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Annex 3 High-Risk AI Systems Referred to in Article 6(2)

ANNEX III

High-risk AI systems referred to in Article 6(2)

High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas:

1.

Biometrics, in so far as their use is permitted under relevant Union or national law:

(a)

remote biometric identification systems.

This shall not include AI systems intended to be used for biometric verification the sole purpose of which is to confirm that a specific natural person is the person he or she claims to be;

(b)

AI systems intended to be used for biometric categorisation, according to sensitive or protected attributes or characteristics based on the inference of those attributes or characteristics;

(c)

AI systems intended to be used for emotion recognition.

2.

Critical infrastructure: AI systems intended to be used as safety components in the management and operation of critical digital infrastructure, road traffic, or in the supply of water, gas, heating or electricity.

3.

Education and vocational training:

(a)

AI systems intended to be used to determine access or admission or to assign natural persons to educational and vocational training institutions at all levels;

(b)

AI systems intended to be used to evaluate learning outcomes, including when those outcomes are used to steer the learning process of natural persons in educational and vocational training institutions at all levels;

(c)

AI systems intended to be used for the purpose of assessing the appropriate level of education that an individual will receive or will be able to access, in the context of or within educational and vocational training institutions at all levels;

(d)

AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the context of or within educational and vocational training institutions at all levels.

4.

Employment, workers’ management and access to self-employment:

(a)

AI systems intended to be used for the recruitment or selection of natural persons, in particular to place targeted job advertisements, to analyse and filter job applications, and to evaluate candidates;

(b)

AI systems intended to be used to make decisions affecting terms of work-related relationships, the promotion or termination of work-related contractual relationships, to allocate tasks based on individual behaviour or personal traits or characteristics or to monitor and evaluate the performance and behaviour of persons in such relationships.

5.

Access to and enjoyment of essential private services and essential public services and benefits:

(a)

AI systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility of natural persons for essential public assistance benefits and services, including healthcare services, as well as to grant, reduce, revoke, or reclaim such benefits and services;

(b)

AI systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score, with the exception of AI systems used for the purpose of detecting financial fraud;

(c)

AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life and health insurance;

(d)

AI systems intended to evaluate and classify emergency calls by natural persons or to be used to dispatch, or to establish priority in the dispatching of, emergency first response services, including by police, firefighters and medical aid, as well as of emergency healthcare patient triage systems.

6.

Law enforcement, in so far as their use is permitted under relevant Union or national law:

(a)

AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies, offices or agencies in support of law enforcement authorities or on their behalf to assess the risk of a natural person becoming the victim of criminal offences;

(b)

AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices or agencies in support of law enforcement authorities as polygraphs or similar tools;

(c)

AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies, offices or agencies, in support of law enforcement authorities to evaluate the reliability of evidence in the course of the investigation or prosecution of criminal offences;

(d)

AI systems intended to be used by law enforcement authorities or on their behalf or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for assessing the risk of a natural person offending or re-offending not solely on the basis of the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680, or to assess personality traits and characteristics or past criminal behaviour of natural persons or groups;

(e)

AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 in the course of the detection, investigation or prosecution of criminal offences.

7.

Migration, asylum and border control management, in so far as their use is permitted under relevant Union or national law:

(a)

AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies as polygraphs or similar tools;

(b)

AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assess a risk, including a security risk, a risk of irregular migration, or a health risk, posed by a natural person who intends to enter or who has entered into the territory of a Member State;

(c)

AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assist competent public authorities for the examination of applications for asylum, visa or residence permits and for associated complaints with regard to the eligibility of the natural persons applying for a status, including related assessments of the reliability of evidence;

(d)

AI systems intended to be used by or on behalf of competent public authorities, or by Union institutions, bodies, offices or agencies, in the context of migration, asylum or border control management, for the purpose of detecting, recognising or identifying natural persons, with the exception of the verification of travel documents.

8.

Administration of justice and democratic processes:

(a)

AI systems intended to be used by a judicial authority or on their behalf to assist a judicial authority in researching and interpreting facts and the law and in applying the law to a concrete set of facts, or to be used in a similar way in alternative dispute resolution;

(b)

AI systems intended to be used for influencing the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda. This does not include AI systems to the output of which natural persons are not directly exposed, such as tools used to organise, optimise or structure political campaigns from an administrative or logistical point of view.

Corresponding Recitals

(48)

The extent of the adverse impact caused by the AI system on the fundamental rights protected by the Charter is of particular relevance when classifying an AI system as high risk. Those rights include the right to human dignity, respect for private and family life, protection of personal data, freedom of expression and information, freedom of assembly and of association, the right to non-discrimination, the right to education, consumer protection, workers’ rights, the rights of persons with disabilities, gender equality, intellectual property rights, the right to an effective remedy and to a fair trial, the right of defence and the presumption of innocence, and the right to good administration. In addition to those rights, it is important to highlight the fact that children have specific rights as enshrined in Article 24 of the Charter and in the United Nations Convention on the Rights of the Child, further developed in the UNCRC General Comment No 25 as regards the digital environment, both of which require consideration of the children’s vulnerabilities and provision of such protection and care as necessary for their well-being. The fundamental right to a high level of environmental protection enshrined in the Charter and implemented in Union policies should also be considered when assessing the severity of the harm that an AI system can cause, including in relation to the health and safety of persons.

View Recital

(52)

As regards stand-alone AI systems, namely high-risk AI systems other than those that are safety components of products, or that are themselves products, it is appropriate to classify them as high-risk if, in light of their intended purpose, they pose a high risk of harm to the health and safety or the fundamental rights of persons, taking into account both the severity of the possible harm and its probability of occurrence and they are used in a number of specifically pre-defined areas specified in this Regulation. The identification of those systems is based on the same methodology and criteria envisaged also for any future amendments of the list of high-risk AI systems that the Commission should be empowered to adopt, via delegated acts, to take into account the rapid pace of technological development, as well as the potential changes in the use of AI systems.

View Recital

(54)

As biometric data constitutes a special category of personal data, it is appropriate to classify as high-risk several critical-use cases of biometric systems, insofar as their use is permitted under relevant Union and national law. Technical inaccuracies of AI systems intended for the remote biometric identification of natural persons can lead to biased results and entail discriminatory effects. The risk of such biased results and discriminatory effects is particularly relevant with regard to age, ethnicity, race, sex or disabilities. Remote biometric identification systems should therefore be classified as high-risk in view of the risks that they pose. Such a classification excludes AI systems intended to be used for biometric verification, including authentication, the sole purpose of which is to confirm that a specific natural person is who that person claims to be and to confirm the identity of a natural person for the sole purpose of having access to a service, unlocking a device or having secure access to premises. In addition, AI systems intended to be used for biometric categorisation according to sensitive attributes or characteristics protected under Article 9(1) of Regulation (EU) 2016/679 on the basis of biometric data, in so far as these are not prohibited under this Regulation, and emotion recognition systems that are not prohibited under this Regulation, should be classified as high-risk. Biometric systems which are intended to be used solely for the purpose of enabling cybersecurity and personal data protection measures should not be considered to be high-risk AI systems.

View Recital

(55)

As regards the management and operation of critical infrastructure, it is appropriate to classify as high-risk the AI systems intended to be used as safety components in the management and operation of critical digital infrastructure as listed in point (8) of the Annex to Directive (EU) 2022/2557, road traffic and the supply of water, gas, heating and electricity, since their failure or malfunctioning may put at risk the life and health of persons at large scale and lead to appreciable disruptions in the ordinary conduct of social and economic activities. Safety components of critical infrastructure, including critical digital infrastructure, are systems used to directly protect the physical integrity of critical infrastructure or the health and safety of persons and property but which are not necessary in order for the system to function. The failure or malfunctioning of such components might directly lead to risks to the physical integrity of critical infrastructure and thus to risks to health and safety of persons and property. Components intended to be used solely for cybersecurity purposes should not qualify as safety components. Examples of safety components of such critical infrastructure may include systems for monitoring water pressure or fire alarm controlling systems in cloud computing centres.

View Recital

(56)

The deployment of AI systems in education is important to promote high-quality digital education and training and to allow all learners and teachers to acquire and share the necessary digital skills and competences, including media literacy, and critical thinking, to take an active part in the economy, society, and in democratic processes. However, AI systems used in education or vocational training, in particular for determining access or admission, for assigning persons to educational and vocational training institutions or programmes at all levels, for evaluating learning outcomes of persons, for assessing the appropriate level of education for an individual and materially influencing the level of education and training that individuals will receive or will be able to access or for monitoring and detecting prohibited behaviour of students during tests should be classified as high-risk AI systems, since they may determine the educational and professional course of a person’s life and therefore may affect that person’s ability to secure a livelihood. When improperly designed and used, such systems may be particularly intrusive and may violate the right to education and training as well as the right not to be discriminated against and perpetuate historical patterns of discrimination, for example against women, certain age groups, persons with disabilities, or persons of certain racial or ethnic origins or sexual orientation.

View Recital

(57)

AI systems used in employment, workers management and access to self-employment, in particular for the recruitment and selection of persons, for making decisions affecting terms of the work-related relationship, promotion and termination of work-related contractual relationships, for allocating tasks on the basis of individual behaviour, personal traits or characteristics and for monitoring or evaluation of persons in work-related contractual relationships, should also be classified as high-risk, since those systems may have an appreciable impact on future career prospects, livelihoods of those persons and workers’ rights. Relevant work-related contractual relationships should, in a meaningful manner, involve employees and persons providing services through platforms as referred to in the Commission Work Programme 2021. Throughout the recruitment process and in the evaluation, promotion, or retention of persons in work-related contractual relationships, such systems may perpetuate historical patterns of discrimination, for example against women, certain age groups, persons with disabilities, or persons of certain racial or ethnic origins or sexual orientation. AI systems used to monitor the performance and behaviour of such persons may also undermine their fundamental rights to data protection and privacy.

View Recital

(58)

Another area in which the use of AI systems deserves special consideration is the access to and enjoyment of certain essential private and public services and benefits necessary for people to fully participate in society or to improve one’s standard of living. In particular, natural persons applying for or receiving essential public assistance benefits and services from public authorities namely healthcare services, social security benefits, social services providing protection in cases such as maternity, illness, industrial accidents, dependency or old age and loss of employment and social and housing assistance, are typically dependent on those benefits and services and in a vulnerable position in relation to the responsible authorities. If AI systems are used for determining whether such benefits and services should be granted, denied, reduced, revoked or reclaimed by authorities, including whether beneficiaries are legitimately entitled to such benefits or services, those systems may have a significant impact on persons’ livelihood and may infringe their fundamental rights, such as the right to social protection, non-discrimination, human dignity or an effective remedy and should therefore be classified as high-risk. Nonetheless, this Regulation should not hamper the development and use of innovative approaches in the public administration, which would stand to benefit from a wider use of compliant and safe AI systems, provided that those systems do not entail a high risk to legal and natural persons. In addition, AI systems used to evaluate the credit score or creditworthiness of natural persons should be classified as high-risk AI systems, since they determine those persons’ access to financial resources or essential services such as housing, electricity, and telecommunication services. AI systems used for those purposes may lead to discrimination between persons or groups and may perpetuate historical patterns of discrimination, such as that based on racial or ethnic origins, gender, disabilities, age or sexual orientation, or may create new forms of discriminatory impacts. However, AI systems provided for by Union law for the purpose of detecting fraud in the offering of financial services and for prudential purposes to calculate credit institutions’ and insurance undertakings’ capital requirements should not be considered to be high-risk under this Regulation. Moreover, AI systems intended to be used for risk assessment and pricing in relation to natural persons for health and life insurance can also have a significant impact on persons’ livelihood and if not duly designed, developed and used, can infringe their fundamental rights and can lead to serious consequences for people’s life and health, including financial exclusion and discrimination. Finally, AI systems used to evaluate and classify emergency calls by natural persons or to dispatch or establish priority in the dispatching of emergency first response services, including by police, firefighters and medical aid, as well as of emergency healthcare patient triage systems, should also be classified as high-risk since they make decisions in very critical situations for the life and health of persons and their property.

View Recital

(59)

Given their role and responsibility, actions by law enforcement authorities involving certain uses of AI systems are characterised by a significant degree of power imbalance and may lead to surveillance, arrest or deprivation of a natural person’s liberty as well as other adverse impacts on fundamental rights guaranteed in the Charter. In particular, if the AI system is not trained with high-quality data, does not meet adequate requirements in terms of its performance, its accuracy or robustness, or is not properly designed and tested before being put on the market or otherwise put into service, it may single out people in a discriminatory or otherwise incorrect or unjust manner. Furthermore, the exercise of important procedural fundamental rights, such as the right to an effective remedy and to a fair trial as well as the right of defence and the presumption of innocence, could be hampered, in particular, where such AI systems are not sufficiently transparent, explainable and documented. It is therefore appropriate to classify as high-risk, insofar as their use is permitted under relevant Union and national law, a number of AI systems intended to be used in the law enforcement context where accuracy, reliability and transparency is particularly important to avoid adverse impacts, retain public trust and ensure accountability and effective redress. In view of the nature of the activities and the risks relating thereto, those high-risk AI systems should include in particular AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices, or agencies in support of law enforcement authorities for assessing the risk of a natural person to become a victim of criminal offences, as polygraphs and similar tools, for the evaluation of the reliability of evidence in in the course of investigation or prosecution of criminal offences, and, insofar as not prohibited under this Regulation, for assessing the risk of a natural person offending or reoffending not solely on the basis of the profiling of natural persons or the assessment of personality traits and characteristics or the past criminal behaviour of natural persons or groups, for profiling in the course of detection, investigation or prosecution of criminal offences. AI systems specifically intended to be used for administrative proceedings by tax and customs authorities as well as by financial intelligence units carrying out administrative tasks analysing information pursuant to Union anti-money laundering law should not be classified as high-risk AI systems used by law enforcement authorities for the purpose of prevention, detection, investigation and prosecution of criminal offences. The use of AI tools by law enforcement and other relevant authorities should not become a factor of inequality, or exclusion. The impact of the use of AI tools on the defence rights of suspects should not be ignored, in particular the difficulty in obtaining meaningful information on the functioning of those systems and the resulting difficulty in challenging their results in court, in particular by natural persons under investigation.

View Recital

(60)

AI systems used in migration, asylum and border control management affect persons who are often in particularly vulnerable position and who are dependent on the outcome of the actions of the competent public authorities. The accuracy, non-discriminatory nature and transparency of the AI systems used in those contexts are therefore particularly important to guarantee respect for the fundamental rights of the affected persons, in particular their rights to free movement, non-discrimination, protection of private life and personal data, international protection and good administration. It is therefore appropriate to classify as high-risk, insofar as their use is permitted under relevant Union and national law, AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies charged with tasks in the fields of migration, asylum and border control management as polygraphs and similar tools, for assessing certain risks posed by natural persons entering the territory of a Member State or applying for visa or asylum, for assisting competent public authorities for the examination, including related assessment of the reliability of evidence, of applications for asylum, visa and residence permits and associated complaints with regard to the objective to establish the eligibility of the natural persons applying for a status, for the purpose of detecting, recognising or identifying natural persons in the context of migration, asylum and border control management, with the exception of verification of travel documents. AI systems in the area of migration, asylum and border control management covered by this Regulation should comply with the relevant procedural requirements set by the Regulation (EC) No 810/2009 of the European Parliament and of the Council (32), the Directive 2013/32/EU of the European Parliament and of the Council (33), and other relevant Union law. The use of AI systems in migration, asylum and border control management should, in no circumstances, be used by Member States or Union institutions, bodies, offices or agencies as a means to circumvent their international obligations under the UN Convention relating to the Status of Refugees done at Geneva on 28 July 1951 as amended by the Protocol of 31 January 1967. Nor should they be used to in any way infringe on the principle of non-refoulement, or to deny safe and effective legal avenues into the territory of the Union, including the right to international protection.

View Recital

(61)

Certain AI systems intended for the administration of justice and democratic processes should be classified as high-risk, considering their potentially significant impact on democracy, the rule of law, individual freedoms as well as the right to an effective remedy and to a fair trial. In particular, to address the risks of potential biases, errors and opacity, it is appropriate to qualify as high-risk AI systems intended to be used by a judicial authority or on its behalf to assist judicial authorities in researching and interpreting facts and the law and in applying the law to a concrete set of facts. AI systems intended to be used by alternative dispute resolution bodies for those purposes should also be considered to be high-risk when the outcomes of the alternative dispute resolution proceedings produce legal effects for the parties. The use of AI tools can support the decision-making power of judges or judicial independence, but should not replace it: the final decision-making must remain a human-driven activity. The classification of AI systems as high-risk should not, however, extend to AI systems intended for purely ancillary administrative activities that do not affect the actual administration of justice in individual cases, such as anonymisation or pseudonymisation of judicial decisions, documents or data, communication between personnel, administrative tasks.

View Recital

(62)

Without prejudice to the rules provided for in Regulation (EU) 2024/900 of the European Parliament and of the Council (34), and in order to address the risks of undue external interference with the right to vote enshrined in Article 39 of the Charter, and of adverse effects on democracy and the rule of law, AI systems intended to be used to influence the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda should be classified as high-risk AI systems with the exception of AI systems whose output natural persons are not directly exposed to, such as tools used to organise, optimise and structure political campaigns from an administrative and logistical point of view.

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(63)

The fact that an AI system is classified as a high-risk AI system under this Regulation should not be interpreted as indicating that the use of the system is lawful under other acts of Union law or under national law compatible with Union law, such as on the protection of personal data, on the use of polygraphs and similar tools or other systems to detect the emotional state of natural persons. Any such use should continue to occur solely in accordance with the applicable requirements resulting from the Charter and from the applicable acts of secondary Union law and national law. This Regulation should not be understood as providing for the legal ground for processing of personal data, including special categories of personal data, where relevant, unless it is specifically otherwise provided for in this Regulation.

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