation on behalf of data subjects.

(83) An official or other servant of the Union who fails to comply with the obligations in this Regulation should be liable to disciplinary or other action, in accordance with the rules and procedures laid down in the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants of the Union, laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (10) (‘Staff Regulations’).

(84) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and the Council (11). The examination procedure should be used for the adoption of standard contractual clauses between controllers and processors and between processors, for the adoption of a list of processing operations requiring prior consultation of the European Data Protection Supervisor by controllers processing personal data for the performance of a task carried out in the public interest, and for the adoption of standard contractual clauses providing appropriate safeguards for international transfers.

(85) The confidential information which the Union and national statistical authorities collect for the production of official European and official national statistics should be protected. European statistics should be developed, produced and disseminated in accordance with the statistical principles set out in Article 338(2) TFEU. Regulation (EC) No 223/2009 of the European Parliament and of the Council (12) provides further specifications on statistical confidentiality for European statistics.

(86) Regulation (EC) No 45/2001 and Decision No 1247/2002/EC of the European Parliament, of the Council and of the Commission (13) should be repealed. The references to the repealed Regulation and Decision should be construed as references to this Regulation.

(87) In order to safeguard the full independence of the members of the independent supervisory authority, the terms of office of the current European Data Protection Supervisor and the current Assistant Supervisor should not be affected by this Regulation. The current Assistant Supervisor should remain in place until the end of his term of office, unless one of the conditions for the premature end of term of the European Data Protection Supervisor laid down in this Regulation is met. The relevant provisions of this Regulation should apply to the Assistant Supervisor until the end of his term of office.

(88) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of ensuring an equivalent level of protection of natural persons with regard to the processing of personal data and the free flow of personal data throughout the Union to lay down rules on processing of personal data in Union institutions and bodies. This Regulation does not go beyond what is necessary in order to achieve the objectives pursued in accordance with Article 5(4) of the TEU.

(89) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and delivered an opinion on 15 March 2017 (14),

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1 Subject matter and objectives 1. This Regulation lays down rules relating to the protection of natural persons with regard to the processing of personal data by the Union institutions and bodies and rules relating to the free movement of personal data between them or to other recipients established in the Union. 2. This Regulation protects fundamental rights and freedoms of natural persons and in particular their right to the protection of personal data. 3. The European Data Protection Supervisor shall monitor the application of the provisions of this Regulation to all processing operations carried out by a Union institution or body.

Article 2 Scope 1. This Regulation applies to the processing of personal data by all Union institutions and bodies. 2. Only Article 3 and Chapter IX of this Regulation shall apply to the processing of operational personal data by Union bodies, offices and agencies when carrying out activities which fall within the scope of Chapter 4 or Chapter 5 of Title V of Part Three TFEU. 3. This Regulation shall not apply to the processing of operational personal data by Europol and the European Public Prosecutor’s Office, until Regulation (EU) 2016/794 of the European Parliament and of the Council (15) and Council Regulation (EU) 2017/1939 (16) are adapted in accordance with Article 98 of this Regulation. 4. This Regulation shall not apply to the processing of personal data by missions referred to in Articles 42(1), 43 and 44 TEU. 5. 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.

Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘personal data’ means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person; (2) ‘operational personal data’ means all personal data processed by Union bodies, offices or agencies when carrying out activities which fall within the scope of Chapter 4 or Chapter 5 of Title V of Part Three TFEU to meet the objectives and tasks laid down in the legal acts establishing those bodies, offices or agencies; (3) ‘processing’ means any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction; (4) ‘restriction of processing’ means the marking of stored personal data with the aim of limiting their processing in the future; (5) ‘profiling’ means any form of automated processing of personal data consisting of the use of personal data to evaluate certain personal aspects relating to a natural person, in particular to analyse or predict aspects concerning that natural person’s performance at work, economic situation, health, personal preferences, interests, reliability, behaviour, location or movements; (6) ‘pseudonymisation’ means the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person; (7) ‘filing system’ means any structured set of personal data which are accessible according to specific criteria, whether centralised, decentralised or dispersed on a functional or geographical basis; (8) ‘controller’ means the Union institution or body or the directorate-general or any other organisational entity which, alone or jointly with others, determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by a specific Union act, the controller or the specific criteria for its nomination can be provided for by Union law; (9) ‘controllers other than Union institutions and bodies’ means controllers within the meaning of point (7) of Article 4 of Regulation (EU) 2016/679 and controllers within the meaning of point (8) of Article 3 of Directive (EU) 2016/680; (10) ‘Union institutions and bodies’ means the Union institutions, bodies, offices and agencies set up by, or on the basis of, the TEU, the TFEU or the Euratom Treaty; (11) ‘competent authority’ means any public authority in a Member State competent for 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; (12) ‘processor’ means a natural or legal person, public authority, agency or other body which processes personal data on behalf of the controller; (13) ‘recipient’ means a natural or legal person, public authority, agency or another body, to which the personal data are disclosed, whether a third party or not. However, public authorities which may receive personal data in the framework of a particular inquiry in accordance with Union or Member State law shall not be regarded as recipients; the processing of those data by those public authorities shall be in compliance with the applicable data protection rules according to the purposes of the processing; (14) ‘third party’ means a natural or legal person, public authority, agency or body other than the data subject, controller, processor and persons who, under the direct authority of the controller or processor, are authorised to process personal data; (15) ‘consent’ of the data subject means any freely given, specific, informed and unambiguous indication of the data subject’s wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her; (16) ‘personal data breach’ means a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed; (17) ‘genetic data’ means personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question; (18) ‘biometric data’ means personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, which allow or confirm the unique identification of that natural person, such as facial images or dactyloscopic data; (19) ‘data concerning health’ means personal data related to the physical or mental health of a natural person, including the provision of healthcare services, which reveal information about his or her health status; (20) ‘information society service’ means a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council (17); (21) ‘international organisation’ means an organisation and its subordinate bodies governed by public international law, or any other body which is set up by, or on the basis of, an agreement between two or more countries; (22) ‘national supervisory authority’ means an independent public authority which is established by a Member State pursuant to Article 51 of Regulation (EU) 2016/679 or pursuant to Article 41 of Directive (EU) 2016/680; (23) ‘user’ means any natural person using a network or terminal equipment operated under the control of a Union institution or body; (24) ‘directory’ means a publicly available directory of users or an internal directory of users available within a Union institution or body or shared between Union institutions and bodies, whether in printed or electronic form; (25) ‘electronic communications network’ means a transmission system, whether or not based on a permanent infrastructure or centralised administration capacity, and, where applicable, switching or routing equipment and other resources, including network elements which are not active, which permit the conveyance of signals by wire, radio, optical or other electromagnetic means, including satellite networks, fixed (circuit- and packet-switched including internet) and mobile terrestrial networks, electricity cable systems, to the extent that they are used for the purpose of transmitting signals, networks used for radio and television broadcasting, and cable television networks, irrespective of the type of information conveyed; (26) ‘terminal equipment’ means terminal equipment as defined in point (1) of Article 1 of Commission Directive 2008/63/EC (18).

CHAPTER II

GENERAL PRINCIPLES

Article 4 Principles relating to processing of personal data 1. Personal data shall be: (a) processed lawfully, fairly and in a transparent manner in relation to the data subject (‘lawfulness, fairness and transparency’); (b) collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes; further processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes shall, in accordance with Article 13, not be considered to be incompatible with the initial purposes (‘purpose limitation’); (c) adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed (‘data minimisation’); (d) accurate and, where necessary, kept up to date; every reasonable step must be taken to ensure that personal data that are inaccurate, having regard to the purposes for which they are processed, are erased or rectified without delay (‘accuracy’); (e) kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the personal data are processed; personal data may be stored for longer periods insofar as the personal data will be processed solely for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 13 subject to implementation of the appropriate technical and organisational measures required by this Regulation in order to safeguard the rights and freedoms of the data subject (‘storage limitation’); (f) processed in a manner that ensures appropriate security of the personal data, including protection against unauthorised or unlawful processing and against accidental loss, destruction or damage, using appropriate technical or organisational measures (‘integrity and confidentiality’). 2. The controller shall be responsible for, and be able to demonstrate compliance with, paragraph 1 (‘accountability’).

Article 5 Lawfulness of processing 1. Processing shall be lawful only if and to the extent that at least one of the following applies: (a) 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 Union institution or body; (b) processing is necessary for compliance with a legal obligation to which the controller is subject; (c) 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; (d) the data subject has given consent to the processing of his or her personal data for one or more specific purposes; (e) processing is necessary in order to protect the vital interests of the data subject or of another natural person. 2. The basis for the processing referred to in points (a) and (b) of paragraph 1 shall be laid down in Union law.

Article 6 Processing for another compatible purpose 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 Union law which constitutes a necessary and proportionate measure in a democratic society to safeguard the objectives referred to in Article 25(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 10, or whether personal data related to criminal convictions and offences are processed, pursuant to Article 11; (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 7 Conditions for consent 1. Where processing is based on consent, the controller shall be able to demonstrate that the data subject has consented to processing of his or her personal data. 2. If the data subject’s consent is given in the context of a written declaration which also concerns other matters, the request for consent shall be presented in a manner which is clearly distinguishable from the other matters, in an intelligible and easily accessible form, using clear and plain language. Any part of such a declaration which constitutes an infringement of this Regulation shall not be binding. 3. The data subject shall have the right to withdraw his or her consent at any time. The withdrawal of consent shall not affect the lawfulness of processing based on consent before its withdrawal. Prior to giving consent, the data subject shall be informed thereof. It shall be as easy to withdraw as to give consent. 4. When assessing whether consent is freely given, utmost account shall be taken of whether, inter alia, the performance of a contract, including the provision of a service, is conditional on consent to the processing of personal data that is not necessary for the performance of that contract.

Article 8 Conditions applicable to a child’s consent in relation to information society services 1. Where point (d) of Article 5(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 13 years old. Where the child is below the age of 13 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. 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 Transmissions of personal data to recipients established in the Union other than Union institutions and bodies 1. Without prejudice to Articles 4 to 6 and 10, personal data shall only be transmitted to recipients established in the Union other than Union institutions and bodies if: (a) the recipient establishes that the data are necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the recipient; or (b) the recipient establishes that it is necessary to have the data transmitted for a specific purpose in the public interest and the controller, where there is any reason to assume that the data subject’s legitimate interests might be prejudiced, establishes that it is proportionate to transmit the personal data for that specific purpose after having demonstrably weighed the various competing interests. 2. Where the controller initiates the transmission under this Article, it shall demonstrate that the transmission of personal data is necessary for and proportionate to the purposes of the transmission by applying the criteria laid down in points (a) or (b) of paragraph 1. 3. Union institutions and bodies shall reconcile the right to the protection of personal data with the right of access to documents in accordance with Union law.

Article 10 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 law provides that the prohibition referred to in paragraph 1 may not be lifted by the data subject; (b) the 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 insofar as it is authorised by Union law providing for appropriate safeguards for the fundamental rights and the interests of the data subject; (c) the processing is necessary to protect the vital interests of the data subject or of another person where the data subject is physically or legally incapable of giving consent; (d) the processing is carried out in the course of its legitimate activities with appropriate safeguards by a non-profit-seeking body which constitutes an entity integrated in a Union institution or body and 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 this body or to persons who have regular contact with it in connection with its purposes and that the data are not disclosed outside that body without the consent of the data subjects; (e) the processing relates to personal data which are manifestly made public by the data subject; (f) the processing is necessary for the establishment, exercise or defence of legal claims or whenever the Court of Justice is acting in its judicial capacity; (g) the processing is necessary for reasons of substantial public interest