REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 27 April 2016
on the protection of natural persons with regard to
the processing of personal data and on the free movement of such data,
and repealing Directive 95/46/EC (General Data Protection
Regulation)
(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 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),
Having regard to the opinion of the Committee of the Regions (2),
Acting in accordance with the ordinary legislative procedure (3),
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.
(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.
(3)
Directive 95/46/EC of the European Parliament and of the Council (4)
seeks to harmonise the protection of fundamental rights and freedoms of
natural persons in respect of processing activities and to ensure the
free flow of personal data between Member States.
(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.
(5)
The economic and social integration
resulting from the functioning of the internal market has led to a
substantial increase in cross-border flows of personal data. The
exchange of personal data between public and private actors, including
natural persons, associations and undertakings across the Union has
increased. National authorities in the Member States are being
called upon by Union law to cooperate and exchange personal data so as
to be able to perform their duties or carry out tasks on behalf of an
authority in another Member State.
(6)
Rapid technological developments and
globalisation have brought new challenges for the protection of personal
data. The scale of the collection and sharing of personal data has
increased significantly. Technology allows both private companies and
public authorities to make use of personal data on an unprecedented
scale in order to pursue their activities. Natural persons increasingly
make personal information available publicly and globally. Technology
has transformed both the economy and social life, and should further
facilitate the free flow of personal data within the Union and the
transfer to third countries and international organisations, while
ensuring a high level of the protection of personal data.
(7)
Those developments require a strong and
more coherent data protection framework in the Union, backed by strong
enforcement, given the importance of creating the trust that will allow
the digital economy to develop across the internal market. Natural
persons should have control of their own personal data. Legal and
practical certainty for natural persons, economic operators and public
authorities should be enhanced.
(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.
(9)
The objectives and principles of
Directive 95/46/EC remain sound, but it has not prevented fragmentation
in the implementation of data protection across the Union, legal
uncertainty or a widespread public perception that there are significant
risks to the protection of natural persons, in particular with regard
to online activity. Differences in the level of protection of the rights
and freedoms of natural persons, in particular the right to the
protection of personal data, with regard to the processing of personal
data in the Member States may prevent the free flow of personal
data throughout the Union. Those differences may therefore constitute an
obstacle to the pursuit of economic activities at the level of the
Union, distort competition and impede authorities in the discharge of
their responsibilities under Union law. Such a difference in levels of
protection is due to the existence of differences in the implementation
and application of Directive 95/46/EC.
(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.
(11)
Effective protection of personal data
throughout the Union requires the strengthening and setting out in
detail of the rights of data subjects and the obligations of those who
process and determine the processing of personal data, as well as
equivalent powers for monitoring and ensuring compliance with the rules
for the protection of personal data and equivalent sanctions for
infringements in the Member States.
(12)
Article 16(2) TFEU mandates the
European Parliament and the Council to lay down the rules relating to
the protection of natural persons with regard to the processing of
personal data and the rules relating to the free movement of personal
data.
(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.
With regard to the processing of
personal data by those competent authorities for purposes falling
within scope of this Regulation, Member States should be able to
maintain or introduce more specific provisions to adapt the application
of the rules of this Regulation. Such provisions may determine more
precisely specific requirements for the processing of personal data by
those competent authorities for those other purposes, taking into
account the constitutional, organisational and administrative structure
of the respective Member State. When the processing of personal data by
private bodies falls within the scope of this Regulation, this
Regulation should provide for the possibility for Member States
under specific conditions to restrict by law certain obligations and
rights when such a restriction constitutes a necessary and proportionate
measure in a democratic society to safeguard specific important
interests including public security and 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. This is relevant for instance
in the framework of anti-money laundering or the activities of forensic
laboratories.
(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.
(30)
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.
(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.
(32)
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.
(33)
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 the opportunity to give
their consent only to certain areas of research or parts of research
projects to the extent allowed by the intended purpose.
(34)
Genetic data should be defined as
personal data relating to the inherited or acquired genetic
characteristics of a natural person which result from the analysis of a
biological sample from the natural person in question, in particular
chromosomal, deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)
analysis, or from the analysis of another element enabling equivalent
information to be obtained.
(35)
Personal data concerning health should
include all data pertaining to the health status of a data subject which
reveal information relating to the past, current or future physical or
mental health status of the data subject. This includes information
about the natural person collected in the course of the registration
for, or the provision of, health care services as referred to in
Directive 2011/24/EU of the European Parliament and of the Council (9)
to that natural person; a number, symbol or particular assigned to a
natural person to uniquely identify the natural person for health
purposes; information derived from the testing or examination of a body
part or bodily substance, including from genetic data and biological
samples; and any information on, for example, a disease, disability,
disease risk, medical history, clinical treatment or the physiological
or biomedical state of the data subject independent of its source, for
example from a physician or other health professional, a hospital, a
medical device or an in vitro diagnostic test.
(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.
(37)
A group of undertakings should cover a
controlling undertaking and its controlled undertakings, whereby the
controlling undertaking should be the undertaking which can exert a
dominant influence over the other undertakings by virtue, for example,
of ownership, financial participation or the rules which govern it or
the power to have personal data protection rules implemented. An
undertaking which controls the processing of personal data in
undertakings affiliated to it should be regarded, together with those
undertakings, as a group of undertakings.
(38)
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 the use of personal data of children for the
purposes of marketing or creating personality or user profiles and the
collection of personal data with regard to children when using services
offered directly to a child. The consent of the holder of parental
responsibility should not be necessary in the context of preventive or
counselling services offered directly to a child.
(39)
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.
(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.
(42)
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 (10)
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.
(43)
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, in particular
where the controller is a public authority and it is therefore unlikely
that consent was freely given in all the circumstances of that specific
situation. Consent is presumed not to be freely given if it does not
allow separate consent to be given to different personal data processing
operations despite it being appropriate in the individual case, or if
the performance of a contract, including the provision of a service, is
dependent on the consent despite such consent not being necessary for
such performance.
(44)
Processing should be lawful where it is necessary in the context of a contract or the intention to enter into a contract.
(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.
(46)
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.
(47)
The legitimate interests of a
controller, including those of a controller to which the personal data
may be disclosed, or of a third party, may provide a legal basis for
processing, provided that the interests or the fundamental rights and
freedoms of the data subject are not overriding, taking into
consideration the reasonable expectations of data subjects based on
their relationship with the controller. Such legitimate interest could
exist for example where there is a relevant and appropriate relationship
between the data subject and the controller in situations such as where
the data subject is a client or in the service of the controller. At
any rate the existence of a legitimate interest would need careful
assessment including whether a data subject can reasonably expect at the
time and in the context of the collection of the personal data that
processing for that purpose may take place. The interests and
fundamental rights of the data subject could in particular override the
interest of the data controller where personal data are processed in
circumstances where data subjects do not reasonably expect further
processing. Given that it is for the legislator to provide by law for
the legal basis for public authorities to process personal data, that
legal basis should not apply to the processing by public authorities in
the performance of their tasks. The processing of personal data strictly
necessary for the purposes of preventing fraud also constitutes a
legitimate interest of the data controller concerned. The processing of
personal data for direct marketing purposes may be regarded as carried
out for a legitimate interest.
(48)
Controllers that are part of a group of
undertakings or institutions affiliated to a central body may have a
legitimate interest in transmitting personal data within the group of
undertakings for internal administrative purposes, including the
processing of clients’ or employees’ personal data. The general
principles for the transfer of personal data, within a group of
undertakings, to an undertaking located in a third country remain
unaffected.
(49)
The processing of personal data to the
extent strictly necessary and proportionate for the purposes of ensuring
network and information security, i.e. the ability of a network or an
information system to resist, at a given level of confidence, accidental
events or unlawful or malicious actions that compromise the
availability, authenticity, integrity and confidentiality of stored or
transmitted personal data, and the security of the related services
offered by, or accessible via, those networks and systems, by public
authorities, by computer emergency response teams (CERTs), computer
security incident response teams (CSIRTs), by providers of electronic
communications networks and services and by providers of security
technologies and services, constitutes a legitimate interest of the data
controller concerned. This could, for example, include preventing
unauthorised access to electronic communications networks and malicious
code distribution and stopping ‘denial of service’ attacks and damage to
computer and electronic communication systems.
(50)
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 or Member State 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 or Member State
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.
Where the data subject has given
consent or the processing is based on Union or Member State law which
constitutes a necessary and proportionate measure in a democratic
society to safeguard, in particular, important objectives of general
public interest, the controller should be allowed to further process the
personal data irrespective of the compatibility of the purposes. In any
case, the application of the principles set out in this Regulation and
in particular the information of the data subject on those other
purposes and on his or her rights including the right to object, should
be ensured. Indicating possible criminal acts or threats to public
security by the controller and transmitting the relevant personal data
in individual cases or in several cases relating to the same criminal
act or threats to public security to a competent authority should be
regarded as being in the legitimate interest pursued by the controller.
However, such transmission in the legitimate interest of the controller
or further processing of personal data should be prohibited if the
processing is not compatible with a legal, professional or other binding
obligation of secrecy.
(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.
(52)
Derogating from the prohibition on
processing special categories of personal data should also be allowed
when provided for in Union or Member State law and subject to suitable
safeguards, so as to protect personal data and other fundamental rights,
where it is in the public interest to do so, in particular processing
personal data in the field of employment law, social protection law
including pensions and for health security, monitoring and alert
purposes, the prevention or control of communicable diseases and other
serious threats to health. Such a derogation may be made for health
purposes, including public health and the management of health-care
services, especially in order to ensure the quality and
cost-effectiveness of the procedures used for settling claims for
benefits and services in the health insurance system, or for archiving
purposes in the public interest, scientific or historical research
purposes or statistical purposes. A derogation should also allow the
processing of such personal data where necessary for the establishment,
exercise or defence of legal claims, whether in court proceedings or in
an administrative or out-of-court procedure.
(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.
(55)
Moreover, the processing of personal
data by official authorities for the purpose of achieving the aims, laid
down by constitutional law or by international public law, of
officially recognised religious associations, is carried out on grounds
of public interest.
(56)
Where in the course of electoral
activities, the operation of the democratic system in a
Member State requires that political parties compile personal data
on people’s political opinions, the processing of such data may be
permitted for reasons of public interest, provided that appropriate
safeguards are established.
(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.
(58)
The principle of transparency requires
that any information addressed to the public or to the data subject be
concise, easily accessible and easy to understand, and that clear and
plain language and, additionally, where appropriate, visualisation be
used. Such information could be provided in electronic form, for
example, when addressed to the public, through a website. This is of
particular relevance in situations where the proliferation of actors and
the technological complexity of practice make it difficult for the data
subject to know and understand whether, by whom and for what purpose
personal data relating to him or her are being collected, such as in the
case of online advertising. Given that children merit specific
protection, any information and communication, where processing is
addressed to a child, should be in such a clear and plain language that
the child can easily understand.
(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.
(60)
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.
(61)
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.
(62)
However, it is not necessary to impose
the obligation to provide information where the data subject already
possesses the information, where the recording or disclosure of the
personal data is expressly laid down by law or where the provision of
information to the data subject proves to be impossible or would involve
a disproportionate effort. The latter could in particular be the case
where processing is carried out for archiving purposes in the public
interest, scientific or historical research purposes or statistical
purposes. In that regard, the number of data subjects, the age of the
data and any appropriate safeguards adopted should be taken into
consideration.
(63)
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. Where
possible, the controller should be able to provide remote access to a
secure system which would provide the data subject with direct access to
his or her personal data. 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.
(64)
The controller should use all
reasonable measures to verify the identity of a data subject who
requests access, in particular in the context of online services and
online identifiers. A controller should not retain personal data for the
sole purpose of being able to react to potential 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.
(66)
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.
(67)
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.
(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.
(69)
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, or on grounds of the legitimate
interests of a controller or a third party, 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.
(70)
Where personal data are processed for
the purposes of direct marketing, the data subject should have the right
to object to such processing, including profiling to the extent that it
is related to such direct marketing, whether with regard to initial or
further processing, at any time and free of charge. That right should be
explicitly brought to the attention of the data subject and presented
clearly and separately from any other information.
(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.
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 that prevents, 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 that result 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.
(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.
(73)
Restrictions concerning specific
principles and the rights of information, access to and rectification or
erasure of personal data, the right to data portability, the right to
object, decisions based on profiling, as well as the communication of a
personal data breach to a data subject and certain related obligations
of the controllers may be imposed by Union or Member State law, as far
as necessary and proportionate in a democratic society to safeguard
public security, including the protection of human life especially in
response to natural or manmade disasters, the prevention, investigation
and prosecution of criminal offences or the execution of criminal
penalties, including the safeguarding against and the prevention of
threats to public security, or of breaches of ethics for regulated
professions, other important objectives of general public interest of
the Union or of a Member State, in particular an important economic or
financial interest of the Union or of a Member State, the keeping of
public registers kept for reasons of general public interest, further
processing of archived personal data to provide specific information
related to the political behaviour under former totalitarian state
regimes or the protection of the data subject or the rights and freedoms
of others, including social protection, public health and humanitarian
purposes. Those restrictions should be in accordance with the
requirements set out in the Charter and in the European Convention for
the Protection of Human Rights and Fundamental Freedoms.
(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.
(75)
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.
(76)
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.
(77)
Guidance on the implementation of
appropriate measures and on the demonstration of compliance by the
controller or the processor, especially as regards the identification of
the risk related to the processing, their assessment in terms of
origin, nature, likelihood and severity, and the identification of best
practices to mitigate the risk, could be provided in particular by means
of approved codes of conduct, approved certifications, guidelines
provided by the Board or indications provided by a data protection
officer. The Board may also issue guidelines on processing operations
that are considered to be unlikely to result in a high risk to the
rights and freedoms of natural persons and indicate what measures may be
sufficient in such cases to address such risk.
(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.
(85)
A personal data breach may, if not
addressed in an appropriate and timely manner, result in physical,
material or non-material damage to natural persons such as loss of
control over their personal data or limitation of their rights,
discrimination, identity theft or fraud, financial loss, unauthorised
reversal of pseudonymisation, damage to reputation, loss of
confidentiality of personal data protected by professional secrecy or
any other significant economic or social disadvantage to the natural
person concerned. Therefore, as soon as the controller becomes aware
that a personal data breach has occurred, the controller should notify
the personal data breach to the supervisory authority 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, the
reasons for the delay should accompany the notification and information
may be provided in phases without undue further delay.
(86)
The controller should communicate to
the data subject a personal data breach, without undue delay, where that
personal data breach is likely to result in a high risk to the rights
and freedoms of the natural person in order to allow him or her to take
the necessary precautions. The communication should describe the nature
of the personal data breach as well as recommendations for the natural
person concerned to mitigate potential adverse effects. Such
communications to data subjects should be made as soon as reasonably
feasible and in close cooperation with the supervisory authority,
respecting guidance provided by it or by other relevant authorities such
as law-enforcement authorities. For example, the need to mitigate an
immediate risk of damage would call for prompt communication with data
subjects whereas the need to implement appropriate measures against
continuing or similar personal data breaches may justify more time for
communication.
(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.
(88)
In setting detailed rules concerning
the format and procedures applicable to the notification of personal
data breaches, due consideration should be given to the circumstances of
that breach, including whether or not personal data had been protected
by appropriate technical protection measures, effectively limiting the
likelihood of identity fraud or other forms of misuse. Moreover, such
rules and procedures should take into account the legitimate interests
of law-enforcement authorities where early disclosure could
unnecessarily hamper the investigation of the circumstances of a
personal data breach.
(89)
Directive 95/46/EC provided for a
general obligation to notify the processing of personal data to the
supervisory authorities. While that obligation produces administrative
and financial burdens, it did not in all cases contribute to improving
the protection of personal data. Such indiscriminate general
notification obligations should therefore be abolished, and replaced by
effective procedures and mechanisms which focus instead on those types
of processing operations which are likely to result in a high risk to
the rights and freedoms of natural persons by virtue of their nature,
scope, context and purposes. Such types of processing operations may be
those which in, particular, involve using new technologies, or are of a
new kind and where no data protection impact assessment has been carried
out before by the controller, or where they become necessary in the
light of the time that has elapsed since the initial processing.
(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.
(91)
This should in particular apply to
large-scale processing operations which aim to process a considerable
amount of personal data at regional, national or supranational level and
which could affect a large number of data subjects and which are likely
to result in a high risk, for example, on account of their sensitivity,
where in accordance with the achieved state of technological knowledge a
new technology is used on a large scale as well as to other processing
operations which result in a high risk to the rights and freedoms of
data subjects, in particular where those operations render it more
difficult for data subjects to exercise their rights. A data protection
impact assessment should also be made where personal data are processed
for taking decisions regarding specific natural persons following any
systematic and extensive evaluation of personal aspects relating to
natural persons based on profiling those data or following the
processing of special categories of personal data, biometric data, or
data on criminal convictions and offences or related security measures. A
data protection impact assessment is equally required for monitoring
publicly accessible areas on a large scale, especially when using
optic-electronic devices or for any other operations where the competent
supervisory authority considers that the processing is likely to result
in a high risk to the rights and freedoms of data subjects, in
particular because they prevent data subjects from exercising a right or
using a service or a contract, or because they are carried out
systematically on a large scale. The processing of personal data should
not be considered to be on a large scale if the processing concerns
personal data from patients or clients by an individual physician, other
health care professional or lawyer. In such cases, a data protection
impact assessment should not be mandatory.
(92)
There are circumstances under which it
may be reasonable and economical for the subject of a data protection
impact assessment to be broader than a single project, for example where
public authorities or bodies intend to establish a common application
or processing platform or where several controllers plan to introduce a
common application or processing environment across an industry sector
or segment or for a widely used horizontal activity.
(93)
In the context of the adoption of the
Member State law on which the performance of the tasks of the public
authority or public body is based and which regulates the specific
processing operation or set of operations in question, Member States may
deem it necessary to carry out such assessment prior to the processing
activities.
(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.
(95)
The processor should assist the
controller, where necessary and upon request, in ensuring compliance
with the obligations deriving from the carrying out of data protection
impact assessments and from prior consultation of the supervisory
authority.
(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.
(99)
When drawing up a code of conduct, or
when amending or extending such a code, associations and other bodies
representing categories of controllers or processors should consult
relevant stakeholders, including data subjects where feasible, and have
regard to submissions received and views expressed in response to such
consultations.
(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.
(103)
The Commission may decide with effect
for the entire Union that a third country, a territory or specified
sector within a third country, or an international organisation, offers
an adequate level of data protection, thus providing legal certainty and
uniformity throughout the Union as regards the third country or
international organisation which is considered to provide such level of
protection. In such cases, transfers of personal data to that third
country or international organisation may take place without the need to
obtain any further authorisation. The Commission may also decide,
having given notice and a full statement setting out the reasons to the
third country or international organisation, to revoke such a decision.
(104)
In line with the fundamental values on
which the Union is founded, in particular the protection of human
rights, the Commission should, in its assessment of the third country,
or of a territory or specified sector within a third country, take into
account how a particular third country respects the rule of law, access
to justice as well as international human rights norms and standards and
its general and sectoral law, including legislation concerning public
security, defence and national security as well as public order and
criminal law. The adoption of an adequacy decision with regard to a
territory or a specified sector in a third country should take into
account clear and objective criteria, such as specific processing
activities and the scope of applicable legal standards and legislation
in force in the third country. The third country should offer guarantees
ensuring an adequate level of protection essentially equivalent to that
ensured within the Union, in particular where personal data are
processed in one or several specific sectors. In particular, the third
country should ensure effective independent data protection supervision
and should provide for cooperation mechanisms with the Member States’
data protection authorities, and the data subjects should be provided
with effective and enforceable rights and effective administrative and
judicial redress.
(105)
Apart from the international
commitments the third country or international organisation has entered
into, the Commission should take account of obligations arising from the
third country’s or international organisation’s participation in
multilateral or regional systems in particular in relation to the
protection of personal data, as well as the implementation of such
obligations. In particular, the third country’s accession to the Council
of Europe Convention of 28 January 1981 for the Protection of
Individuals with regard to the Automatic Processing of Personal Data
and its Additional Protocol should be taken into account. The Commission
should consult the Board when assessing the level of protection in
third countries or international organisations.
(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.
(108)
In the absence of an adequacy decision,
the controller or processor should take measures to compensate for the
lack of data protection in a third country by way of appropriate
safeguards for the data subject. Such appropriate safeguards may consist
of making use of binding corporate rules, standard data protection
clauses adopted by the Commission, standard data protection clauses
adopted by a supervisory authority or contractual clauses authorised by a
supervisory authority. Those safeguards should ensure compliance with
data protection requirements and the rights of the data subjects
appropriate to processing within the Union, including the availability
of enforceable data subject rights and of effective legal remedies,
including to obtain effective administrative or judicial redress and to
claim compensation, in the Union or in a third country. They should
relate in particular to compliance with the general principles relating
to personal data processing, the principles of data protection by design
and by default. Transfers may also be carried out by public authorities
or bodies with public authorities or bodies in third countries or with
international organisations with corresponding duties or functions,
including on the basis of provisions to be inserted into administrative
arrangements, such as a memorandum of understanding, providing for
enforceable and effective rights for data subjects. Authorisation by the
competent supervisory authority should be obtained when the safeguards
are provided for in administrative arrangements that are not legally
binding.
(109)
The possibility for the controller or
processor to use standard data-protection clauses adopted by the
Commission or by a supervisory authority 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 a
supervisory authority 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 protection clauses.
(110)
A group of undertakings, or a group of
enterprises engaged in a joint economic activity, should be able to make
use of approved binding corporate rules for its international transfers
from the Union to organisations within the same group of undertakings,
or group of enterprises engaged in a joint economic activity, provided
that such corporate rules include all essential principles and
enforceable rights to ensure appropriate safeguards for transfers or
categories of transfers of personal data.
(111)
Provisions should be made for the
possibility for transfers in certain circumstances where the data
subject has given his or her explicit consent, where the transfer is
occasional and necessary in relation to a contract or a legal claim,
regardless of whether in a judicial procedure or whether in an
administrative or any out-of-court procedure, including procedures
before regulatory bodies. Provision should also be made for the
possibility for transfers where important grounds of public interest
laid down by Union or Member State law so require or where the
transfer is made from a register established by law and intended for
consultation by the public or persons having a legitimate interest. In
the latter case, such a transfer should not involve the entirety of the
personal data or entire categories of the data contained in the register
and, when the register is intended for consultation by persons having a
legitimate interest, the transfer should be made only at the request of
those persons or, if they are to be the recipients, taking into full
account the interests and fundamental rights of the data subject.
(112)
Those derogations should in particular
apply to data transfers required and necessary for important reasons of
public interest, for example in cases of international data exchange
between competition authorities, tax or customs administrations, between
financial supervisory authorities, between services competent for
social security matters, or for public health, for example in the case
of contact tracing for contagious diseases or in order to reduce and/or
eliminate doping in sport. A transfer of personal data should also be
regarded as lawful where it is necessary to protect an interest which is
essential for the data subject’s or another person’s vital interests,
including physical integrity or life, if the data subject is incapable
of giving consent. In the absence of an adequacy decision, Union or
Member State law may, for important reasons of public interest,
expressly set limits to the transfer of specific categories of data to a
third country or an international organisation. Member States
should notify such provisions to the Commission. Any transfer to an
international humanitarian organisation of personal data of a data
subject who is physically or legally incapable of giving consent, with a
view to accomplishing a task incumbent under the Geneva Conventions or
to complying with international humanitarian law applicable in armed
conflicts, could be considered to be necessary for an important reason
of public interest or because it is in the vital interest of the data
subject.
(113)
Transfers which can be qualified as not
repetitive and that only concern a limited number of data subjects,
could also be possible for the purposes of the compelling legitimate
interests pursued by the controller, when those interests are not
overridden by the interests or rights and freedoms of the data subject
and when the controller has assessed all the circumstances surrounding
the data transfer. The controller should give particular consideration
to the nature of the personal data, the purpose and duration of the
proposed processing operation or operations, as well as the situation in
the country of origin, the third country and the country of final
destination, and should provide suitable safeguards to protect
fundamental rights and freedoms of natural persons with regard to the
processing of their personal data. Such transfers should be possible
only in residual cases where none of the other grounds for transfer are
applicable. For scientific or historical research purposes or
statistical purposes, the legitimate expectations of society for an
increase of knowledge should be taken into consideration. The controller
should inform the supervisory authority and the data subject about the
transfer.
(114)
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.
(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.
(117)
The establishment of supervisory
authorities in Member States, empowered to perform their tasks and
exercise their powers with complete independence, is an essential
component of the protection of natural persons with regard to the
processing of their personal data. Member States should be able to
establish more than one supervisory authority, to reflect their
constitutional, organisational and administrative structure.
(118)
The independence of supervisory
authorities should not mean that the supervisory authorities cannot be
subject to control or monitoring mechanisms regarding their financial
expenditure or to judicial review.
(119)
Where a Member State establishes
several supervisory authorities, it should establish by law mechanisms
for ensuring the effective participation of those supervisory
authorities in the consistency mechanism. That Member State should in
particular designate the supervisory authority which functions as a
single contact point for the effective participation of those
authorities in the mechanism, to ensure swift and smooth cooperation
with other supervisory authorities, the Board and the Commission.
(120)
Each supervisory authority should be
provided with the financial and human resources, premises and
infrastructure necessary for the effective performance of their tasks,
including those related to mutual assistance and cooperation with other
supervisory authorities throughout the Union. Each supervisory authority
should have a separate, public annual budget, which may be part of the
overall state or national budget.
(121)
The general conditions for the member
or members of the supervisory authority should be laid down by law in
each Member State and should in particular provide that those
members are to be appointed, by means of a transparent procedure, either
by the parliament, government or the head of State of the Member State
on the basis of a proposal from the government, a member of the
government, the parliament or a chamber of the parliament, or by an
independent body entrusted under Member State law. In order to
ensure the independence of the supervisory authority, the member or
members should act with integrity, refrain from any action that is
incompatible with their duties and should not, during their term of
office, engage in any incompatible occupation, whether gainful or not.
The supervisory authority should have its own staff, chosen by the
supervisory authority or an independent body established by
Member State law, which should be subject to the exclusive
direction of the member or members of the supervisory authority.
(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.
(127)
Each supervisory authority not acting
as the lead supervisory authority should be competent to handle local
cases where the controller or processor is established in more than one
Member State, but the subject matter of the specific processing concerns
only processing carried out in a single Member State and involves
only data subjects in that single Member State, for example, where the
subject matter concerns the processing of employees’ personal data in
the specific employment context of a Member State. In such cases, the
supervisory authority should inform the lead supervisory authority
without delay about the matter. After being informed, the lead
supervisory authority should decide, whether it will handle the case
pursuant to the provision on cooperation between the lead supervisory
authority and other supervisory authorities concerned (‘one-stop-shop
mechanism’), or whether the supervisory authority which informed it
should handle the case at local level. When deciding whether it will
handle the case, the lead supervisory authority should take into account
whether there is an establishment of the controller or processor in the
Member State of the supervisory authority which informed it in order to
ensure effective enforcement of a decision vis-a-vis
the controller or processor. Where the lead supervisory authority
decides to handle the case, the supervisory authority which informed it
should have the possibility to submit a draft for a decision, of which
the lead supervisory authority should take utmost account when preparing
its draft decision in that one-stop-shop mechanism.
(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.
(132)
Awareness-raising activities by
supervisory authorities addressed to the public should include specific
measures directed at controllers and processors, including micro, small
and medium-sized enterprises, as well as natural persons in particular
in the educational context.
(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.
(134)
Each supervisory authority should,
where appropriate, participate in joint operations with other
supervisory authorities. The requested supervisory authority should be
obliged to respond to the request within a specified time period.
(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.
(137)
There may be an urgent need to act in
order to protect the rights and freedoms of data subjects, in particular
when the danger exists that the enforcement of a right of a data
subject could be considerably impeded. A supervisory authority should
therefore be able to adopt duly justified provisional measures on its
territory with a specified period of validity which should not exceed
three months.
(138)
The application of such mechanism
should be a condition for the lawfulness of a measure intended to
produce legal effects by a supervisory authority in those cases where
its application is mandatory. In other cases of cross-border relevance,
the cooperation mechanism between the lead supervisory authority and
supervisory authorities concerned should be applied and mutual
assistance and joint operations might be carried out between the
supervisory authorities concerned on a bilateral or multilateral basis
without triggering the consistency mechanism.
(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.
(143)
Any natural or legal person has the
right to bring an action for annulment of decisions of the Board before
the Court of Justice under the conditions provided for in
Article 263 TFEU. As addressees of such decisions, the
supervisory authorities concerned which wish to challenge them have to
bring action within two months of being notified of them, in accordance
with Article 263 TFEU. Where decisions of the Board are of direct
and individual concern to a controller, processor or complainant, the
latter may bring an action for annulment against those decisions within
two months of their publication on the website of the Board, in
accordance with Article 263 TFEU. Without prejudice to this
right under Article 263 TFEU, each natural or legal person
should have an effective judicial remedy before the competent national
court against a decision of a supervisory authority which produces legal
effects concerning that person. Such a decision concerns in particular
the exercise of investigative, corrective and authorisation powers by
the supervisory authority or the dismissal or rejection of complaints.
However, the right to an effective judicial remedy does not encompass
measures taken by supervisory authorities which are not legally binding,
such as opinions issued by or advice provided by the supervisory
authority. Proceedings against a supervisory authority should be brought
before the courts of the Member State where the supervisory authority
is established and should be conducted in accordance with that
Member State’s procedural law. Those courts should exercise full
jurisdiction, which should include jurisdiction to examine all questions
of fact and law relevant to the dispute before them.
Where a complaint has been rejected or
dismissed by a supervisory authority, the complainant may bring
proceedings before the courts in the same Member State. In the context
of judicial remedies relating to the application of this Regulation,
national courts which consider a decision on the question necessary to
enable them to give judgment, may, or in the case provided for in
Article 267 TFEU, must, request the Court of Justice to give a
preliminary ruling on the interpretation of Union law, including this
Regulation. Furthermore, where a decision of a supervisory authority
implementing a decision of the Board is challenged before a national
court and the validity of the decision of the Board is at issue, that
national court does not have the power to declare the Board’s decision
invalid but must refer the question of validity to the Court of Justice
in accordance with Article 267 TFEU as interpreted by the
Court of Justice, where it considers the decision invalid. However, a
national court may not refer a question on the validity of the decision
of the Board at the request of a natural or legal person which had the
opportunity to bring an action for annulment of that decision, in
particular if it was directly and individually concerned by that
decision, but had not done so within the period laid down in
Article 263 TFEU.
(144)
Where a court seized of proceedings
against a decision by a supervisory authority has reason to believe that
proceedings concerning the same processing, such as the same subject
matter as regards processing by the same controller or processor, or the
same cause of action, are brought before a competent court in another
Member State, it should contact that court in order to confirm the
existence of such related proceedings. If related proceedings are
pending before a court in another Member State, any court other
than the court first seized may stay its proceedings or may, on request
of one of the parties, decline jurisdiction in favour of the court first
seized if that court has jurisdiction over the proceedings in question
and its law permits the consolidation of such related proceedings.
Proceedings are deemed to be related where they are so closely connected
that it is expedient to hear and determine them together in order to
avoid the risk of irreconcilable judgments resulting from separate
proceedings.
(145)
For proceedings against a controller or
processor, the plaintiff should have the choice to bring the action
before the courts of the Member States where the controller or
processor has an establishment or where the data subject resides, unless
the controller is a public authority of a Member State acting in
the exercise of its public powers.
(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.
(155)
Member State law or collective
agreements, including ‘works agreements’, may provide for specific rules
on the processing of employees’ personal data in the employment
context, in particular for the conditions under which personal data in
the employment context may be processed on the basis of the consent of
the employee, the purposes of the recruitment, the performance of the
contract of employment, including discharge of obligations laid down by
law or by collective agreements, management, planning and organisation
of work, equality and diversity in the workplace, health and safety at
work, and for the purposes of the exercise and enjoyment, on an
individual or collective basis, of rights and benefits related to
employment, and for the purpose of the termination of the employment
relationship.
(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.
(157)
By coupling information from
registries, researchers can obtain new knowledge of great value with
regard to widespread medical conditions such as cardiovascular disease,
cancer and depression. On the basis of registries, research results can
be enhanced, as they draw on a larger population. Within social science,
research on the basis of registries enables researchers to obtain
essential knowledge about the long-term correlation of a number of
social conditions such as unemployment and education with other life
conditions. Research results obtained through registries provide solid,
high-quality knowledge which can provide the basis for the formulation
and implementation of knowledge-based policy, improve the quality of
life for a number of people and improve the efficiency of social
services. In order to facilitate scientific research, personal data can
be processed for scientific research purposes, subject to appropriate
conditions and safeguards set out in Union or Member State law.
(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.
(168)
The examination procedure should be
used for the adoption of implementing acts on standard contractual
clauses between controllers and processors and between processors; codes
of conduct; technical standards and mechanisms for certification; the
adequate level of protection afforded by a third country, a territory or
a specified sector within that third country, or an international
organisation; standard protection clauses; formats and procedures for
the exchange of information by electronic means between controllers,
processors and supervisory authorities for binding corporate rules;
mutual assistance; and arrangements for the exchange of information by
electronic means between supervisory authorities, and between
supervisory authorities and the Board.
(169)
The Commission should adopt immediately
applicable implementing acts where available evidence reveals that a
third country, a territory or a specified sector within that third
country, or an international organisation does not ensure an adequate
level of protection, and imperative grounds of urgency so require.
(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-a-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,
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 and rules relating to the free movement of
personal data.
2. This Regulation protects
fundamental rights and freedoms of natural persons and in particular
their right to the protection of personal data.
3. The free movement of personal
data within the Union shall be neither restricted nor prohibited for
reasons connected with the protection of natural persons with regard to
the processing of personal data.
Article 2
Material scope
1. This Regulation applies to the
processing of personal data wholly or partly by automated means and to
the processing other than by automated means of personal data which form
part of a filing system or are intended to form part of a filing
system.
2. This Regulation does not apply to the processing of personal data:
(a)
in the course of an activity which falls outside the scope of Union law;
(b)
by the Member States when carrying out activities which fall within the scope of Chapter 2 of Title V of the TEU;
(c)
by a natural person in the course of a purely personal or household activity;
(d)
by competent authorities for the
purposes of the prevention, investigation, detection or prosecution of
criminal offences or the execution of criminal penalties, including the
safeguarding against and the prevention of threats to public security.
3. For the processing of personal
data by the Union institutions, bodies, offices and agencies, Regulation
(EC) No 45/2001 applies. Regulation (EC) No 45/2001 and other Union
legal acts applicable to such processing of personal data shall be
adapted to the principles and rules of this Regulation in accordance
with Article 98.
4. This Regulation shall be
without prejudice to the application of Directive 2000/31/EC, in
particular of the liability rules of intermediary service providers in
Articles 12 to 15 of that Directive.
Article 3
Territorial scope
1. This Regulation applies to the
processing of personal data in the context of the activities of an
establishment of a controller or a processor in the Union, regardless of
whether the processing takes place in the Union or not.
2. This Regulation applies to the
processing of personal data of data subjects who are in the Union by a
controller or processor not established in the Union, where the
processing activities are related to:
(a)
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
(b)
the monitoring of their behaviour as far as their behaviour takes place within the Union.
3. This Regulation applies to the
processing of personal data by a controller not established in the
Union, but in a place where Member State law applies by virtue of
public international law.
Article 4
Definitions
For the purposes of this Regulation:
(1)
‘personal data’ means any information
relating to an identified or identifiable natural person (‘data
subject’); an identifiable natural person is one who can be identified,
directly or indirectly, in particular by reference to an identifier such
as a name, an identification number, location data, an online
identifier or to one or more factors specific to the physical,
physiological, genetic, mental, economic, cultural or social identity of
that natural person;
(2)
‘processing’ means any operation or set
of operations which is performed on personal data or on sets of
personal data, whether or not by automated means, such as collection,
recording, organisation, structuring, storage, adaptation or alteration,
retrieval, consultation, use, disclosure by transmission, dissemination
or otherwise making available, alignment or combination, restriction,
erasure or destruction;
(3)
‘restriction of processing’ means the marking of stored personal data with the aim of limiting their processing in the future;
(4)
‘profiling’ means any form of automated
processing of personal data consisting of the use of personal data to
evaluate certain personal aspects relating to a natural person, in
particular to analyse or predict aspects concerning that natural
person’s performance at work, economic situation, health, personal
preferences, interests, reliability, behaviour, location or movements;
(5)
‘pseudonymisation’ means the processing
of personal data in such a manner that the personal data can no longer
be attributed to a specific data subject without the use of additional
information, provided that such additional information is kept
separately and is subject to technical and organisational measures to
ensure that the personal data are not attributed to an identified or
identifiable natural person;
(6)
‘filing system’ means any structured
set of personal data which are accessible according to specific
criteria, whether centralised, decentralised or dispersed on a
functional or geographical basis;
(7)
‘controller’ means the natural or legal
person, public authority, agency or other body which, alone or jointly
with others, determines the purposes and means of the processing of
personal data; where the purposes and means of such processing are
determined by Union or Member State law, the controller or the specific
criteria for its nomination may be provided for by Union or
Member State law;
(8)
‘processor’ means a natural or legal
person, public authority, agency or other body which processes personal
data on behalf of the controller;
(9)
‘recipient’ means a natural or legal
person, public authority, agency or another body, to which the personal
data are disclosed, whether a third party or not. However, public
authorities which may receive personal data in the framework of a
particular inquiry in accordance with Union or Member State
law shall not be regarded as recipients; the processing of those
data by those public authorities shall be in compliance with the
applicable data protection rules according to the purposes of the
processing;
(10)
‘third party’ means a natural or legal
person, public authority, agency or body other than the data subject,
controller, processor and persons who, under the direct authority of the
controller or processor, are authorised to process personal data;
(11)
‘consent’ of the data subject means any
freely given, specific, informed and unambiguous indication of the data
subject’s wishes by which he or she, by a statement or by a clear
affirmative action, signifies agreement to the processing of personal
data relating to him or her;
(12)
‘personal data breach’ means a breach
of security leading to the accidental or unlawful destruction, loss,
alteration, unauthorised disclosure of, or access to, personal data
transmitted, stored or otherwise processed;
(13)
‘genetic data’ means personal data
relating to the inherited or acquired genetic characteristics of a
natural person which give unique information about the physiology or the
health of that natural person and which result, in particular, from an
analysis of a biological sample from the natural person in question;
(14)
‘biometric data’ means personal data
resulting from specific technical processing relating to the physical,
physiological or behavioural characteristics of a natural person, which
allow or confirm the unique identification of that natural person, such
as facial images or dactyloscopic data;
(15)
‘data concerning health’ means personal
data related to the physical or mental health of a natural person,
including the provision of health care services, which reveal
information about his or her health status;
(16)
‘main establishment’ means:
(a)
as regards a controller
with establishments in more than one Member State, the place of its
central administration in the Union, unless the decisions on the
purposes and means of the processing of personal data are taken in
another establishment of the controller in the Union and the latter
establishment has the power to have such decisions implemented, in which
case the establishment having taken such decisions is to be considered
to be the main establishment;
(b)
as regards a processor with
establishments in more than one Member State, the place of its central
administration in the Union, or, if the processor has no central
administration in the Union, the establishment of the processor in the
Union where the main processing activities in the context of the
activities of an establishment of the processor take place to the extent
that the processor is subject to specific obligations under this
Regulation;
(17)
‘representative’ means a natural or
legal person established in the Union who, designated by the controller
or processor in writing pursuant to Article 27, represents the
controller or processor with regard to their respective obligations
under this Regulation;
(18)
‘enterprise’ means a natural or legal
person engaged in an economic activity, irrespective of its legal form,
including partnerships or associations regularly engaged in an economic
activity;
(19)
‘group of undertakings’ means a controlling undertaking and its controlled undertakings;
(20)
‘binding corporate rules’ means
personal data protection policies which are adhered to by a controller
or processor established on the territory of a Member State for
transfers or a set of transfers of personal data to a controller or
processor in one or more third countries within a group of undertakings,
or group of enterprises engaged in a joint economic activity;
(21)
‘supervisory authority’ means an
independent public authority which is established by a Member State
pursuant to Article 51;
(22)
‘supervisory authority concerned’ means a supervisory authority which is concerned by the processing of personal data because:
(a)
the controller or processor is established on the territory of the Member State of that supervisory authority;
(b)
data subjects residing in
the Member State of that supervisory authority are substantially
affected or likely to be substantially affected by the processing; or
(c)
a complaint has been lodged with that supervisory authority;
(23)
‘cross-border processing’ means either:
(a)
processing of personal data
which takes place in the context of the activities of establishments in
more than one Member State of a controller or processor in the
Union where the controller or processor is established in more than one
Member State; or
(b)
processing of personal data
which takes place in the context of the activities of a single
establishment of a controller or processor in the Union but which
substantially affects or is likely to substantially affect data subjects
in more than one Member State.
(24)
‘relevant and reasoned objection’ means
an objection to a draft decision as to whether there is an infringement
of this Regulation, or whether envisaged action in relation to the
controller or processor complies with this Regulation, which clearly
demonstrates the significance of the risks posed by the draft decision
as regards the fundamental rights and freedoms of data subjects and,
where applicable, the free flow of personal data within the Union;
(25)
‘information society service’ means a
service as defined in point (b) of Article 1(1) of Directive
(EU) 2015/1535 of the European Parliament and of the Council (19);
(26)
‘international organisation’ means an
organisation and its subordinate bodies governed by public international
law, or any other body which is set up by, or on the basis of, an
agreement between two or more countries.
CHAPTER II
Principles
Article 5
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
89(1), 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 89(1) 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 6
Lawfulness of processing
1. Processing shall be lawful only if and to the extent that at least one of the following applies:
(a)
the data subject has given consent to the processing of his or her personal data for one or more specific purposes;
(b)
processing is necessary for the
performance of a contract to which the data subject is party or in order
to take steps at the request of the data subject prior to entering into
a contract;
(c)
processing is necessary for compliance with a legal obligation to which the controller is subject;
(d)
processing is necessary in order to protect the vital interests of the data subject or of another natural person;
(e)
processing is necessary for the
performance of a task carried out in the public interest or in the
exercise of official authority vested in the controller;
(f)
processing is necessary for the
purposes of the legitimate interests pursued by the controller or by a
third party, except where such interests are overridden by the interests
or fundamental rights and freedoms of the data subject which require
protection of personal data, in particular where the data subject is a
child.
Point (f) of the first subparagraph shall not apply
to processing carried out by public authorities in the performance of
their tasks.
2. Member States may maintain or
introduce more specific provisions to adapt the application of the rules
of this Regulation with regard to processing for compliance with
points (c) and (e) of paragraph 1 by determining more
precisely specific requirements for the processing and other measures to
ensure lawful and fair processing including for other specific
processing situations as provided for in Chapter IX.
3. The basis for the processing referred to in point (c) and (e) of paragraph 1 shall be laid down by:
(a)
Union law; or
(b)
Member State law to which the controller is subject.
The purpose of the processing shall be determined
in that legal basis or, as regards the processing referred to in point
(e) of paragraph 1, shall be necessary for the performance of a task
carried out in the public interest or in the exercise of official
authority vested in the controller. That legal basis may contain
specific provisions to adapt the application of rules of this
Regulation, inter alia: the general conditions governing the lawfulness
of processing by the controller; the types of data which are subject to
the processing; the data subjects concerned; the entities to, and the
purposes for which, the personal data may be disclosed; the purpose
limitation; storage periods; and processing operations and processing
procedures, including measures to ensure lawful and fair processing such
as those for other specific processing situations as provided for in
Chapter IX. The Union or the Member State law shall meet an
objective of public interest and be proportionate to the legitimate aim
pursued.
4. Where the processing for a
purpose other than that for which the personal data have been collected
is not based on the data subject’s consent or on a Union or
Member State law which constitutes a necessary and proportionate
measure in a democratic society to safeguard the objectives referred to
in Article 23(1), the controller shall, in order to ascertain whether
processing for another purpose is compatible with the purpose for which
the personal data are initially collected, take into account, inter
alia:
(a)
any link between the purposes for which
the personal data have been collected and the purposes of the intended
further processing;
(b)
the context in which the personal data
have been collected, in particular regarding the relationship between
data subjects and the controller;
(c)
the nature of the personal data, in
particular whether special categories of personal data are processed,
pursuant to Article 9, or whether personal data related to criminal
convictions and offences are processed, pursuant to Article 10;
(d)
the possible consequences of the intended further processing for data subjects;
(e)
the existence of appropriate safeguards, which may include encryption or pseudonymisation.
Article 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 child’s consent in relation to information society services
1. Where point (a) of Article 6(1)
applies, in relation to the offer of information society services
directly to a child, the processing of the personal data of a child
shall be lawful where the child is at least 16 years old. Where the
child is below the age of 16 years, such processing shall be lawful only
if and to the extent that consent is given or authorised by the holder
of parental responsibility over the child.
Member States may provide by law for a lower age for those purposes provided that such lower age is not below 13 years.
2. The controller shall make
reasonable efforts to verify in such cases that consent is given or
authorised by the holder of parental responsibility over the child,
taking into consideration available technology.
3. Paragraph 1 shall not affect
the general contract law of Member States such as the rules on the
validity, formation or effect of a contract in relation to a child.
Article 9
Processing of special categories of personal data
1. Processing of personal data
revealing racial or ethnic origin, political opinions, religious or
philosophical beliefs, or trade union membership, and the processing of
genetic data, biometric data for the purpose of uniquely identifying a
natural person, data concerning health or data concerning a natural
person’s sex life or sexual orientation shall be prohibited.
2. Paragraph 1 shall not apply if one of the following applies:
(a)
the data subject has given explicit
consent to the processing of those personal data for one or more
specified purposes, except where Union or Member State law provide
that the prohibition referred to in paragraph 1 may not be lifted by the
data subject;
(b)
processing is necessary for the
purposes of carrying out the obligations and exercising specific rights
of the controller or of the data subject in the field of employment and
social security and social protection law in so far as it is authorised
by Union or Member State law or a collective agreement pursuant to
Member State law providing for appropriate safeguards for the
fundamental rights and the interests of the data subject;
(c)
processing is necessary to protect the
vital interests of the data subject or of another natural person where
the data subject is physically or legally incapable of giving consent;
(d)
processing is carried out in the course
of its legitimate activities with appropriate safeguards by a
foundation, association or any other not-for-profit body with a
political, philosophical, religious or trade union aim and on condition
that the processing relates solely to the members or to former members
of the body or to persons who have regular contact with it in connection
with its purposes and that the personal data are not disclosed outside
that body without the consent of the data subjects;
(e)
processing relates to personal data which are manifestly made public by the data subject;
(f)
processing is necessary for the
establishment, exercise or defence of legal claims or whenever courts
are acting in their judicial capacity;
(g)
processing is necessary for reasons of
substantial public interest, on the basis of Union or Member State law
which shall be proportionate to the aim pursued, respect the essence of
the right to data protection and provide for suitable and specific
measures to safeguard the fundamental rights and the interests of the
data subject;
(h)
processing is necessary for the
purposes of preventive or occupational medicine, for the assessment of
the working capacity of the employee, medical diagnosis, the provision
of health or social care or treatment or the management of health or
social care systems and services on the basis of Union or
Member State law or pursuant to contract with a health professional
and subject to the conditions and safeguards referred to in
paragraph 3;
(i)
processing is necessary for reasons of
public interest in the area of public health, such as protecting against
serious cross-border threats to health or ensuring high standards of
quality and safety of health care and of medicinal products or medical
devices, on the basis of Union or Member State law which provides
for suitable and specific measures to safeguard the rights and freedoms
of the data subject, in particular professional secrecy;
(j)
processing is necessary for archiving
purposes in the public interest, scientific or historical research
purposes or statistical purposes in accordance with Article 89(1)
based on Union or Member State law which shall be proportionate to the
aim pursued, respect the essence of the right to data protection and
provide for suitable and specific measures to safeguard the fundamental
rights and the interests of the data subject.
3. Personal data referred to in
paragraph 1 may be processed for the purposes referred to in
point (h) of paragraph 2 when those data are processed by or
under the responsibility of a professional subject to the obligation of
professional secrecy under Union or Member State law or rules
established by national competent bodies or by another person also
subject to an obligation of secrecy under Union or Member State law
or rules established by national competent bodies.
4. Member States may maintain or
introduce further conditions, including limitations, with regard to the
processing of genetic data, biometric data or data concerning health.
Article 10
Processing of personal data relating to criminal convictions and offences
Processing of personal data relating to criminal
convictions and offences or related security measures based on
Article 6(1) shall be carried out only under the control of
official authority or when the processing is authorised by Union or
Member State law providing for appropriate safeguards for the
rights and freedoms of data subjects. Any comprehensive register of
criminal convictions shall be kept only under the control of official
authority.
Article 11
Processing which does not require identification
1. If the purposes for which a
controller processes personal data do not or do no longer require the
identification of a data subject by the controller, the controller shall
not be obliged to maintain, acquire or process additional information
in order to identify the data subject for the sole purpose of complying
with this Regulation.
2. Where, in cases referred to in
paragraph 1 of this Article, the controller is able to demonstrate that
it is not in a position to identify the data subject, the controller
shall inform the data subject accordingly, if possible. In such cases,
Articles 15 to 20 shall not apply except where the data subject, for the
purpose of exercising his or her rights under those articles, provides
additional information enabling his or her identification.
CHAPTER III
Rights of the data subject
Article 12
Transparent information, communication and modalities for the exercise of the rights of the data subject
1. The controller shall take
appropriate measures to provide any information referred to in
Articles 13 and 14 and any communication under Articles 15 to 22
and 34 relating to processing to the data subject in a concise,
transparent, intelligible and easily accessible form, using clear and
plain language, in particular for any information addressed specifically
to a child. The information shall be provided in writing, or by other
means, including, where appropriate, by electronic means. When requested
by the data subject, the information may be provided orally, provided
that the identity of the data subject is proven by other means.
2. The controller shall facilitate
the exercise of data subject rights under Articles 15 to 22. In
the cases referred to in Article 11(2), the controller shall not refuse
to act on the request of the data subject for exercising his or her
rights under Articles 15 to 22, unless the controller demonstrates that
it is not in a position to identify the data subject.
3. The controller shall provide
information on action taken on a request under Articles 15
to 22 to the data subject without undue delay and in any event
within one month of receipt of the request. That period may be extended
by two further months where necessary, taking into account the
complexity and number of the requests. The controller shall inform the
data subject of any such extension within one month of receipt of the
request, together with the reasons for the delay. Where the data subject
makes the request by electronic form means, the information shall be
provided by electronic means where possible, unless otherwise requested
by the data subject.
4. If the controller does not take
action on the request of the data subject, the controller shall inform
the data subject without delay and at the latest within one month of
receipt of the request of the reasons for not taking action and on the
possibility of lodging a complaint with a supervisory authority and
seeking a judicial remedy.
5. Information provided under
Articles 13 and 14 and any communication and any actions taken under
Articles 15 to 22 and 34 shall be provided free of charge. Where
requests from a data subject are manifestly unfounded or excessive, in
particular because of their repetitive character, the controller may
either:
(a)
charge a reasonable fee taking into
account the administrative costs of providing the information or
communication or taking the action requested; or
(b)
refuse to act on the request.
The controller shall bear the burden of demonstrating the manifestly unfounded or excessive character of the request.
6. Without prejudice to Article
11, where the controller has reasonable doubts concerning the identity
of the natural person making the request referred to in Articles 15 to
21, the controller may request the provision of additional information
necessary to confirm the identity of the data subject.
7. The information to be provided
to data subjects pursuant to Articles 13 and 14 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 shall be machine-readable.
8. The Commission shall be
empowered to adopt delegated acts in accordance with Article 92 for
the purpose of determining the information to be presented by the icons
and the procedures for providing standardised icons.
Article 13
Information to be provided where personal data are collected from the data subject
1. Where personal data relating to
a data subject are collected from the data subject, the controller
shall, at the time when personal data are obtained, provide the data
subject with all of the following information:
(a)
the identity and the contact details of the controller and, where applicable, of the controller’s representative;
(b)
the contact details of the data protection officer, where applicable;
(c)
the purposes of the processing for which the personal data are intended as well as the legal basis for the processing;
(d)
where the processing is based on point
(f) of Article 6(1), the legitimate interests pursued by the controller
or by a third party;
(e)
the recipients or categories of recipients of the personal data, if any;
(f)
where applicable, the fact that the
controller intends to transfer personal data to a third country or
international organisation and the existence or absence of an adequacy
decision by the Commission, or in the case of transfers referred to in
Article 46 or 47, or the second subparagraph of Article 49(1),
reference to the appropriate or suitable safeguards and the means by
which to obtain a copy of them or where they have been made available.
2. In addition to the information
referred to in paragraph 1, the controller shall, at the time when
personal data are obtained, provide the data subject with the following
further information necessary to ensure fair and transparent processing:
(a)
the period for which the personal data will be stored, or if that is not possible, the criteria used to determine that period;
(b)
the existence of the right to request
from the controller access to and rectification or erasure of personal
data or restriction of processing concerning the data subject or to
object to processing as well as the right to data portability;
(c)
where the processing is based on point
(a) of Article 6(1) or point (a) of Article 9(2), the existence of
the right to withdraw consent at any time, without affecting the
lawfulness of processing based on consent before its withdrawal;
(d)
the right to lodge a complaint with a supervisory authority;
(e)
whether the provision of personal data
is a statutory or contractual requirement, or a requirement necessary to
enter into a contract, as well as whether the data subject is obliged
to provide the personal data and of the possible consequences of failure
to provide such data;
(f)
the existence of automated
decision-making, including profiling, referred to in Article 22(1) and
(4) and, at least in those cases, meaningful information about the logic
involved, as well as the significance and the envisaged consequences of
such processing for the data subject.
3. Where the controller intends to
further process the personal data for a purpose other than that for
which the personal data were collected, the controller shall provide the
data subject prior to that further processing with information on that
other purpose and with any relevant further information as referred to
in paragraph 2.
4. Paragraphs 1, 2 and 3 shall not apply where and insofar as the data subject already has the information.
Article 14
Information to be provided where personal data have not been obtained from the data subject
1. Where personal data have not
been obtained from the data subject, the controller shall provide the
data subject with the following information:
(a)
the identity and the contact details of the controller and, where applicable, of the controller’s representative;
(b)
the contact details of the data protection officer, where applicable;
(c)
the purposes of the processing for which the personal data are intended as well as the legal basis for the processing;
(d)
the categories of personal data concerned;
(e)
the recipients or categories of recipients of the personal data, if any;
(f)
where applicable, that the controller
intends to transfer personal data to a recipient in a third country or
international organisation and the existence or absence of an adequacy
decision by the Commission, or in the case of transfers referred to in
Article 46 or 47, or the second subparagraph of Article 49(1),
reference to the appropriate or suitable safeguards and the means to
obtain a copy of them or where they have been made available.
2. In addition to the information
referred to in paragraph 1, the controller shall provide the data
subject with the following information necessary to ensure fair and
transparent processing in respect of the data subject:
(a)
the period for which the personal data will be stored, or if that is not possible, the criteria used to determine that period;
(b)
where the processing is based on point
(f) of Article 6(1), the legitimate interests pursued by the controller
or by a third party;
(c)
the existence of the right to request
from the controller access to and rectification or erasure of personal
data or restriction of processing concerning the data subject and to
object to processing as well as the right to data portability;
(d)
where processing is based on point (a)
of Article 6(1) or point (a) of Article 9(2), the existence of the right
to withdraw consent at any time, without affecting the lawfulness of
processing based on consent before its withdrawal;
(e)
the right to lodge a complaint with a supervisory authority;
(f)
from which source the personal data originate, and if applicable, whether it came from publicly accessible sources;
(g)
the existence of automated
decision-making, including profiling, referred to in Article 22(1)
and (4) and, at least in those cases, meaningful information about the
logic involved, as well as the significance and the envisaged
consequences of such processing for the data subject.
3. The controller shall provide the information referred to in paragraphs 1 and 2:
(a)
within a reasonable period after
obtaining the personal data, but at the latest within one month, having
regard to the specific circumstances in which the personal data are
processed;
(b)
if the personal data are to be used for
communication with the data subject, at the latest at the time of the
first communication to that data subject; or
(c)
if a disclosure to another recipient is envisaged, at the latest when the personal data are first disclosed.
4. Where the controller intends to
further process the personal data for a purpose other than that for
which the personal data were obtained, the controller shall provide the
data subject prior to that further processing with information on that
other purpose and with any relevant further information as referred to
in paragraph 2.
5. Paragraphs 1 to 4 shall not apply where and insofar as:
(a)
the data subject already has the information;
(b)
the provision of such information
proves impossible or would involve a disproportionate effort, in
particular for processing for archiving purposes in the public interest,
scientific or historical research purposes or statistical purposes,
subject to the conditions and safeguards referred to in Article 89(1) or
in so far as the obligation referred to in paragraph 1 of this
Article is likely to render impossible or seriously impair the
achievement of the objectives of that processing. In such cases the
controller shall take appropriate measures to protect the data subject’s
rights and freedoms and legitimate interests, including making the
information publicly available;
(c)
obtaining or disclosure is expressly
laid down by Union or Member State law to which the controller is
subject and which provides appropriate measures to protect the data
subject’s legitimate interests; or
(d)
where the personal data must remain
confidential subject to an obligation of professional secrecy regulated
by Union or Member State law, including a statutory obligation of
secrecy.
Article 15
Right of access by the data subject
1. The data subject shall have the
right to obtain from the controller confirmation as to whether or not
personal data concerning him or her are being processed, and, where that
is the case, access to the personal data and the following information:
(a)
the purposes of the processing;
(b)
the categories of personal data concerned;
(c)
the recipients or categories of
recipient to whom the personal data have been or will be disclosed, in
particular recipients in third countries or international organisations;
(d)
where possible, the envisaged period
for which the personal data will be stored, or, if not possible, the
criteria used to determine that period;
(e)
the existence of the right to request
from the controller rectification or erasure of personal data or
restriction of processing of personal data concerning the data subject
or to object to such processing;
(f)
the right to lodge a complaint with a supervisory authority;
(g)
where the personal data are not collected from the data subject, any available information as to their source;
(h)
the existence of automated
decision-making, including profiling, referred to in Article 22(1)
and (4) and, at least in those cases, meaningful information about the
logic involved, as well as the significance and the envisaged
consequences of such processing for the data subject.
2. Where personal data are
transferred to a third country or to an international organisation, the
data subject shall have the right to be informed of the appropriate
safeguards pursuant to Article 46 relating to the transfer.
3. The controller shall provide a
copy of the personal data undergoing processing. For any further copies
requested by the data subject, the controller may charge a reasonable
fee based on administrative costs. Where the data subject makes the
request by electronic means, and unless otherwise requested by the data
subject, the information shall be provided in a commonly used electronic
form.
4. The right to obtain a copy
referred to in paragraph 3 shall not adversely affect the rights and
freedoms of others.
Article 16
Right to rectification
The data subject shall have the right to obtain
from the controller without undue delay the rectification of inaccurate
personal data concerning him or her. Taking into account the purposes of
the processing, the data subject shall have the right to have
incomplete personal data completed, including by means of providing a
supplementary statement.
Article 17
Right to erasure (‘right to be forgotten’)
1. The data subject shall have the
right to obtain from the controller the erasure of personal data
concerning him or her without undue delay and the controller shall have
the obligation to erase personal data without undue delay where one of
the following grounds applies:
(a)
the personal data are no longer necessary in relation to the purposes for which they were collected or otherwise processed;
(b)
the data subject withdraws consent on
which the processing is based according to point (a) of Article
6(1), or point (a) of Article 9(2), and where there is no other
legal ground for the processing;
(c)
the data subject objects to the
processing pursuant to Article 21(1) and there are no overriding
legitimate grounds for the processing, or the data subject objects to
the processing pursuant to Article 21(2);
(d)
the personal data have been unlawfully processed;
(e)
the personal data have to be erased for
compliance with a legal obligation in Union or Member State law to
which the controller is subject;
(f)
the personal data have been collected in relation to the offer of information society services referred to in Article 8(1).
2. Where the controller has made
the personal data public and is obliged pursuant to paragraph 1 to
erase the personal data, the controller, taking account of available
technology and the cost of implementation, shall take reasonable steps,
including technical measures, to inform controllers which are processing
the personal data that the data subject has requested the erasure by
such controllers of any links to, or copy or replication of, those
personal data.
3. Paragraphs 1 and 2 shall not apply to the extent that processing is necessary:
(a)
for exercising the right of freedom of expression and information;
(b)
for compliance with a legal obligation
which requires processing by Union or Member State law to which the
controller is subject or for the performance of a task carried out in
the public interest or in the exercise of official authority vested in
the controller;
(c)
for reasons of public interest in the
area of public health in accordance with points (h) and (i) of
Article 9(2) as well as Article 9(3);
(d)
for archiving purposes in the public
interest, scientific or historical research purposes or statistical
purposes in accordance with Article 89(1) in so far as the right
referred to in paragraph 1 is likely to render impossible or
seriously impair the achievement of the objectives of that processing;
or
(e)
for the establishment, exercise or defence of legal claims.
Article 18
Right to restriction of processing
1. The data subject shall have the
right to obtain from the controller restriction of processing where one
of the following applies:
(a)
the accuracy of the personal data is
contested by the data subject, for a period enabling the controller to
verify the accuracy of the personal data;
(b)
the processing is unlawful and the data
subject opposes the erasure of the personal data and requests the
restriction of their use instead;
(c)
the controller no longer needs the
personal data for the purposes of the processing, but they are required
by the data subject for the establishment, exercise or defence of legal
claims;
(d)
the data subject has objected to
processing pursuant to Article 21(1) pending the verification
whether the legitimate grounds of the controller override those of the
data subject.
2. Where processing has been
restricted under paragraph 1, such personal data shall, with the
exception of storage, only be processed with the data subject’s consent
or for the establishment, exercise or defence of legal claims or for the
protection of the rights of another natural or legal person or for
reasons of important public interest of the Union or of a
Member State.
3. A data subject who has obtained
restriction of processing pursuant to paragraph 1 shall be
informed by the controller before the restriction of processing is
lifted.
Article 19
Notification obligation regarding rectification or erasure of personal data or restriction of processing
The controller shall communicate any rectification
or erasure of personal data or restriction of processing carried out in
accordance with Article 16, Article 17(1) and Article 18 to each
recipient to whom the personal data have been disclosed, unless this
proves impossible or involves disproportionate effort. The controller
shall inform the data subject about those recipients if the data subject
requests it.
Article 20
Right to data portability
1. The data subject shall have the
right to receive the personal data concerning him or her, which he or
she has provided to a controller, in a structured, commonly used and
machine-readable format and have the right to transmit those data to
another controller without hindrance from the controller to which the
personal data have been provided, where:
(a)
the processing is based on consent
pursuant to point (a) of Article 6(1) or point (a) of Article 9(2)
or on a contract pursuant to point (b) of Article 6(1); and
(b)
the processing is carried out by automated means.
2. In exercising his or her right
to data portability pursuant to paragraph 1, the data subject shall have
the right to have the personal data transmitted directly from one
controller to another, where technically feasible.
3. The exercise of the right
referred to in paragraph 1 of this Article shall be without
prejudice to Article 17. That right shall not apply to processing
necessary for the performance of a task carried out in the public
interest or in the exercise of official authority vested in the
controller.
4. The right referred to in paragraph 1 shall not adversely affect the rights and freedoms of others.
Article 21
Right to object
1. The data subject shall have the
right to object, on grounds relating to his or her particular
situation, at any time to processing of personal data concerning him or
her which is based on point (e) or (f) of Article 6(1), including
profiling based on those provisions. The controller shall no longer
process the personal data unless the controller demonstrates compelling
legitimate grounds for the processing which override the interests,
rights and freedoms of the data subject or for the establishment,
exercise or defence of legal claims.
2. Where personal data are
processed for direct marketing purposes, the data subject shall have the
right to object at any time to processing of personal data concerning
him or her for such marketing, which includes profiling to the extent
that it is related to such direct marketing.
3. Where the data subject objects
to processing for direct marketing purposes, the personal data shall no
longer be processed for such purposes.
4. At the latest at the time of
the first communication with the data subject, the right referred to in
paragraphs 1 and 2 shall be explicitly brought to the attention of
the data subject and shall be presented clearly and separately from any
other information.
5. In the context of the use of
information society services, and notwithstanding
Directive 2002/58/EC, the data subject may exercise his or her
right to object by automated means using technical specifications.
6. Where personal data are
processed for scientific or historical research purposes or statistical
purposes pursuant to Article 89(1), the data subject, on grounds
relating to his or her particular situation, shall have the right to
object to processing of personal data concerning him or her, unless the
processing is necessary for the performance of a task carried out for
reasons of public interest.
Article 22
Automated individual decision-making, including profiling
1. The data subject shall have the
right not to be subject to a decision based solely on automated
processing, including profiling, which produces legal effects concerning
him or her or similarly significantly affects him or her.
2. Paragraph 1 shall not apply if the decision:
(a)
is necessary for entering into, or performance of, a contract between the data subject and a data controller;
(b)
is authorised by Union or
Member State law to which the controller is subject and which also
lays down suitable measures to safeguard the data subject’s rights and
freedoms and legitimate interests; or
(c)
is based on the data subject’s explicit consent.
3. In the cases referred to in
points (a) and (c) of paragraph 2, the data controller shall
implement suitable measures to safeguard the data subject’s rights and
freedoms and legitimate interests, at least the right to obtain human
intervention on the part of the controller, to express his or her point
of view and to contest the decision.
4. Decisions referred to in
paragraph 2 shall not be based on special categories of personal data
referred to in Article 9(1), unless point (a) or (g) of Article
9(2) applies and suitable measures to safeguard the data subject’s
rights and freedoms and legitimate interests are in place.
Article 23
Restrictions
1. Union or Member State law
to which the data controller or processor is subject may restrict by way
of a legislative measure the scope of the obligations and rights
provided for in Articles 12 to 22 and Article 34, as well as
Article 5 in so far as its provisions correspond to the rights and
obligations provided for in Articles 12 to 22, when such a
restriction respects the essence of the fundamental rights and freedoms
and is a necessary and proportionate measure in a democratic society to
safeguard:
(a)
national security;
(b)
defence;
(c)
public security;
(d)
the prevention, investigation,
detection or prosecution of criminal offences or the execution of
criminal penalties, including the safeguarding against and the
prevention of threats to public security;
(e)
other important objectives of general
public interest of the Union or of a Member State, in particular an
important economic or financial interest of the Union or of a
Member State, including monetary, budgetary and taxation a matters,
public health and social security;
(f)
the protection of judicial independence and judicial proceedings;
(g)
the prevention, investigation, detection and prosecution of breaches of ethics for regulated professions;
(h)
a monitoring, inspection or regulatory
function connected, even occasionally, to the exercise of official
authority in the cases referred to in points (a) to (e) and (g);
(i)
the protection of the data subject or the rights and freedoms of others;
(j)
the enforcement of civil law claims.
2. In particular, any legislative
measure referred to in paragraph 1 shall contain specific provisions at
least, where relevant, as to:
(a)
the purposes of the processing or categories of processing;
(b)
the categories of personal data;
(c)
the scope of the restrictions introduced;
(d)
the safeguards to prevent abuse or unlawful access or transfer;
(e)
the specification of the controller or categories of controllers;
(f)
the storage periods and the applicable
safeguards taking into account the nature, scope and purposes of the
processing or categories of processing;
(g)
the risks to the rights and freedoms of data subjects; and
(h)
the right of data subjects to be
informed about the restriction, unless that may be prejudicial to the
purpose of the restriction.
CHAPTER IV
Controller and processor
Article 24
Responsibility of the controller
1. Taking into account the nature,
scope, context and purposes of processing as well as the risks of
varying likelihood and severity for the rights and freedoms of natural
persons, the controller shall implement appropriate technical and
organisational measures to ensure and to be able to demonstrate that
processing is performed in accordance with this Regulation. Those
measures shall be reviewed and updated where necessary.
2. Where proportionate in relation
to processing activities, the measures referred to in paragraph 1
shall include the implementation of appropriate data protection policies
by the controller.
3. Adherence to approved codes of
conduct as referred to in Article 40 or approved certification
mechanisms as referred to in Article 42 may be used as an element
by which to demonstrate compliance with the obligations of the
controller.
Article 25
Data protection by design and by default
1. Taking into account the state
of the art, the cost of implementation and the nature, scope, context
and purposes of processing as well as the risks of varying likelihood
and severity for rights and freedoms of natural persons posed by the
processing, the controller shall, both at the time of the determination
of the means for processing and at the time of the processing itself,
implement appropriate technical and organisational measures, such as
pseudonymisation, which are designed to implement data-protection
principles, such as data minimisation, in an effective manner and to
integrate the necessary safeguards into the processing in order to meet
the requirements of this Regulation and protect the rights of data
subjects.
2. The controller shall implement
appropriate technical and organisational measures for ensuring that, by
default, only personal data which are necessary for each specific
purpose of the processing are processed. That obligation applies to the
amount of personal data collected, the extent of their processing, the
period of their storage and their accessibility. In particular, such
measures shall ensure that by default personal data are not made
accessible without the individual’s intervention to an indefinite number
of natural persons.
3. An approved certification
mechanism pursuant to Article 42 may be used as an element to
demonstrate compliance with the requirements set out in
paragraphs 1 and 2 of this Article.
Article 26
Joint controllers
1. Where two or more controllers
jointly determine the purposes and means of processing, they shall be
joint controllers. They shall in a transparent manner determine their
respective responsibilities for compliance with the obligations under
this Regulation, in particular as regards the exercising of the rights
of the data subject and their respective duties to provide the
information referred to in Articles 13 and 14, by means of an
arrangement between them unless, and in so far as, the respective
responsibilities of the controllers are determined by Union or
Member State law to which the controllers are subject. The
arrangement may designate a contact point for data subjects.
2. The arrangement referred to in
paragraph 1 shall duly reflect the respective roles and relationships of
the joint controllers vis-a-vis the data subjects. The essence of the arrangement shall be made available to the data subject.
3. Irrespective of the terms of
the arrangement referred to in paragraph 1, the data subject may
exercise his or her rights under this Regulation in respect of and
against each of the controllers.
Article 27
Representatives of controllers or processors not established in the Union
1. Where Article 3(2) applies, the
controller or the processor shall designate in writing a representative
in the Union.
2. The obligation laid down in paragraph 1 of this Article shall not apply to:
(a)
processing which is occasional, does
not include, on a large scale, processing of special categories of data
as referred to in Article 9(1) or processing of personal data relating
to criminal convictions and offences referred to in Article 10, and is
unlikely to result in a risk to the rights and freedoms of natural
persons, taking into account the nature, context, scope and purposes of
the processing; or
(b)
a public authority or body.
3. The representative shall be
established in one of the Member States where the data subjects, whose
personal data are processed in relation to the offering of goods or
services to them, or whose behaviour is monitored, are.
4. The representative shall be
mandated by the controller or processor to be addressed in addition to
or instead of the controller or the processor by, in particular,
supervisory authorities and data subjects, on all issues related to
processing, for the purposes of ensuring compliance with this
Regulation.
5. The designation of a
representative by the controller or processor shall be without prejudice
to legal actions which could be initiated against the controller or the
processor themselves.
Article 28
Processor
1. Where processing is to be
carried out on behalf of a controller, the controller shall use only
processors providing sufficient guarantees to implement appropriate
technical and organisational measures in such a manner that processing
will meet the requirements of this Regulation and ensure the protection
of the rights of the data subject.
2. The processor shall not engage
another processor without prior specific or general written
authorisation of the controller. In the case of general written
authorisation, the processor shall inform the controller of any intended
changes concerning the addition or replacement of other processors,
thereby giving the controller the opportunity to object to such changes.
3. Processing by a processor shall
be governed by a contract or other legal act under Union or
Member State law, that is binding on the processor with regard to
the controller and that sets out the subject-matter and duration of the
processing, the nature and purpose of the processing, the type of
personal data and categories of data subjects and the obligations and
rights of the controller. That contract or other legal act shall
stipulate, in particular, that the processor:
(a)
processes the personal data only on
documented instructions from the controller, including with regard to
transfers of personal data to a third country or an international
organisation, unless required to do so by Union or Member State law
to which the processor is subject; in such a case, the processor shall
inform the controller of that legal requirement before processing,
unless that law prohibits such information on important grounds of
public interest;
(b)
ensures that persons authorised to
process the personal data have committed themselves to confidentiality
or are under an appropriate statutory obligation of confidentiality;
(c)
takes all measures required pursuant to Article 32;
(d)
respects the conditions referred to in paragraphs 2 and 4 for engaging another processor;
(e)
taking into account the nature of the
processing, assists the controller by appropriate technical and
organisational measures, insofar as this is possible, for the fulfilment
of the controller’s obligation to respond to requests for exercising
the data subject’s rights laid down in Chapter III;
(f)
assists the controller in ensuring
compliance with the obligations pursuant to Articles 32 to 36
taking into account the nature of processing and the information
available to the processor;
(g)
at the choice of the controller,
deletes or returns all the personal data to the controller after the end
of the provision of services relating to processing, and deletes
existing copies unless Union or Member State law requires storage of the
personal data;
(h)
makes available to the controller all
information necessary to demonstrate compliance with the obligations
laid down in this Article and allow for and contribute to audits,
including inspections, conducted by the controller or another auditor
mandated by the controller.
With regard to point (h) of the first
subparagraph, the processor shall immediately inform the controller if,
in its opinion, an instruction infringes this Regulation or other Union
or Member State data protection provisions.
4. Where a processor engages
another processor for carrying out specific processing activities on
behalf of the controller, the same data protection obligations as set
out in the contract or other legal act between the controller and the
processor as referred to in paragraph 3 shall be imposed on that other
processor by way of a contract or other legal act under Union or Member
State law, in particular providing sufficient guarantees to implement
appropriate technical and organisational measures in such a manner that
the processing will meet the requirements of this Regulation. Where that
other processor fails to fulfil its data protection obligations, the
initial processor shall remain fully liable to the controller for the
performance of that other processor’s obligations.
5. Adherence of a processor to an
approved code of conduct as referred to in Article 40 or an
approved certification mechanism as referred to in Article 42 may
be used as an element by which to demonstrate sufficient guarantees as
referred to in paragraphs 1 and 4 of this Article.
6. Without prejudice to an
individual contract between the controller and the processor, the
contract or the other legal act referred to in paragraphs 3 and 4 of
this Article may be based, in whole or in part, on standard contractual
clauses referred to in paragraphs 7 and 8 of this Article,
including when they are part of a certification granted to the
controller or processor pursuant to Articles 42 and 43.
7. The Commission may lay down
standard contractual clauses for the matters referred to in paragraph 3
and 4 of this Article and in accordance with the examination procedure
referred to in Article 93(2).
8. A supervisory authority may
adopt standard contractual clauses for the matters referred to in
paragraph 3 and 4 of this Article and in accordance with the consistency
mechanism referred to in Article 63.
9. The contract or the other legal
act referred to in paragraphs 3 and 4 shall be in writing, including in
electronic form.
10. Without prejudice to Articles
82, 83 and 84, if a processor infringes this Regulation by determining
the purposes and means of processing, the processor shall be considered
to be a controller in respect of that processing.
Article 29
Processing under the authority of the controller or processor
The processor and any person acting under the
authority of the controller or of the processor, who has access to
personal data, shall not process those data except on instructions from
the controller, unless required to do so by Union or Member State
law.
Article 30
Records of processing activities
1. Each controller and, where
applicable, the controller’s representative, shall maintain a record of
processing activities under its responsibility. That record shall
contain all of the following information:
(a)
the name and contact details of the
controller and, where applicable, the joint controller, the controller’s
representative and the data protection officer;
(b)
the purposes of the processing;
(c)
a description of the categories of data subjects and of the categories of personal data;
(d)
the categories of recipients to whom
the personal data have been or will be disclosed including recipients in
third countries or international organisations;
(e)
where applicable, transfers of personal
data to a third country or an international organisation, including the
identification of that third country or international organisation and,
in the case of transfers referred to in the second subparagraph of
Article 49(1), the documentation of suitable safeguards;
(f)
where possible, the envisaged time limits for erasure of the different categories of data;
(g)
where possible, a general description of the technical and organisational security measures referred to in Article 32(1).
2. Each processor and, where
applicable, the processor’s representative shall maintain a record of
all categories of processing activities carried out on behalf of a
controller, containing:
(a)
the name and contact details of the
processor or processors and of each controller on behalf of which the
processor is acting, and, where applicable, of the controller’s or the
processor’s representative, and the data protection officer;
(b)
the categories of processing carried out on behalf of each controller;
(c)
where applicable, transfers of personal
data to a third country or an international organisation, including the
identification of that third country or international organisation and,
in the case of transfers referred to in the second subparagraph of
Article 49(1), the documentation of suitable safeguards;
(d)
where possible, a general description of the technical and organisational security measures referred to in Article 32(1).
3. The records referred to in paragraphs 1 and 2 shall be in writing, including in electronic form.
4. The controller or the processor
and, where applicable, the controller’s or the processor’s
representative, shall make the record available to the supervisory
authority on request.
5. The obligations referred to in
paragraphs 1 and 2 shall not apply to an enterprise or an organisation
employing fewer than 250 persons unless the processing it carries out is
likely to result in a risk to the rights and freedoms of
data subjects, the processing is not occasional, or the processing
includes special categories of data as referred to in Article 9(1)
or personal data relating to criminal convictions and offences referred
to in Article 10.
Article 31
Cooperation with the supervisory authority
The controller and the processor and, where
applicable, their representatives, shall cooperate, on request, with the
supervisory authority in the performance of its tasks.
Article 32
Security of processing
1. Taking into account the state
of the art, the costs of implementation and the nature, scope, context
and purposes of processing as well as the risk of varying likelihood and
severity for the rights and freedoms of natural persons, the controller
and the processor shall implement appropriate technical and
organisational measures to ensure a level of security appropriate to the
risk, including inter alia as appropriate:
(a)
the pseudonymisation and encryption of personal data;
(b)
the ability to ensure the ongoing confidentiality, integrity, availability and resilience of processing systems and services;
(c)
the ability to restore the availability
and access to personal data in a timely manner in the event of a
physical or technical incident;
(d)
a process for regularly testing,
assessing and evaluating the effectiveness of technical and
organisational measures for ensuring the security of the processing.
2. In assessing the appropriate
level of security account shall be taken in particular of the risks that
are presented by processing, in particular from accidental or unlawful
destruction, loss, alteration, unauthorised disclosure of, or access to
personal data transmitted, stored or otherwise processed.
3. Adherence to an approved code
of conduct as referred to in Article 40 or an approved certification
mechanism as referred to in Article 42 may be used as an element by
which to demonstrate compliance with the requirements set out in
paragraph 1 of this Article.
4. The controller and processor
shall take steps to ensure that any natural person acting under the
authority of the controller or the processor who has access to personal
data does not process them except on instructions from the controller,
unless he or she is required to do so by Union or Member State law.
Article 33
Notification of a personal data breach to the supervisory authority
1. In the case of a personal data
breach, the controller shall without undue delay and, where feasible,
not later than 72 hours after having become aware of it, notify the
personal data breach to the supervisory authority competent in
accordance with Article 55, unless the personal data breach is
unlikely to result in a risk to the rights and freedoms of natural
persons. Where the notification to the supervisory authority is not made
within 72 hours, it shall be accompanied by reasons for the delay.
2. The processor shall notify the
controller without undue delay after becoming aware of a personal data
breach.
3. The notification referred to in paragraph 1 shall at least:
(a)
describe the nature of the personal
data breach including where possible, the categories and approximate
number of data subjects concerned and the categories and approximate
number of personal data records concerned;
(b)
communicate the name and contact
details of the data protection officer or other contact point where more
information can be obtained;
(c)
describe the likely consequences of the personal data breach;
(d)
describe the measures taken or proposed
to be taken by the controller to address the personal data breach,
including, where appropriate, measures to mitigate its possible adverse
effects.
4. Where, and in so far as, it is
not possible to provide the information at the same time, the
information may be provided in phases without undue further delay.
5. The controller shall document
any personal data breaches, comprising the facts relating to the
personal data breach, its effects and the remedial action taken. That
documentation shall enable the supervisory authority to verify
compliance with this Article.
Article 34
Communication of a personal data breach to the data subject
1. When the personal data breach
is likely to result in a high risk to the rights and freedoms of natural
persons, the controller shall communicate the personal data breach to
the data subject without undue delay.
2. The communication to the data
subject referred to in paragraph 1 of this Article shall describe in
clear and plain language the nature of the personal data breach and
contain at least the information and measures referred to in
points (b), (c) and (d) of Article 33(3).
3. The communication to the data
subject referred to in paragraph 1 shall not be required if any of
the following conditions are met:
(a)
the controller has implemented
appropriate technical and organisational protection measures, and those
measures were applied to the personal data affected by the personal data
breach, in particular those that render the personal data
unintelligible to any person who is not authorised to access it, such as
encryption;
(b)
the controller has taken subsequent
measures which ensure that the high risk to the rights and freedoms of
data subjects referred to in paragraph 1 is no longer likely to
materialise;
(c)
it would involve disproportionate
effort. In such a case, there shall instead be a public communication or
similar measure whereby the data subjects are informed in an equally
effective manner.
4. If the controller has not
already communicated the personal data breach to the data subject, the
supervisory authority, having considered the likelihood of the personal
data breach resulting in a high risk, may require it to do so or may
decide that any of the conditions referred to in paragraph 3 are met.
Article 35
Data protection impact assessment
1. Where a type of processing in
particular using new technologies, and taking into account the nature,
scope, context and purposes of the processing, is likely to result in a
high risk to the rights and freedoms of natural persons, the controller
shall, prior to the processing, carry out an assessment of the impact of
the envisaged processing operations on the protection of personal data.
A single assessment may address a set of similar processing operations
that present similar high risks.
2. The controller shall seek the
advice of the data protection officer, where designated, when carrying
out a data protection impact assessment.
3. A data protection impact
assessment referred to in paragraph 1 shall in particular be
required in the case of:
(a)
a systematic and extensive evaluation
of personal aspects relating to natural persons which is based on
automated processing, including profiling, and on which decisions are
based that produce legal effects concerning the natural person or
similarly significantly affect the natural person;
(b)
processing on a large scale of special
categories of data referred to in Article 9(1), or of personal data
relating to criminal convictions and offences referred to in
Article 10; or
(c)
a systematic monitoring of a publicly accessible area on a large scale.
4. The supervisory authority shall
establish and make public a list of the kind of processing operations
which are subject to the requirement for a data protection impact
assessment pursuant to paragraph 1. The supervisory authority shall
communicate those lists to the Board referred to in Article 68.
5. The supervisory authority may
also establish and make public a list of the kind of processing
operations for which no data protection impact assessment is required.
The supervisory authority shall communicate those lists to the Board.
6. Prior to the adoption of the
lists referred to in paragraphs 4 and 5, the competent supervisory
authority shall apply the consistency mechanism referred to in
Article 63 where such lists involve processing activities which are
related to the offering of goods or services to data subjects or to the
monitoring of their behaviour in several Member States, or may
substantially affect the free movement of personal data within the
Union.
7. The assessment shall contain at least:
(a)
a systematic description of the
envisaged processing operations and the purposes of the processing,
including, where applicable, the legitimate interest pursued by the
controller;
(b)
an assessment of the necessity and proportionality of the processing operations in relation to the purposes;
(c)
an assessment of the risks to the rights and freedoms of data subjects referred to in paragraph 1; and
(d)
the measures envisaged to address the
risks, including safeguards, security measures and mechanisms to ensure
the protection of personal data and to demonstrate compliance with this
Regulation taking into account the rights and legitimate interests of
data subjects and other persons concerned.
8. Compliance with approved codes
of conduct referred to in Article 40 by the relevant controllers or
processors shall be taken into due account in assessing the impact of
the processing operations performed by such controllers or processors,
in particular for the purposes of a data protection impact assessment.
9. Where appropriate, the
controller shall seek the views of data subjects or their
representatives on the intended processing, without prejudice to the
protection of commercial or public interests or the security of
processing operations.
10. Where processing pursuant to
point (c) or (e) of Article 6(1) has a legal basis in Union law or in
the law of the Member State to which the controller is subject,
that law regulates the specific processing operation or set of
operations in question, and a data protection impact assessment has
already been carried out as part of a general impact assessment in the
context of the adoption of that legal basis, paragraphs 1 to 7
shall not apply unless Member States deem it to be necessary to
carry out such an assessment prior to processing activities.
11. Where necessary, the
controller shall carry out a review to assess if processing is performed
in accordance with the data protection impact assessment at least when
there is a change of the risk represented by processing operations.
Article 36
Prior consultation
1. The controller shall consult
the supervisory authority prior to processing where a data protection
impact assessment under Article 35 indicates that the processing would
result in a high risk in the absence of measures taken by the controller
to mitigate the risk.
2. Where the supervisory authority
is of the opinion that the intended processing referred to in
paragraph 1 would infringe this Regulation, in particular where the
controller has insufficiently identified or mitigated the risk, the
supervisory authority shall, within period of up to eight weeks of
receipt of the request for consultation, provide written advice to the
controller and, where applicable to the processor, and may use any of
its powers referred to in Article 58. That period may be extended
by six weeks, taking into account the complexity of the intended
processing. The supervisory authority shall inform the controller and,
where applicable, the processor, of any such extension within one month
of receipt of the request for consultation together with the reasons for
the delay. Those periods may be suspended until the supervisory
authority has obtained information it has requested for the purposes of
the consultation.
3. When consulting the supervisory
authority pursuant to paragraph 1, the controller shall provide
the supervisory authority with:
(a)
where applicable, the respective
responsibilities of the controller, joint controllers and processors
involved in the processing, in particular for processing within a group
of undertakings;
(b)
the purposes and means of the intended processing;
(c)
the measures and safeguards provided to protect the rights and freedoms of data subjects pursuant to this Regulation;
(d)
where applicable, the contact details of the data protection officer;
(e)
the data protection impact assessment provided for in Article 35; and
(f)
any other information requested by the supervisory authority.
4. Member States shall consult the
supervisory authority during the preparation of a proposal for a
legislative measure to be adopted by a national parliament, or of a
regulatory measure based on such a legislative measure, which relates to
processing.
5. Notwithstanding
paragraph 1, Member State law may require controllers to
consult with, and obtain prior authorisation from, the supervisory
authority in relation to processing by a controller for the performance
of a task carried out by the controller in the public interest,
including processing in relation to social protection and public health.
Article 37
Designation of the data protection officer
1. The controller and the processor shall designate a data protection officer in any case where:
(a)
the processing is carried out by a public authority or body, except for courts acting in their judicial capacity;
(b)
the core activities of the controller
or the processor consist of processing operations which, by virtue of
their nature, their scope and/or their purposes, require regular and
systematic monitoring of data subjects on a large scale; or
(c)
the core activities of the controller
or the processor consist of processing on a large scale of special
categories of data pursuant to Article 9 and personal data relating
to criminal convictions and offences referred to in Article 10.
2. A group of undertakings may
appoint a single data protection officer provided that a data protection
officer is easily accessible from each establishment.
3. Where the controller or the
processor is a public authority or body, a single data protection
officer may be designated for several such authorities or bodies, taking
account of their organisational structure and size.
4. In cases other than those
referred to in paragraph 1, the controller or processor or
associations and other bodies representing categories of controllers or
processors may or, where required by Union or Member State law shall,
designate a data protection officer. The data protection officer may act
for such associations and other bodies representing controllers or
processors.
5. The data protection officer
shall be designated on the basis of professional qualities and, in
particular, expert knowledge of data protection law and practices and
the ability to fulfil the tasks referred to in Article 39.
6. The data protection officer may
be a staff member of the controller or processor, or fulfil the tasks
on the basis of a service contract.
7. The controller or the processor
shall publish the contact details of the data protection officer and
communicate them to the supervisory authority.
Article 38
Position of the data protection officer
1. The controller and the
processor shall ensure that the data protection officer is involved,
properly and in a timely manner, in all issues which relate to the
protection of personal data.
2. The controller and processor
shall support the data protection officer in performing the tasks
referred to in Article 39 by providing resources necessary to carry
out those tasks and access to personal data and processing operations,
and to maintain his or her expert knowledge.
3. The controller and processor
shall ensure that the data protection officer does not receive any
instructions regarding the exercise of those tasks. He or she shall not
be dismissed or penalised by the controller or the processor for
performing his tasks. The data protection officer shall directly report
to the highest management level of the controller or the processor.
4. Data subjects may contact the
data protection officer with regard to all issues related to processing
of their personal data and to the exercise of their rights under this
Regulation.
5. The data protection officer
shall be bound by secrecy or confidentiality concerning the performance
of his or her tasks, in accordance with Union or Member State law.
6. The data protection officer may
fulfil other tasks and duties. The controller or processor shall ensure
that any such tasks and duties do not result in a conflict of
interests.
Article 39
Tasks of the data protection officer
1. The data protection officer shall have at least the following tasks:
(a)
to inform and advise the controller or
the processor and the employees who carry out processing of their
obligations pursuant to this Regulation and to other Union or Member
State data protection provisions;
(b)
to monitor compliance with this
Regulation, with other Union or Member State data protection
provisions and with the policies of the controller or processor in
relation to the protection of personal data, including the assignment of
responsibilities, awareness-raising and training of staff involved in
processing operations, and the related audits;
(c)
to provide advice where requested as
regards the data protection impact assessment and monitor its
performance pursuant to Article 35;
(d)
to cooperate with the supervisory authority;
(e)
to act as the contact point for the
supervisory authority on issues relating to processing, including the
prior consultation referred to in Article 36, and to consult, where
appropriate, with regard to any other matter.
2. The data protection officer
shall in the performance of his or her tasks have due regard to the risk
associated with processing operations, taking into account the nature,
scope, context and purposes of processing.
Article 40
Codes of conduct
1. The Member States, the
supervisory authorities, the Board and the Commission shall encourage
the drawing up of codes of conduct intended to contribute to the proper
application of this Regulation, taking account of the specific features
of the various processing sectors and the specific needs of micro, small
and medium-sized enterprises.
2. Associations and other bodies
representing categories of controllers or processors may prepare codes
of conduct, or amend or extend such codes, for the purpose of specifying
the application of this Regulation, such as with regard to:
(a)
fair and transparent processing;
(b)
the legitimate interests pursued by controllers in specific contexts;
(c)
the collection of personal data;
(d)
the pseudonymisation of personal data;
(e)
the information provided to the public and to data subjects;
(f)
the exercise of the rights of data subjects;
(g)
the information provided to, and the
protection of, children, and the manner in which the consent of the
holders of parental responsibility over children is to be obtained;
(h)
the measures and procedures referred to
in Articles 24 and 25 and the measures to ensure security of processing
referred to in Article 32;
(i)
the notification of personal data
breaches to supervisory authorities and the communication of such
personal data breaches to data subjects;
(j)
the transfer of personal data to third countries or international organisations; or
(k)
out-of-court proceedings and other
dispute resolution procedures for resolving disputes between controllers
and data subjects with regard to processing, without prejudice to the
rights of data subjects pursuant to Articles 77 and 79.
3. In addition to adherence by
controllers or processors subject to this Regulation, codes of conduct
approved pursuant to paragraph 5 of this Article and having general
validity pursuant to paragraph 9 of this Article may also be adhered to
by controllers or processors that are not subject to this Regulation
pursuant to Article 3 in order to provide appropriate safeguards
within the framework of personal data transfers to third countries or
international organisations under the terms referred to in point (e) of
Article 46(2). Such controllers or processors shall make binding
and enforceable commitments, via contractual or other legally binding
instruments, to apply those appropriate safeguards including with regard
to the rights of data subjects.
4. A code of conduct referred to
in paragraph 2 of this Article shall contain mechanisms which enable the
body referred to in Article 41(1) to carry out the mandatory
monitoring of compliance with its provisions by the controllers or
processors which undertake to apply it, without prejudice to the tasks
and powers of supervisory authorities competent pursuant to
Article 55 or 56.
5. Associations and other bodies
referred to in paragraph 2 of this Article which intend to prepare a
code of conduct or to amend or extend an existing code shall submit the
draft code, amendment or extension to the supervisory authority which is
competent pursuant to Article 55. The supervisory authority shall
provide an opinion on whether the draft code, amendment or extension
complies with this Regulation and shall approve that draft code,
amendment or extension if it finds that it provides sufficient
appropriate safeguards.
6. Where the draft code, or
amendment or extension is approved in accordance with paragraph 5,
and where the code of conduct concerned does not relate to processing
activities in several Member States, the supervisory authority
shall register and publish the code.
7. Where a draft code of conduct
relates to processing activities in several Member States, the
supervisory authority which is competent pursuant to Article 55 shall,
before approving the draft code, amendment or extension, submit it in
the procedure referred to in Article 63 to the Board which shall
provide an opinion on whether the draft code, amendment or extension
complies with this Regulation or, in the situation referred to in
paragraph 3 of this Article, provides appropriate safeguards.
8. Where the opinion referred to
in paragraph 7 confirms that the draft code, amendment or extension
complies with this Regulation, or, in the situation referred to in
paragraph 3, provides appropriate safeguards, the Board shall
submit its opinion to the Commission.
9. The Commission may, by way of
implementing acts, decide that the approved code of conduct, amendment
or extension submitted to it pursuant to paragraph 8 of this
Article have general validity within the Union. Those implementing acts
shall be adopted in accordance with the examination procedure set out in
Article 93(2).
10. The Commission shall ensure
appropriate publicity for the approved codes which have been decided as
having general validity in accordance with paragraph 9.
11. The Board shall collate all
approved codes of conduct, amendments and extensions in a register and
shall make them publicly available by way of appropriate means.
Article 41
Monitoring of approved codes of conduct
1. Without prejudice to the tasks
and powers of the competent supervisory authority under Articles 57
and 58, the monitoring of compliance with a code of conduct pursuant to
Article 40 may be carried out by a body which has an appropriate
level of expertise in relation to the subject-matter of the code and is
accredited for that purpose by the competent supervisory authority.
2. A body as referred to in
paragraph 1 may be accredited to monitor compliance with a code of
conduct where that body has:
(a)
demonstrated its independence and
expertise in relation to the subject-matter of the code to the
satisfaction of the competent supervisory authority;
(b)
established procedures which allow it
to assess the eligibility of controllers and processors concerned to
apply the code, to monitor their compliance with its provisions and to
periodically review its operation;
(c)
established procedures and structures
to handle complaints about infringements of the code or the manner in
which the code has been, or is being, implemented by a controller or
processor, and to make those procedures and structures transparent to
data subjects and the public; and
(d)
demonstrated to the satisfaction of the
competent supervisory authority that its tasks and duties do not result
in a conflict of interests.
3. The competent supervisory
authority shall submit the draft criteria for accreditation of a body as
referred to in paragraph 1 of this Article to the Board pursuant to the
consistency mechanism referred to in Article 63.
4. Without prejudice to the tasks
and powers of the competent supervisory authority and the provisions of
Chapter VIII, a body as referred to in paragraph 1 of this Article
shall, subject to appropriate safeguards, take appropriate action in
cases of infringement of the code by a controller or processor,
including suspension or exclusion of the controller or processor
concerned from the code. It shall inform the competent supervisory
authority of such actions and the reasons for taking them.
5. The competent supervisory
authority shall revoke the accreditation of a body as referred to in
paragraph 1 if the conditions for accreditation are not, or are no
longer, met or where actions taken by the body infringe this Regulation.
6. This Article shall not apply to processing carried out by public authorities and bodies.
Article 42
Certification
1. The Member States, the
supervisory authorities, the Board and the Commission shall encourage,
in particular at Union level, the establishment of data protection
certification mechanisms and of data protection seals and marks, for the
purpose of demonstrating compliance with this Regulation of processing
operations by controllers and processors. The specific needs of micro,
small and medium-sized enterprises shall be taken into account.
2. In addition to adherence by
controllers or processors subject to this Regulation, data protection
certification mechanisms, seals or marks approved pursuant to
paragraph 5 of this Article may be established for the purpose of
demonstrating the existence of appropriate safeguards provided by
controllers or processors that are not subject to this Regulation
pursuant to Article 3 within the framework of personal data
transfers to third countries or international organisations under the
terms referred to in point (f) of Article 46(2). Such
controllers or processors shall make binding and enforceable
commitments, via contractual or other legally binding instruments, to
apply those appropriate safeguards, including with regard to the rights
of data subjects.
3. The certification shall be voluntary and available via a process that is transparent.
4. A certification pursuant to
this Article does not reduce the responsibility of the controller or the
processor for compliance with this Regulation and is without prejudice
to the tasks and powers of the supervisory authorities which are
competent pursuant to Article 55 or 56.
5. A certification pursuant to
this Article shall be issued by the certification bodies referred to in
Article 43 or by the competent supervisory authority, on the basis
of criteria approved by that competent supervisory authority pursuant to
Article 58(3) or by the Board pursuant to Article 63. Where
the criteria are approved by the Board, this may result in a common
certification, the European Data Protection Seal.
6. The controller or processor
which submits its processing to the certification mechanism shall
provide the certification body referred to in Article 43, or where
applicable, the competent supervisory authority, with all information
and access to its processing activities which are necessary to conduct
the certification procedure.
7. Certification shall be issued
to a controller or processor for a maximum period of three years and may
be renewed, under the same conditions, provided that the relevant
requirements continue to be met. Certification shall be withdrawn, as
applicable, by the certification bodies referred to in Article 43
or by the competent supervisory authority where the requirements for the
certification are not or are no longer met.
8. The Board shall collate all
certification mechanisms and data protection seals and marks in a
register and shall make them publicly available by any appropriate
means.
Article 43
Certification bodies
1. Without prejudice to the tasks
and powers of the competent supervisory authority under Articles 57
and 58, certification bodies which have an appropriate level of
expertise in relation to data protection shall, after informing the
supervisory authority in order to allow it to exercise its powers
pursuant to point (h) of Article 58(2) where necessary, issue and
renew certification. Member States shall ensure that those certification
bodies are accredited by one or both of the following:
(a)
the supervisory authority which is competent pursuant to Article 55 or 56;
(b)
the national accreditation body named
in accordance with Regulation (EC) No 765/2008 of the European
Parliament and of the Council (20)
in accordance with EN-ISO/IEC 17065/2012 and with the additional
requirements established by the supervisory authority which is competent
pursuant to Article 55 or 56.
2. Certification bodies referred
to in paragraph 1 shall be accredited in accordance with that
paragraph only where they have:
(a)
demonstrated their independence and
expertise in relation to the subject-matter of the certification to the
satisfaction of the competent supervisory authority;
(b)
undertaken to respect the criteria
referred to in Article 42(5) and approved by the supervisory
authority which is competent pursuant to Article 55 or 56 or
by the Board pursuant to Article 63;
(c)
established procedures for the issuing, periodic review and withdrawal of data protection certification, seals and marks;
(d)
established procedures and structures
to handle complaints about infringements of the certification or the
manner in which the certification has been, or is being, implemented by
the controller or processor, and to make those procedures and structures
transparent to data subjects and the public; and
(e)
demonstrated, to the satisfaction of
the competent supervisory authority, that their tasks and duties do not
result in a conflict of interests.
3. The accreditation of
certification bodies as referred to in paragraphs 1 and 2 of this
Article shall take place on the basis of criteria approved by the
supervisory authority which is competent pursuant to Article 55 or
56 or by the Board pursuant to Article 63. In the case of
accreditation pursuant to point (b) of paragraph 1 of this
Article, those requirements shall complement those envisaged in
Regulation (EC) No 765/2008 and the technical rules that describe
the methods and procedures of the certification bodies.
4. The certification bodies
referred to in paragraph 1 shall be responsible for the proper
assessment leading to the certification or the withdrawal of such
certification without prejudice to the responsibility of the controller
or processor for compliance with this Regulation. The accreditation
shall be issued for a maximum period of five years and may be renewed on
the same conditions provided that the certification body meets the
requirements set out in this Article.
5. The certification bodies
referred to in paragraph 1 shall provide the competent supervisory
authorities with the reasons for granting or withdrawing the requested
certification.
6. The requirements referred to in
paragraph 3 of this Article and the criteria referred to in
Article 42(5) shall be made public by the supervisory authority in
an easily accessible form. The supervisory authorities shall also
transmit those requirements and criteria to the Board. The Board shall
collate all certification mechanisms and data protection seals in a
register and shall make them publicly available by any appropriate
means.
7. Without prejudice to Chapter
VIII, the competent supervisory authority or the national accreditation
body shall revoke an accreditation of a certification body pursuant to
paragraph 1 of this Article where the conditions for the
accreditation are not, or are no longer, met or where actions taken by a
certification body infringe this Regulation.
8. The Commission shall be
empowered to adopt delegated acts in accordance with Article 92 for
the purpose of specifying the requirements to be taken into account for
the data protection certification mechanisms referred to in
Article 42(1).
9. The Commission may adopt
implementing acts laying down technical standards for certification
mechanisms and data protection seals and marks, and mechanisms to
promote and recognise those certification mechanisms, seals and marks.
Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 93(2).
CHAPTER V
Transfers of personal data to third countries or international organisations
Article 44
General principle for transfers
Any transfer of personal data which are undergoing
processing or are intended for processing after transfer to a third
country or to an international organisation shall take place only if,
subject to the other provisions of this Regulation, the conditions laid
down in this Chapter are complied with by the controller and processor,
including for onward transfers of personal data from the third country
or an international organisation to another third country or to another
international organisation. All provisions in this Chapter shall be
applied in order to ensure that the level of protection of natural
persons guaranteed by this Regulation is not undermined.
Article 45
Transfers on the basis of an adequacy decision
1. A transfer of personal data to a
third country or an international organisation may take place where the
Commission has decided that the third country, a territory or one or
more specified sectors within that third country, or the international
organisation in question ensures an adequate level of protection. Such a
transfer shall not require any specific authorisation.
2. When assessing the adequacy of
the level of protection, the Commission shall, in particular, take
account of the following elements:
(a)
the rule of law, respect for human
rights and fundamental freedoms, relevant legislation, both general and
sectoral, including concerning public security, defence, national
security and criminal law and the access of public authorities to
personal data, as well as the implementation of such legislation, data
protection rules, professional rules and security measures, including
rules for the onward transfer of personal data to another third country
or international organisation which are complied with in that country or
international organisation, case-law, as well as effective and
enforceable data subject rights and effective administrative and
judicial redress for the data subjects whose personal data are being
transferred;
(b)
the existence and effective functioning
of one or more independent supervisory authorities in the third country
or to which an international organisation is subject, with
responsibility for ensuring and enforcing compliance with the data
protection rules, including adequate enforcement powers, for assisting
and advising the data subjects in exercising their rights and for
cooperation with the supervisory authorities of the Member States;
and
(c)
the international commitments the third
country or international organisation concerned has entered into, or
other obligations arising from legally binding conventions or
instruments as well as from its participation in multilateral or
regional systems, in particular in relation to the protection of
personal data.
3. The Commission, after assessing
the adequacy of the level of protection, may decide, by means of
implementing act, that a third country, a territory or one or more
specified sectors within a third country, or an international
organisation ensures an adequate level of protection within the meaning
of paragraph 2 of this Article. The implementing act shall provide
for a mechanism for a periodic review, at least every four years, which
shall take into account all relevant developments in the third country
or international organisation. The implementing act shall specify its
territorial and sectoral application and, where applicable, identify the
supervisory authority or authorities referred to in point (b) of
paragraph 2 of this Article. The implementing act shall be adopted in
accordance with the examination procedure referred to in Article 93(2).
4. The Commission shall, on an
ongoing basis, monitor developments in third countries and international
organisations that could affect the functioning of decisions adopted
pursuant to paragraph 3 of this Article and decisions adopted on
the basis of Article 25(6) of Directive 95/46/EC.
5. The Commission shall, where
available information reveals, in particular following the review
referred to in paragraph 3 of this Article, that a third country, a
territory or one or more specified sectors within a third country, or an
international organisation no longer ensures an adequate level of
protection within the meaning of paragraph 2 of this Article, to
the extent necessary, repeal, amend or suspend the decision referred to
in paragraph 3 of this Article by means of implementing acts
without retro-active effect. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in
Article 93(2).
On duly justified imperative grounds of urgency,
the Commission shall adopt immediately applicable implementing acts in
accordance with the procedure referred to in Article 93(3).
6. The Commission shall enter into
consultations with the third country or international organisation with
a view to remedying the situation giving rise to the decision made
pursuant to paragraph 5.
7. A decision pursuant to
paragraph 5 of this Article is without prejudice to transfers of
personal data to the third country, a territory or one or more specified
sectors within that third country, or the international organisation in
question pursuant to Articles 46 to 49.
8. The Commission shall publish in the Official Journal of the European Union
and on its website a list of the third countries, territories and
specified sectors within a third country and international organisations
for which it has decided that an adequate level of protection is or is
no longer ensured.
9. Decisions adopted by the
Commission on the basis of Article 25(6) of Directive 95/46/EC
shall remain in force until amended, replaced or repealed by a
Commission Decision adopted in accordance with paragraph 3 or 5 of
this Article.
Article 46
Transfers subject to appropriate safeguards
1. In the absence of a decision
pursuant to Article 45(3), a controller or processor may transfer
personal data to a third country or an international organisation only
if the controller or processor has provided appropriate safeguards, and
on condition that enforceable data subject rights and effective legal
remedies for data subjects are available.
2. The appropriate safeguards
referred to in paragraph 1 may be provided for, without requiring any
specific authorisation from a supervisory authority, by:
(a)
a legally binding and enforceable instrument between public authorities or bodies;
(b)
binding corporate rules in accordance with Article 47;
(c)
standard data protection clauses
adopted by the Commission in accordance with the examination procedure
referred to in Article 93(2);
(d)
standard data protection clauses
adopted by a supervisory authority and approved by the Commission
pursuant to the examination procedure referred to in Article 93(2);
(e)
an approved code of conduct pursuant to
Article 40 together with binding and enforceable commitments of the
controller or processor in the third country to apply the appropriate
safeguards, including as regards data subjects’ rights; or
(f)
an approved certification mechanism
pursuant to Article 42 together with binding and enforceable
commitments of the controller or processor in the third country to apply
the appropriate safeguards, including as regards data subjects’ rights.
3. Subject to the authorisation
from the competent supervisory authority, the appropriate safeguards
referred to in paragraph 1 may also be provided for, in particular,
by:
(a)
contractual clauses between the
controller or processor and the controller, processor or the recipient
of the personal data in the third country or international organisation;
or
(b)
provisions to be inserted into
administrative arrangements between public authorities or bodies which
include enforceable and effective data subject rights.
4. The supervisory authority shall
apply the consistency mechanism referred to in Article 63 in the
cases referred to in paragraph 3 of this Article.
5. Authorisations by a Member
State or supervisory authority on the basis of Article 26(2) of
Directive 95/46/EC shall remain valid until amended, replaced or
repealed, if necessary, by that supervisory authority. Decisions adopted
by the Commission on the basis of Article 26(4) of
Directive 95/46/EC shall remain in force until amended, replaced or
repealed, if necessary, by a Commission Decision adopted in accordance
with paragraph 2 of this Article.
Article 47
Binding corporate rules
1. The competent supervisory
authority shall approve binding corporate rules in accordance with the
consistency mechanism set out in Article 63, provided that they:
(a)
are legally binding and apply to and
are enforced by every member concerned of the group of undertakings, or
group of enterprises engaged in a joint economic activity, including
their employees;
(b)
expressly confer enforceable rights on data subjects with regard to the processing of their personal data; and
(c)
fulfil the requirements laid down in paragraph 2.
2. The binding corporate rules referred to in paragraph 1 shall specify at least:
(a)
the structure and contact details of
the group of undertakings, or group of enterprises engaged in a joint
economic activity and of each of its members;
(b)
the data transfers or set of transfers,
including the categories of personal data, the type of processing and
its purposes, the type of data subjects affected and the identification
of the third country or countries in question;
(c)
their legally binding nature, both internally and externally;
(d)
the application of the general data
protection principles, in particular purpose limitation, data
minimisation, limited storage periods, data quality, data protection by
design and by default, legal basis for processing, processing of special
categories of personal data, measures to ensure data security, and the
requirements in respect of onward transfers to bodies not bound by the
binding corporate rules;
(e)
the rights of data subjects in regard
to processing and the means to exercise those rights, including the
right not to be subject to decisions based solely on automated
processing, including profiling in accordance with Article 22, the
right to lodge a complaint with the competent supervisory authority and
before the competent courts of the Member States in accordance with
Article 79, and to obtain redress and, where appropriate,
compensation for a breach of the binding corporate rules;
(f)
the acceptance by the controller or
processor established on the territory of a Member State of
liability for any breaches of the binding corporate rules by any member
concerned not established in the Union; the controller or the processor
shall be exempt from that liability, in whole or in part, only if it
proves that that member is not responsible for the event giving rise to
the damage;
(g)
how the information on the binding
corporate rules, in particular on the provisions referred to in points
(d), (e) and (f) of this paragraph is provided to the data subjects
in addition to Articles 13 and 14;
(h)
the tasks of any data protection
officer designated in accordance with Article 37 or any other
person or entity in charge of the monitoring compliance with the binding
corporate rules within the group of undertakings, or group of
enterprises engaged in a joint economic activity, as well as monitoring
training and complaint-handling;
(i)
the complaint procedures;
(j)
the mechanisms within the group of
undertakings, or group of enterprises engaged in a joint economic
activity for ensuring the verification of compliance with the binding
corporate rules. Such mechanisms shall include data protection audits
and methods for ensuring corrective actions to protect the rights of the
data subject. Results of such verification should be communicated to
the person or entity referred to in point (h) and to the board of
the controlling undertaking of a group of undertakings, or of the group
of enterprises engaged in a joint economic activity, and should be
available upon request to the competent supervisory authority;
(k)
the mechanisms for reporting and recording changes to the rules and reporting those changes to the supervisory authority;
(l)
the cooperation mechanism with the
supervisory authority to ensure compliance by any member of the group of
undertakings, or group of enterprises engaged in a joint economic
activity, in particular by making available to the supervisory authority
the results of verifications of the measures referred to in point (j);
(m)
the mechanisms for reporting to the
competent supervisory authority any legal requirements to which a member
of the group of undertakings, or group of enterprises engaged in a
joint economic activity is subject in a third country which are likely
to have a substantial adverse effect on the guarantees provided by the
binding corporate rules; and
(n)
the appropriate data protection training to personnel having permanent or regular access to personal data.
3. The Commission may specify the
format and procedures for the exchange of information between
controllers, processors and supervisory authorities for binding
corporate rules within the meaning of this Article. Those implementing
acts shall be adopted in accordance with the examination procedure set
out in Article 93(2).
Article 48
Transfers or disclosures not authorised by Union law
Any judgment of a court or tribunal and any
decision of an administrative authority of a third country requiring a
controller or processor to transfer or disclose personal data may only
be recognised or enforceable in any manner if 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,
without prejudice to other grounds for transfer pursuant to this
Chapter.
Article 49
Derogations for specific situations
1. In the absence of an adequacy
decision pursuant to Article 45(3), or of appropriate safeguards
pursuant to Article 46, including binding corporate rules, a
transfer or a set of transfers of personal data to a third country or an
international organisation shall take place only on one of the
following conditions:
(a)
the data subject has explicitly
consented to the proposed transfer, after having been informed of the
possible risks of such transfers for the data subject due to the absence
of an adequacy decision and appropriate safeguards;
(b)
the transfer is necessary for the
performance of a contract between the data subject and the controller or
the implementation of pre-contractual measures taken at the data
subject’s request;
(c)
the transfer is necessary for the
conclusion or performance of a contract concluded in the interest of the
data subject between the controller and another natural or legal
person;
(d)
the transfer is necessary for important reasons of public interest;
(e)
the transfer is necessary for the establishment, exercise or defence of legal claims;
(f)
the transfer is necessary in order to
protect the vital interests of the data subject or of other persons,
where the data subject is physically or legally incapable of giving
consent;
(g)
the transfer is made from a register
which according to Union or Member State law is intended to provide
information to the public and which is open to consultation either by
the public in general or by any person who can demonstrate a legitimate
interest, but only to the extent that the conditions laid down by Union
or Member State law for consultation are fulfilled in the
particular case.
Where a transfer could not be based on a provision
in Article 45 or 46, including the provisions on binding corporate
rules, and none of the derogations for a specific situation referred to
in the first subparagraph of this paragraph is applicable, a transfer to
a third country or an international organisation may take place only if
the transfer is not repetitive, concerns only a limited number of data
subjects, is necessary for the purposes of compelling legitimate
interests pursued by the controller which are not overridden by the
interests or rights and freedoms of the data subject, and the controller
has assessed all the circumstances surrounding the data transfer and
has on the basis of that assessment provided suitable safeguards with
regard to the protection of personal data. The controller shall inform
the supervisory authority of the transfer. The controller shall, in
addition to providing the information referred to in Articles 13
and 14, inform the data subject of the transfer and on the compelling
legitimate interests pursued.
2. A transfer pursuant to point
(g) of the first subparagraph of paragraph 1 shall not involve the
entirety of the personal data or entire categories of the personal data
contained in the register. Where the register is intended for
consultation by persons having a legitimate interest, the transfer shall
be made only at the request of those persons or if they are to be the
recipients.
3. Points (a), (b) and (c) of the
first subparagraph of paragraph 1 and the second subparagraph thereof
shall not apply to activities carried out by public authorities in the
exercise of their public powers.
4. The public interest referred to
in point (d) of the first subparagraph of paragraph 1 shall be
recognised in Union law or in the law of the Member State to which the
controller is subject.
5. In the absence of an adequacy
decision, Union or Member State law may, for important reasons of public
interest, expressly set limits to the transfer of specific categories
of personal data to a third country or an international organisation.
Member States shall notify such provisions to the Commission.
6. The controller or processor
shall document the assessment as well as the suitable safeguards
referred to in the second subparagraph of paragraph 1 of this
Article in the records referred to in Article 30.
Article 50
International cooperation for the protection of personal data
In relation to third countries and international
organisations, the Commission and supervisory authorities shall take
appropriate steps to:
(a)
develop international cooperation
mechanisms to facilitate the effective enforcement of legislation for
the protection of personal data;
(b)
provide international mutual assistance
in the enforcement of legislation for the protection of personal data,
including through notification, complaint referral, investigative
assistance and information exchange, subject to appropriate safeguards
for the protection of personal data and other fundamental rights and
freedoms;
(c)
engage relevant stakeholders in
discussion and activities aimed at furthering international cooperation
in the enforcement of legislation for the protection of personal data;
(d)
promote the exchange and documentation
of personal data protection legislation and practice, including on
jurisdictional conflicts with third countries.
CHAPTER VI
Independent supervisory authorities
Article 51
Supervisory authority
1. Each Member State shall provide
for one or more independent public authorities to be responsible for
monitoring the application of this Regulation, in order to protect the
fundamental rights and freedoms of natural persons in relation to
processing and to facilitate the free flow of personal data within the
Union (‘supervisory authority’).
2. Each supervisory authority
shall contribute to the consistent application of this Regulation
throughout the Union. For that purpose, the supervisory authorities
shall cooperate with each other and the Commission in accordance with
Chapter VII.
3. Where more than one supervisory
authority is established in a Member State, that Member State
shall designate the supervisory authority which is to represent those
authorities in the Board and shall set out the mechanism to ensure
compliance by the other authorities with the rules relating to the
consistency mechanism referred to in Article 63.
4. Each Member State shall notify
to the Commission the provisions of its law which it adopts pursuant to
this Chapter, by 25 May 2018 and, without delay, any subsequent
amendment affecting them.
Article 52
Independence
1. Each supervisory authority
shall act with complete independence in performing its tasks and
exercising its powers in accordance with this Regulation.
2. The member or members of each
supervisory authority shall, in the performance of their tasks and
exercise of their powers in accordance with this Regulation, remain free
from external influence, whether direct or indirect, and shall neither
seek nor take instructions from anybody.
3. Member or members of each
supervisory authority shall refrain from any action incompatible with
their duties and shall not, during their term of office, engage in any
incompatible occupation, whether gainful or not.
4. Each Member State shall ensure
that each supervisory authority is provided with the human, technical
and financial resources, premises and infrastructure necessary for the
effective performance of its tasks and exercise of its powers, including
those to be carried out in the context of mutual assistance,
cooperation and participation in the Board.
5. Each Member State shall ensure
that each supervisory authority chooses and has its own staff which
shall be subject to the exclusive direction of the member or members of
the supervisory authority concerned.
6. Each Member State shall ensure
that each supervisory authority is subject to financial control which
does not affect its independence and that it has separate, public annual
budgets, which may be part of the overall state or national budget.
Article 53
General conditions for the members of the supervisory authority
1. Member States shall provide for
each member of their supervisory authorities to be appointed by means
of a transparent procedure by:
—
their parliament;
—
their government;
—
their head of State; or
—
an independent body entrusted with the appointment under Member State law.
2. Each member shall have the
qualifications, experience and skills, in particular in the area of the
protection of personal data, required to perform its duties and exercise
its powers.
3. The duties of a member shall
end in the event of the expiry of the term of office, resignation or
compulsory retirement, in accordance with the law of the
Member State concerned.
4. A member shall be dismissed
only in cases of serious misconduct or if the member no longer fulfils
the conditions required for the performance of the duties.
Article 54
Rules on the establishment of the supervisory authority
1. Each Member State shall provide by law for all of the following:
(a)
the establishment of each supervisory authority;
(b)
the qualifications and eligibility conditions required to be appointed as member of each supervisory authority;
(c)
the rules and procedures for the appointment of the member or members of each supervisory authority;
(d)
the duration of the term of the member
or members of each supervisory authority of no less than four years,
except for the first appointment after 24 May 2016, part of which may
take place for a shorter period where that is necessary to protect the
independence of the supervisory authority by means of a staggered
appointment procedure;
(e)
whether and, if so, for how many terms the member or members of each supervisory authority is eligible for reappointment;
(f)
the conditions governing the
obligations of the member or members and staff of each supervisory
authority, prohibitions on actions, occupations and benefits
incompatible therewith during and after the term of office and rules
governing the cessation of employment.
2. The member or members and the
staff of each supervisory authority shall, in accordance with Union or
Member State law, be subject to a duty of professional secrecy both
during and after their term of office, with regard to any confidential
information which has come to their knowledge in the course of the
performance of their tasks or exercise of their powers. During their
term of office, that duty of professional secrecy shall in particular
apply to reporting by natural persons of infringements of this
Regulation.
Article 55
Competence
1. Each supervisory authority
shall be competent for the performance of the tasks assigned to and the
exercise of the powers conferred on it in accordance with this
Regulation on the territory of its own Member State.
2. Where processing is carried out
by public authorities or private bodies acting on the basis of
point (c) or (e) of Article 6(1), the supervisory authority of the
Member State concerned shall be competent. In such cases Article 56
does not apply.
3. Supervisory authorities shall
not be competent to supervise processing operations of courts acting in
their judicial capacity.
Article 56
Competence of the lead supervisory authority
1. Without prejudice to Article
55, the supervisory authority of the main establishment or of the single
establishment of the controller or processor shall be competent to act
as lead supervisory authority for the cross-border processing carried
out by that controller or processor in accordance with the procedure
provided in Article 60.
2. By derogation from paragraph 1,
each supervisory authority shall be competent to handle a complaint
lodged with it or a possible infringement of this Regulation, if the
subject matter relates only to an establishment in its Member State or
substantially affects data subjects only in its Member State.
3. In the cases referred to in
paragraph 2 of this Article, the supervisory authority shall inform the
lead supervisory authority without delay on that matter. Within a period
of three weeks after being informed the lead supervisory authority
shall decide whether or not it will handle the case in accordance with
the procedure provided in Article 60, taking into account whether or not
there is an establishment of the controller or processor in the Member
State of which the supervisory authority informed it.
4. Where the lead supervisory
authority decides to handle the case, the procedure provided in Article
60 shall apply. The supervisory authority which informed the lead
supervisory authority may submit to the lead supervisory authority a
draft for a decision. The lead supervisory authority shall take utmost
account of that draft when preparing the draft decision referred to in
Article 60(3).
5. Where the lead supervisory
authority decides not to handle the case, the supervisory authority
which informed the lead supervisory authority shall handle it according
to Articles 61 and 62.
6. The lead supervisory authority
shall be the sole interlocutor of the controller or processor for the
cross-border processing carried out by that controller or processor.
Article 57
Tasks
1. Without prejudice to other
tasks set out under this Regulation, each supervisory authority shall on
its territory:
(a)
monitor and enforce the application of this Regulation;
(b)
promote public awareness and
understanding of the risks, rules, safeguards and rights in relation to
processing. Activities addressed specifically to children shall receive
specific attention;
(c)
advise, in accordance with Member State
law, the national parliament, the government, and other institutions
and bodies on legislative and administrative measures relating to the
protection of natural persons’ rights and freedoms with regard to
processing;
(d)
promote the awareness of controllers and processors of their obligations under this Regulation;
(e)
upon request, provide information to
any data subject concerning the exercise of their rights under this
Regulation and, if appropriate, cooperate with the supervisory
authorities in other Member States to that end;
(f)
handle complaints lodged by a data
subject, or by a body, organisation or association in accordance with
Article 80, and investigate, to the extent appropriate, the subject
matter of the complaint and inform the complainant of the progress and
the outcome of the investigation within a reasonable period, in
particular if further investigation or coordination with another
supervisory authority is necessary;
(g)
cooperate with, including sharing
information and provide mutual assistance to, other supervisory
authorities with a view to ensuring the consistency of application and
enforcement of this Regulation;
(h)
conduct investigations on the
application of this Regulation, including on the basis of information
received from another supervisory authority or other public authority;
(i)
monitor relevant developments, insofar
as they have an impact on the protection of personal data, in particular
the development of information and communication technologies and
commercial practices;
(j)
adopt standard contractual clauses referred to in Article 28(8) and in point (d) of Article 46(2);
(k)
establish and maintain a list in
relation to the requirement for data protection impact assessment
pursuant to Article 35(4);
(l)
give advice on the processing operations referred to in Article 36(2);
(m)
encourage the drawing up of codes of
conduct pursuant to Article 40(1) and provide an opinion and
approve such codes of conduct which provide sufficient safeguards,
pursuant to Article 40(5);
(n)
encourage the establishment of data
protection certification mechanisms and of data protection seals and
marks pursuant to Article 42(1), and approve the criteria of
certification pursuant to Article 42(5);
(o)
where applicable, carry out a periodic review of certifications issued in accordance with Article 42(7);
(p)
draft and publish the criteria for
accreditation of a body for monitoring codes of conduct pursuant to
Article 41 and of a certification body pursuant to Article 43;
(q)
conduct the accreditation of a body for
monitoring codes of conduct pursuant to Article 41 and of a
certification body pursuant to Article 43;
(r)
authorise contractual clauses and provisions referred to in Article 46(3);
(s)
approve binding corporate rules pursuant to Article 47;
(t)
contribute to the activities of the Board;
(u)
keep internal records of infringements of this Regulation and of measures taken in accordance with Article 58(2); and
(v)
fulfil any other tasks related to the protection of personal data.
2. Each supervisory authority
shall facilitate the submission of complaints referred to in
point (f) of paragraph 1 by measures such as a complaint submission
form which can also be completed electronically, without excluding
other means of communication.
3. The performance of the tasks of
each supervisory authority shall be free of charge for the data subject
and, where applicable, for the data protection officer.
4. Where requests are manifestly
unfounded or excessive, in particular because of their repetitive
character, the supervisory authority may charge a reasonable fee based
on administrative costs, or refuse to act on the request. The
supervisory authority shall bear the burden of demonstrating the
manifestly unfounded or excessive character of the request.
Article 58
Powers
1. Each supervisory authority shall have all of the following investigative powers:
(a)
to order the controller and the
processor, and, where applicable, the controller’s or the processor’s
representative to provide any information it requires for the
performance of its tasks;
(b)
to carry out investigations in the form of data protection audits;
(c)
to carry out a review on certifications issued pursuant to Article 42(7);
(d)
to notify the controller or the processor of an alleged infringement of this Regulation;
(e)
to obtain, from the controller and the
processor, access to all personal data and to all information necessary
for the performance of its tasks;
(f)
to obtain access to any premises of the
controller and the processor, including to any data processing
equipment and means, in accordance with Union or Member State
procedural law.
2. Each supervisory authority shall have all of the following corrective powers:
(a)
to issue warnings to a controller or
processor that intended processing operations are likely to infringe
provisions of this Regulation;
(b)
to issue reprimands to a controller or a processor where processing operations have infringed provisions of this Regulation;
(c)
to order the controller or the
processor to comply with the data subject’s requests to exercise his or
her rights pursuant to this Regulation;
(d)
to order the controller or processor to
bring processing operations into compliance with the provisions of this
Regulation, where appropriate, in a specified manner and within a
specified period;
(e)
to order the controller to communicate a personal data breach to the data subject;
(f)
to impose a temporary or definitive limitation including a ban on processing;
(g)
to order the rectification or erasure
of personal data or restriction of processing pursuant to
Articles 16, 17 and 18 and the notification of such actions to
recipients to whom the personal data have been disclosed pursuant to
Article 17(2) and Article 19;
(h)
to withdraw a certification or to order
the certification body to withdraw a certification issued pursuant to
Articles 42 and 43, or to order the certification body not to issue
certification if the requirements for the certification are not or are
no longer met;
(i)
to impose an administrative fine
pursuant to Article 83, in addition to, or instead of measures referred
to in this paragraph, depending on the circumstances of each individual
case;
(j)
to order the suspension of data flows to a recipient in a third country or to an international organisation.
3. Each supervisory authority shall have all of the following authorisation and advisory powers:
(a)
to advise the controller in accordance with the prior consultation procedure referred to in Article 36;
(b)
to issue, on its own initiative or on
request, opinions to the national parliament, the Member State
government or, in accordance with Member State law, to other
institutions and bodies as well as to the public on any issue related to
the protection of personal data;
(c)
to authorise processing referred to in Article 36(5), if the law of the Member State requires such prior authorisation;
(d)
to issue an opinion and approve draft codes of conduct pursuant to Article 40(5);
(e)
to accredit certification bodies pursuant to Article 43;
(f)
to issue certifications and approve criteria of certification in accordance with Article 42(5);
(g)
to adopt standard data protection clauses referred to in Article 28(8) and in point (d) of Article 46(2);
(h)
to authorise contractual clauses referred to in point (a) of Article 46(3);
(i)
to authorise administrative arrangements referred to in point (b) of Article 46(3);
(j)
to approve binding corporate rules pursuant to Article 47.
4. The exercise of the powers
conferred on the supervisory authority pursuant to this Article shall be
subject to appropriate safeguards, including effective judicial remedy
and due process, set out in Union and Member State law in
accordance with the Charter.
5. Each Member State shall
provide by law that its supervisory authority shall have the power to
bring infringements of this Regulation to the attention of the judicial
authorities and where appropriate, to commence or engage otherwise in
legal proceedings, in order to enforce the provisions of this
Regulation.
6. Each Member State may provide
by law that its supervisory authority shall have additional powers to
those referred to in paragraphs 1, 2 and 3. The exercise of those
powers shall not impair the effective operation of Chapter VII.
Article 59
Activity reports
Each supervisory authority shall draw up an annual
report on its activities, which may include a list of types of
infringement notified and types of measures taken in accordance with
Article 58(2). Those reports shall be transmitted to the national
parliament, the government and other authorities as designated by
Member State law. They shall be made available to the public, to
the Commission and to the Board.
CHAPTER VII
Cooperation and consistency
Article 60
Cooperation between the lead supervisory authority and the other supervisory authorities concerned
1. The lead supervisory authority
shall cooperate with the other supervisory authorities concerned in
accordance with this Article in an endeavour to reach consensus. The
lead supervisory authority and the supervisory authorities concerned
shall exchange all relevant information with each other.
2. The lead supervisory authority
may request at any time other supervisory authorities concerned to
provide mutual assistance pursuant to Article 61 and may conduct joint
operations pursuant to Article 62, in particular for carrying out
investigations or for monitoring the implementation of a measure
concerning a controller or processor established in another Member
State.
3. The lead supervisory authority
shall, without delay, communicate the relevant information on the matter
to the other supervisory authorities concerned. It shall without delay
submit a draft decision to the other supervisory authorities concerned
for their opinion and take due account of their views.
4. Where any of the other
supervisory authorities concerned within a period of four weeks after
having been consulted in accordance with paragraph 3 of this Article,
expresses a relevant and reasoned objection to the draft decision, the
lead supervisory authority shall, if it does not follow the relevant and
reasoned objection or is of the opinion that the objection is not
relevant or reasoned, submit the matter to the consistency mechanism
referred to in Article 63.
5. Where the lead supervisory
authority intends to follow the relevant and reasoned objection made, it
shall submit to the other supervisory authorities concerned a revised
draft decision for their opinion. That revised draft decision shall be
subject to the procedure referred to in paragraph 4 within a period
of two weeks.
6. Where none of the other
supervisory authorities concerned has objected to the draft decision
submitted by the lead supervisory authority within the period referred
to in paragraphs 4 and 5, the lead supervisory authority and the
supervisory authorities concerned shall be deemed to be in agreement
with that draft decision and shall be bound by it.
7. The lead supervisory authority
shall adopt and notify the decision to the main establishment or single
establishment of the controller or processor, as the case may be and
inform the other supervisory authorities concerned and the Board of the
decision in question, including a summary of the relevant facts and
grounds. The supervisory authority with which a complaint has been
lodged shall inform the complainant on the decision.
8. By derogation from paragraph 7,
where a complaint is dismissed or rejected, the supervisory authority
with which the complaint was lodged shall adopt the decision and notify
it to the complainant and shall inform the controller thereof.
9. Where the lead supervisory
authority and the supervisory authorities concerned agree to dismiss or
reject parts of a complaint and to act on other parts of that complaint,
a separate decision shall be adopted for each of those parts of the
matter. The lead supervisory authority shall adopt the decision for the
part concerning actions in relation to the controller, shall notify it
to the main establishment or single establishment of the controller or
processor on the territory of its Member State and shall inform the
complainant thereof, while the supervisory authority of the complainant
shall adopt the decision for the part concerning dismissal or rejection
of that complaint, and shall notify it to that complainant and shall
inform the controller or processor thereof.
10. After being notified of the
decision of the lead supervisory authority pursuant to paragraphs 7 and
9, the controller or processor shall take the necessary measures to
ensure compliance with the decision as regards processing activities in
the context of all its establishments in the Union. The controller or
processor shall notify the measures taken for complying with the
decision to the lead supervisory authority, which shall inform the other
supervisory authorities concerned.
11. Where, in exceptional
circumstances, a supervisory authority concerned has reasons to consider
that there is an urgent need to act in order to protect the interests
of data subjects, the urgency procedure referred to in Article 66 shall
apply.
12. The lead supervisory authority
and the other supervisory authorities concerned shall supply the
information required under this Article to each other by electronic
means, using a standardised format.
Article 61
Mutual assistance
1. Supervisory authorities shall
provide each other with relevant information and mutual assistance in
order to implement and apply this Regulation in a consistent manner, and
shall put in place measures for effective cooperation with one another.
Mutual assistance shall cover, in particular, information requests and
supervisory measures, such as requests to carry out prior authorisations
and consultations, inspections and investigations.
2. Each supervisory authority
shall take all appropriate measures required to reply to a request of
another supervisory authority without undue delay and no later than one
month after receiving the request. Such measures may include, in
particular, the transmission of relevant information on the conduct of
an investigation.
3. Requests for assistance shall
contain all the necessary information, including the purpose of and
reasons for the request. Information exchanged shall be used only for
the purpose for which it was requested.
4. The requested supervisory authority shall not refuse to comply with the request unless:
(a)
it is not competent for the subject-matter of the request or for the measures it is requested to execute; or
(b)
compliance with the request would
infringe this Regulation or Union or Member State law to which the
supervisory authority receiving the request is subject.
5. The requested supervisory
authority shall inform the requesting supervisory authority of the
results or, as the case may be, of the progress of the measures taken in
order to respond to the request. The requested supervisory authority
shall provide reasons for any refusal to comply with a request pursuant
to paragraph 4.
6. Requested supervisory
authorities shall, as a rule, supply the information requested by other
supervisory authorities by electronic means, using a standardised
format.
7. Requested supervisory
authorities shall not charge a fee for any action taken by them pursuant
to a request for mutual assistance. Supervisory authorities may agree
on rules to indemnify each other for specific expenditure arising from
the provision of mutual assistance in exceptional circumstances.
8. Where a supervisory authority
does not provide the information referred to in paragraph 5 of this
Article within one month of receiving the request of another
supervisory authority, the requesting supervisory authority may adopt a
provisional measure on the territory of its Member State in accordance
with Article 55(1). In that case, the urgent need to act under
Article 66(1) shall be presumed to be met and require an urgent
binding decision from the Board pursuant to Article 66(2).
9. The Commission may, by means of
implementing acts, specify the format and procedures for mutual
assistance referred to in this Article and the arrangements for the
exchange of information by electronic means between supervisory
authorities, and between supervisory authorities and the Board, in
particular the standardised format referred to in paragraph 6 of
this Article. Those implementing acts shall be adopted in accordance
with the examination procedure referred to in Article 93(2).
Article 62
Joint operations of supervisory authorities
1. The supervisory authorities
shall, where appropriate, conduct joint operations including joint
investigations and joint enforcement measures in which members or staff
of the supervisory authorities of other Member States are involved.
2. Where the controller or
processor has establishments in several Member States or where a
significant number of data subjects in more than one Member State are
likely to be substantially affected by processing operations, a
supervisory authority of each of those Member States shall have the
right to participate in joint operations. The supervisory authority
which is competent pursuant to Article 56(1) or (4) shall invite
the supervisory authority of each of those Member States to take part in
the joint operations and shall respond without delay to the request of a
supervisory authority to participate.
3. A supervisory authority may, in
accordance with Member State law, and with the seconding
supervisory authority’s authorisation, confer powers, including
investigative powers on the seconding supervisory authority’s members or
staff involved in joint operations or, in so far as the law of the
Member State of the host supervisory authority permits, allow the
seconding supervisory authority’s members or staff to exercise their
investigative powers in accordance with the law of the Member State
of the seconding supervisory authority. Such investigative powers may
be exercised only under the guidance and in the presence of members or
staff of the host supervisory authority. The seconding supervisory
authority’s members or staff shall be subject to the Member State
law of the host supervisory authority.
4. Where, in accordance with
paragraph 1, staff of a seconding supervisory authority operate in
another Member State, the Member State of the host supervisory
authority shall assume responsibility for their actions, including
liability, for any damage caused by them during their operations, in
accordance with the law of the Member State in whose territory they
are operating.
5. The Member State in whose
territory the damage was caused shall make good such damage under the
conditions applicable to damage caused by its own staff. The
Member State of the seconding supervisory authority whose staff has
caused damage to any person in the territory of another
Member State shall reimburse that other Member State in full
any sums it has paid to the persons entitled on their behalf.
6. Without prejudice to the exercise of its rights vis-a-vis
third parties and with the exception of paragraph 5, each
Member State shall refrain, in the case provided for in
paragraph 1, from requesting reimbursement from another
Member State in relation to damage referred to in paragraph 4.
7. Where a joint operation is
intended and a supervisory authority does not, within one month, comply
with the obligation laid down in the second sentence of paragraph 2
of this Article, the other supervisory authorities may adopt a
provisional measure on the territory of its Member State in accordance
with Article 55. In that case, the urgent need to act under Article
66(1) shall be presumed to be met and require an opinion or an urgent
binding decision from the Board pursuant to Article 66(2).
Article 63
Consistency mechanism
In order to contribute to the consistent
application of this Regulation throughout the Union, the supervisory
authorities shall cooperate with each other and, where relevant, with
the Commission, through the consistency mechanism as set out in this
Section.
Article 64
Opinion of the Board
1. The Board shall issue an
opinion where a competent supervisory authority intends to adopt any of
the measures below. To that end, the competent supervisory authority
shall communicate the draft decision to the Board, when it:
(a)
aims to adopt a list of the processing
operations subject to the requirement for a data protection impact
assessment pursuant to Article 35(4);
(b)
concerns a matter pursuant to
Article 40(7) whether a draft code of conduct or an amendment or
extension to a code of conduct complies with this Regulation;
(c)
aims to approve the criteria for
accreditation of a body pursuant to Article 41(3) or a
certification body pursuant to Article 43(3);
(d)
aims to determine standard data protection clauses referred to in point (d) of Article 46(2) and in Article 28(8);
(e)
aims to authorise contractual clauses referred to in point (a) of Article 46(3); or
(f)
aims to approve binding corporate rules within the meaning of Article 47.
2. Any supervisory authority, the
Chair of the Board or the Commission may request that any matter of
general application or producing effects in more than one
Member State be examined by the Board with a view to obtaining an
opinion, in particular where a competent supervisory authority does not
comply with the obligations for mutual assistance in accordance with
Article 61 or for joint operations in accordance with
Article 62.
3. In the cases referred to in
paragraphs 1 and 2, the Board shall issue an opinion on the matter
submitted to it provided that it has not already issued an opinion on
the same matter. That opinion shall be adopted within eight weeks by
simple majority of the members of the Board. That period may be extended
by a further six weeks, taking into account the complexity of the
subject matter. Regarding the draft decision referred to in
paragraph 1 circulated to the members of the Board in accordance
with paragraph 5, a member which has not objected within a
reasonable period indicated by the Chair, shall be deemed to be in
agreement with the draft decision.
4. Supervisory authorities and the
Commission shall, without undue delay, communicate by electronic means
to the Board, using a standardised format any relevant information,
including as the case may be a summary of the facts, the draft decision,
the grounds which make the enactment of such measure necessary, and the
views of other supervisory authorities concerned.
5. The Chair of the Board shall, without undue, delay inform by electronic means:
(a)
the members of the Board and the
Commission of any relevant information which has been communicated to it
using a standardised format. The secretariat of the Board shall, where
necessary, provide translations of relevant information; and
(b)
the supervisory authority referred to,
as the case may be, in paragraphs 1 and 2, and the Commission of
the opinion and make it public.
6. The competent supervisory
authority shall not adopt its draft decision referred to in paragraph 1
within the period referred to in paragraph 3.
7. The supervisory authority
referred to in paragraph 1 shall take utmost account of the opinion of
the Board and shall, within two weeks after receiving the opinion,
communicate to the Chair of the Board by electronic means whether it
will maintain or amend its draft decision and, if any, the amended draft
decision, using a standardised format.
8. Where the supervisory authority
concerned informs the Chair of the Board within the period referred to
in paragraph 7 of this Article that it does not intend to follow the
opinion of the Board, in whole or in part, providing the relevant
grounds, Article 65(1) shall apply.
Article 65
Dispute resolution by the Board
1. In order to ensure the correct
and consistent application of this Regulation in individual cases, the
Board shall adopt a binding decision in the following cases:
(a)
where, in a case referred to in Article
60(4), a supervisory authority concerned has raised a relevant and
reasoned objection to a draft decision of the lead authority or the lead
authority has rejected such an objection as being not relevant or
reasoned. The binding decision shall concern all the matters which are
the subject of the relevant and reasoned objection, in particular
whether there is an infringement of this Regulation;
(b)
where there are conflicting views on which of the supervisory authorities concerned is competent for the main establishment;
(c)
where a competent supervisory authority
does not request the opinion of the Board in the cases referred to in
Article 64(1), or does not follow the opinion of the Board issued
under Article 64. In that case, any supervisory authority concerned
or the Commission may communicate the matter to the Board.
2. The decision referred to in
paragraph 1 shall be adopted within one month from the referral of the
subject-matter by a two-thirds majority of the members of the Board.
That period may be extended by a further month on account of the
complexity of the subject-matter. The decision referred to in paragraph 1
shall be reasoned and addressed to the lead supervisory authority and
all the supervisory authorities concerned and binding on them.
3. Where the Board has been unable
to adopt a decision within the periods referred to in paragraph 2,
it shall adopt its decision within two weeks following the expiration
of the second month referred to in paragraph 2 by a simple majority of
the members of the Board. Where the members of the Board are split, the
decision shall by adopted by the vote of its Chair.
4. The supervisory authorities
concerned shall not adopt a decision on the subject matter submitted to
the Board under paragraph 1 during the periods referred to in
paragraphs 2 and 3.
5. The Chair of the Board shall
notify, without undue delay, the decision referred to in paragraph 1 to
the supervisory authorities concerned. It shall inform the Commission
thereof. The decision shall be published on the website of the Board
without delay after the supervisory authority has notified the final
decision referred to in paragraph 6.
6. The lead supervisory authority
or, as the case may be, the supervisory authority with which the
complaint has been lodged shall adopt its final decision on the basis of
the decision referred to in paragraph 1 of this Article, without undue
delay and at the latest by one month after the Board has notified its
decision. The lead supervisory authority or, as the case may be, the
supervisory authority with which the complaint has been lodged, shall
inform the Board of the date when its final decision is notified
respectively to the controller or the processor and to the data subject.
The final decision of the supervisory authorities concerned shall be
adopted under the terms of Article 60(7), (8) and (9). The
final decision shall refer to the decision referred to in
paragraph 1 of this Article and shall specify that the decision
referred to in that paragraph will be published on the website of the
Board in accordance with paragraph 5 of this Article. The final decision
shall attach the decision referred to in paragraph 1 of this
Article.
Article 66
Urgency procedure
1. In exceptional circumstances,
where a supervisory authority concerned considers that there is an
urgent need to act in order to protect the rights and freedoms of data
subjects, it may, by way of derogation from the consistency mechanism
referred to in Articles 63, 64 and 65 or the procedure referred to
in Article 60, immediately adopt provisional measures intended to
produce legal effects on its own territory with a specified period of
validity which shall not exceed three months. The supervisory authority
shall, without delay, communicate those measures and the reasons for
adopting them to the other supervisory authorities concerned, to the
Board and to the Commission.
2. Where a supervisory authority
has taken a measure pursuant to paragraph 1 and considers that
final measures need urgently be adopted, it may request an urgent
opinion or an urgent binding decision from the Board, giving reasons for
requesting such opinion or decision.
3. Any supervisory authority may
request an urgent opinion or an urgent binding decision, as the case may
be, from the Board where a competent supervisory authority has not
taken an appropriate measure in a situation where there is an urgent
need to act, in order to protect the rights and freedoms of data
subjects, giving reasons for requesting such opinion or decision,
including for the urgent need to act.
4. By derogation from
Article 64(3) and Article 65(2), an urgent opinion or an urgent
binding decision referred to in paragraphs 2 and 3 of this
Article shall be adopted within two weeks by simple majority of the
members of the Board.
Article 67
Exchange of information
The Commission may adopt implementing acts of
general scope in order to specify the arrangements for the exchange of
information by electronic means between supervisory authorities, and
between supervisory authorities and the Board, in particular the
standardised format referred to in Article 64.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2).
Article 68
European Data Protection Board
1. The European Data Protection
Board (the ‘Board’) is hereby established as a body of the Union and
shall have legal personality.
2. The Board shall be represented by its Chair.
3. The Board shall be composed of
the head of one supervisory authority of each Member State and of
the European Data Protection Supervisor, or their respective
representatives.
4. Where in a Member State more
than one supervisory authority is responsible for monitoring the
application of the provisions pursuant to this Regulation, a joint
representative shall be appointed in accordance with that Member State’s
law.
5. The Commission shall have the
right to participate in the activities and meetings of the Board without
voting right. The Commission shall designate a representative. The
Chair of the Board shall communicate to the Commission the activities of
the Board.
6. In the cases referred to in
Article 65, the European Data Protection Supervisor shall have voting
rights only on decisions which concern principles and rules applicable
to the Union institutions, bodies, offices and agencies which correspond
in substance to those of this Regulation.
Article 69
Independence
1. The Board shall act
independently when performing its tasks or exercising its powers
pursuant to Articles 70 and 71.
2. Without prejudice to requests
by the Commission referred to in point (b) of Article 70(1) and in
Article 70(2), the Board shall, in the performance of its tasks or the
exercise of its powers, neither seek nor take instructions from anybody.
Article 70
Tasks of the Board
1. The Board shall ensure the
consistent application of this Regulation. To that end, the Board shall,
on its own initiative or, where relevant, at the request of the
Commission, in particular:
(a)
monitor and ensure the correct
application of this Regulation in the cases provided for in Articles 64
and 65 without prejudice to the tasks of national supervisory
authorities;
(b)
advise the Commission on any issue
related to the protection of personal data in the Union, including on
any proposed amendment of this Regulation;
(c)
advise the Commission on the format and
procedures for the exchange of information between controllers,
processors and supervisory authorities for binding corporate rules;
(d)
issue guidelines, recommendations, and
best practices on procedures for erasing links, copies or replications
of personal data from publicly available communication services as
referred to in Article 17(2);
(e)
examine, on its own initiative, on
request of one of its members or on request of the Commission, any
question covering the application of this Regulation and issue
guidelines, recommendations and best practices in order to encourage
consistent application of this Regulation;
(f)
issue guidelines, recommendations and
best practices in accordance with point (e) of this paragraph for
further specifying the criteria and conditions for decisions based on
profiling pursuant to Article 22(2);
(g)
issue guidelines, recommendations and
best practices in accordance with point (e) of this paragraph for
establishing the personal data breaches and determining the undue delay
referred to in Article 33(1) and (2) and for the particular
circumstances in which a controller or a processor is required to notify
the personal data breach;
(h)
issue guidelines, recommendations and
best practices in accordance with point (e) of this paragraph as to
the circumstances in which a personal data breach is likely to result
in a high risk to the rights and freedoms of the natural persons
referred to in Article 34(1).
(i)
issue guidelines, recommendations and
best practices in accordance with point (e) of this paragraph for
the purpose of further specifying the criteria and requirements for
personal data transfers based on binding corporate rules adhered to by
controllers and binding corporate rules adhered to by processors and on
further necessary requirements to ensure the protection of personal data
of the data subjects concerned referred to in Article 47;
(j)
issue guidelines, recommendations and
best practices in accordance with point (e) of this paragraph for
the purpose of further specifying the criteria and requirements for the
personal data transfers on the basis of Article 49(1);
(k)
draw up guidelines for supervisory
authorities concerning the application of measures referred to in
Article 58(1), (2) and (3) and the setting of administrative fines
pursuant to Article 83;
(l)
review the practical application of the guidelines, recommendations and best practices referred to in points (e) and (f);
(m)
issue guidelines, recommendations and
best practices in accordance with point (e) of this paragraph for
establishing common procedures for reporting by natural persons of
infringements of this Regulation pursuant to Article 54(2);
(n)
encourage the drawing-up of codes of
conduct and the establishment of data protection certification
mechanisms and data protection seals and marks pursuant to Articles 40
and 42;
(o)
carry out the accreditation of
certification bodies and its periodic review pursuant to Article 43 and
maintain a public register of accredited bodies pursuant to
Article 43(6) and of the accredited controllers or processors
established in third countries pursuant to Article 42(7);
(p)
specify the requirements referred to in Article 43(3) with a view to the accreditation of certification bodies under Article 42;
(q)
provide the Commission with an opinion on the certification requirements referred to in Article 43(8);
(r)
provide the Commission with an opinion on the icons referred to in Article 12(7);
(s)
provide the Commission with an opinion
for the assessment of the adequacy of the level of protection in a third
country or international organisation, including for the assessment
whether a third country, a territory or one or more specified sectors
within that third country, or an international organisation no longer
ensures an adequate level of protection. To that end, the Commission
shall provide the Board with all necessary documentation, including
correspondence with the government of the third country, with regard to
that third country, territory or specified sector, or with the
international organisation.
(t)
issue opinions on draft decisions of
supervisory authorities pursuant to the consistency mechanism referred
to in Article 64(1), on matters submitted pursuant to Article 64(2) and
to issue binding decisions pursuant to Article 65, including in cases
referred to in Article 66;
(u)
promote the cooperation and the
effective bilateral and multilateral exchange of information and best
practices between the supervisory authorities;
(v)
promote common training programmes and
facilitate personnel exchanges between the supervisory authorities and,
where appropriate, with the supervisory authorities of third countries
or with international organisations;
(w)
promote the exchange of knowledge and
documentation on data protection legislation and practice with data
protection supervisory authorities worldwide.
(x)
issue opinions on codes of conduct drawn up at Union level pursuant to Article 40(9); and
(y)
maintain a publicly accessible
electronic register of decisions taken by supervisory authorities and
courts on issues handled in the consistency mechanism.
2. Where the Commission requests
advice from the Board, it may indicate a time limit, taking into account
the urgency of the matter.
3. The Board shall forward its
opinions, guidelines, recommendations, and best practices to the
Commission and to the committee referred to in Article 93 and make them
public.
4. The Board shall, where
appropriate, consult interested parties and give them the opportunity to
comment within a reasonable period. The Board shall, without prejudice
to Article 76, make the results of the consultation procedure publicly
available.
Article 71
Reports
1. The Board shall draw up an
annual report regarding the protection of natural persons with regard to
processing in the Union and, where relevant, in third countries and
international organisations. The report shall be made public and be
transmitted to the European Parliament, to the Council and to the
Commission.
2. The annual report shall include
a review of the practical application of the guidelines,
recommendations and best practices referred to in point (l) of Article
70(1) as well as of the binding decisions referred to in Article 65.
Article 72
Procedure
1. The Board shall take decisions
by a simple majority of its members, unless otherwise provided for in
this Regulation.
2. The Board shall adopt its own
rules of procedure by a two-thirds majority of its members and organise
its own operational arrangements.
Article 73
Chair
1. The Board shall elect a chair and two deputy chairs from amongst its members by simple majority.
2. The term of office of the Chair and of the deputy chairs shall be five years and be renewable once.
Article 74
Tasks of the Chair
1. The Chair shall have the following tasks:
(a)
to convene the meetings of the Board and prepare its agenda;
(b)
to notify decisions adopted by the
Board pursuant to Article 65 to the lead supervisory authority and the
supervisory authorities concerned;
(c)
to ensure the timely performance of the
tasks of the Board, in particular in relation to the consistency
mechanism referred to in Article 63.
2. The Board shall lay down the
allocation of tasks between the Chair and the deputy chairs in its rules
of procedure.
Article 75
Secretariat
1. The Board shall have a secretariat, which shall be provided by the European Data Protection Supervisor.
2. The secretariat shall perform its tasks exclusively under the instructions of the Chair of the Board.
3. The staff of the European Data
Protection Supervisor involved in carrying out the tasks conferred on
the Board by this Regulation shall be subject to separate reporting
lines from the staff involved in carrying out tasks conferred on the
European Data Protection Supervisor.
4. Where appropriate, the Board
and the European Data Protection Supervisor shall establish and publish a
Memorandum of Understanding implementing this Article, determining the
terms of their cooperation, and applicable to the staff of the European
Data Protection Supervisor involved in carrying out the tasks conferred
on the Board by this Regulation.
5. The secretariat shall provide analytical, administrative and logistical support to the Board.
6. The secretariat shall be responsible in particular for:
(a)
the day-to-day business of the Board;
(b)
communication between the members of the Board, its Chair and the Commission;
(c)
communication with other institutions and the public;
(d)
the use of electronic means for the internal and external communication;
(e)
the translation of relevant information;
(f)
the preparation and follow-up of the meetings of the Board;
(g)
the preparation, drafting and
publication of opinions, decisions on the settlement of disputes between
supervisory authorities and other texts adopted by the Board.
Article 76
Confidentiality
1. The discussions of the Board
shall be confidential where the Board deems it necessary, as provided
for in its rules of procedure.
2. Access to documents submitted
to members of the Board, experts and representatives of third parties
shall be governed by Regulation (EC) No 1049/2001 of the European
Parliament and of the Council (21).
CHAPTER VIII
Remedies, liability and penalties
Article 77
Right to lodge a complaint with a supervisory authority
1. Without prejudice to any other
administrative or judicial remedy, every data subject shall have the
right to lodge a complaint with a supervisory authority, in particular
in the Member State of his or her habitual residence, place of work or
place of the alleged infringement if the data subject considers that the
processing of personal data relating to him or her infringes this
Regulation.
2. The supervisory authority with
which the complaint has been lodged shall inform the complainant on the
progress and the outcome of the complaint including the possibility of a
judicial remedy pursuant to Article 78.
Article 78
Right to an effective judicial remedy against a supervisory authority
1. Without prejudice to any other
administrative or non-judicial remedy, each natural or legal person
shall have the right to an effective judicial remedy against a legally
binding decision of a supervisory authority concerning them.
2. Without prejudice to any other
administrative or non-judicial remedy, each data subject shall have the
right to a an effective judicial remedy where the supervisory authority
which is competent pursuant to Articles 55 and 56 does not handle a
complaint or does not inform the data subject within three months on
the progress or outcome of the complaint lodged pursuant to
Article 77.
3. Proceedings against a
supervisory authority shall be brought before the courts of the
Member State where the supervisory authority is established.
4. Where proceedings are brought
against a decision of a supervisory authority which was preceded by an
opinion or a decision of the Board in the consistency mechanism, the
supervisory authority shall forward that opinion or decision to the
court.
Article 79
Right to an effective judicial remedy against a controller or processor
1. Without prejudice to any
available administrative or non-judicial remedy, including the right to
lodge a complaint with a supervisory authority pursuant to
Article 77, each data subject shall have the right to an effective
judicial remedy where he or she considers that his or her rights under
this Regulation have been infringed as a result of the processing of his
or her personal data in non-compliance with this Regulation.
2. Proceedings against a
controller or a processor shall be brought before the courts of the
Member State where the controller or processor has an
establishment. Alternatively, such proceedings may be brought before the
courts of the Member State where the data subject has his or her
habitual residence, unless the controller or processor is a public
authority of a Member State acting in the exercise of its public
powers.
Article 80
Representation of data subjects
1. The data subject shall have the
right to mandate a not-for-profit body, organisation or association
which has been properly constituted in accordance with the law of a
Member State, has statutory objectives which are in the public
interest, and is active in the field of the protection of data subjects’
rights and freedoms with regard to the protection of their personal
data to lodge the complaint on his or her behalf, to exercise the rights
referred to in Articles 77, 78 and 79 on his or her behalf, and to
exercise the right to receive compensation referred to in
Article 82 on his or her behalf where provided for by
Member State law.
2. Member States may provide that
any body, organisation or association referred to in paragraph 1 of
this Article, independently of a data subject’s mandate, has the right
to lodge, in that Member State, a complaint with the supervisory
authority which is competent pursuant to Article 77 and to exercise the
rights referred to in Articles 78 and 79 if it considers that
the rights of a data subject under this Regulation have been infringed
as a result of the processing.
Article 81
Suspension of proceedings
1. Where a competent court of a
Member State has information on proceedings, concerning the same subject
matter as regards processing by the same controller or processor, that
are pending in a court in another Member State, it shall contact
that court in the other Member State to confirm the existence of
such proceedings.
2. Where proceedings concerning
the same subject matter as regards processing of the same controller or
processor are pending in a court in another Member State, any
competent court other than the court first seized may suspend its
proceedings.
3. Where those proceedings are
pending at first instance, any court other than the court first seized
may also, on the application of one of the parties, decline jurisdiction
if the court first seized has jurisdiction over the actions in question
and its law permits the consolidation thereof.
Article 82
Right to compensation and liability
1. Any person who has suffered
material or non-material damage as a result of an infringement of this
Regulation shall have the right to receive compensation from the
controller or processor for the damage suffered.
2. Any controller involved in
processing shall be liable for the damage caused by processing which
infringes this Regulation. A processor shall be liable for the damage
caused by processing only where it has not complied with obligations of
this Regulation specifically directed to processors or where it has
acted outside or contrary to lawful instructions of the controller.
3. A controller or processor shall
be exempt from liability under paragraph 2 if it proves that it is
not in any way responsible for the event giving rise to the damage.
4. Where more than one controller
or processor, or both a controller and a processor, are involved in the
same processing and where they are, under paragraphs 2 and 3,
responsible for any damage caused by processing, each controller or
processor shall be held liable for the entire damage in order to ensure
effective compensation of the data subject.
5. Where a controller or processor
has, in accordance with paragraph 4, paid full compensation for
the damage suffered, that controller or processor shall be entitled to
claim back from the other controllers or processors involved in the same
processing that part of the compensation corresponding to their part of
responsibility for the damage, in accordance with the conditions set
out in paragraph 2.
6. Court proceedings for
exercising the right to receive compensation shall be brought before the
courts competent under the law of the Member State referred to in
Article 79(2).
Article 83
General conditions for imposing administrative fines
1. Each supervisory authority
shall ensure that the imposition of administrative fines pursuant to
this Article in respect of infringements of this Regulation referred to
in paragraphs 4, 5 and 6 shall in each individual case be
effective, proportionate and dissuasive.
2. Administrative fines shall,
depending on the circumstances of each individual case, be imposed in
addition to, or instead of, measures referred to in points (a) to (h)
and (j) of Article 58(2). When deciding whether to impose an
administrative fine and deciding on the amount of the administrative
fine in each individual case due regard shall be given to the following:
(a)
the nature, gravity and duration of the
infringement taking into account the nature scope or purpose of the
processing concerned as well as the number of data subjects affected and
the level of damage suffered by them;
(b)
the intentional or negligent character of the infringement;
(c)
any action taken by the controller or processor to mitigate the damage suffered by data subjects;
(d)
the degree of responsibility of the
controller or processor taking into account technical and organisational
measures implemented by them pursuant to Articles 25 and 32;
(e)
any relevant previous infringements by the controller or processor;
(f)
the degree of cooperation with the
supervisory authority, in order to remedy the infringement and mitigate
the possible adverse effects of the infringement;
(g)
the categories of personal data affected by the infringement;
(h)
the manner in which the infringement
became known to the supervisory authority, in particular whether, and if
so to what extent, the controller or processor notified the
infringement;
(i)
where measures referred to in Article
58(2) have previously been ordered against the controller or processor
concerned with regard to the same subject-matter, compliance with those
measures;
(j)
adherence to approved codes of conduct pursuant to Article 40 or approved certification mechanisms pursuant to Article 42; and
(k)
any other aggravating or mitigating
factor applicable to the circumstances of the case, such as financial
benefits gained, or losses avoided, directly or indirectly, from the
infringement.
3. If a controller or processor
intentionally or negligently, for the same or linked processing
operations, infringes several provisions of this Regulation, the total
amount of the administrative fine shall not exceed the amount specified
for the gravest infringement.
4. Infringements of the following
provisions shall, in accordance with paragraph 2, be subject to
administrative fines up to 10 000 000 EUR, or in the case
of an undertaking, up to 2 % of the total worldwide annual turnover of
the preceding financial year, whichever is higher:
(a)
the obligations of the controller and the processor pursuant to Articles 8, 11, 25 to 39 and 42 and 43;
(b)
the obligations of the certification body pursuant to Articles 42 and 43;
(c)
the obligations of the monitoring body pursuant to Article 41(4).
5. Infringements of the following
provisions shall, in accordance with paragraph 2, be subject to
administrative fines up to 20 000 000 EUR, or in the case of
an undertaking, up to 4 % of the total worldwide annual turnover of the
preceding financial year, whichever is higher:
(a)
the basic principles for processing, including conditions for consent, pursuant to Articles 5, 6, 7 and 9;
(b)
the data subjects’ rights pursuant to Articles 12 to 22;
(c)
the transfers of personal data to a
recipient in a third country or an international organisation pursuant
to Articles 44 to 49;
(d)
any obligations pursuant to Member State law adopted under Chapter IX;
(e)
non-compliance with an order or a
temporary or definitive limitation on processing or the suspension of
data flows by the supervisory authority pursuant to Article 58(2)
or failure to provide access in violation of Article 58(1).
6. Non-compliance with an order by
the supervisory authority as referred to in Article 58(2) shall,
in accordance with paragraph 2 of this Article, be subject to
administrative fines up to 20 000 000 EUR, or in the case of
an undertaking, up to 4 % of the total worldwide annual turnover of the
preceding financial year, whichever is higher.
7. Without prejudice to the
corrective powers of supervisory authorities pursuant to
Article 58(2), each Member State may lay down the rules on
whether and to what extent administrative fines may be imposed on public
authorities and bodies established in that Member State.
8. The exercise by the supervisory
authority of its powers under this Article shall be subject to
appropriate procedural safeguards in accordance with Union and
Member State law, including effective judicial remedy and due
process.
9. Where the legal system of the
Member State does not provide for administrative fines, this
Article may be applied in such a manner that the fine is initiated by
the competent supervisory authority and imposed by competent national
courts, while ensuring that those legal remedies are effective and have
an equivalent effect to the administrative fines imposed by supervisory
authorities. In any event, the fines imposed shall be effective,
proportionate and dissuasive. Those Member States shall notify to the
Commission the provisions of their laws which they adopt pursuant to
this paragraph by 25 May 2018 and, without delay, any subsequent
amendment law or amendment affecting them.
Article 84
Penalties
1. Member States shall lay down
the rules on other penalties applicable to infringements of this
Regulation in particular for infringements which are not subject to
administrative fines pursuant to Article 83, and shall take all measures
necessary to ensure that they are implemented. Such penalties shall be
effective, proportionate and dissuasive.
2. Each Member State shall notify
to the Commission the provisions of its law which it adopts pursuant to
paragraph 1, by 25 May 2018 and, without delay, any subsequent
amendment affecting them.
CHAPTER IX
Provisions relating to specific processing situations
Article 85
Processing and freedom of expression and information
1. Member States shall by law
reconcile the right to the protection of personal data pursuant to this
Regulation with the right to freedom of expression and information,
including processing for journalistic purposes and the purposes of
academic, artistic or literary expression.
2. For processing carried out for
journalistic purposes or the purpose of academic artistic or literary
expression, Member States shall provide for exemptions or
derogations from Chapter II (principles), Chapter III (rights of the
data subject), Chapter IV (controller and processor), Chapter V
(transfer of personal data to third countries or international
organisations), Chapter VI (independent supervisory authorities),
Chapter VII (cooperation and consistency) and Chapter IX
(specific data processing situations) if they are necessary to reconcile
the right to the protection of personal data with the freedom of
expression and information.
3. Each Member State shall notify
to the Commission the provisions of its law which it has adopted
pursuant to paragraph 2 and, without delay, any subsequent
amendment law or amendment affecting them.
Article 86
Processing and public access to official documents
Personal data in official documents held by a
public authority or a public body or a private body for the performance
of a task carried out in the public interest may be disclosed by the
authority or body in accordance with Union or Member State law to which
the public authority or body is subject in order to reconcile public
access to official documents with the right to the protection of
personal data pursuant to this Regulation.
Article 87
Processing of the national identification number
Member States may further determine the specific
conditions for the processing of a national identification number or any
other identifier of general application. In that case the national
identification number or any other identifier of general application
shall be used only under appropriate safeguards for the rights and
freedoms of the data subject pursuant to this Regulation.
Article 88
Processing in the context of employment
1. Member States may, by law or by
collective agreements, provide for more specific rules to ensure the
protection of the rights and freedoms in respect of the processing of
employees’ personal data in the employment context, in particular for
the purposes of the recruitment, the performance of the contract of
employment, including discharge of obligations laid down by law or by
collective agreements, management, planning and organisation of work,
equality and diversity in the workplace, health and safety at work,
protection of employer’s or customer’s property and for the purposes of
the exercise and enjoyment, on an individual or collective basis, of
rights and benefits related to employment, and for the purpose of the
termination of the employment relationship.
2. Those rules shall include
suitable and specific measures to safeguard the data subject’s human
dignity, legitimate interests and fundamental rights, with particular
regard to the transparency of processing, the transfer of personal data
within a group of undertakings, or a group of enterprises engaged in a
joint economic activity and monitoring systems at the work place.
3. Each Member State shall notify
to the Commission those provisions of its law which it adopts pursuant
to paragraph 1, by 25 May 2018 and, without delay, any subsequent
amendment affecting them.
Article 89
Safeguards and derogations relating to processing
for archiving purposes in the public interest, scientific or historical
research purposes or statistical purposes
1. Processing for archiving
purposes in the public interest, scientific or historical research
purposes or statistical purposes, shall be subject to appropriate
safeguards, in accordance with this Regulation, for the rights and
freedoms of the data subject. Those safeguards shall ensure that
technical and organisational measures are in place in particular in
order to ensure respect for the principle of data minimisation. Those
measures may include pseudonymisation provided that those purposes can
be fulfilled in that manner. Where those purposes can be fulfilled by
further processing which does not permit or no longer permits the
identification of data subjects, those purposes shall be fulfilled in
that manner.
2. Where personal data are
processed for scientific or historical research purposes or statistical
purposes, Union or Member State law may provide for derogations from the
rights referred to in Articles 15, 16, 18 and 21 subject to the
conditions and safeguards referred to in paragraph 1 of this Article in
so far as such rights are likely to render impossible or seriously
impair the achievement of the specific purposes, and such derogations
are necessary for the fulfilment of those purposes.
3. Where personal data are
processed for archiving purposes in the public interest, Union or Member
State law may provide for derogations from the rights referred to in
Articles 15, 16, 18, 19, 20 and 21 subject to the conditions and
safeguards referred to in paragraph 1 of this Article in so far as such
rights are likely to render impossible or seriously impair the
achievement of the specific purposes, and such derogations are necessary
for the fulfilment of those purposes.
4. Where processing referred to in
paragraphs 2 and 3 serves at the same time another purpose, the
derogations shall apply only to processing for the purposes referred to
in those paragraphs.
Article 90
Obligations of secrecy
1. Member States may adopt
specific rules to set out the powers of the supervisory authorities laid
down in points (e) and (f) of Article 58(1) in relation to controllers
or processors that are subject, under Union or Member State law or rules
established by national competent bodies, to an obligation of
professional secrecy or other equivalent obligations of secrecy where
this is necessary and proportionate to reconcile the right of the
protection of personal data with the obligation of secrecy. Those rules
shall apply only with regard to personal data which the controller or
processor has received as a result of or has obtained in an activity
covered by that obligation of secrecy.
2. Each Member State shall notify
to the Commission the rules adopted pursuant to paragraph 1, by 25 May
2018 and, without delay, any subsequent amendment affecting them.
Article 91
Existing data protection rules of churches and religious associations
1. Where in a Member State,
churches and religious associations or communities apply, at the time of
entry into force of this Regulation, comprehensive rules relating to
the protection of natural persons with regard to processing, such rules
may continue to apply, provided that they are brought into line with
this Regulation.
2. Churches and religious
associations which apply comprehensive rules in accordance with
paragraph 1 of this Article shall be subject to the supervision of an
independent supervisory authority, which may be specific, provided that
it fulfils the conditions laid down in Chapter VI of this
Regulation.
CHAPTER X
Delegated acts and implementing acts
Article 92
Exercise of the delegation
1. The power to adopt delegated
acts is conferred on the Commission subject to the conditions laid down
in this Article.
2. The delegation of power
referred to in Article 12(8) and Article 43(8) shall be conferred on the
Commission for an indeterminate period of time from 24 May 2016.
3. The delegation of power
referred to in Article 12(8) and Article 43(8) may be revoked at any
time by the European Parliament or by the Council. A decision of
revocation shall put an end to the delegation of power specified in that
decision. It shall take effect the day following that of its
publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a
delegated act, the Commission shall notify it simultaneously to the
European Parliament and to the Council.
5. A delegated act adopted
pursuant to Article 12(8) and Article 43(8) shall enter into force only
if no objection has been expressed by either the European Parliament or
the Council within a period of three months of notification of that act
to the European Parliament and the Council or if, before the expiry of
that period, the European Parliament and the Council have both informed
the Commission that they will not object. That period shall be extended
by three months at the initiative of the European Parliament or of the
Council.
Article 93
Committee procedure
1. The Commission shall be
assisted by a committee. That committee shall be a committee within the
meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this
paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction
with Article 5 thereof, shall apply.
CHAPTER XI
Final provisions
Article 94
Repeal of Directive 95/46/EC
1. Directive 95/46/EC is repealed with effect from 25 May 2018.
2. References to the repealed
Directive shall be construed as references to this Regulation.
References to the Working Party on the Protection of Individuals with
regard to the Processing of Personal Data established by Article 29 of
Directive 95/46/EC shall be construed as references to the European Data
Protection Board established by this Regulation.
Article 95
Relationship with Directive 2002/58/EC
This Regulation shall not impose additional
obligations on natural or legal persons in relation to processing in
connection with the provision of publicly available electronic
communications services in public communication networks in the Union in
relation to matters for which they are subject to specific obligations
with the same objective set out in Directive 2002/58/EC.
Article 96
Relationship with previously concluded Agreements
International agreements involving the transfer of
personal data to third countries or international organisations which
were concluded by Member States prior to 24 May 2016, and which comply
with Union law as applicable prior to that date, shall remain in force
until amended, replaced or revoked.
Article 97
Commission reports
1. By 25 May 2020 and every four
years thereafter, the Commission shall submit a report on the evaluation
and review of this Regulation to the European Parliament and to the
Council. The reports shall be made public.
2. In the context of the
evaluations and reviews referred to in paragraph 1, the Commission shall
examine, in particular, the application and functioning of:
(a)
Chapter V on the transfer of personal
data to third countries or international organisations with particular
regard to decisions adopted pursuant to Article 45(3) of this
Regulation and decisions adopted on the basis of Article 25(6) of
Directive 95/46/EC;
(b)
Chapter VII on cooperation and consistency.
3. For the purpose of paragraph 1,
the Commission may request information from Member States and
supervisory authorities.
4. In carrying out the evaluations
and reviews referred to in paragraphs 1 and 2, the Commission shall
take into account the positions and findings of the European Parliament,
of the Council, and of other relevant bodies or sources.
5. The Commission shall, if
necessary, submit appropriate proposals to amend this Regulation, in
particular taking into account of developments in information technology
and in the light of the state of progress in the information society.
Article 98
Review of other Union legal acts on data protection
The Commission shall, if appropriate, submit
legislative proposals with a view to amending other Union legal acts on
the protection of personal data, in order to ensure uniform and
consistent protection of natural persons with regard to processing. This
shall in particular concern the rules relating to the protection of
natural persons with regard to processing by Union institutions, bodies,
offices and agencies and on the free movement of such data.
Article 99
Entry into force and application
1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
2. It shall apply from 25 May 2018.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 April 2016.
For the European Parliament
The President
M. SCHULZ
For the Council
The President
J.A. HENNIS-PLASSCHAERT
(1) OJ C 229, 31.7.2012, p. 90.
(2) OJ C 391, 18.12.2012, p. 127.
(3) Position
of the European Parliament of 12 March 2014 (not yet
published in the Official Journal) and position of the Council at first
reading of 8 April 2016 (not yet published in the Official Journal).
Position of the European Parliament of 14 April 2016.
(4) Directive
95/46/EC of the European Parliament and of the Council of
24 October 1995 on the protection of individuals with regard
to the processing of personal data and on the free movement of such data
(OJ L 281, 23.11.1995, p. 31).
(5) Commission
Recommendation of 6 May 2003 concerning the definition of
micro, small and medium-sized enterprises (C(2003) 1422) (OJ L 124, 20.5.2003, p. 36).
(6) Regulation
(EC) No 45/2001 of the European Parliament and of the Council of
18 December 2000 on the protection of individuals with regard
to the processing of personal data by the Community institutions and
bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).
(7) Directive
(EU) 2016/680 of the European Parliament and of the Council of 27 April
2016 on the protection of natural persons with regard to the processing
of personal data by competent authorities for the purposes of
prevention, investigation, detection or prosecution of criminal offences
or the execution of criminal penalties, and the free movement of such
data and repealing Council Framework Decision 2008/977/JHA (see page 89
of this Official Journal).
(8) Directive
2000/31/EC of the European Parliament and of the Council of
8 June 2000 on certain legal aspects of information society
services, in particular electronic commerce, in the Internal Market
(‘Directive on electronic commerce’) (OJ L 178, 17.7.2000, p. 1).
(9) Directive
2011/24/EU of the European Parliament and of the Council of
9 March 2011 on the application of patients’ rights in
cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
(10) Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29).
(11) Regulation
(EC) No 1338/2008 of the European Parliament and of the Council of
16 December 2008 on Community statistics on public health and
health and safety at work (OJ L 354, 31.12.2008, p. 70).
(12) Regulation
(EU) No 182/2011 of the European Parliament and of the Council of
16 February 2011 laying down the rules and general principles
concerning mechanisms for control by Member States of the Commission’s
exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(13) Regulation
(EU) No 1215/2012 of the European Parliament and of the Council of
12 December 2012 on jurisdiction and the recognition and
enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1).
(14) Directive
2003/98/EC of the European Parliament and of the Council of
17 November 2003 on the re-use of public sector information (OJ L 345, 31.12.2003, p. 90).
(15) Regulation
(EU) No 536/2014 of the European Parliament and of the Council of
16 April 2014 on clinical trials on medicinal products for
human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
(16) Regulation
(EC) No 223/2009 of the European Parliament and of the Council of
11 March 2009 on European statistics and repealing Regulation
(EC, Euratom) No 1101/2008 of the European Parliament and of the
Council on the transmission of data subject to statistical
confidentiality to the Statistical Office of the European Communities,
Council Regulation (EC) No 322/97 on Community Statistics, and
Council Decision 89/382/EEC, Euratom establishing a Committee on
the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164).
(17) OJ C 192, 30.6.2012, p. 7.
(18) Directive
2002/58/EC of the European Parliament and of the Council of
12 July 2002 concerning the processing of personal data and
the protection of privacy in the electronic communications sector
(Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).
(19) Directive
(EU) 2015/1535 of the European Parliament and of the Council of
9 September 2015 laying down a procedure for the provision of
information in the field of technical regulations and of rules on
Information Society services (OJ L 241, 17.9.2015, p. 1).
(20) Regulation
(EC) No 765/2008 of the European Parliament and of the Council of
9 July 2008 setting out the requirements for accreditation and
market surveillance relating to the marketing of products and repealing
Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
(21) Regulation
(EC) No 1049/2001 of the European Parliament and of the Council of
30 May 2001 regarding public access to European Parliament,
Council and Commission documents (OJ L 145, 31.5.2001, p. 43).