interactive GDPR 2016/0679 EN

(2) The principles of, and rules on the protection of natural persons with regard to the processing of their personal_data should, whatever their nationality or residence, respect their fundamental rights and freedoms, in particular their right to the protection of personal_data.

  This regulation is intended to contribute to the accomplishment of an area of freedom, security and justice and of an economic union, to economic and social progress, to the strengthening and the convergence of the economies within the internal market, and to the well-being of natural persons.

(4) The processing of personal_data should be designed to serve mankind.

  The right to the protection of personal_data is not an absolute right; it must be considered in relation to its function in society and be balanced against other fundamental rights, in accordance with the principle of proportionality.

  This regulation respects all fundamental rights and observes the freedoms and principles recognised in the Charter as enshrined in the Treaties, in particular the respect for private and family life, home and communications, the protection of personal_data, freedom of thought, conscience and religion, freedom of expression and information, freedom to conduct a business, the right to an effective remedy and to a fair trial, and cultural, religious and linguistic diversity.

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

(10) In order to ensure a consistent and high level of protection of natural persons and to remove the obstacles to flows of personal_data within the Union, the level of protection of the rights and freedoms of natural persons with regard to the processing of such data should be equivalent in all Member States.

  Consistent and homogenous application of the rules for the protection of the fundamental rights and freedoms of natural persons with regard to the processing of personal_data should be ensured throughout the Union.

  Regarding the processing of personal_data for compliance with a legal obligation, for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller, Member States should be allowed to maintain or introduce national provisions to further specify the application of the rules of this regulation.

  In conjunction with the general and horizontal law on data protection implementing Directive 95/46/EC, Member States have several sector-specific laws in areas that need more specific provisions.

  This regulation also provides a margin of manoeuvre for Member States to specify its rules, including for the processing of special categories of personal_data (‘sensitive data’).

  To that extent, this regulation does not exclude Member State law that sets out the circumstances for specific processing situations, including determining more precisely the conditions under which the processing of personal_data is lawful.

(13) In order to ensure a consistent level of protection for natural persons throughout the Union and to prevent divergences hampering the free movement of personal_data within the internal market, a regulation is necessary to provide legal certainty and transparency for economic operators, including micro, small and medium-sized enterprises, and to provide natural persons in all Member States with the same level of legally enforceable rights and obligations and responsibilities for controllers and processors, to ensure consistent monitoring of the processing of personal_data, and equivalent sanctions in all Member States as well as effective cooperation between the supervisory authorities of different Member States.

  The proper functioning of the internal market requires that the free movement of personal_data within the Union is not restricted or prohibited for reasons connected with the protection of natural persons with regard to the processing of personal_data.

  To take account of the specific situation of micro, small and medium-sized enterprises, this regulation includes a derogation for organisations with fewer than 250 employees with regard to record-keeping.

  In addition, the Union institutions and bodies, and Member States and their supervisory authorities, are encouraged to take account of the specific needs of micro, small and medium-sized enterprises in the application of this regulation.

  The notion of micro, small and medium-sized enterprises should draw from Article 2 of the Annex to Commission Recommendation 2003/361/EC (5).

(14) The protection afforded by this regulation should apply to natural persons, whatever their nationality or place of residence, in relation to the processing of their personal_data.

  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.

(15) 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.

  The protection of natural persons should apply to the processing of personal_data by automated means, as well as to manual processing, if the personal_data are contained or are intended to be contained in 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.

(16) This regulation does not apply to issues of protection of fundamental rights and freedoms or the free flow of personal_data related to activities which fall outside the scope of Union law, such as activities concerning national security.

  This regulation does not apply to the processing of personal_data by the Member States when carrying out activities in relation to the common foreign and security policy of the Union.

(17) regulation (EC) No 45/2001 of the European Parliament and of the Council (6) applies to the processing of personal_data by the Union institutions, bodies, offices and agencies.

  regulation (EC) No 45/2001 and other Union legal acts applicable to such processing of personal_data should be adapted to the principles and rules established in this regulation and applied in the light of this regulation.

  In order to provide a strong and coherent data protection framework in the Union, the necessary adaptations of regulation (EC) No 45/2001 should follow after the adoption of this regulation, in order to allow application at the same time as this regulation.

(18) This regulation does not apply to the processing of personal_data by a natural person in the course of a purely personal or household activity and thus with no connection to a professional or commercial activity.

  Personal or household activities could include correspondence and the holding of addresses, or social networking and online activity undertaken within the context of such activities.

  However, this regulation applies to controllers or processors which provide the means for processing personal_data for such personal or household activities.

(19) The protection of natural persons with regard to the processing of personal_data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security and the free movement of such data, is the subject of a specific Union legal act.

  This regulation should not, therefore, apply to processing activities for those purposes.

  However, personal_data processed by public authorities under this regulation should, when used for those purposes, be governed by a more specific Union legal act, namely Directive (EU) 2016/680 of the European Parliament and of the Council (7).

  Member States may entrust competent authorities within the meaning of Directive (EU) 2016/680 with tasks which are not necessarily carried out for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and prevention of threats to public security, so that the processing of personal_data for those other purposes, in so far as it is within the scope of Union law, falls within the scope of this regulation.

(20) While this regulation applies, inter alia, to the activities of courts and other judicial authorities, Union or Member State law could specify the processing operations and processing procedures in relation to the processing of personal_data by courts and other judicial authorities.

  The competence of the supervisory authorities should not cover the processing of personal_data when courts are acting in their judicial capacity, in order to safeguard the independence of the judiciary in the performance of its judicial tasks, including decision-making.

  It should be possible to entrust supervision of such data processing operations to specific bodies within the judicial system of the Member State, which should, in particular ensure compliance with the rules of this regulation, enhance awareness among members of the judiciary of their obligations under this regulation and handle complaints in relation to such data processing operations.

(21) This regulation is without prejudice to the application of Directive 2000/31/EC of the European Parliament and of the Council (8), in particular of the liability rules of intermediary service providers in Articles 12 to 15 of that Directive.

  That Directive seeks to contribute to the proper functioning of the internal market by ensuring the free movement of information_society_services between Member States.

(22) Any processing of personal_data in the context of the activities of an establishment of a controller or a processor in the Union should be carried out in accordance with this regulation, regardless of whether the processing itself takes place within the Union.

  Establishment implies the effective and real exercise of activity through stable arrangements.

  The legal form of such arrangements, whether through a branch or a subsidiary with a legal personality, is not the determining factor in that respect.

(23) In order to ensure that natural persons are not deprived of the protection to which they are entitled under this regulation, the processing of personal_data of data subjects who are in the Union by a controller or a processor not established in the Union should be subject to this regulation where the processing activities are related to offering goods or services to such data subjects irrespective of whether connected to a payment.

  In order to determine whether such a controller or processor is offering goods or services to data subjects who are in the Union, it should be ascertained whether it is apparent that the controller or processor envisages offering services to data subjects in one or more Member States in the Union.

  Whereas the mere accessibility of the controller's, processor's or an intermediary's website in the Union, of an email address or of other contact details, or the use of a language generally used in the third country where the controller is established, is insufficient to ascertain such intention, factors such as the use of a language or a currency generally used in one or more Member States with the possibility of ordering goods and services in that other language, or the mentioning of customers or users who are in the Union, may make it apparent that the controller envisages offering goods or services to data subjects in the Union.

(24) The processing of personal_data of data subjects who are in the Union by a controller or processor not established in the Union should also be subject to this regulation when it is related to the monitoring of the behaviour of such data subjects in so far as their behaviour takes place within the Union.

  In order to determine whether a processing activity can be considered to monitor the behaviour of data subjects, it should be ascertained whether natural persons are tracked on the internet including potential subsequent use of personal_data processing techniques which consist of profiling a natural person, particularly in order to take decisions concerning her or him or for analysing or predicting her or his personal preferences, behaviours and attitudes.

(25) Where Member State law applies by virtue of public international law, this regulation should also apply to a controller not established in the Union, such as in a Member State's diplomatic mission or consular post.

(26) 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.

(27) This regulation does not apply to the personal_data of deceased persons.

  Member States may provide for rules regarding the processing of personal_data of deceased persons.

(28) 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.

(29) In order to create incentives to apply pseudonymisation when processing personal_data, measures of pseudonymisation should, whilst allowing general analysis, be possible within the same controller when that controller has taken technical and organisational measures necessary to ensure, for the processing concerned, that this regulation is implemented, and that additional information for attributing the personal_data to a specific data subject is kept separately.

  The controller processing the personal_data should indicate the authorised persons within the same controller.

(31) Public authorities to which personal_data are disclosed in accordance with a legal obligation for the exercise of their official mission, such as tax and customs authorities, financial investigation units, independent administrative authorities, or financial market authorities responsible for the regulation and supervision of securities markets should not be regarded as recipients if they receive personal_data which are necessary to carry out a particular inquiry in the general interest, in accordance with Union or Member State law.

  The requests for disclosure sent by the public authorities should always be in writing, reasoned and occasional and should not concern the entirety of a filing_system or lead to the interconnection of filing_systems.

  The processing of personal_data by those public authorities should comply with the applicable data-protection rules according to the purposes of the processing.

(36) The main_establishment of a controller in the Union should be the place of its central administration in the Union, unless the decisions on the purposes and means of the processing of personal_data are taken in another establishment of the controller in the Union, in which case that other establishment should be considered to be the main_establishment.

  The main_establishment of a controller in the Union should be determined according to objective criteria and should imply the effective and real exercise of management activities determining the main decisions as to the purposes and means of processing through stable arrangements.

  That criterion should not depend on whether the processing of personal_data is carried out at that location.

  The presence and use of technical means and technologies for processing personal_data or processing activities do not, in themselves, constitute a main_establishment and are therefore not determining criteria for a main_establishment.

  The main_establishment of the processor should be the place of its central administration in the Union or, if it has no central administration in the Union, the place where the main processing activities take place in the Union.

  In cases involving both the controller and the processor, the competent lead supervisory_authority should remain the supervisory_authority of the Member State where the controller has its main_establishment, but the supervisory_authority of the processor should be considered to be a supervisory_authority concerned and that supervisory_authority should participate in the cooperation procedure provided for by this regulation.

  In any case, the supervisory authorities of the Member State or Member States where the processor has one or more establishments should not be considered to be supervisory authorities concerned where the draft decision concerns only the controller.

  Where the processing is carried out by a group_of_undertakings, the main_establishment of the controlling undertaking should be considered to be the main_establishment of the group_of_undertakings, except where the purposes and means of processing are determined by another undertaking.

(40) In order for processing to be lawful, personal_data should be processed on the basis of the consent of the data subject concerned or some other legitimate basis, laid down by law, either in this regulation or in other Union or Member State law as referred to in this regulation, including the necessity for compliance with the legal obligation to which the controller is subject or 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.

(41) Where this regulation refers to a legal basis or a legislative measure, this does not necessarily require a legislative act adopted by a parliament, without prejudice to requirements pursuant to the constitutional order of the Member State concerned.

  However, such a legal basis or legislative measure should be clear and precise and its application should be foreseeable to persons subject to it, in accordance with the case-law of the Court of Justice of the European Union (the ‘Court of Justice’) and the European Court of Human Rights.

(45) Where processing is carried out in accordance with a legal obligation to which the controller is subject or where processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority, the processing should have a basis in Union or Member State law.

  This regulation does not require a specific law for each individual processing.

  A law as a basis for several processing operations based on a legal obligation to which the controller is subject or where processing is necessary for the performance of a task carried out in the public interest or in the exercise of an official authority may be sufficient.

  It should also be for Union or Member State law to determine the purpose of processing.

  Furthermore, that law could specify the general conditions of this regulation governing the lawfulness of personal_data processing, establish specifications for determining the controller, the type of personal_data which are subject to the processing, the data subjects concerned, the entities to which the personal_data may be disclosed, the purpose limitations, the storage period and other measures to ensure lawful and fair processing.

  It should also be for Union or Member State law to determine whether the controller performing a task carried out in the public interest or in the exercise of official authority should be a public authority or another natural or legal person governed by public law, or, where it is in the public interest to do so, including for health purposes such as public health and social protection and the management of health care services, by private law, such as a professional association.

(51) Personal data which are, by their nature, particularly sensitive in relation to fundamental rights and freedoms merit specific protection as the context of their processing could create significant risks to the fundamental rights and freedoms.

  Those personal_data should include personal_data revealing racial or ethnic origin, whereby the use of the term ‘racial origin’ in this regulation does not imply an acceptance by the Union of theories which attempt to determine the existence of separate human races.

  The processing of photographs should not systematically be considered to be processing of special categories of personal_data as they are covered by the definition of biometric_data only when processed through a specific technical means allowing the unique identification or authentication of a natural person.

  Such personal_data should not be processed, unless processing is allowed in specific cases set out in this regulation, taking into account that Member States law may lay down specific provisions on data protection in order to adapt the application of the rules of this regulation for compliance with a legal obligation or for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

  In addition to the specific requirements for such processing, the general principles and other rules of this regulation should apply, in particular as regards the conditions for lawful processing.

  Derogations from the general prohibition for processing such special categories of personal_data should be explicitly provided, inter alia, where the data subject gives his or her explicit consent or in respect of specific needs in particular where the processing is carried out in the course of legitimate activities by certain associations or foundations the purpose of which is to permit the exercise of fundamental freedoms.

(53) Special categories of personal_data which merit higher protection should be processed for health-related purposes only where necessary to achieve those purposes for the benefit of natural persons and society as a whole, in particular in the context of the management of health or social care services and systems, including processing by the management and central national health authorities of such data for the purpose of quality control, management information and the general national and local supervision of the health or social care system, and ensuring continuity of health or social care and cross-border healthcare or health security, monitoring and alert purposes, or for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes, based on Union or Member State law which has to meet an objective of public interest, as well as for studies conducted in the public interest in the area of public health.

  Therefore, this regulation should provide for harmonised conditions for the processing of special categories of personal_data concerning health, in respect of specific needs, in particular where the processing of such data is carried out for certain health-related purposes by persons subject to a legal obligation of professional secrecy.

  Union or Member State law should provide for specific and suitable measures so as to protect the fundamental rights and the personal_data of natural persons.

  Member States should be allowed to maintain or introduce further conditions, including limitations, with regard to the processing of genetic_data, biometric_data or data_concerning_health.

  However, this should not hamper the free flow of personal_data within the Union when those conditions apply to cross-border processing of such data.

(54) 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 (11), namely all elements related to health, namely health status, including morbidity and disability, the determinants having an effect on that health status, health care needs, resources allocated to health care, the provision of, and universal access to, health care as well as health care 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 by third parties such as employers or insurance and banking companies.

(57) 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 authentication mechanism such as the same credentials, used by the data subject to log-in to the on-line service offered by the data controller.

(59) 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.

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

  In particular, 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.

(68) 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 not apply where processing is based on a legal ground other than consent or contract.

  By its very nature, that right should not be exercised against controllers processing personal_data in the exercise of their public duties.

  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.

(71) 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 automatic refusal of an online credit application or 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 or Member State law to which the controller is subject, including for fraud and tax-evasion monitoring and prevention purposes conducted in accordance with the regulations, standards and recommendations of Union institutions or national oversight bodies and to ensure the security and reliability of a service provided by the controller, or necessary for the entering or performance of a contract between the data subject and a controller, or when the data subject has given his or her explicit consent.

  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.

(72) Profiling is subject to the rules of this regulation governing the processing of personal_data, such as the legal grounds for processing or data protection principles.

  The European Data Protection Board established by this regulation (the ‘Board’) should be able to issue guidance in that context.

(74) 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.

(78) 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.

  When developing, designing, selecting and using applications, services and products that are based on the processing of personal_data or process personal_data to fulfil their task, producers of the products, services and applications should be encouraged to take into account the right to data protection when developing and designing such products, services and applications and, with due regard to the state of the art, to make sure that controllers and processors are able to fulfil their data protection obligations.

  The principles of data protection by design and by default should also be taken into consideration in the context of public tenders.

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

(80) Where a controller or a processor not established in the Union is processing personal_data of data subjects who are in the Union whose processing activities are related to the offering of goods or services, irrespective of whether a payment of the data subject is required, to such data subjects in the Union, or to the monitoring of their behaviour as far as their behaviour takes place within the Union, the controller or the processor should designate a representative, unless the processing is occasional, does not include processing, on a large scale, of special categories of personal_data or the processing of personal_data relating to criminal convictions and offences, and is unlikely to result in a risk to the rights and freedoms of natural persons, taking into account the nature, context, scope and purposes of the processing or if the controller is a public authority or body.

  The representative should act on behalf of the controller or the processor and may be addressed by any supervisory_authority.

  The representative should be explicitly designated by a written mandate of the controller or of the processor to act on its behalf with regard to its obligations under this regulation.

  The designation of such a representative does not affect the responsibility or liability of the controller or of the processor under this regulation.

  Such a representative should perform its tasks according to the mandate received from the controller or processor, including cooperating with the competent supervisory authorities with regard to any action taken to ensure compliance with this regulation.

  The designated representative should be subject to enforcement proceedings in the event of non-compliance by the controller or processor.

(81) 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 will meet the requirements of this regulation, including for the security of processing.

  The adherence of the processor to an approved code of conduct or an approved certification mechanism may be used as an element to demonstrate compliance with the obligations of the controller.

  The carrying-out of processing by a processor should be governed by a contract or other legal act under Union or Member State 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 may choose to use an individual contract or standard contractual clauses which are adopted either directly by the Commission or by a supervisory_authority in accordance with the consistency mechanism 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 the personal_data under Union or Member State law to which the processor is subject.

(82) In order to demonstrate compliance with this regulation, the controller or processor should maintain records of processing activities under its responsibility.

  Each controller and processor should be obliged to cooperate with the supervisory_authority and make those records, on request, available to it, so that it might serve for monitoring those processing operations.

(83) 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.

(84) In order to enhance compliance with this regulation where processing operations are likely to result in a high risk to the rights and freedoms of natural persons, the controller should be responsible for the carrying-out of a data protection impact assessment to evaluate, in particular, the origin, nature, particularity and severity of that risk.

  The outcome of the assessment should be taken into account when determining the appropriate measures to be taken in order to demonstrate that the processing of personal_data complies with this regulation.

  Where a data-protection impact assessment indicates that processing operations involve a high risk which the controller cannot mitigate by appropriate measures in terms of available technology and costs of implementation, a consultation of the supervisory_authority should take place prior to the processing.

(87) It should be ascertained whether all appropriate technological protection and organisational measures have been implemented to establish immediately whether a personal_data breach has taken place and to inform promptly the supervisory_authority and the data subject.

  The fact that the notification was made without undue delay should be established taking into account in particular the nature and gravity of the personal_data breach and its consequences and adverse effects for the data subject.

  Such notification may result in an intervention of the supervisory_authority in accordance with its tasks and powers laid down in this regulation.

(90) 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.

(94) 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 supervisory_authority 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 may result also in a realisation of damage or interference with the rights and freedoms of the natural person.

  The supervisory_authority should respond to the request for consultation within a specified period.

  However, the absence of a reaction of the supervisory_authority within that period should be without prejudice to any intervention of the supervisory_authority in accordance with its tasks and powers laid down in this regulation, including the power to prohibit processing operations.

  As part of that consultation process, the outcome of a data protection impact assessment carried out with regard to the processing at issue may be submitted to the supervisory_authority, in particular the measures envisaged to mitigate the risk to the rights and freedoms of natural persons.

(96) A consultation of the supervisory_authority should also take place in the course of the preparation of a legislative or regulatory measure which provides for the processing of personal_data, in order to ensure compliance of the intended processing with this regulation and in particular to mitigate the risk involved for the data subject.

(97) Where the processing is carried out by a public authority, except for courts or independent judicial authorities when acting in their judicial capacity, where, in the private sector, processing is carried out by a controller whose core activities consist of processing operations that require regular and systematic monitoring of the data subjects on a large scale, or where the core activities of the controller or the processor consist of processing on a large scale of special categories of personal_data and data relating to criminal convictions and offences, a person with expert knowledge of data protection law and practices should assist the controller or processor to monitor internal compliance with this regulation.

  In the private sector, the core activities of a controller relate to its primary activities and do not relate to the processing of personal_data as ancillary activities.

  The necessary level of expert knowledge should be determined in particular according to the data processing operations carried out and the protection required for the personal_data processed by the controller or the processor.

  Such data protection officers, whether or not they are an employee of the controller, should be in a position to perform their duties and tasks in an independent manner.

(98) Associations or other bodies representing categories of controllers or processors should be encouraged to draw up codes of conduct, within the limits of this regulation, so as to facilitate the effective application of this regulation, taking account of the specific characteristics of the processing carried out in certain sectors and the specific needs of micro, small and medium enterprises.

  In particular, such codes of conduct could calibrate the obligations of controllers and processors, taking into account the risk likely to result from the processing for the rights and freedoms of natural persons.

(100) In order to enhance transparency and compliance with this regulation, the establishment of certification mechanisms and data protection seals and marks should be encouraged, allowing data subjects to quickly assess the level of data protection of relevant products and services.

(101) Flows of personal_data to and from countries outside the Union and international_organisations are necessary for the expansion of international trade and international cooperation.

  The increase in such flows has raised new challenges and concerns with regard to the protection of personal_data.

  However, when personal_data are transferred from the Union to controllers, processors or other recipients in third countries or to international_organisations, the level of protection of natural persons ensured in the Union by this regulation should not be undermined, including in cases of onward transfers of personal_data from the third country or international_organisation to controllers, processors in the same or another third country or international_organisation.

  In any event, transfers to third countries and international_organisations may only be carried out in full compliance with this regulation.

  A transfer could take place only if, subject to the other provisions of this regulation, the conditions laid down in the provisions of this regulation relating to the transfer of personal_data to third countries or international_organisations are complied with by the controller or processor.

(102) This regulation is without prejudice to international agreements concluded between the Union and third countries regulating the transfer of personal_data including appropriate safeguards for the data subjects.

  Member States may conclude international agreements which involve the transfer of personal_data to third countries or international_organisations, as far as such agreements do not affect this regulation or any other provisions of Union law and include an appropriate level of protection for the fundamental rights of the data subjects.

(106) The Commission should monitor the functioning of decisions on the level of protection in a third country, a territory or specified sector within a third country, or an international_organisation, and monitor the functioning of decisions adopted on the basis of Article 25(6) or Article 26(4) of Directive 95/46/EC.

  In its adequacy decisions, the Commission should provide for a periodic review mechanism of their functioning.

  That periodic review should be conducted in consultation with the third country or international_organisation in question and take into account all relevant developments in the third country or international_organisation.

  For the purposes of monitoring and of carrying out the periodic reviews, the Commission should take into consideration the views and findings of the European Parliament and of the Council as well as of other relevant bodies and sources.

  The Commission should evaluate, within a reasonable time, the functioning of the latter decisions and report any relevant findings to the Committee within the meaning of regulation (EU) No 182/2011 of the European Parliament and of the Council (12) as established under this regulation, to the European Parliament and to the Council.

(107) The Commission may recognise that a third country, a territory or a specified sector within a third country, or an international_organisation no longer ensures an adequate level of data protection.

  Consequently the transfer of personal_data to that third country or international_organisation should be prohibited, unless the requirements in this regulation relating to transfers subject to appropriate safeguards, including binding_corporate_rules, and derogations for specific situations are fulfilled.

  In that case, provision should be made for consultations between the Commission and such third countries or international_organisations.

  The Commission should, in a timely manner, inform the third country or international_organisation of the reasons and enter into consultations with it in order to remedy the situation.

(115) Some third countries adopt laws, regulations and other legal acts which purport to directly regulate the processing activities of natural and legal persons under the jurisdiction of the Member States.

  This may include judgments of courts or tribunals or decisions of administrative authorities in third countries requiring a controller or processor to transfer or disclose personal_data, and which are not based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or a Member State.

  The extraterritorial application of those laws, regulations and other legal acts may be in breach of international law and may impede the attainment of the protection of natural persons ensured in the Union by this regulation.

  Transfers should only be allowed where the conditions of this regulation for a transfer to third countries are met.

  This may be the case, inter alia, where disclosure is necessary for an important ground of public interest recognised in Union or Member State law to which the controller is subject.

(116) When personal_data moves across borders outside the Union it may put at increased risk the ability of natural persons to exercise data protection rights in particular to protect themselves from the unlawful use or disclosure of that information.

  At the same time, supervisory authorities may find that they are unable to pursue complaints or conduct investigations relating to the activities outside their borders.

  Their efforts to work together in the cross-border context may also be hampered by insufficient preventative or remedial powers, inconsistent legal regimes, and practical obstacles like resource constraints.

  Therefore, there is a need to promote closer cooperation among data protection supervisory authorities to help them exchange information and carry out investigations with their international counterparts.

  For the purposes of developing international cooperation mechanisms to facilitate and provide international mutual assistance for the enforcement of legislation for the protection of personal_data, the Commission and the supervisory authorities should exchange information and cooperate in activities related to the exercise of their powers with competent authorities in third countries, based on reciprocity and in accordance with this regulation.

(122) Each supervisory_authority should be competent on the territory of its own Member State to exercise the powers and to perform the tasks conferred on it in accordance with this regulation.

  This should cover in particular the processing in the context of the activities of an establishment of the controller or processor on the territory of its own Member State, the processing of personal_data carried out by public authorities or private bodies acting in the public interest, processing affecting data subjects on its territory or processing carried out by a controller or processor not established in the Union when targeting data subjects residing on its territory.

  This should include handling complaints lodged by a data subject, conducting investigations on the application of this regulation and promoting public awareness of the risks, rules, safeguards and rights in relation to the processing of personal_data.

(123) The supervisory authorities should monitor the application of the provisions pursuant to this regulation and contribute to its consistent application throughout the Union, in order to protect natural persons in relation to the processing of their personal_data and to facilitate the free flow of personal_data within the internal market.

  For that purpose, the supervisory authorities should cooperate with each other and with the Commission, without the need for any agreement between Member States on the provision of mutual assistance or on such cooperation.

(124) Where the processing of personal_data takes place in the context of the activities of an establishment of a controller or a processor in the Union and the controller or processor is established in more than one Member State, or where processing taking place in the context of the activities of a single establishment of a controller or processor in the Union substantially affects or is likely to substantially affect data subjects in more than one Member State, the supervisory_authority for the main_establishment of the controller or processor or for the single establishment of the controller or processor should act as lead authority.

  It should cooperate with the other authorities concerned, because the controller or processor has an establishment on the territory of their Member State, because data subjects residing on their territory are substantially affected, or because a complaint has been lodged with them.

  Also where a data subject not residing in that Member State has lodged a complaint, the supervisory_authority with which such complaint has been lodged should also be a supervisory_authority concerned.

  Within its tasks to issue guidelines on any question covering the application of this regulation, the Board should be able to issue guidelines in particular on the criteria to be taken into account in order to ascertain whether the processing in question substantially affects data subjects in more than one Member State and on what constitutes a relevant_and_reasoned_objection.

(125) The lead authority should be competent to adopt binding decisions regarding measures applying the powers conferred on it in accordance with this regulation.

  In its capacity as lead authority, the supervisory_authority should closely involve and coordinate the supervisory authorities concerned in the decision-making process.

  Where the decision is to reject the complaint by the data subject in whole or in part, that decision should be adopted by the supervisory_authority with which the complaint has been lodged.

(126) The decision should be agreed jointly by the lead supervisory_authority and the supervisory authorities concerned and should be directed towards the main or single establishment of the controller or processor and be binding on the controller and processor.

  The controller or processor should take the necessary measures to ensure compliance with this regulation and the implementation of the decision notified by the lead supervisory_authority to the main_establishment of the controller or processor as regards the processing activities in the Union.

(128) The rules on the lead supervisory_authority and the one-stop-shop mechanism should not apply where the processing is carried out by public authorities or private bodies in the public interest.

  In such cases the only supervisory_authority competent to exercise the powers conferred to it in accordance with this regulation should be the supervisory_authority of the Member State where the public authority or private body is established.

(129) In order to ensure consistent monitoring and enforcement of this regulation throughout the Union, the supervisory authorities should have in each Member State the same tasks and effective powers, including powers of investigation, corrective powers and sanctions, and authorisation and advisory powers, in particular in cases of complaints from natural persons, and without prejudice to the powers of prosecutorial authorities under Member State law, to bring infringements of this regulation to the attention of the judicial authorities and engage in legal proceedings.

  Such powers should also include the power to impose a temporary or definitive limitation, including a ban, on processing.

  Member States may specify other tasks related to the protection of personal_data under this regulation.

  The powers of supervisory authorities should be exercised in accordance with appropriate procedural safeguards set out in Union and Member State law, impartially, fairly and within a reasonable time.

  In particular each measure should be appropriate, necessary and proportionate in view of ensuring compliance with this regulation, taking into account the circumstances of each individual case, respect the right of every person to be heard before any individual measure which would affect him or her adversely is taken and avoid superfluous costs and excessive inconveniences for the persons concerned.

  Investigatory powers as regards access to premises should be exercised in accordance with specific requirements in Member State procedural law, such as the requirement to obtain a prior judicial authorisation.

  Each legally binding measure of the supervisory_authority should be in writing, be clear and unambiguous, indicate the supervisory_authority which has issued the measure, the date of issue of the measure, bear the signature of the head, or a member of the supervisory_authority authorised by him or her, give the reasons for the measure, and refer to the right of an effective remedy.

  This should not preclude additional requirements pursuant to Member State procedural law.

  The adoption of a legally binding decision implies that it may give rise to judicial review in the Member State of the supervisory_authority that adopted the decision.

(130) Where the supervisory_authority with which the complaint has been lodged is not the lead supervisory_authority, the lead supervisory_authority should closely cooperate with the supervisory_authority with which the complaint has been lodged in accordance with the provisions on cooperation and consistency laid down in this regulation.

  In such cases, the lead supervisory_authority should, when taking measures intended to produce legal effects, including the imposition of administrative fines, take utmost account of the view of the supervisory_authority with which the complaint has been lodged and which should remain competent to carry out any investigation on the territory of its own Member State in liaison with the competent supervisory_authority.

(131) Where another supervisory_authority should act as a lead supervisory_authority for the processing activities of the controller or processor but the concrete subject matter of a complaint or the possible infringement concerns only processing activities of the controller or processor in the Member State where the complaint has been lodged or the possible infringement detected and the matter does not substantially affect or is not likely to substantially affect data subjects in other Member States, the supervisory_authority receiving a complaint or detecting or being informed otherwise of situations that entail possible infringements of this regulation should seek an amicable settlement with the controller and, if this proves unsuccessful, exercise its full range of powers.

  This should include: specific processing carried out in the territory of the Member State of the supervisory_authority or with regard to data subjects on the territory of that Member State; processing that is carried out in the context of an offer of goods or services specifically aimed at data subjects in the territory of the Member State of the supervisory_authority; or processing that has to be assessed taking into account relevant legal obligations under Member State law.

(133) The supervisory authorities should assist each other in performing their tasks and provide mutual assistance, so as to ensure the consistent application and enforcement of this regulation in the internal market.

  A supervisory_authority requesting mutual assistance may adopt a provisional measure if it receives no response to a request for mutual assistance within one month of the receipt of that request by the other supervisory_authority.

(135) In order to ensure the consistent application of this regulation throughout the Union, a consistency mechanism for cooperation between the supervisory authorities should be established.

  That mechanism should in particular apply where a supervisory_authority intends to adopt a measure intended to produce legal effects as regards processing operations which substantially affect a significant number of data subjects in several Member States.

  It should also apply where any supervisory_authority concerned or the Commission requests that such matter should be handled in the consistency mechanism.

  That mechanism should be without prejudice to any measures that the Commission may take in the exercise of its powers under the Treaties.

(136) In applying the consistency mechanism, the Board should, within a determined period of time, issue an opinion, if a majority of its members so decides or if so requested by any supervisory_authority concerned or the Commission.

  The Board should also be empowered to adopt legally binding decisions where there are disputes between supervisory authorities.

  For that purpose, it should issue, in principle by a two-thirds majority of its members, legally binding decisions in clearly specified cases where there are conflicting views among supervisory authorities, in particular in the cooperation mechanism between the lead supervisory_authority and supervisory authorities concerned on the merits of the case, in particular whether there is an infringement of this regulation.

(139) In order to promote the consistent application of this regulation, the Board should be set up as an independent body of the Union.

  To fulfil its objectives, the Board should have legal personality.

  The Board should be represented by its Chair.

  It should replace the Working Party on the Protection of Individuals with Regard to the Processing of Personal Data established by Directive 95/46/EC.

  It should consist of the head of a supervisory_authority of each Member State and the European Data Protection Supervisor or their respective representatives.

  The Commission should participate in the Board's activities without voting rights and the European Data Protection Supervisor should have specific voting rights.

  The Board should contribute to the consistent application of this regulation throughout the Union, including by advising the Commission, in particular on the level of protection in third countries or international_organisations, and promoting cooperation of the supervisory authorities throughout the Union.

  The Board should act independently when performing its tasks.

(140) The Board should be assisted by a secretariat provided by the European Data Protection Supervisor.

  The staff of the European Data Protection Supervisor involved in carrying out the tasks conferred on the Board by this regulation should perform its tasks exclusively under the instructions of, and report to, the Chair of the Board.

(141) Every data subject should have the right to lodge a complaint with a single supervisory_authority, in particular in the Member State of his or her habitual residence, and the right to an effective judicial remedy in accordance with Article 47 of the Charter if the data subject considers that his or her rights under this regulation are infringed or where the supervisory_authority 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 supervisory_authority should inform the data subject of the progress and the outcome of the complaint within a reasonable period.

  If the case requires further investigation or coordination with another supervisory_authority, intermediate information should be given to the data subject.

  In order to facilitate the submission of complaints, each supervisory_authority should take measures such as providing a complaint submission form which can also be completed electronically, without excluding other means of communication.

(142) 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 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 a supervisory_authority, exercise the right to a judicial remedy on behalf of data subjects or, if provided for in Member State law, exercise the right to receive compensation on behalf of data subjects.

  A Member State may provide for such a body, organisation or association to have the right to lodge a complaint in that Member State, independently of a data subject's mandate, and the right to an effective judicial remedy where it has reasons to consider that the rights of a data subject have been infringed as a result of the processing of personal_data which infringes this regulation.

  That body, organisation or association may not be allowed to claim compensation on a data subject's behalf independently of the data subject's mandate.

(146) The controller or processor should compensate any damage which a person may suffer as a result of processing that infringes this regulation.

  The controller or processor should be exempt from liability if it proves that it is not in any way responsible for the damage.

  The concept of damage should be broadly interpreted in the light of the case-law of the Court of Justice in a manner which fully reflects the objectives of this regulation.

  This is without prejudice to any claims for damage deriving from the violation of other rules in Union or Member State law.

  Processing that infringes this regulation also includes processing that infringes delegated and implementing acts adopted in accordance with this regulation and Member State law specifying rules of this regulation.

  Data subjects should receive full and effective compensation for the damage they have suffered.

  Where controllers or processors are involved in the same processing, each controller or processor should be held liable for the entire damage.

  However, where they are joined to the same judicial proceedings, in accordance with Member State law, compensation may be apportioned according to the responsibility of each controller or processor for the damage caused by the processing, provided that full and effective compensation of the data subject who suffered the damage is ensured.

  Any controller or processor which has paid full compensation may subsequently institute recourse proceedings against other controllers or processors involved in the same processing.

(147) Where specific rules on jurisdiction are contained in this regulation, in particular as regards proceedings seeking a judicial remedy including compensation, against a controller or processor, general jurisdiction rules such as those of regulation (EU) No 1215/2012 of the European Parliament and of the Council (13) should not prejudice the application of such specific rules.

(148) In order to strengthen the enforcement of the rules of this regulation, penalties including administrative fines should be imposed for any infringement of this regulation, in addition to, or instead of appropriate measures imposed by the supervisory_authority pursuant to this regulation.

  In a case of a minor infringement or if the fine likely to be imposed would constitute a disproportionate burden to a natural person, a reprimand may be issued instead of a fine.

  Due regard should however be given to the nature, gravity and duration of the infringement, the intentional character of the infringement, actions taken to mitigate the damage suffered, degree of responsibility or any relevant previous infringements, the manner in which the infringement became known to the supervisory_authority, compliance with measures ordered against the controller or processor, adherence to a code of conduct and any other aggravating or mitigating factor.

  The imposition of penalties including administrative fines should be subject to appropriate procedural safeguards in accordance with the general principles of Union law and the Charter, including effective judicial protection and due process.

(149) Member States should be able to lay down the rules on criminal penalties for infringements of this regulation, including for infringements of national rules adopted pursuant to and within the limits of this regulation.

  Those criminal penalties may also allow for the deprivation of the profits obtained through infringements of this regulation.

  However, the imposition of criminal penalties for infringements of such national rules and of administrative penalties should not lead to a breach of the principle of ne bis in idem, as interpreted by the Court of Justice.

(150) In order to strengthen and harmonise administrative penalties for infringements of this regulation, each supervisory_authority should have the power to impose administrative fines.

  This regulation should indicate infringements and the upper limit and criteria for setting the related administrative fines, which should be determined by the competent supervisory_authority in each individual case, taking into account all relevant circumstances of the specific situation, with due regard in particular to the nature, gravity and duration of the infringement and of its consequences and the measures taken to ensure compliance with the obligations under this regulation and to prevent or mitigate the consequences of the infringement.

  Where administrative fines are imposed on an undertaking, an undertaking should be understood to be an undertaking in accordance with Articles 101 and 102 TFEU for those purposes.

  Where administrative fines are imposed on persons that are not an undertaking, the supervisory_authority should take account of the general level of income in the Member State as well as the economic situation of the person in considering the appropriate amount of the fine.

  The consistency mechanism may also be used to promote a consistent application of administrative fines.

  It should be for the Member States to determine whether and to which extent public authorities should be subject to administrative fines.

  Imposing an administrative fine or giving a warning does not affect the application of other powers of the supervisory authorities or of other penalties under this regulation.

(151) The legal systems of Denmark and Estonia do not allow for administrative fines as set out in this regulation.

  The rules on administrative fines may be applied in such a manner that in Denmark the fine is imposed by competent national courts as a criminal penalty and in Estonia the fine is imposed by the supervisory_authority in the framework of a misdemeanour procedure, provided that such an application of the rules in those Member States has an equivalent effect to administrative fines imposed by supervisory authorities.

  Therefore the competent national courts should take into account the recommendation by the supervisory_authority initiating the fine.

  In any event, the fines imposed should be effective, proportionate and dissuasive.

(152) Where this regulation does not harmonise administrative penalties or where necessary in other cases, for example in cases of serious infringements of this regulation, Member States should implement a system which provides for effective, proportionate and dissuasive penalties.

  The nature of such penalties, criminal or administrative, should be determined by Member State law.

(153) Member States law should reconcile the rules governing freedom of expression and information, including journalistic, academic, artistic and or literary expression with the right to the protection of personal_data pursuant to this regulation.

  The processing of personal_data solely for journalistic purposes, or for the purposes of academic, artistic or literary expression should be subject to derogations or exemptions from certain provisions of this regulation if necessary to reconcile the right to the protection of personal_data with the right to freedom of expression and information, as enshrined in Article 11 of the Charter.

  This should apply in particular to the processing of personal_data in the audiovisual field and in news archives and press libraries.

  Therefore, Member States should adopt legislative measures which lay down the exemptions and derogations necessary for the purpose of balancing those fundamental rights.

  Member States should adopt such exemptions and derogations on general principles, the rights of the data subject, the controller and the processor, the transfer of personal_data to third countries or international_organisations, the independent supervisory authorities, cooperation and consistency, and specific data- processing situations.

  Where such exemptions or derogations differ from one Member State to another, the law of the Member State to which the controller is subject should apply.

  In order to take account of the importance of the right to freedom of expression in every democratic society, it is necessary to interpret notions relating to that freedom, such as journalism, broadly.

(154) This regulation allows the principle of public access to official documents to be taken into account when applying this regulation.

  Public access to official documents may be considered to be in the public interest.

  Personal data in documents held by a public authority or a public body should be able to be publicly disclosed by that authority or body if the disclosure is provided for by Union or Member State law to which the public authority or public body is subject.

  Such laws should reconcile public access to official documents and the reuse of public sector information with the right to the protection of personal_data and may therefore provide for the necessary reconciliation with the right to the protection of personal_data pursuant to this regulation.

  The reference to public authorities and bodies should in that context include all authorities or other bodies covered by Member State law on public access to documents.

  Directive 2003/98/EC of the European Parliament and of the Council (14) leaves intact and in no way affects the level of protection of natural persons with regard to the processing of personal_data under the provisions of Union and Member State law, and in particular does not alter the obligations and rights set out in this regulation.

  In particular, that Directive should not apply to documents to which access is excluded or restricted by virtue of the access regimes on the grounds of protection of personal_data, and parts of documents accessible by virtue of those regimes which contain personal_data the re-use of which has been provided for by law as being incompatible with the law concerning the protection of natural persons with regard to the processing of personal_data.

(156) The processing of personal_data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes should be subject to appropriate safeguards for the rights and freedoms of the data subject pursuant to this regulation.

  Those safeguards should ensure that technical and organisational measures are in place in order to ensure, in particular, the principle of data minimisation.

  The further processing of personal_data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes is to be carried out when the controller has assessed the feasibility to fulfil those purposes by processing data which do not permit or no longer permit the identification of data subjects, provided that appropriate safeguards exist (such as, for instance, pseudonymisation of the data).

  Member States should provide for appropriate safeguards for the processing of personal_data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes.

  Member States should be authorised to provide, under specific conditions and subject to appropriate safeguards for data subjects, specifications and derogations with regard to the information requirements and rights to rectification, to erasure, to be forgotten, to restriction of processing, to data portability, and to object when processing personal_data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes.

  The conditions and safeguards in question may entail specific procedures for data subjects to exercise those rights if this is appropriate in the light of the purposes sought by the specific processing along with technical and organisational measures aimed at minimising the processing of personal_data in pursuance of the proportionality and necessity principles.

  The processing of personal_data for scientific purposes should also comply with other relevant legislation such as on clinical trials.

(158) Where personal_data are processed for archiving purposes, this regulation should also apply to that processing, bearing in mind that this regulation should not apply to deceased persons.

  Public authorities or public or private bodies that hold records of public interest should be services which, pursuant to Union or Member State law, have a legal obligation to acquire, preserve, appraise, arrange, describe, communicate, promote, disseminate and provide access to records of enduring value for general public interest.

  Member States should also be authorised to provide for the further processing of personal_data for archiving purposes, for example with a view to providing specific information related to the political behaviour under former totalitarian state regimes, genocide, crimes against humanity, in particular the Holocaust, or war crimes.

(159) Where personal_data are processed for scientific research purposes, this regulation should also apply to that processing.

  For the purposes of this regulation, the processing of personal_data for scientific research purposes should be interpreted in a broad manner including for example technological development and demonstration, fundamental research, applied research and privately funded research.

  In addition, it should take into account the Union's objective under Article 179(1) TFEU of achieving a European Research Area.

  Scientific research purposes should also include studies conducted in the public interest in the area of public health.

  To meet the specificities of processing personal_data for scientific research purposes, specific conditions should apply in particular as regards the publication or otherwise disclosure of personal_data in the context of scientific research purposes.

  If the result of scientific research in particular in the health context gives reason for further measures in the interest of the data subject, the general rules of this regulation should apply in view of those measures.

(160) Where personal_data are processed for historical research purposes, this regulation should also apply to that processing.

  This should also include historical research and research for genealogical purposes, bearing in mind that this regulation should not apply to deceased persons.

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

(162) Where personal_data are processed for statistical purposes, this regulation should apply to that processing.

  Union or Member State law should, within the limits of this regulation, determine statistical content, control of access, specifications for the processing of personal_data for statistical purposes and appropriate measures to safeguard the rights and freedoms of the data subject and for ensuring statistical confidentiality.

  Statistical purposes mean any operation of collection and the processing of personal_data necessary for statistical surveys or for the production of statistical results.

  Those statistical results may further be used for different purposes, including a scientific research purpose.

  The statistical purpose implies that the result of processing for statistical purposes is not personal_data, but aggregate data, and that this result or the personal_data are not used in support of measures or decisions regarding any particular natural person.

(163) The confidential information which the Union and national statistical authorities collect for the production of official European and official national statistics should be protected.

  European statistics should be developed, produced and disseminated in accordance with the statistical principles as set out in Article 338(2) TFEU, while national statistics should also comply with Member State law.

  regulation (EC) No 223/2009 of the European Parliament and of the Council (16) provides further specifications on statistical confidentiality for European statistics.

(164) As regards the powers of the supervisory authorities to obtain from the controller or processor access to personal_data and access to their premises, Member States may adopt by law, within the limits of this regulation, specific rules in order to safeguard the professional or other equivalent secrecy obligations, in so far as necessary to reconcile the right to the protection of personal_data with an obligation of professional secrecy.

  This is without prejudice to existing Member State obligations to adopt rules on professional secrecy where required by Union law.

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

(166) In order to fulfil the objectives of this regulation, namely to protect the fundamental rights and freedoms of natural persons and in particular their right to the protection of personal_data and to ensure the free movement of personal_data within the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission.

  In particular, delegated acts should be adopted in respect of criteria and requirements for certification mechanisms, information to be presented by standardised icons and procedures for providing such icons.

  It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.

  The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(167) In order to ensure uniform conditions for the implementation of this regulation, implementing powers should be conferred on the Commission when provided for by this regulation.

  Those powers should be exercised in accordance with regulation (EU) No 182/2011.

  In that context, the Commission should consider specific measures for micro, small and medium-sized enterprises.

(170) Since the objective of this regulation, namely to ensure an equivalent level of protection of natural persons and the free flow of personal_data throughout the Union, cannot be sufficiently achieved by the Member States and can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU).

  In accordance with the principle of proportionality as set out in that Article, this regulation does not go beyond what is necessary in order to achieve that objective.

(171) Directive 95/46/EC should be repealed by this regulation.

  Processing already under way on the date of application of this regulation should be brought into conformity with this regulation within the period of two years after which this regulation enters into force.

  Where processing is based on consent pursuant to Directive 95/46/EC, it is not necessary for the data subject to give his or her consent again if the manner in which the consent has been given is in line with the conditions of this regulation, so as to allow the controller to continue such processing after the date of application of this regulation.

  Commission decisions adopted and authorisations by supervisory authorities based on Directive 95/46/EC remain in force until amended, replaced or repealed.

(172) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of regulation (EC) No 45/2001 and delivered an opinion on 7 March 2012 (17).

(173) This regulation should apply to all matters concerning the protection of fundamental rights and freedoms vis-à-vis the processing of personal_data which are not subject to specific obligations with the same objective set out in Directive 2002/58/EC of the European Parliament and of the Council (18), including the obligations on the controller and the rights of natural persons.

  In order to clarify the relationship between this regulation and Directive 2002/58/EC, that Directive should be amended accordingly.

  Once this regulation is adopted, Directive 2002/58/EC should be reviewed in particular in order to ensure consistency with this regulation,