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5455/16

VH/np

ANNEX

DGD 2C

(16a) While this Regulation applies also 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 its decision-

making. Supervision of such data processing operations may be entrusted to specific bodies

within the judicial system of the Member State, which should in particular control compliance

with the rules of this Regulation, promote the awareness of the judiciary of their obligations

under this Regulation and deal with complaints in relation to such processing.

(17) This Regulation should be without prejudice to the application of Directive 2000/31/EC of the

European Parliament and of the Council, 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.

(18) (…)

(19) 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 or not.

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 this respect.

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5455/16

VH/np

ANNEX

DGD 2C

(20) In order to ensure that individuals 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 the offering of goods or services to such data

subjects irrespective of whether connected to a payment or not. 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 is envisaging the

offering of services to data subjects in one or more Member States in the Union. Whereas the

mere accessibility of the controller’s or an intermediary’s website in the Union or of an email

address and 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, and/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 such data subjects in the Union.

(21) 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 as far as their behaviour takes

places within the European Union. In order to determine whether a processing activity can be

considered to monitor the behaviour of data subjects, it should be ascertained whether

individuals are tracked on the Internet including potential subsequent use of data processing

techniques which consist of profiling an individual, particularly in order to take decisions

concerning her or him or for analysing or predicting her or his personal preferences,

behaviours and attitudes.

(22) Where the national law of a Member State 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.

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5455/16

VH/np

ANNEX

DGD 2C

(23) The principles of data protection should apply to any information concerning an identified or

identifiable natural person. Data which has undergone pseudonymisation, which could be

attributed to a natural person by the use of additional information, should be considered as

information on an identifiable natural person. To determine whether a 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 any other person to identify the individual directly or indirectly.

To ascertain whether means are reasonable likely to be used to identify the individual, account

should be taken of all objective factors, such as the costs of and the amount of time required

for identification, taking into consideration both available technology at the time of the

processing and technological development. The principles of data protection should therefore

not apply to anonymous information, that is information which does not relate to an identified

or identifiable natural person or to data rendered anonymous in such a way that the data

subject is not or no longer identifiable. This Regulation does therefore not concern the

processing of such anonymous information, including for statistical and research purposes.

(23aa)

This Regulation should not apply to data of deceased persons. Member States may provide for

rules regarding the processing of data of deceased persons.

(23a) The application of pseudonymisation to personal data can reduce the risks for the data

subjects concerned and help controllers and processors meet their data protection obligations.

The explicit introduction of ‘pseudonymisation’ through the articles of this Regulation is thus

not intended to preclude any other measures of data protection.

(23b) (…)

(23c) In order to create incentives for applying pseudonymisation when processing personal data,

measures of pseudonymisation whilst allowing general analysis should be possible within the

same controller when the controller has taken technical and organisational measures necessary

to ensure, for the respective processing, that the provisions of this Regulation are

implemented, and ensuring that additional information for attributing the personal data to a

specific data subject is kept separately. The controller processing the data shall also refer to

authorised persons within the same controller.

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5455/16

VH/np

ANNEX

DGD 2C

(24) Individuals 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 individuals and identify them.

(24c new) Public authorities to whom data are disclosed in compliance 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, may not be regarded as

recipients if they receive 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 written, reasoned and occasional and should

not concern the entirety of a filing system or lead to the interconnection of filing systems. The

processing of these data by those public authorities should be in compliance with the

applicable data protection rules according to the purposes of the processing.

(25) Consent should be given by a clear affirmative action establishing a freely given, specific,

informed and unambiguous indication of the data subject's agreement to personal data relating

to him or her being processed, such as by a written, including electronic, or oral statement.

This could include ticking a box when visiting an Internet website, choosing technical settings

for information society services or by any other statement or conduct which clearly indicates

in this context the data subject's acceptance of the proposed processing of their personal data.

Silence, pre-ticked boxes or inactivity should therefore not 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 granted for all of the processing

purposes. If the data subject's consent is to be given following an electronic request, the

request must be clear, concise and not unnecessarily disruptive to the use of the service for

which it is provided.

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5455/16

VH/np

ANNEX

DGD 2C

(25aa) It is often not possible to fully identify the purpose of 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.

(25a) Genetic data should be defined as personal data relating to the genetic characteristics of an

individual which have been inherited or acquired as they result from an analysis of a

biological sample from the individual in question, in particular by chromosomal,

deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) analysis or analysis of any other

element enabling equivalent information to be obtained.

(26) 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; including information about the individual collected in the

course of the registration for and the provision of health care services as referred to in

Directive 2011/24/EU to the individual; a number, symbol or particular assigned to an

individual to uniquely identify the individual for health purposes; information derived from

the testing or examination of a body part or bodily substance, including genetic data and

biological samples; or any information on e.g. a disease, disability, disease risk, medical

history, clinical treatment, or the actual physiological or biomedical state of the data subject

independent of its source, such as e.g. from a physician or other health professional, a

hospital, a medical device, or an in vitro diagnostic test.

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5455/16

VH/np

ANNEX

DGD 2C

(27) 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 processing of

personal data are taken in another establishment of the controller in the Union. In this case the

latter should be considered as 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. This criterion should not

depend on whether the processing of personal data is actually 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 such 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 and, 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 as a supervisory authority concerned and participate to 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 as concerned supervisory authorities when 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 as the main establishment

of the group of undertakings, except where the purposes and means of processing are

determined by another undertaking.

5455/16

VH/np

ANNEX

DGD 2C

(28) A group of undertakings should cover a controlling undertaking and its controlled

undertakings, whereby the controlling undertaking should be the undertaking which can

exercise 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. A central undertaking which controls the processing of

personal data in undertakings affiliated to it forms together with these undertakings an entity

which may be treated as “group of undertakings”.

(29) Children deserve specific protection of their personal data, as they may be less aware of risks,

consequences, safeguards and their rights in relation to the processing of personal data. This

concerns especially the use of personal data of children for the purposes of marketing or

creating personality or user profiles and the collection of child data 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.

5455/16

VH/np

ANNEX

DGD 2C

(30) Any processing of personal data should be lawful and fair. It should be transparent for the

individuals that personal data concerning them are collected, used, consulted or otherwise

processed and to which extent the data are processed or will be processed. The principle of

transparency requires that any information and communication relating to the processing of

those data should be easily accessible and easy to understand, and that clear and plain

language is used. This concerns in particular the information of 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 individuals concerned and their right to get

confirmation and communication of personal data being processed concerning them.

Individuals should be made aware on risks, rules, safeguards and rights in relation to the

processing of personal data and how to exercise his or her rights in relation to the processing.

In particular, the specific purposes for which the data are processed should be explicit and

legitimate and determined at the time of the collection of the data. The data should be

adequate, relevant and limited to what is necessary for the purposes for which the data are

processed; this requires in particular ensuring that the period for which the data are stored is

limited to a strict minimum. Personal data should only be processed if the purpose of the

processing could not reasonably be fulfilled by other means. In order to ensure that the 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 the use of personal data and the equipment used for the

processing.

5455/16

VH/np

ANNEX

DGD 2C

(31) In order for processing to be lawful, personal data should be processed on the basis of the

consent of the person 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.

(31a) Wherever 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 the constitutional order of the Member State concerned, however such

legal basis or a legislative measure should be clear and precise and its application foreseeable

for those subject to it as required by the case law of the Court of Justice of the European

Union and the European Court of Human Rights.

(32) Where processing is based on the data subject's consent, the controller should be able to

demonstrate that the data subject has given the 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 that and the extent to which consent is given. In line with

Council Directive 93/13/EEC

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 and free choice and is unable to refuse or withdraw consent

without detriment.

(33) (…)

5455/16

VH/np

ANNEX

DGD 2C

(34) In order to safeguard that consent has been 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 this makes it unlikely that consent was given freely 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 data processing operations despite it is

appropriate in the individual case, or if the performance of a contract, including the provision

of a service is made dependent on the consent despite this is not necessary for such

performance.

(35) Processing should be lawful where it is necessary in the context of a contract or the intended

entering into a contract.

(35a) (…)

(36) Where processing is carried out in compliance 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 an official authority, the processing should have a basis in

Union law, or in the national law of a Member State. This Regulation does not require that a

specific law is necessary 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 be also for Union or Member

State law to determine the purpose of processing. Furthermore, this basis could specify the

general conditions of the Regulation governing the lawfulness of data processing, determine

specifications for determining the controller, the type of data which are subject to the

processing, the data subjects concerned, the entities to which the 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 by private law such as a professional association, where grounds of public interest so

justify including for health purposes, such as public health and social protection and the

management of health care services.

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