EUROPEAN UNIONTHE EUROPEAN PARLIAMENT

THE COUNCIL
Brussels, 14 May 2024
(OR. en)2021/0106(COD)

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TELECOM 54
JAI 238
COPEN 69
CYBER 37DATAPROTECT 76
EJUSTICE 11
COSI 16
IXIM 49
ENFOPOL 63
RELEX 180
MI 151COMPET 154
CODEC 412
LEGISLATIVE ACTS AND OTHER INSTRUMENTS
Subject:

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL laying down harmonised rules on artificial intelligence andamending Regulations (EC) No 300/2008, (EU) No 167/2013,(EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144
and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial
Intelligence Act)

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REGULATION (EU) 2024/…
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of …
laying down harmonised rules on artificial intelligence
and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144
and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828(Artificial Intelligence Act)
(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 Articles 16
and 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,

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Having regard to the opinion of the European Economic and Social Committee1,
Having regard to the opinion of the European Central Bank2,
Having regard to the opinion of the Committee of the Regions3,
Acting in accordance with the ordinary legislative procedure4,

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OJ C 517, 22.12.2021, p. 56.
OJ C 115, 11.3.2022, p. 5.
OJ C 97, 28.2.2022, p. 60.
Position of the European Parliament of 13 March 2024 (not yet published in the Official
Journal) and decision of the Council of …

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2ENWhereas:(1)

The purpose of this Regulation is to improve the functioning of the internal market bylaying down a uniform legal framework in particular for the development, the placing on
the market, the putting into service and the use of artificial intelligence systems(AI systems) in the Union, in accordance with Union values, to promote the uptake ofhuman centric and trustworthy artificial intelligence (AI) while ensuring a high level ofprotection of health, safety, fundamental rights as enshrined in the Charter of Fundamental
Rights of the European Union (the ‘Charter’), including democracy, the rule of law andenvironmental protection, to protect against the harmful effects of AI systems in the Union,
and to support innovation. This Regulation ensures the free movement, cross-border, of
AI-based goods and services, thus preventing Member States from imposing restrictions on
the development, marketing and use of AI systems, unless explicitly authorised bythis Regulation.

(2)

This Regulation should be applied in accordance with the values of the Union enshrined asin the Charter, facilitating the protection of natural persons, undertakings, democracy, therule of law and environmental protection, while boosting innovation and employment andmaking the Union a leader in the uptake of trustworthy AI.

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(3)

AI systems can be easily deployed in a large variety of sectors of the economy and many
parts of society, including across borders, and can easily circulate throughout the Union.
Certain Member States have already explored the adoption of national rules to ensure that
AI is trustworthy and safe and is developed and used in accordance with fundamental
rights obligations. Diverging national rules may lead to the fragmentation of the internalmarket and may decrease legal certainty for operators that develop, import or use AI
systems. A consistent and high level of protection throughout the Union should therefore
be ensured in order to achieve trustworthy AI, while divergences hampering the freecirculation, innovation, deployment and the uptake of AI systems and related products andservices within the internal market should be prevented by laying down uniform
obligations for operators and guaranteeing the uniform protection of overriding reasons ofpublic interest and of rights of persons throughout the internal market on the basis of
Article 114 of the Treaty on the Functioning of the European Union (TFEU). To the extent
that this Regulation contains specific rules on the protection of individuals with regard to
the processing of personal data concerning restrictions of the use of AI systems for remotebiometric identification for the purpose of law enforcement, of the use of AI systems forrisk assessments of natural persons for the purpose of law enforcement and of the use of AI
systems of biometric categorisation for the purpose of law enforcement, it is appropriate tobase this Regulation, in so far as those specific rules are concerned, on Article 16 TFEU. In
light of those specific rules and the recourse to Article 16 TFEU, it is appropriate toconsult the European Data Protection Board.

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(4)

AI is a fast evolving family of technologies that contributes to a wide array of economic,
environmental and societal benefits across the entire spectrum of industries and social
activities. By improving prediction, optimising operations and resource allocation, andpersonalising digital solutions available for individuals and organisations, the use of AI canprovide key competitive advantages to undertakings and support socially andenvironmentally beneficial outcomes, for example in healthcare, agriculture, food safety,
education and training, media, sports, culture, infrastructure management, energy, transportand logistics, public services, security, justice, resource and energy efficiency,
environmental monitoring, the conservation and restoration of biodiversity and ecosystems
and climate change mitigation and adaptation.

(5)

At the same time, depending on the circumstances regarding its specific application, use,
and level of technological development, AI may generate risks and cause harm to public
interests and fundamental rights that are protected by Union law. Such harm might bematerial or immaterial, including physical, psychological, societal or economic harm.

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(6)

Given the major impact that AI can have on society and the need to build trust, it is vitalfor AI and its regulatory framework to be developed in accordance with Union values as
enshrined in Article 2 of the Treaty on European Union (TEU), the fundamental rights andfreedoms enshrined in the Treaties and, pursuant to Article 6 TEU, the Charter. As aprerequisite, AI should be a human-centric technology. It should serve as a tool for people,
with the ultimate aim of increasing human well-being.

(7)

In order to ensure a consistent and high level of protection of public interests as regards
health, safety and fundamental rights, common rules for high-risk AI systems should beestablished. Those rules should be consistent with the Charter, non-discriminatory and inline with the Union’s international trade commitments. They should also take into accountthe European Declaration on Digital Rights and Principles for the Digital Decade and the
Ethics guidelines for trustworthy AI of the High-Level Expert Group on Artificial
Intelligence (AI HLEG).

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(8)

A Union legal framework laying down harmonised rules on AI is therefore needed to foster
the development, use and uptake of AI in the internal market that at the same time meets ahigh level of protection of public interests, such as health and safety and the protection of
fundamental rights, including democracy, the rule of law and environmental protection asrecognised and protected by Union law. To achieve that objective, rules regulating theplacing on the market, the putting into service and the use of certain AI systems should belaid down, thus ensuring the smooth functioning of the internal market and allowing thosesystems to benefit from the principle of free movement of goods and services. Those rules
should be clear and robust in protecting fundamental rights, supportive of new innovative
solutions, enabling a European ecosystem of public and private actors creating AI systems
in line with Union values and unlocking the potential of the digital transformation acrossall regions of the Union. By laying down those rules as well as measures in support ofinnovation with a particular focus on small and medium enterprises (SMEs), including
startups, this Regulation supports the objective of promoting the European human-centric
approach to AI and being a global leader in the development of secure, trustworthy andethical AI as stated by the European Council5, and it ensures the protection of ethicalprinciples, as specifically requested by the European Parliament6.

5
6European Council, Special meeting of the European Council (1 and 2 October 2020) –Conclusions, EUCO 13/20, 2020, p. 6.
European Parliament resolution of 20 October 2020 with recommendations to theCommission on a framework of ethical aspects of artificial intelligence, robotics and related
technologies, 2020/2012(INL).

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(9)

Harmonised rules applicable to the placing on the market, the putting into service and theuse of high-risk AI systems should be laid down consistently with Regulation(EC) No 765/2008 of the European Parliament and of the Council7,
Decision No 768/2008/EC of the European Parliament and of the Council8 andRegulation (EU) 2019/1020 of the European Parliament and of the Council9 (NewLegislative Framework). The harmonised rules laid down in this Regulation should apply
across sectors and, in line with the New Legislative Framework, should be without
prejudice to existing Union law, in particular on data protection, consumer protection,
fundamental rights, employment, and protection of workers, and product safety, to which
this Regulation is complementary. As a consequence, all rights and remedies provided forby such Union law to consumers, and other persons on whom AI systems may have anegative impact, including as regards the compensation of possible damages pursuant toCouncil Directive 85/374/EEC10 remain unaffected and fully applicable.

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Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008
setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93(OJ L 218, 13.8.2008, p. 30).
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on
a common framework for the marketing of products, and repealing Council Decision
93/465/EEC (OJ L 218, 13.8.2008, p. 82).
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019
on market surveillance and compliance of products and amending Directive 2004/42/EC andRegulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).
Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws,
regulations and administrative provisions of the Member States concerning liability fordefective products (OJ L 210, 7.8.1985, p. 29).

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Furthermore, in the context of employment and protection of workers, this Regulation
should therefore not affect Union law on social policy and national labour law, incompliance with Union law, concerning employment and working conditions, including
health and safety at work and the relationship between employers and workers. This
Regulation should also not affect the exercise of fundamental rights as recognised in theMember States and at Union level, including the right or freedom to strike or to take otheraction covered by the specific industrial relations systems in Member States as well as theright to negotiate, to conclude and enforce collective agreements or to take collective
action in accordance with national law. This Regulation should not affect the provisions
aiming to improve working conditions in platform work laid down in a Directive of theEuropean Parliament and of the Council on improving working conditions in platformwork. Moreover, this Regulation aims to strengthen the effectiveness of such existingrights and remedies by establishing specific requirements and obligations, including inrespect of the transparency, technical documentation and record-keeping of AI systems.
Furthermore, the obligations placed on various operators involved in the AI value chain
under this Regulation should apply without prejudice to national law, in compliance with
Union law, having the effect of limiting the use of certain AI systems where such law falls
outside the scope of this Regulation or pursues legitimate public interest objectives otherthan those pursued by this Regulation. For example, national labour law and law on theprotection of minors, namely persons below the age of 18, taking into account the UNCRC
General Comment No 25 (2021) on children’s rights in relation to the digital environment,
insofar as they are not specific to AI systems and pursue other legitimate public interest
objectives, should not be affected by this Regulation.

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(10)

The fundamental right to the protection of personal data is safeguarded in particular by
Regulations (EU) 2016/67911 and (EU) 2018/172512 of the European Parliament and of theCouncil and Directive (EU) 2016/680 of the European Parliament and of the Council13.
Directive 2002/58/EC of the European Parliament and of the Council14 additionallyprotects private life and the confidentiality of communications, including by way ofproviding conditions for any storing of personal and non-personal data in, and access from,terminal equipment. Those Union legal acts provide the basis for sustainable andresponsible data processing, including where data sets include a mix of personal andnon-personal data. This Regulation does not seek to affect the application of existing
Union law governing the processing of personal data, including the tasks and powers of the
independent supervisory authorities competent to monitor compliance with those
instruments.

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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 thefree movement of such data, and repealing Directive 95/46/EC (General Data Protection
Regulation) (OJ L 119, 4.5.2016, p. 1).
Regulation (EU) 2018/1725 of the European Parliament and of the Councilof 23 October 2018 on the protection of natural persons with regard to the processing of
personal data by the Union institutions, bodies, offices and agencies and on the freemovement of such data, and repealing Regulation (EC) No 45/2001 and Decision
No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
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 competentauthorities for the purposes of the prevention, investigation, detection or prosecution of
criminal offences or the execution of criminal penalties, and on the free movement of suchdata, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016,p. 89).
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).

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It also does not affect the obligations of providers and deployers of AI systems in their roleas data controllers or processors stemming from Union or national law on the protection of
personal data in so far as the design, the development or the use of AI systems involves theprocessing of personal data. It is also appropriate to clarify that data subjects continue toenjoy all the rights and guarantees awarded to them by such Union law, including therights related to solely automated individual decision-making, including profiling.
Harmonised rules for the placing on the market, the putting into service and the use of AI
systems established under this Regulation should facilitate the effective implementationand enable the exercise of the data subjects’ rights and other remedies guaranteed under
Union law on the protection of personal data and of other fundamental rights.
(11)This Regulation should be without prejudice to the provisions regarding the liability ofproviders of intermediary services as set out in Regulation (EU) 2022/2065 of theEuropean Parliament and of the Council15.

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Regulation (EU) 2022/2065 of the European Parliament and of the Councilof 19 October 2022 on a Single Market For Digital Services and amending Directive
2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1).

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(12)

The notion of ‘AI system’ in this Regulation should be clearly defined and should beclosely aligned with the work of international organisations working on AI to ensure legal
certainty, facilitate international convergence and wide acceptance, while providing theflexibility to accommodate the rapid technological developments in this field. Moreover,the definition should be based on key characteristics of AI systems that distinguish it from
simpler traditional software systems or programming approaches and should not coversystems that are based on the rules defined solely by natural persons to automatically
execute operations. A key characteristic of AI systems is their capability to infer. This
capability to infer refers to the process of obtaining the outputs, such as predictions,content, recommendations, or decisions, which can influence physical and virtualenvironments, and to a capability of AI systems to derive models or algorithms, or both,from inputs or data. The techniques that enable inference while building an AI system
include machine learning approaches that learn from data how to achieve certain
objectives, and logic- and knowledge-based approaches that infer from encoded knowledge
or symbolic representation of the task to be solved. The capacity of an AI system to infertranscends basic data processing by enabling learning, reasoning or modelling. The term‘machine-based’ refers to the fact that AI systems run on machines.

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The reference to explicit or implicit objectives underscores that AI systems can operateaccording to explicit defined objectives or to implicit objectives. The objectives of the AI
system may be different from the intended purpose of the AI system in a specific context.
For the purposes of this Regulation, environments should be understood to be the contexts
in which the AI systems operate, whereas outputs generated by the AI system reflect
different functions performed by AI systems and include predictions, content,
recommendations or decisions. AI systems are designed to operate with varying levels of
autonomy, meaning that they have some degree of independence of actions from human
involvement and of capabilities to operate without human intervention. The adaptivenessthat an AI system could exhibit after deployment, refers to self-learning capabilities,
allowing the system to change while in use. AI systems can be used on a stand-alone basis
or as a component of a product, irrespective of whether the system is physically integrated
into the product (embedded) or serves the functionality of the product without being
integrated therein (non-embedded).

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(13)

The notion of ‘deployer’ referred to in this Regulation should be interpreted as any naturalor legal person, including a public authority, agency or other body, using an AI system
under its authority, except where the AI system is used in the course of a personal
non-professional activity. Depending on the type of AI system, the use of the system may
affect persons other than the deployer.

(14)

The notion of ‘biometric data’ used in this Regulation should be interpreted in light of thenotion of biometric data as defined in Article 4, point (14) of Regulation (EU) 2016/679,
Article 3, point (18) of Regulation (EU) 2018/1725 and Article 3, point (13) of Directive(EU) 2016/680. Biometric data can allow for the authentication, identification or
categorisation of natural persons and for the recognition of emotions of natural persons.

(15)

The notion of ‘biometric identification’ referred to in this Regulation should be defined as
the automated recognition of physical, physiological and behavioural human features suchas the face, eye movement, body shape, voice, prosody, gait, posture, heart rate, bloodpressure, odour, keystrokes characteristics, for the purpose of establishing an individual’s
identity by comparing biometric data of that individual to stored biometric data of
individuals in a reference database, irrespective of whether the individual has given its
consent or not. This excludes AI systems intended to be used for biometric verification,
which includes authentication, whose sole purpose is to confirm that a specific natural
person is the person he or she 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 security
access to premises.

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(16)

The notion of ‘biometric categorisation’ referred to in this Regulation should be defined as
assigning natural persons to specific categories on the basis of their biometric data. Suchspecific categories can relate to aspects such as sex, age, hair colour, eye colour, tattoos,
behavioural or personality traits, language, religion, membership of a national minority,
sexual or political orientation. This does not include biometric categorisation systems thatare a purely ancillary feature intrinsically linked to another commercial service, meaningthat the feature cannot, for objective technical reasons, be used without the principal
service, and the integration of that feature or functionality is not a means to circumvent theapplicability of the rules of this Regulation. For example, filters categorising facial or bodyfeatures used on online marketplaces could constitute such an ancillary feature as they canbe used only in relation to the principal service which consists in selling a product by
allowing the consumer to preview the display of the product on him or herself and help theconsumer to make a purchase decision. Filters used on online social network services
which categorise facial or body features to allow users to add or modify pictures or videos
could also be considered to be ancillary feature as such filter cannot be used without the
principal service of the social network services consisting in the sharing of content online.

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(17)

The notion of ‘remote biometric identification system’ referred to in this Regulation should
be defined functionally, as an AI system intended for the identification of natural persons
without their active involvement, typically at a distance, through the comparison of aperson’s biometric data with the biometric data contained in a reference database,irrespectively of the particular technology, processes or types of biometric data used. Suchremote biometric identification systems are typically used to perceive multiple persons or
their behaviour simultaneously in order to facilitate significantly the identification ofnatural persons without their active involvement. This excludes AI systems intended to be
used for biometric verification, which includes authentication, the sole purpose of which is
to confirm that a specific natural person is the person he or she 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 security access to premises. That exclusion is justified by the fact thatsuch systems are likely to have a minor impact on fundamental rights of natural persons
compared to the remote biometric identification systems which may be used for theprocessing of the biometric data of a large number of persons without their active
involvement. In the case of ‘real-time’ systems, the capturing of the biometric data, thecomparison and the identification occur all instantaneously, near-instantaneously or in any
event without a significant delay. In this regard, there should be no scope forcircumventing the rules of this Regulation on the ‘real-time’ use of the AI systems
concerned by providing for minor delays. ‘Real-time’ systems involve the use of ‘live’ or‘near-live’ material, such as video footage, generated by a camera or other device withsimilar functionality. In the case of ‘post’ systems, in contrast, the biometric data has
already been captured and the comparison and identification occur only after a significant
delay. This involves material, such as pictures or video footage generated by closed circuit
television cameras or private devices, which has been generated before the use of thesystem in respect of the natural persons concerned.

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(18)

The notion of ‘emotion recognition system’ referred to in this Regulation should be
defined as an AI system for the purpose of identifying or inferring emotions or intentionsof natural persons on the basis of their biometric data. The notion refers to emotions or
intentions such as happiness, sadness, anger, surprise, disgust, embarrassment, excitement,
shame, contempt, satisfaction and amusement. It does not include physical states, such as
pain or fatigue, including, for example, systems used in detecting the state of fatigue of
professional pilots or drivers for the purpose of preventing accidents. This does also notinclude the mere detection of readily apparent expressions, gestures or movements, unlessthey are used for identifying or inferring emotions. Those expressions can be basic facial
expressions, such as a frown or a smile, or gestures such as the movement of hands, armsor head, or characteristics of a person’s voice, such as a raised voice or whispering.

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(19)

For the purposes of this Regulation the notion of ‘publicly accessible space’ should beunderstood as referring to any physical space that is accessible to an undetermined numberof natural persons, and irrespective of whether the space in question is privately or publicly
owned, irrespective of the activity for which the space may be used, such as for commerce,
for example, shops, restaurants, cafés; for services, for example, banks, professional
activities, hospitality; for sport, for example, swimming pools, gyms, stadiums; fortransport, for example, bus, metro and railway stations, airports, means of transport; forentertainment, for example, cinemas, theatres, museums, concert and conference halls; orfor leisure or otherwise, for example, public roads and squares, parks, forests, playgrounds.
A space should also be classified as being publicly accessible if, regardless of potential
capacity or security restrictions, access is subject to certain predetermined conditions
which can be fulfilled by an undetermined number of persons, such as the purchase of aticket or title of transport, prior registration or having a certain age. In contrast, a spaceshould not be considered to be publicly accessible if access is limited to specific anddefined natural persons through either Union or national law directly related to public
safety or security or through the clear manifestation of will by the person having therelevant authority over the space. The factual possibility of access alone, such as an
unlocked door or an open gate in a fence, does not imply that the space is publicly
accessible in the presence of indications or circumstances suggesting the contrary, such as.
signs prohibiting or restricting access. Company and factory premises, as well as offices
and workplaces that are intended to be accessed only by relevant employees and service
providers, are spaces that are not publicly accessible. Publicly accessible spaces should notinclude prisons or border control. Some other spaces may comprise both publicly
accessible and non-publicly accessible spaces, such as the hallway of a private residentialbuilding necessary to access a doctor’s office or an airport. Online spaces are not covered,as they are not physical spaces. Whether a given space is accessible to the public should
however be determined on a case-by-case basis, having regard to the specificities of theindividual situation at hand.

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(20)

In order to obtain the greatest benefits from AI systems while protecting fundamental
rights, health and safety and to enable democratic control, AI literacy should equip
providers, deployers and affected persons with the necessary notions to make informed
decisions regarding AI systems. Those notions may vary with regard to the relevant
context and can include understanding the correct application of technical elements during
the AI system’s development phase, the measures to be applied during its use, the suitableways in which to interpret the AI system’s output, and, in the case of affected persons, theknowledge necessary to understand how decisions taken with the assistance of AI will
have an impact on them. In the context of the application this Regulation, AI literacy
should provide all relevant actors in the AI value chain with the insights required to ensure
the appropriate compliance and its correct enforcement. Furthermore, the wide
implementation of AI literacy measures and the introduction of appropriate follow-up
actions could contribute to improving working conditions and ultimately sustain the
consolidation, and innovation path of trustworthy AI in the Union. The European Artificial
Intelligence Board (the ‘Board’) should support the Commission, to promote AI literacy
tools, public awareness and understanding of the benefits, risks, safeguards, rights andobligations in relation to the use of AI systems. In cooperation with the relevant
stakeholders, the Commission and the Member States should facilitate the drawing up of
voluntary codes of conduct to advance AI literacy among persons dealing with thedevelopment, operation and use of AI.

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(21)

In order to ensure a level playing field and an effective protection of rights and freedoms ofindividuals across the Union, the rules established by this Regulation should apply toproviders of AI systems in a non-discriminatory manner, irrespective of whether they are
established within the Union or in a third country, and to deployers of AI systems
established within the Union.

(22)

In light of their digital nature, certain AI systems should fall within the scope of thisRegulation even when they are not placed on the market, put into service, or used in theUnion. This is the case, for example, where an operator established in the Union contracts
certain services to an operator established in a third country in relation to an activity to be
performed by an AI system that would qualify as high-risk. In those circumstances, the AI
system used in a third country by the operator could process data lawfully collected in andtransferred from the Union, and provide to the contracting operator in the Union the outputof that AI system resulting from that processing, without that AI system being placed on
the market, put into service or used in the Union. To prevent the circumvention of thisRegulation and to ensure an effective protection of natural persons located in the Union,
this Regulation should also apply to providers and deployers of AI systems that are
established in a third country, to the extent the output produced by those systems is
intended to be used in the Union.

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Nonetheless, to take into account existing arrangements and special needs for futurecooperation with foreign partners with whom information and evidence is exchanged, thisRegulation should not apply to public authorities of a third country and internationalorganisations when acting in the framework of cooperation or international agreements
concluded at Union or national level for law enforcement and judicial cooperation with theUnion or the Member States, provided that the relevant third country or internationalorganisation provides adequate safeguards with respect to the protection of fundamental
rights and freedoms of individuals. Where relevant, this may cover activities of entities
entrusted by the third countries to carry out specific tasks in support of such law
enforcement and judicial cooperation. Such framework for cooperation or agreements havebeen established bilaterally between Member States and third countries or between theEuropean Union, Europol and other Union agencies and third countries and internationalorganisations. The authorities competent for supervision of the law enforcement andjudicial authorities under this Regulation should assess whether those frameworks forcooperation or international agreements include adequate safeguards with respect to theprotection of fundamental rights and freedoms of individuals. Recipient national
authorities and Union institutions, bodies, offices and agencies making use of such outputs
in the Union remain accountable to ensure their use complies with Union law. When thoseinternational agreements are revised or new ones are concluded in the future, thecontracting parties should make utmost efforts to align those agreements with therequirements of this Regulation.
(23)

This Regulation should also apply to Union institutions, bodies, offices and agencies whenacting as a provider or deployer of an AI system.

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(24)

If, and insofar as, AI systems are placed on the market, put into service, or used with orwithout modification of such systems for military, defence or national security purposes,
those should be excluded from the scope of this Regulation regardless of which type ofentity is carrying out those activities, such as whether it is a public or private entity. As
regards military and defence purposes, such exclusion is justified both by Article 4(2) TEU
and by the specificities of the Member States’ and the common Union defence policy
covered by Chapter 2 of Title V TEU that are subject to public international law, which istherefore the more appropriate legal framework for the regulation of AI systems in thecontext of the use of lethal force and other AI systems in the context of military anddefence activities. As regards national security purposes, the exclusion is justified both by
the fact that national security remains the sole responsibility of Member States inaccordance with Article 4(2) TEU and by the specific nature and operational needs ofnational security activities and specific national rules applicable to those activities.
Nonetheless, if an AI system developed, placed on the market, put into service or used formilitary, defence or national security purposes is used outside those temporarily or
permanently for other purposes, for example, civilian or humanitarian purposes, law
enforcement or public security purposes, such a system would fall within the scope of thisRegulation. In that case, the entity using the AI system for other than military, defence or
national security purposes should ensure the compliance of the AI system with thisRegulation, unless the system is already compliant with this Regulation. AI systems placedon the market or put into service for an excluded purpose, namely military, defence or
national security, and one or more non-excluded purposes, such as civilian purposes or law
enforcement, fall within the scope of this Regulation and providers of those systems should
ensure compliance with this Regulation. In those cases, the fact that an AI system may fallwithin the scope of this Regulation should not affect the possibility of entities carrying out
national security, defence and military activities, regardless of the type of entity carryingout those activities, to use AI systems for national security, military and defence purposes,
the use of which is excluded from the scope of this Regulation. An AI system placed on themarket for civilian or law enforcement purposes which is used with or without
modification for military, defence or national security purposes should not fall within thescope of this Regulation, regardless of the type of entity carrying out those activities.

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(25)

This Regulation should support innovation, should respect freedom of science, and should
not undermine research and development activity. It is therefore necessary to exclude fromits scope AI systems and models specifically developed and put into service for the sole
purpose of scientific research and development. Moreover, it is necessary to ensure that
this Regulation does not otherwise affect scientific research and development activity on
AI systems or models prior to being placed on the market or put into service. As regards
product-oriented research, testing and development activity regarding AI systems ormodels, the provisions of this Regulation should also not apply prior to those systems andmodels being put into service or placed on the market. That exclusion is without prejudice
to the obligation to comply with this Regulation where an AI system falling into the scopeof this Regulation is placed on the market or put into service as a result of such researchand development activity and to the application of provisions on AI regulatory sandboxes
and testing in real world conditions. Furthermore, without prejudice to the exclusion of AI
systems specifically developed and put into service for the sole purpose of scientificresearch and development, any other AI system that may be used for the conduct of any
research and development activity should remain subject to the provisions of thisRegulation. In any event, any research and development activity should be carried out inaccordance with recognised ethical and professional standards for scientific research andshould be conducted in accordance with applicable Union law.

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(26)

In order to introduce a proportionate and effective set of binding rules for AI systems, aclearly defined risk-based approach should be followed. That approach should tailor thetype and content of such rules to the intensity and scope of the risks that AI systems cangenerate. It is therefore necessary to prohibit certain unacceptable AI practices, to lay
down requirements for high-risk AI systems and obligations for the relevant operators, andto lay down transparency obligations for certain AI systems.

(27)

While the risk-based approach is the basis for a proportionate and effective set of binding
rules, it is important to recall the 2019 Ethics guidelines for trustworthy AI developed by
the independent AI HLEG appointed by the Commission. In those guidelines, the AI
HLEG developed seven non-binding ethical principles for AI which are intended to help
ensure that AI is trustworthy and ethically sound. The seven principles include humanagency and oversight; technical robustness and safety; privacy and data governance;transparency; diversity, non-discrimination and fairness; societal and environmental
well-being and accountability. Without prejudice to the legally binding requirements ofthis Regulation and any other applicable Union law, those guidelines contribute to thedesign of coherent, trustworthy and human-centric AI, in line with the Charter and with thevalues on which the Union is founded. According to the guidelines of the AI HLEG,
human agency and oversight means that AI systems are developed and used as a tool thatserves people, respects human dignity and personal autonomy, and that is functioning in a
way that can be appropriately controlled and overseen by humans.

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Technical robustness and safety means that AI systems are developed and used in a waythat allows robustness in the case of problems and resilience against attempts to alter theuse or performance of the AI system so as to allow unlawful use by third parties, andminimise unintended harm. Privacy and data governance means that AI systems aredeveloped and used in accordance with privacy and data protection rules, while processing
data that meets high standards in terms of quality and integrity. Transparency means thatAI systems are developed and used in a way that allows appropriate traceability andexplainability, while making humans aware that they communicate or interact with an AI
system, as well as duly informing deployers of the capabilities and limitations of that AI
system and affected persons about their rights. Diversity, non-discrimination and fairness
means that AI systems are developed and used in a way that includes diverse actors andpromotes equal access, gender equality and cultural diversity, while avoiding
discriminatory impacts and unfair biases that are prohibited by Union or national law.
Social and environmental well-being means that AI systems are developed and used in asustainable and environmentally friendly manner as well as in a way to benefit all humanbeings, while monitoring and assessing the long-term impacts on the individual, society
and democracy. The application of those principles should be translated, when possible, inthe design and use of AI models. They should in any case serve as a basis for the draftingof codes of conduct under this Regulation. All stakeholders, including industry, academia,
civil society and standardisation organisations, are encouraged to take into account, as
appropriate, the ethical principles for the development of voluntary best practices andstandards.

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(28)

Aside from the many beneficial uses of AI, it can also be misused and provide novel andpowerful tools for manipulative, exploitative and social control practices. Such practices
are particularly harmful and abusive and should be prohibited because they contradict
Union values of respect for human dignity, freedom, equality, democracy and the rule oflaw and fundamental rights enshrined in the Charter, including the right tonon-discrimination, to data protection and to privacy and the rights of the child.

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(29)

AI-enabled manipulative techniques can be used to persuade persons to engage inunwanted behaviours, or to deceive them by nudging them into decisions in a way thatsubverts and impairs their autonomy, decision-making and free choices. The placing on themarket, the putting into service or the use of certain AI systems with the objective to or theeffect of materially distorting human behaviour, whereby significant harms, in particularhaving sufficiently important adverse impacts on physical, psychological health or
financial interests are likely to occur, are particularly dangerous and should therefore beprohibited. Such AI systems deploy subliminal components such as audio, image, video
stimuli that persons cannot perceive, as those stimuli are beyond human perception, orother manipulative or deceptive techniques that subvert or impair person’s autonomy,
decision-making or free choice in ways that people are not consciously aware of thosetechniques or, where they are aware of them, can still be deceived or are not able to control
or resist them. This could be facilitated, for example, by machine-brain interfaces or virtual
reality as they allow for a higher degree of control of what stimuli are presented to persons,insofar as they may materially distort their behaviour in a significantly harmful manner. In
addition, AI systems may also otherwise exploit the vulnerabilities of a person or a specificgroup of persons due to their age, disability within the meaning of Directive(EU) 2019/882 of the European Parliament and of the Council16, or a specific social or
economic situation that is likely to make those persons more vulnerable to exploitationsuch as persons living in extreme poverty, ethnic or religious minorities.

16

Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on
the accessibility requirements for products and services (OJ L 151, 7.6.2019, p. 70).

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Such AI systems can be placed on the market, put into service or used with the objective toor the effect of materially distorting the behaviour of a person and in a manner that causes
or is reasonably likely to cause significant harm to that or another person or groups of
persons, including harms that may be accumulated over time and should therefore beprohibited. It may not be possible to assume that there is an intention to distort behaviour
where the distortion results from factors external to the AI system which are outside thecontrol of the provider or the deployer, namely factors that may not be reasonably
foreseeable and therefore not possible for the provider or the deployer of the AI system tomitigate. In any case, it is not necessary for the provider or the deployer to have theintention to cause significant harm, provided that such harm results from the manipulative
or exploitative AI-enabled practices. The prohibitions for such AI practices arecomplementary to the provisions contained in Directive 2005/29/EC of the European
Parliament and of the Council17, in particular unfair commercial practices leading toeconomic or financial harms to consumers are prohibited under all circumstances,
irrespective of whether they are put in place through AI systems or otherwise. The
prohibitions of manipulative and exploitative practices in this Regulation should not affectlawful practices in the context of medical treatment such as psychological treatment of amental disease or physical rehabilitation, when those practices are carried out inaccordance with the applicable law and medical standards, for example explicit consent of
the individuals or their legal representatives. In addition, common and legitimate
commercial practices, for example in the field of advertising, that comply with theapplicable law should not, in themselves, be regarded as constituting harmful manipulative
AI-enabled practices.

17

Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005
concerning unfair business-to-consumer commercial practices in the internal market andamending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of
the European Parliament and of the Council and Regulation (EC) No 2006/2004 of theEuropean Parliament and of the Council (‘Unfair Commercial Practices Directive’)(OJ L 149, 11.6.2005, p. 22).

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(30)

Biometric categorisation systems that are based on natural persons’ biometric data, such as
an individual person’s face or fingerprint, to deduce or infer an individuals’ politicalopinions, trade union membership, religious or philosophical beliefs, race, sex life orsexual orientation should be prohibited. That prohibition should not cover the lawfullabelling, filtering or categorisation of biometric data sets acquired in line with Union or
national law according to biometric data, such as the sorting of images according to haircolour or eye colour, which can for example be used in the area of law enforcement.

(31)

AI systems providing social scoring of natural persons by public or private actors may leadto discriminatory outcomes and the exclusion of certain groups. They may violate the rightto dignity and non-discrimination and the values of equality and justice. Such AI systems
evaluate or classify natural persons or groups thereof on the basis of multiple data points
related to their social behaviour in multiple contexts or known, inferred or predictedpersonal or personality characteristics over certain periods of time. The social scoreobtained from such AI systems may lead to the detrimental or unfavourable treatment of
natural persons or whole groups thereof in social contexts, which are unrelated to thecontext in which the data was originally generated or collected or to a detrimental
treatment that is disproportionate or unjustified to the gravity of their social behaviour. AI
systems entailing such unacceptable scoring practices and leading to such detrimental orunfavourable outcomes should therefore be prohibited. That prohibition should not affectlawful evaluation practices of natural persons that are carried out for a specific purpose inaccordance with Union and national law.

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(32)

The use of AI systems for ‘real-time’ remote biometric identification of natural persons inpublicly accessible spaces for the purpose of law enforcement is particularly intrusive tothe rights and freedoms of the concerned persons, to the extent that it may affect theprivate life of a large part of the population, evoke a feeling of constant surveillance andindirectly dissuade the exercise of the freedom of assembly and other fundamental rights.
Technical inaccuracies of AI systems intended for the remote biometric identification ofnatural persons can lead to biased results and entail discriminatory effects. Such possible
biased results and discriminatory effects are particularly relevant with regard to age,
ethnicity, race, sex or disabilities. In addition, the immediacy of the impact and the limited
opportunities for further checks or corrections in relation to the use of such systems
operating in real-time carry heightened risks for the rights and freedoms of the persons
concerned in the context of, or impacted by, law enforcement activities.

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(33)

The use of those systems for the purpose of law enforcement should therefore beprohibited, except in exhaustively listed and narrowly defined situations, where the use isstrictly necessary to achieve a substantial public interest, the importance of which
outweighs the risks. Those situations involve the search for certain victims of crime
including missing persons; certain threats to the life or to the physical safety of natural
persons or of a terrorist attack; and the localisation or identification of perpetrators orsuspects of the criminal offences listed in an annex to this Regulation, where thosecriminal offences are punishable in the Member State concerned by a custodial sentence ora detention order for a maximum period of at least four years and as they are defined in thelaw of that Member State. Such a threshold for the custodial sentence or detention order inaccordance with national law contributes to ensuring that the offence should be serious
enough to potentially justify the use of ‘real-time’ remote biometric identification systems.
Moreover, the list of criminal offences provided in an annex to this Regulation is based on
the 32 criminal offences listed in the Council Framework Decision 2002/584/JHA18, taking
into account that some of those offences are, in practice, likely to be more relevant thanothers, in that the recourse to ‘real-time’ remote biometric identification could,
foreseeably, be necessary and proportionate to highly varying degrees for the practicalpursuit of the localisation or identification of a perpetrator or suspect of the different
criminal offences listed and having regard to the likely differences in the seriousness,probability and scale of the harm or possible negative consequences.

18

Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest
warrant and the surrender procedures between Member States (OJ L 190, 18.7.2002, p. 1).

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An imminent threat to life or the physical safety of natural persons could also result from a
serious disruption of critical infrastructure, as defined in Article 2, point (4) of Directive(EU) 2022/2557 of the European Parliament and of the Council19, where the disruption or
destruction of such critical infrastructure would result in an imminent threat to life or thephysical safety of a person, including through serious harm to the provision of basic
supplies to the population or to the exercise of the core function of the State. In addition,
this Regulation should preserve the ability for law enforcement, border control,
immigration or asylum authorities to carry out identity checks in the presence of the person
concerned in accordance with the conditions set out in Union and national law for suchchecks. In particular, law enforcement, border control, immigration or asylum authorities
should be able to use information systems, in accordance with Union or national law, toidentify persons who, during an identity check, either refuse to be identified or are unable
to state or prove their identity, without being required by this Regulation to obtain priorauthorisation. This could be, for example, a person involved in a crime, being unwilling, or
unable due to an accident or a medical condition, to disclose their identity to law
enforcement authorities.

19

Directive (EU) 2022/2557 of the European Parliament and of the Councilof 14 December 2022 on the resilience of critical entities and repealing Council Directive
2008/114/EC (OJ L 333, 27.12.2022, p. 164).

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(34)

In order to ensure that those systems are used in a responsible and proportionate manner, it
is also important to establish that, in each of those exhaustively listed and narrowly defined
situations, certain elements should be taken into account, in particular as regards the natureof the situation giving rise to the request and the consequences of the use for the rights andfreedoms of all persons concerned and the safeguards and conditions provided for with theuse. In addition, the use of ‘real-time’ remote biometric identification systems in publicly
accessible spaces for the purpose of law enforcement should be deployed only to confirm
the specifically targeted individual’s identity and should be limited to what is strictly
necessary concerning the period of time, as well as the geographic and personal scope,
having regard in particular to the evidence or indications regarding the threats, the victims
or perpetrator. The use of the real-time remote biometric identification system in publicly
accessible spaces should be authorised only if the relevant law enforcement authority hascompleted a fundamental rights impact assessment and, unless provided otherwise in thisRegulation, has registered the system in the database as set out in this Regulation. The
reference database of persons should be appropriate for each use case in each of thesituations mentioned above.

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(35)

Each use of a ‘real-time’ remote biometric identification system in publicly accessible
spaces for the purpose of law enforcement should be subject to an express and specificauthorisation by a judicial authority or by an independent administrative authority of a
Member State whose decision is binding. Such authorisation should, in principle, beobtained prior to the use of the AI system with a view to identifying a person or persons.
Exceptions to that rule should be allowed in duly justified situations on grounds ofurgency, namely in situations where the need to use the systems concerned is such as tomake it effectively and objectively impossible to obtain an authorisation before
commencing the use of the AI system. In such situations of urgency, the use of the AI
system should be restricted to the absolute minimum necessary and should be subject toappropriate safeguards and conditions, as determined in national law and specified in thecontext of each individual urgent use case by the law enforcement authority itself. In
addition, the law enforcement authority should in such situations request such authorisation
while providing the reasons for not having been able to request it earlier, without undue
delay and at the latest within 24 hours. If such an authorisation is rejected, the use ofreal-time biometric identification systems linked to that authorisation should cease withimmediate effect and all the data related to such use should be discarded and deleted. Suchdata includes input data directly acquired by an AI system in the course of the use of such
system as well as the results and outputs of the use linked to that authorisation. It should
not include input that is legally acquired in accordance with another Union or national law.
In any case, no decision producing an adverse legal effect on a person should be taken
based solely on the output of the remote biometric identification system.

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(36)

In order to carry out their tasks in accordance with the requirements set out in thisRegulation as well as in national rules, the relevant market surveillance authority and thenational data protection authority should be notified of each use of the real-time biometricidentification system. Market surveillance authorities and the national data protection
authorities that have been notified should submit to the Commission an annual report on
the use of real-time biometric identification systems.

(37)

Furthermore, it is appropriate to provide, within the exhaustive framework set by thisRegulation that such use in the territory of a Member State in accordance with thisRegulation should only be possible where and in as far as the Member State concerned has
decided to expressly provide for the possibility to authorise such use in its detailed rules ofnational law. Consequently, Member States remain free under this Regulation not toprovide for such a possibility at all or to only provide for such a possibility in respect ofsome of the objectives capable of justifying authorised use identified in this Regulation.
Such national rules should be notified to the Commission within 30 days of their adoption.

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(38)

The use of AI systems for real-time remote biometric identification of natural persons inpublicly accessible spaces for the purpose of law enforcement necessarily involves theprocessing of biometric data. The rules of this Regulation that prohibit, subject to certain
exceptions, such use, which are based on Article 16 TFEU, should apply as lex specialis inrespect of the rules on the processing of biometric data contained in Article 10 of Directive(EU) 2016/680, thus regulating such use and the processing of biometric data involved in
an exhaustive manner. Therefore, such use and processing should be possible only in as far
as it is compatible with the framework set by this Regulation, without there being scope,outside that framework, for the competent authorities, where they act for purpose of law
enforcement, to use such systems and process such data in connection thereto on the
grounds listed in Article 10 of Directive (EU) 2016/680. In that context, this Regulation is
not intended to provide the legal basis for the processing of personal data under Article 8
of Directive (EU) 2016/680. However, the use of real-time remote biometric identification
systems in publicly accessible spaces for purposes other than law enforcement, including
by competent authorities, should not be covered by the specific framework regarding suchuse for the purpose of law enforcement set by this Regulation. Such use for purposes otherthan law enforcement should therefore not be subject to the requirement of an authorisation
under this Regulation and the applicable detailed rules of national law that may give effectto that authorisation.

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(39)

Any processing of biometric data and other personal data involved in the use of AI systems
for biometric identification, other than in connection to the use of real-time remotebiometric identification systems in publicly accessible spaces for the purpose of law
enforcement as regulated by this Regulation, should continue to comply with all
requirements resulting from Article 10 of Directive (EU) 2016/680. For purposes otherthan law enforcement, Article 9(1) of Regulation (EU) 2016/679 and Article 10(1) ofRegulation (EU) 2018/1725 prohibit the processing of biometric data subject to limited
exceptions as provided in those Articles. In the application of Article 9(1) of Regulation(EU) 2016/679, the use of remote biometric identification for purposes other than law
enforcement has already been subject to prohibition decisions by national data protection
authorities.

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(40)

In accordance with Article 6a of Protocol No 21 on the position of the United Kingdom
and Ireland in respect of the area of freedom, security and justice, as annexed to the TEU
and to the TFEU, Ireland is not bound by the rules laid down in Article 5(1), firstsubparagraph, point (g), to the extent it applies to the use of biometric categorisation
systems for activities in the field of police cooperation and judicial cooperation in criminal
matters, Article 5(1), first subparagraph, point (d), to the extent it applies to the use of AI
systems covered by that provision, Article 5(1), first subparagraph, point (h), Article 5(2)to (6) and Article 26(10) of this Regulation adopted on the basis of Article 16 TFEU which
relate to the processing of personal data by the Member States when carrying out activities
falling within the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the TFEU,
where Ireland is not bound by the rules governing the forms of judicial cooperation incriminal matters or police cooperation which require compliance with the provisions laid
down on the basis of Article 16 TFEU.

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(41)

In accordance with Articles 2 and 2a of Protocol No 22 on the position of Denmark,annexed to the TEU and to the TFEU, Denmark is not bound by rules laid down in
Article 5(1), first subparagraph, point (g), to the extent it applies to the use of biometriccategorisation systems for activities in the field of police cooperation and judicial
cooperation in criminal matters, Article 5(1), first subparagraph, point (d), to the extent it
applies to the use of AI systems covered by that provision, Article 5(1), first subparagraph,point (h), (2) to (6) and Article 26(10) of this Regulation adopted on the basis of Article 16
TFEU, or subject to their application, which relate to the processing of personal data by theMember States when carrying out activities falling within the scope of Chapter 4 or
Chapter 5 of Title V of Part Three of the TFEU.

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(42)

In line with the presumption of innocence, natural persons in the Union should always be
judged on their actual behaviour. Natural persons should never be judged on AI-predictedbehaviour based solely on their profiling, personality traits or characteristics, such as
nationality, place of birth, place of residence, number of children, level of debt or type ofcar, without a reasonable suspicion of that person being involved in a criminal activity
based on objective verifiable facts and without human assessment thereof. Therefore, risk
assessments carried out with regard to natural persons in order to assess the likelihood of
their offending or to predict the occurrence of an actual or potential criminal offence based
solely on profiling them or on assessing their personality traits and characteristics should
be prohibited. In any case, that prohibition does not refer to or touch upon risk analytics
that are not based on the profiling of individuals or on the personality traits andcharacteristics of individuals, such as AI systems using risk analytics to assess thelikelihood of financial fraud by undertakings on the basis of suspicious transactions or risk
analytic tools to predict the likelihood of the localisation of narcotics or illicit goods bycustoms authorities, for example on the basis of known trafficking routes.

(43)

The placing on the market, the putting into service for that specific purpose, or the use of
AI systems that create or expand facial recognition databases through the untargeted
scraping of facial images from the internet or CCTV footage, should be prohibited becausethat practice adds to the feeling of mass surveillance and can lead to gross violations offundamental rights, including the right to privacy.

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(44)

There are serious concerns about the scientific basis of AI systems aiming to identify orinfer emotions, particularly as expression of emotions vary considerably across culturesand situations, and even within a single individual. Among the key shortcomings of such
systems are the limited reliability, the lack of specificity and the limited generalisability.
Therefore, AI systems identifying or inferring emotions or intentions of natural persons on
the basis of their biometric data may lead to discriminatory outcomes and can be intrusive
to the rights and freedoms of the concerned persons. Considering the imbalance of powerin the context of work or education, combined with the intrusive nature of these systems,
such systems could lead to detrimental or unfavourable treatment of certain natural persons
or whole groups thereof. Therefore, the placing on the market, the putting into service, or
the use of AI systems intended to be used to detect the emotional state of individuals insituations related to the workplace and education should be prohibited. That prohibition
should not cover AI systems placed on the market strictly for medical or safety reasons,such as systems intended for therapeutical use.

(45)

Practices that are prohibited by Union law, including data protection law,non-discrimination law, consumer protection law, and competition law, should not beaffected by this Regulation.

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(46)

High-risk AI systems should only be placed on the Union market, put into service or used
if they comply with certain mandatory requirements. Those requirements should ensurethat high-risk AI systems available in the Union or whose output is otherwise used in theUnion do not pose unacceptable risks to important Union public interests as recognised andprotected by Union law. On the basis of the New Legislative Framework, as clarified in theCommission notice ‘The “Blue Guide” on the implementation of EU product rules 2022’20,
the general rule is that more than one legal act of Union harmonisation legislation, such as
Regulations (EU) 2017/74521 and (EU) 2017/74622 of the European Parliament and of theCouncil or Directive 2006/42/EC of the European Parliament and of the Council23, may be
applicable to one product, since the making available or putting into service can take place
only when the product complies with all applicable Union harmonisation legislation. To
ensure consistency and avoid unnecessary administrative burdens or costs, providers of a
product that contains one or more high-risk AI systems, to which the requirements of thisRegulation and of the Union harmonisation legislation listed in an annex to this Regulation
apply, should have flexibility with regard to operational decisions on how to ensurecompliance of a product that contains one or more AI systems with all applicablerequirements of the Union harmonisation legislation in an optimal manner. AI systems
identified as high-risk should be limited to those that have a significant harmful impact on
the health, safety and fundamental rights of persons in the Union and such limitation
should minimise any potential restriction to international trade.

20
21

22

23

OJ C 247, 29.6.2022, p. 1.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017
on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and93/42/EEC (OJ L 117, 5.5.2017, p. 1).
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017
on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission
Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on
machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).

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(47)

AI systems could have an adverse impact on the health and safety of persons, in particularwhen such systems operate as safety components of products. Consistent with theobjectives of Union harmonisation legislation to facilitate the free movement of products in
the internal market and to ensure that only safe and otherwise compliant products find theirway into the market, it is important that the safety risks that may be generated by a productas a whole due to its digital components, including AI systems, are duly prevented andmitigated. For instance, increasingly autonomous robots, whether in the context ofmanufacturing or personal assistance and care should be able to safely operate andperforms their functions in complex environments. Similarly, in the health sector where thestakes for life and health are particularly high, increasingly sophisticated diagnostics
systems and systems supporting human decisions should be reliable and accurate.

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(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 highrisk. 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 assemblyand 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 ofdefence 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 specificrights 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 asregards the digital environment, both of which require consideration of the children’svulnerabilities 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 Charterand implemented in Union policies should also be considered when assessing the severityof the harm that an AI system can cause, including in relation to the health and safety of
persons.

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(49)

As regards high-risk AI systems that are safety components of products or systems, or
which are themselves products or systems falling within the scope of Regulation(EC) No 300/2008 of the European Parliament and of the Council24, Regulation(EU) No 167/2013 of the European Parliament and of the Council25, Regulation(EU) No 168/2013 of the European Parliament and of the Council26, Directive 2014/90/EUof the European Parliament and of the Council27, Directive (EU) 2016/797 of the European
Parliament and of the Council28,

24

25

26

27
28

Regulation (EC) No 300/2008 of the European Parliament and of the Councilof 11 March 2008 on common rules in the field of civil aviation security and repealing
Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72).
Regulation (EU) No 167/2013 of the European Parliament and of the Councilof 5 February 2013 on the approval and market surveillance of agricultural and forestry
vehicles (OJ L 60, 2.3.2013, p. 1).
Regulation (EU) No 168/2013 of the European Parliament and of the Councilof 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles
and quadricycles (OJ L 60, 2.3.2013, p. 52).
Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on
marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146).
Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on
the interoperability of the rail system within the European Union (OJ L 138, 26.5.2016,p. 44).

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Regulation (EU) 2018/858 of the European Parliament and of the Council29, Regulation(EU) 2018/1139 of the European Parliament and of the Council30, and Regulation(EU) 2019/2144 of the European Parliament and of the Council31, it is appropriate toamend those acts to ensure that the Commission takes into account, on the basis of thetechnical and regulatory specificities of each sector, and without interfering with existing
governance, conformity assessment and enforcement mechanisms and authorities
established therein, the mandatory requirements for high-risk AI systems laid down in thisRegulation when adopting any relevant delegated or implementing acts on the basis of
those acts.

29

30

31

Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018
on the approval and market surveillance of motor vehicles and their trailers, and of systems,
components and separate technical units intended for such vehicles, amending Regulations(EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151,
14.6.2018, p. 1).
Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018
on common rules in the field of civil aviation and establishing a European Union Aviation
Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008,(EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of theEuropean Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and(EC) No 216/2008 of the European Parliament and of the Council and Council Regulation(EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).
Regulation (EU) 2019/2144 of the European Parliament and of the Councilof 27 November 2019 on type-approval requirements for motor vehicles and their trailers,and systems, components and separate technical units intended for such vehicles, as regards
their general safety and the protection of vehicle occupants and vulnerable road users,
amending Regulation (EU) 2018/858 of the European Parliament and of the Council andrepealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of theEuropean Parliament and of the Council and Commission Regulations (EC) No 631/2009,(EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010,(EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011,(EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012,(EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1).

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(50)

As regards AI systems that are safety components of products, or which are themselves
products, falling within the scope of certain Union harmonisation legislation listed in anannex to this Regulation, it is appropriate to classify them as high-risk under thisRegulation if the product concerned undergoes the conformity assessment procedure with athird-party conformity assessment body pursuant to that relevant Union harmonisation
legislation. In particular, such products are machinery, toys, lifts, equipment and protective
systems intended for use in potentially explosive atmospheres, radio equipment, pressure
equipment, recreational craft equipment, cableway installations, appliances burning
gaseous fuels, medical devices, in vitro diagnostic medical devices, automotive andaviation.

(51)

The classification of an AI system as high-risk pursuant to this Regulation should notnecessarily mean that the product whose safety component is the AI system, or the AI
system itself as a product, is considered to be high-risk under the criteria established in therelevant Union harmonisation legislation that applies to the product. This is, in particular,
the case for Regulations (EU) 2017/745 and (EU) 2017/746, where a third-party
conformity assessment is provided for medium-risk and high-risk products.

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(52)

As regards stand-alone AI systems, namely high-risk AI systems other than those that aresafety 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 thehealth and safety or the fundamental rights of persons, taking into account both the severityof 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 thosesystems 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 empoweredto adopt, via delegated acts, to take into account the rapid pace of technologicaldevelopment, as well as the potential changes in the use of AI systems.

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(53)

It is also important to clarify that there may be specific cases in which AI systems referred
to in pre-defined areas specified in this Regulation do not lead to a significant risk of harmto the legal interests protected under those areas because they do not materially influence
the decision-making or do not harm those interests substantially. For the purposes of thisRegulation, an AI system that does not materially influence the outcome ofdecision-making should be understood to be an AI system that does not have an impact on
the substance, and thereby the outcome, of decision-making, whether human or automated.
An AI system that does not materially influence the outcome of decision-making could
include situations in which one or more of the following conditions are fulfilled. The firstsuch condition should be that the AI system is intended to perform a narrow proceduraltask, such as an AI system that transforms unstructured data into structured data, an AI
system that classifies incoming documents into categories or an AI system that is used todetect duplicates among a large number of applications. Those tasks are of such narrowand limited nature that they pose only limited risks which are not increased through the useof an AI system in a context that is listed as a high-risk use in an annex to this Regulation.
The second condition should be that the task performed by the AI system is intended to
improve the result of a previously completed human activity that may be relevant for the
purposes of the high-risk uses listed in an annex to this Regulation. Considering thosecharacteristics, the AI system provides only an additional layer to a human activity withconsequently lowered risk. That condition would, for example, apply to AI systems that are
intended to improve the language used in previously drafted documents, for example inrelation to professional tone, academic style of language or by aligning text to a certain
brand messaging. The third condition should be that the AI system is intended to detectdecision-making patterns or deviations from prior decision-making patterns.

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The risk would be lowered because the use of the AI system follows a previously
completed human assessment which it is not meant to replace or influence, without proper
human review. Such AI systems include for instance those that, given a certain grading
pattern of a teacher, can be used to check ex post whether the teacher may have deviatedfrom the grading pattern so as to flag potential inconsistencies or anomalies. The fourth
condition should be that the AI system is intended to perform a task that is only
preparatory to an assessment relevant for the purposes of the AI systems listed in an annex
to this Regulation, thus making the possible impact of the output of the system very low interms of representing a risk for the assessment to follow. That condition covers, inter alia,
smart solutions for file handling, which include various functions from indexing,
searching, text and speech processing or linking data to other data sources, or AI systems
used for translation of initial documents. In any case, AI systems used in high-risk
use-cases listed in an annex to this Regulation should be considered to pose significant
risks of harm to the health, safety or fundamental rights if the AI system implies profilingwithin the meaning of Article 4, point (4) of Regulation (EU) 2016/679 or Article 3,
point (4) of Directive (EU) 2016/680 or Article 3, point (5) of Regulation (EU) 2018/1725.
To ensure traceability and transparency, a provider who considers that an AI system is nothigh-risk on the basis of the conditions referred to above should draw up documentation of
the assessment before that system is placed on the market or put into service and should
provide that documentation to national competent authorities upon request. Such a provider
should be obliged to register the AI system in the EU database established under thisRegulation. With a view to providing further guidance for the practical implementation of
the conditions under which the AI systems listed in an annex to this Regulation are, on an
exceptional basis, non-high-risk, the Commission should, after consulting the Board,
provide guidelines specifying that practical implementation, completed by acomprehensive list of practical examples of use cases of AI systems that are high-risk anduse cases that are not.

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(54)

As biometric data constitutes a special category of personal data, it is appropriate toclassify as high-risk several critical-use cases of biometric systems, insofar as their use ispermitted 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 viewof 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 ofa 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 biometriccategorisation 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 notprohibited 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.

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(55)

As regards the management and operation of critical infrastructure, it is appropriate toclassify 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 theAnnex to Directive (EU) 2022/2557, road traffic and the supply of water, gas, heating andelectricity, 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 socialand economic activities. Safety components of critical infrastructure, including critical
digital infrastructure, are systems used to directly protect the physical integrity of criticalinfrastructure 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 torisks 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 waterpressure or fire alarm controlling systems in cloud computing centres.

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(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 thenecessary digital skills and competences, including media literacy, and critical thinking, totake 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 oradmission, for assigning persons to educational and vocational training institutions orprogrammes at all levels, for evaluating learning outcomes of persons, for assessing theappropriate 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 formonitoring and detecting prohibited behaviour of students during tests should be classified
as high-risk AI systems, since they may determine the educational and professional courseof 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 discriminatedagainst 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.

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(57)

AI systems used in employment, workers management and access to self-employment, inparticular 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 andworkers’ rights. Relevant work-related contractual relationships should, in a meaningfulmanner, involve employees and persons providing services through platforms as referred toin the Commission Work Programme 2021. Throughout the recruitment process and in theevaluation, 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 ofsuch persons may also undermine their fundamental rights to data protection and privacy.

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(58)

Another area in which the use of AI systems deserves special consideration is the access toand enjoyment of certain essential private and public services and benefits necessary forpeople 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 havea significant impact on persons’ livelihood and may infringe their fundamental rights, suchas 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 nothamper 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.

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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, andtelecommunication services. AI systems used for those purposes may lead todiscrimination between persons or groups and may perpetuate historical patterns of
discrimination, such as that based on racial or ethnic origins, gender, disabilities, age orsexual 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 offinancial services and for prudential purposes to calculate credit institutions’ and insurance
undertakings’ capital requirements should not be considered to be high-risk under thisRegulation. 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 theirfundamental rights and can lead to serious consequences for people’s life and health,including financial exclusion and discrimination. Finally, AI systems used to evaluate andclassify emergency calls by natural persons or to dispatch or establish priority in the
dispatching of emergency first response services, including by police, firefighters andmedical aid, as well as of emergency healthcare patient triage systems, should also beclassified as high-risk since they make decisions in very critical situations for the life andhealth of persons and their property.

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(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 asother 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 interms 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 ofimportant procedural fundamental rights, such as the right to an effective remedy and to afair 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 andtransparency is particularly important to avoid adverse impacts, retain public trust andensure accountability and effective redress.

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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 oflaw enforcement authorities for assessing the risk of a natural person to become a victim ofcriminal offences, as polygraphs and similar tools, for the evaluation of the reliability ofevidence 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 offendingor reoffending not solely on the basis of the profiling of natural persons or the assessmentof personality traits and characteristics or the past criminal behaviour of natural persons orgroups, 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 forthe 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 afactor of inequality, or exclusion. The impact of the use of AI tools on the defence rights ofsuspects 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.

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(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 theactions of the competent public authorities. The accuracy, non-discriminatory nature andtransparency of the AI systems used in those contexts are therefore particularly importantto guarantee respect for the fundamental rights of the affected persons, in particular theirrights 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 andresidence permits and associated complaints with regard to the objective to establish theeligibility 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 bordercontrol management, with the exception of verification of travel documents.

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AI systems in the area of migration, asylum and border control management covered bythis Regulation should comply with the relevant procedural requirements set by theRegulation (EC) No 810/2009 of the European Parliament and of the Council32, theDirective 2013/32/EU of the European Parliament and of the Council33, 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 theprinciple of non-refoulement, or to deny safe and effective legal avenues into the territoryof the Union, including the right to international protection.

32

33

Regulation (EC) No 810/2009 of the European Parliament and of the Councilof 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243,15.9.2009, p. 1).
Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 oncommon procedures for granting and withdrawing international protection (OJ L 180,
29.6.2013, p. 60).

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(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 thelaw and in applying the law to a concrete set of facts. AI systems intended to be used byalternative dispute resolution bodies for those purposes should also be considered to behigh-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 ofjudges or judicial independence, but should not replace it: the final decision-making mustremain 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.

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(62)

Without prejudice to the rules provided for in Regulation (EU) 2024/… of the European
Parliament and of the Council34+, and in order to address the risks of undue externalinterference 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 theoutcome of an election or referendum or the voting behaviour of natural persons in theexercise 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.

(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 actsof Union law or under national law compatible with Union law, such as on the protectionof personal data, on the use of polygraphs and similar tools or other systems to detect theemotional state of natural persons. Any such use should continue to occur solely inaccordance with the applicable requirements resulting from the Charter and from theapplicable 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.

34+

Regulation (EU) 2024/… of the European parliament and of the Council of … on thetransparency and targeting of political advertising (OJ L, …, ELI: …).
OJ: please, insert in the text the number of the Regulation in PE 90/23 (2021/0381(COD))
and complete the corresponding footnote.

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(64)

To mitigate the risks from high-risk AI systems placed on the market or put into service
and to ensure a high level of trustworthiness, certain mandatory requirements should apply
to high-risk AI systems, taking into account the intended purpose and the context of use of
the AI system and according to the risk-management system to be established by theprovider. The measures adopted by the providers to comply with the mandatory
requirements of this Regulation should take into account the generally acknowledged stateof the art on AI, be proportionate and effective to meet the objectives of this Regulation.
Based on the New Legislative Framework, as clarified in Commission notice ‘The “Blue
Guide” on the implementation of EU product rules 2022’, the general rule is that more than
one legal act of Union harmonisation legislation may be applicable to one product, since
the making available or putting into service can take place only when the product complies
with all applicable Union harmonisation legislation. The hazards of AI systems covered by
the requirements of this Regulation concern different aspects than the existing Union
harmonisation legislation and therefore the requirements of this Regulation would
complement the existing body of the Union harmonisation legislation. For example,
machinery or medical devices products incorporating an AI system might present risks notaddressed by the essential health and safety requirements set out in the relevant Union
harmonised legislation, as that sectoral law does not deal with risks specific to AI systems.

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This calls for a simultaneous and complementary application of the various legislative acts.
To ensure consistency and to avoid an unnecessary administrative burden and unnecessary
costs, providers of a product that contains one or more high-risk AI system, to which therequirements of this Regulation and of the Union harmonisation legislation based on the
New Legislative Framework and listed in an annex to this Regulation apply, should haveflexibility with regard to operational decisions on how to ensure compliance of a productthat contains one or more AI systems with all the applicable requirements of that Union
harmonised legislation in an optimal manner. That flexibility could mean, for example adecision by the provider to integrate a part of the necessary testing and reporting processes,
information and documentation required under this Regulation into already existing
documentation and procedures required under existing Union harmonisation legislation
based on the New Legislative Framework and listed in an annex to this Regulation. Thisshould not, in any way, undermine the obligation of the provider to comply with all theapplicable requirements.

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(65)

The risk-management system should consist of a continuous, iterative process that isplanned and run throughout the entire lifecycle of a high-risk AI system. That process
should be aimed at identifying and mitigating the relevant risks of AI systems on health,safety and fundamental rights. The risk-management system should be regularly reviewed
and updated to ensure its continuing effectiveness, as well as justification anddocumentation of any significant decisions and actions taken subject to this Regulation.
This process should ensure that the provider identifies risks or adverse impacts andimplements mitigation measures for the known and reasonably foreseeable risks of AI
systems to the health, safety and fundamental rights in light of their intended purpose andreasonably foreseeable misuse, including the possible risks arising from the interaction
between the AI system and the environment within which it operates. The
risk-management system should adopt the most appropriate risk-management measures inlight of the state of the art in AI. When identifying the most appropriate risk-management
measures, the provider should document and explain the choices made and, when relevant,involve experts and external stakeholders. In identifying the reasonably foreseeable misuseof high-risk AI systems, the provider should cover uses of AI systems which, while notdirectly covered by the intended purpose and provided for in the instruction for use may
nevertheless be reasonably expected to result from readily predictable human behaviour inthe context of the specific characteristics and use of a particular AI system. Any known orforeseeable circumstances related to the use of the high-risk AI system in accordance with
its intended purpose or under conditions of reasonably foreseeable misuse, which may leadto risks to the health and safety or fundamental rights should be included in the instructions
for use that are provided by the provider. This is to ensure that the deployer is aware andtakes them into account when using the high-risk AI system. Identifying and implementing
risk mitigation measures for foreseeable misuse under this Regulation should not require
specific additional training for the high-risk AI system by the provider to address
foreseeable misuse. The providers however are encouraged to consider such additional
training measures to mitigate reasonable foreseeable misuses as necessary and appropriate.

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(66)

Requirements should apply to high-risk AI systems as regards risk management, thequality and relevance of data sets used, technical documentation and record-keeping,transparency and the provision of information to deployers, human oversight, androbustness, accuracy and cybersecurity. Those requirements are necessary to effectively
mitigate the risks for health, safety and fundamental rights. As no other less trade
restrictive measures are reasonably available those requirements are not unjustified
restrictions to trade.

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(67)

High-quality data and access to high-quality data plays a vital role in providing structure
and in ensuring the performance of many AI systems, especially when techniques
involving the training of models are used, with a view to ensure that the high-risk AI
system performs as intended and safely and it does not become a source of discriminationprohibited by Union law. High-quality data sets for training, validation and testing require
the implementation of appropriate data governance and management practices. Data sets
for training, validation and testing, including the labels, should be relevant, sufficiently
representative, and to the best extent possible free of errors and complete in view of theintended purpose of the system. In order to facilitate compliance with Union dataprotection law, such as Regulation (EU) 2016/679, data governance and management
practices should include, in the case of personal data, transparency about the original
purpose of the data collection. The data sets should also have the appropriate statisticalproperties, including as regards the persons or groups of persons in relation to whom thehigh-risk AI system is intended to be used, with specific attention to the mitigation of
possible biases in the data sets, that are likely to affect the health and safety of persons,have a negative impact on fundamental rights or lead to discrimination prohibited under
Union law, especially where data outputs influence inputs for future operations (feedback
loops). Biases can for example be inherent in underlying data sets, especially when
historical data is being used, or generated when the systems are implemented in real world
settings.

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Results provided by AI systems could be influenced by such inherent biases that are
inclined to gradually increase and thereby perpetuate and amplify existing discrimination,in particular for persons belonging to certain vulnerable groups, including racial or ethnic
groups. The requirement for the data sets to be to the best extent possible complete andfree of errors should not affect the use of privacy-preserving techniques in the context ofthe development and testing of AI systems. In particular, data sets should take into
account, to the extent required by their intended purpose, the features, characteristics orelements that are particular to the specific geographical, contextual, behavioural orfunctional setting which the AI system is intended to be used. The requirements related todata governance can be complied with by having recourse to third parties that offer
certified compliance services including verification of data governance, data set integrity,and data training, validation and testing practices, as far as compliance with the datarequirements of this Regulation are ensured.

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(68)

For the development and assessment of high-risk AI systems, certain actors, such asproviders, notified bodies and other relevant entities, such as European Digital Innovation
Hubs, testing experimentation facilities and researchers, should be able to access and use
high-quality data sets within the fields of activities of those actors which are related to thisRegulation. European common data spaces established by the Commission and thefacilitation of data sharing between businesses and with government in the public interest
will be instrumental to provide trustful, accountable and non-discriminatory access tohigh-quality data for the training, validation and testing of AI systems. For example, in
health, the European health data space will facilitate non-discriminatory access to healthdata and the training of AI algorithms on those data sets, in a privacy-preserving, secure,timely, transparent and trustworthy manner, and with an appropriate institutional
governance. Relevant competent authorities, including sectoral ones, providing or
supporting the access to data may also support the provision of high-quality data for the
training, validation and testing of AI systems.

(69)

The right to privacy and to protection of personal data must be guaranteed throughout theentire lifecycle of the AI system. In this regard, the principles of data minimisation anddata protection by design and by default, as set out in Union data protection law, areapplicable when personal data are processed. Measures taken by providers to ensurecompliance with those principles may include not only anonymisation and encryption, butalso the use of technology that permits algorithms to be brought to the data and allows
training of AI systems without the transmission between parties or copying of the raw or
structured data themselves, without prejudice to the requirements on data governanceprovided for in this Regulation.

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(70)

In order to protect the right of others from the discrimination that might result from thebias in AI systems, the providers should, exceptionally, to the extent that it is strictly
necessary for the purpose of ensuring bias detection and correction in relation to thehigh-risk AI systems, subject to appropriate safeguards for the fundamental rights andfreedoms of natural persons and following the application of all applicable conditions laid
down under this Regulation in addition to the conditions laid down in Regulations(EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, be able to process also
special categories of personal data, as a matter of substantial public interest within themeaning of Article 9(2), point (g) of Regulation (EU) 2016/679 and Article 10(2), point (g)of Regulation (EU) 2018/1725.

(71)

Having comprehensible information on how high-risk AI systems have been developed
and how they perform throughout their lifetime is essential to enable traceability of thosesystems, verify compliance with the requirements under this Regulation, as well as
monitoring of their operations and post market monitoring. This requires keeping records
and the availability of technical documentation, containing information which is necessary
to assess the compliance of the AI system with the relevant requirements and facilitate post
market monitoring. Such information should include the general characteristics,
capabilities and limitations of the system, algorithms, data, training, testing and validation
processes used as well as documentation on the relevant risk-management system anddrawn in a clear and comprehensive form. The technical documentation should be kept up
to date, appropriately throughout the lifetime of the AI system. Furthermore, high-risk AI
systems should technically allow for the automatic recording of events, by means of logs,
over the duration of the lifetime of the system.

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(72)

To address concerns related to opacity and complexity of certain AI systems and help
deployers to fulfil their obligations under this Regulation, transparency should be requiredfor high-risk AI systems before they are placed on the market or put it into service.
High-risk AI systems should be designed in a manner to enable deployers to understandhow the AI system works, evaluate its functionality, and comprehend its strengths andlimitations. High-risk AI systems should be accompanied by appropriate information in theform of instructions of use. Such information should include the characteristics,
capabilities and limitations of performance of the AI system. Those would cover
information on possible known and foreseeable circumstances related to the use of thehigh-risk AI system, including deployer action that may influence system behaviour andperformance, under which the AI system can lead to risks to health, safety, andfundamental rights, on the changes that have been pre-determined and assessed forconformity by the provider and on the relevant human oversight measures, including themeasures to facilitate the interpretation of the outputs of the AI system by the deployers.
Transparency, including the accompanying instructions for use, should assist deployers in
the use of the system and support informed decision making by them. Deployers should,
inter alia, be in a better position to make the correct choice of the system that they intend touse in light of the obligations applicable to them, be educated about the intended andprecluded uses, and use the AI system correctly and as appropriate. In order to enhance
legibility and accessibility of the information included in the instructions of use, whereappropriate, illustrative examples, for instance on the limitations and on the intended andprecluded uses of the AI system, should be included. Providers should ensure that all
documentation, including the instructions for use, contains meaningful, comprehensive,
accessible and understandable information, taking into account the needs and foreseeableknowledge of the target deployers. Instructions for use should be made available in alanguage which can be easily understood by target deployers, as determined by theMember State concerned.

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(73)

High-risk AI systems should be designed and developed in such a way that natural persons
can oversee their functioning, ensure that they are used as intended and that their impacts
are addressed over the system’s lifecycle. To that end, appropriate human oversightmeasures should be identified by the provider of the system before its placing on themarket or putting into service. In particular, where appropriate, such measures should
guarantee that the system is subject to in-built operational constraints that cannot be
overridden by the system itself and is responsive to the human operator, and that thenatural persons to whom human oversight has been assigned have the necessarycompetence, training and authority to carry out that role. It is also essential, as appropriate,
to ensure that high-risk AI systems include mechanisms to guide and inform a natural
person to whom human oversight has been assigned to make informed decisions if, whenand how to intervene in order to avoid negative consequences or risks, or stop the system if
it does not perform as intended. Considering the significant consequences for persons in
the case of an incorrect match by certain biometric identification systems, it is appropriate
to provide for an enhanced human oversight requirement for those systems so that noaction or decision may be taken by the deployer on the basis of the identification resulting
from the system unless this has been separately verified and confirmed by at least twonatural persons. Those persons could be from one or more entities and include the person
operating or using the system. This requirement should not pose unnecessary burden ordelays and it could be sufficient that the separate verifications by the different persons areautomatically recorded in the logs generated by the system. Given the specificities of theareas of law enforcement, migration, border control and asylum, this requirement should
not apply where Union or national law considers the application of that requirement to bedisproportionate.

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(74)

High-risk AI systems should perform consistently throughout their lifecycle and meet anappropriate level of accuracy, robustness and cybersecurity, in light of their intended
purpose and in accordance with the generally acknowledged state of the art. The
Commission and relevant organisations and stakeholders are encouraged to take due
consideration of the mitigation of risks and the negative impacts of the AI system. The
expected level of performance metrics should be declared in the accompanying instructionsof use. Providers are urged to communicate that information to deployers in a clear andeasily understandable way, free of misunderstandings or misleading statements. Union law
on legal metrology, including Directives 2014/31/EU35 and 2014/32/EU36 of the European
Parliament and of the Council, aims to ensure the accuracy of measurements and to help
the transparency and fairness of commercial transactions. In that context, in cooperation
with relevant stakeholders and organisation, such as metrology and benchmarking
authorities, the Commission should encourage, as appropriate, the development ofbenchmarks and measurement methodologies for AI systems. In doing so, the Commission
should take note and collaborate with international partners working on metrology andrelevant measurement indicators relating to AI.

35

36

Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014
on the harmonisation of the laws of the Member States relating to the making available on
the market of non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107).
Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014
on the harmonisation of the laws of the Member States relating to the making available on
the market of measuring instruments (OJ L 096 29.3.2014, p. 149).

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(75)

Technical robustness is a key requirement for high-risk AI systems. They should beresilient in relation to harmful or otherwise undesirable behaviour that may result fromlimitations within the systems or the environment in which the systems operate (e.g. errors,
faults, inconsistencies, unexpected situations). Therefore, technical and organisational
measures should be taken to ensure robustness of high-risk AI systems, for example bydesigning and developing appropriate technical solutions to prevent or minimize harmful
or otherwise undesirable behaviour. Those technical solution may include for instancemechanisms enabling the system to safely interrupt its operation (fail-safe plans) in thepresence of certain anomalies or when operation takes place outside certain predeterminedboundaries. Failure to protect against these risks could lead to safety impacts or negatively
affect the fundamental rights, for example due to erroneous decisions or wrong or biased
outputs generated by the AI system.

(76)

Cybersecurity plays a crucial role in ensuring that AI systems are resilient against attempts
to alter their use, behaviour, performance or compromise their security properties bymalicious third parties exploiting the system’s vulnerabilities. Cyberattacks against AI
systems can leverage AI specific assets, such as training data sets (e.g. data poisoning) ortrained models (e.g. adversarial attacks or membership inference), or exploit vulnerabilities
in the AI system’s digital assets or the underlying ICT infrastructure. To ensure a level ofcybersecurity appropriate to the risks, suitable measures, such as security controls, should
therefore be taken by the providers of high-risk AI systems, also taking into account as
appropriate the underlying ICT infrastructure.

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(77)

Without prejudice to the requirements related to robustness and accuracy set out in thisRegulation, high-risk AI systems which fall within the scope of a regulation of theEuropean Parliament and of the Council on horizontal cybersecurity requirements for
products with digital elements, in accordance with that regulation may demonstratecompliance with the cybersecurity requirements of this Regulation by fulfilling theessential cybersecurity requirements set out in that regulation. When high-risk AI systems
fulfil the essential requirements of a regulation of the European Parliament and of theCouncil on horizontal cybersecurity requirements for products with digital elements, theyshould be deemed compliant with the cybersecurity requirements set out in this Regulation
in so far as the achievement of those requirements is demonstrated in the EU declaration ofconformity or parts thereof issued under that regulation. To that end, the assessment of thecybersecurity risks, associated to a product with digital elements classified as high-risk AI
system according to this Regulation, carried out under a regulation of the European
Parliament and of the Council on horizontal cybersecurity requirements for products withdigital elements, should consider risks to the cyber resilience of an AI system as regards
attempts by unauthorised third parties to alter its use, behaviour or performance, including
AI specific vulnerabilities such as data poisoning or adversarial attacks, as well as, as
relevant, risks to fundamental rights as required by this Regulation.

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(78)

The conformity assessment procedure provided by this Regulation should apply in relation
to the essential cybersecurity requirements of a product with digital elements covered by aregulation of the European Parliament and of the Council on horizontal cybersecurity
requirements for products with digital elements and classified as a high-risk AI system
under this Regulation. However, this rule should not result in reducing the necessary levelof assurance for critical products with digital elements covered by a regulation of theEuropean Parliament and of the Council on horizontal cybersecurity requirements for
products with digital elements. Therefore, by way of derogation from this rule, high-risk
AI systems that fall within the scope of this Regulation and are also qualified as importantand critical products with digital elements pursuant to a regulation of the European
Parliament and of the Council on horizontal cybersecurity requirements for products withdigital elements and to which the conformity assessment procedure based on internal
control set out in an annex to this Regulation applies, are subject to the conformity
assessment provisions of a regulation of the European Parliament and of the Council on
horizontal cybersecurity requirements for products with digital elements insofar as theessential cybersecurity requirements of that regulation are concerned. In this case, for all
the other aspects covered by this Regulation the respective provisions on conformity
assessment based on internal control set out in an annex to this Regulation should apply.
Building on the knowledge and expertise of ENISA on the cybersecurity policy and tasks
assigned to ENISA under the Regulation (EU) 2019/881 of the European Parliament and of
the Council37, the Commission should cooperate with ENISA on issues related tocybersecurity of AI systems.

37

Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019
on ENISA (the European Union Agency for Cybersecurity) and on information andcommunications technology cybersecurity certification and repealing Regulation(EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 15).

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(79)

It is appropriate that a specific natural or legal person, defined as the provider, takes
responsibility for the placing on the market or the putting into service of a high-risk AI
system, regardless of whether that natural or legal person is the person who designed ordeveloped the system.

(80)

As signatories to the United Nations Convention on the Rights of Persons with Disabilities,
the Union and the Member States are legally obliged to protect persons with disabilities
from discrimination and promote their equality, to ensure that persons with disabilities
have access, on an equal basis with others, to information and communications
technologies and systems, and to ensure respect for privacy for persons with disabilities.
Given the growing importance and use of AI systems, the application of universal designprinciples to all new technologies and services should ensure full and equal access foreveryone potentially affected by or using AI technologies, including persons withdisabilities, in a way that takes full account of their inherent dignity and diversity. It istherefore essential that providers ensure full compliance with accessibility requirements,
including Directive (EU) 2016/2102 of the European Parliament and of the Council38 andDirective (EU) 2019/882. Providers should ensure compliance with these requirements bydesign. Therefore, the necessary measures should be integrated as much as possible into
the design of the high-risk AI system.

38

Directive (EU) 2016/2102 of the European Parliament and of the Councilof 26 October 2016 on the accessibility of the websites and mobile applications of public
sector bodies (OJ L 327, 2.12.2016, p. 1).

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(81)

The provider should establish a sound quality management system, ensure theaccomplishment of the required conformity assessment procedure, draw up the relevant
documentation and establish a robust post-market monitoring system. Providers ofhigh-risk AI systems that are subject to obligations regarding quality management systems
under relevant sectoral Union law should have the possibility to include the elements of thequality management system provided for in this Regulation as part of the existing quality
management system provided for in that other sectoral Union law. The complementarity
between this Regulation and existing sectoral Union law should also be taken into accountin future standardisation activities or guidance adopted by the Commission. Publicauthorities which put into service high-risk AI systems for their own use may adopt andimplement the rules for the quality management system as part of the quality management
system adopted at a national or regional level, as appropriate, taking into account the
specificities of the sector and the competences and organisation of the public authority
concerned.

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(82)

To enable enforcement of this Regulation and create a level-playing field for operators,
and, taking into account the different forms of making available of digital products, it isimportant to ensure that, under all circumstances, a person established in the Union can
provide authorities with all the necessary information on the compliance of an AI system.
Therefore, prior to making their AI systems available in the Union, providers established inthird countries should, by written mandate, appoint an authorised representative establishedin the Union. This authorised representative plays a pivotal role in ensuring the complianceof the high-risk AI systems placed on the market or put into service in the Union by those
providers who are not established in the Union and in serving as their contact person
established in the Union.

(83)

In light of the nature and complexity of the value chain for AI systems and in line with the
New Legislative Framework, it is essential to ensure legal certainty and facilitate thecompliance with this Regulation. Therefore, it is necessary to clarify the role and thespecific obligations of relevant operators along that value chain, such as importers anddistributors who may contribute to the development of AI systems. In certain situations
those operators could act in more than one role at the same time and should therefore fulfil
cumulatively all relevant obligations associated with those roles. For example, an operator
could act as a distributor and an importer at the same time.

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(84)

To ensure legal certainty, it is necessary to clarify that, under certain specific conditions,any distributor, importer, deployer or other third-party should be considered to be aprovider of a high-risk AI system and therefore assume all the relevant obligations. This
would be the case if that party puts its name or trademark on a high-risk AI system alreadyplaced on the market or put into service, without prejudice to contractual arrangements
stipulating that the obligations are allocated otherwise. This would also be the case if thatparty makes a substantial modification to a high-risk AI system that has already beenplaced on the market or has already been put into service in a way that it remains ahigh-risk AI system in accordance with this Regulation, or if it modifies the intended
purpose of an AI system, including a general-purpose AI system, which has not beenclassified as high-risk and has already been placed on the market or put into service, in a
way that the AI system becomes a high-risk AI system in accordance with this Regulation.
Those provisions should apply without prejudice to more specific provisions established incertain Union harmonisation legislation based on the New Legislative Framework, together
with which this Regulation should apply. For example, Article 16(2) of Regulation(EU) 2017/745, establishing that certain changes should not be considered to bemodifications of a device that could affect its compliance with the applicable requirements,
should continue to apply to high-risk AI systems that are medical devices within themeaning of that Regulation.

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(85)

General-purpose AI systems may be used as high-risk AI systems by themselves or becomponents of other high-risk AI systems. Therefore, due to their particular nature and inorder to ensure a fair sharing of responsibilities along the AI value chain, the providers ofsuch systems should, irrespective of whether they may be used as high-risk AI systems as
such by other providers or as components of high-risk AI systems and unless provided
otherwise under this Regulation, closely cooperate with the providers of the relevant
high-risk AI systems to enable their compliance with the relevant obligations under thisRegulation and with the competent authorities established under this Regulation.

(86)

Where, under the conditions laid down in this Regulation, the provider that initially placed
the AI system on the market or put it into service should no longer be considered to be theprovider for the purposes of this Regulation, and when that provider has not expressly
excluded the change of the AI system into a high-risk AI system, the former provider
should nonetheless closely cooperate and make available the necessary information andprovide the reasonably expected technical access and other assistance that are required forthe fulfilment of the obligations set out in this Regulation, in particular regarding thecompliance with the conformity assessment of high-risk AI systems.

(87)

In addition, where a high-risk AI system that is a safety component of a product whichfalls within the scope of Union harmonisation legislation based on the New Legislative
Framework is not placed on the market or put into service independently from the product,
the product manufacturer defined in that legislation should comply with the obligations of
the provider established in this Regulation and should, in particular, ensure that the AI
system embedded in the final product complies with the requirements of this Regulation.

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(88)

Along the AI value chain multiple parties often supply AI systems, tools and services but
also components or processes that are incorporated by the provider into the AI system withvarious objectives, including the model training, model retraining, model testing andevaluation, integration into software, or other aspects of model development. Those parties
have an important role to play in the value chain towards the provider of the high-risk AI
system into which their AI systems, tools, services, components or processes areintegrated, and should provide by written agreement this provider with the necessary
information, capabilities, technical access and other assistance based on the generally
acknowledged state of the art, in order to enable the provider to fully comply with the
obligations set out in this Regulation, without compromising their own intellectual
property rights or trade secrets.

(89)

Third parties making accessible to the public tools, services, processes, or AI components
other than general-purpose AI models, should not be mandated to comply withrequirements targeting the responsibilities along the AI value chain, in particular towards
the provider that has used or integrated them, when those tools, services, processes, or AI
components are made accessible under a free and open-source licence. Developers of free
and open-source tools, services, processes, or AI components other than general-purpose
AI models should be encouraged to implement widely adopted documentation practices,such as model cards and data sheets, as a way to accelerate information sharing along the
AI value chain, allowing the promotion of trustworthy AI systems in the Union.

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(90)

The Commission could develop and recommend voluntary model contractual terms
between providers of high-risk AI systems and third parties that supply tools, services,components or processes that are used or integrated in high-risk AI systems, to facilitate
the cooperation along the value chain. When developing voluntary model contractual
terms, the Commission should also take into account possible contractual requirements
applicable in specific sectors or business cases.

(91)

Given the nature of AI systems and the risks to safety and fundamental rights possibly
associated with their use, including as regards the need to ensure proper monitoring of theperformance of an AI system in a real-life setting, it is appropriate to set specificresponsibilities for deployers. Deployers should in particular take appropriate technical andorganisational measures to ensure they use high-risk AI systems in accordance with the
instructions of use and certain other obligations should be provided for with regard tomonitoring of the functioning of the AI systems and with regard to record-keeping, as
appropriate. Furthermore, deployers should ensure that the persons assigned to implement
the instructions for use and human oversight as set out in this Regulation have thenecessary competence, in particular an adequate level of AI literacy, training and authority
to properly fulfil those tasks. Those obligations should be without prejudice to other
deployer obligations in relation to high-risk AI systems under Union or national law.

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(92)

This Regulation is without prejudice to obligations for employers to inform or to informand consult workers or their representatives under Union or national law and practice,including Directive 2002/14/EC of the European Parliament and of the Council39, on
decisions to put into service or use AI systems. It remains necessary to ensure informationof workers and their representatives on the planned deployment of high-risk AI systems at
the workplace where the conditions for those information or information and consultation
obligations in other legal instruments are not fulfilled. Moreover, such information right isancillary and necessary to the objective of protecting fundamental rights that underlies thisRegulation. Therefore, an information requirement to that effect should be laid down inthis Regulation, without affecting any existing rights of workers.

39

Directive 2002/14/EC of the European Parliament and of the Council of 11 March 2002
establishing a general framework for informing and consulting employees in the European
Community (OJ L 80, 23.3.2002, p. 29).

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(93)

Whilst risks related to AI systems can result from the way such systems are designed, risks
can as well stem from how such AI systems are used. Deployers of high-risk AI system
therefore play a critical role in ensuring that fundamental rights are protected,
complementing the obligations of the provider when developing the AI system. Deployers
are best placed to understand how the high-risk AI system will be used concretely and cantherefore identify potential significant risks that were not foreseen in the development
phase, due to a more precise knowledge of the context of use, the persons or groups of
persons likely to be affected, including vulnerable groups. Deployers of high-risk AI
systems listed in an annex to this Regulation also play a critical role in informing natural
persons and should, when they make decisions or assist in making decisions related tonatural persons, where applicable, inform the natural persons that they are subject to theuse of the high-risk AI system. This information should include the intended purpose andthe type of decisions it makes. The deployer should also inform the natural persons about
their right to an explanation provided under this Regulation. With regard to high-risk AI
systems used for law enforcement purposes, that obligation should be implemented inaccordance with Article 13 of Directive (EU) 2016/680.

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(94)

Any processing of biometric data involved in the use of AI systems for biometricidentification for the purpose of law enforcement needs to comply with Article 10 of
Directive (EU) 2016/680, that allows such processing only where strictly necessary,
subject to appropriate safeguards for the rights and freedoms of the data subject, and where
authorised by Union or Member State law. Such use, when authorised, also needs torespect the principles laid down in Article 4 (1) of Directive (EU) 2016/680 including
lawfulness, fairness and transparency, purpose limitation, accuracy and storage limitation.

(95)

Without prejudice to applicable Union law, in particular Regulation (EU) 2016/679 and
Directive (EU) 2016/680, considering the intrusive nature of post-remote biometricidentification systems, the use of post-remote biometric identification systems should be
subject to safeguards. Post-remote biometric identification systems should always be used
in a way that is proportionate, legitimate and strictly necessary, and thus targeted, in termsof the individuals to be identified, the location, temporal scope and based on a closed data
set of legally acquired video footage. In any case, post-remote biometric identification
systems should not be used in the framework of law enforcement to lead to indiscriminate
surveillance. The conditions for post-remote biometric identification should in any case notprovide a basis to circumvent the conditions of the prohibition and strict exceptions for realtime remote biometric identification.

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(96)

In order to efficiently ensure that fundamental rights are protected, deployers of high-risk
AI systems that are bodies governed by public law, or private entities providing public
services and deployers of certain high-risk AI systems listed in an annex to this Regulation,such as banking or insurance entities, should carry out a fundamental rights impact
assessment prior to putting it into use. Services important for individuals that are of public
nature may also be provided by private entities. Private entities providing such public
services are linked to tasks in the public interest such as in the areas of education,
healthcare, social services, housing, administration of justice. The aim of the fundamental
rights impact assessment is for the deployer to identify the specific risks to the rights ofindividuals or groups of individuals likely to be affected, identify measures to be taken in
the case of a materialisation of those risks. The impact assessment should be performed
prior to deploying the high-risk AI system, and should be updated when the deployer
considers that any of the relevant factors have changed. The impact assessment should
identify the deployer’s relevant processes in which the high-risk AI system will be used inline with its intended purpose, and should include a description of the period of time andfrequency in which the system is intended to be used as well as of specific categories ofnatural persons and groups who are likely to be affected in the specific context of use.

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The assessment should also include the identification of specific risks of harm likely tohave an impact on the fundamental rights of those persons or groups. While performing
this assessment, the deployer should take into account information relevant to a proper
assessment of the impact, including but not limited to the information given by theprovider of the high-risk AI system in the instructions for use. In light of the risks
identified, deployers should determine measures to be taken in the case of a materialisationof those risks, including for example governance arrangements in that specific context ofuse, such as arrangements for human oversight according to the instructions of use or,complaint handling and redress procedures, as they could be instrumental in mitigating
risks to fundamental rights in concrete use-cases. After performing that impact assessment,
the deployer should notify the relevant market surveillance authority. Where appropriate,
to collect relevant information necessary to perform the impact assessment, deployers ofhigh-risk AI system, in particular when AI systems are used in the public sector, could
involve relevant stakeholders, including the representatives of groups of persons likely tobe affected by the AI system, independent experts, and civil society organisations in
conducting such impact assessments and designing measures to be taken in the case ofmaterialisation of the risks. The European Artificial Intelligence Office (AI Office) should
develop a template for a questionnaire in order to facilitate compliance and reduce theadministrative burden for deployers.

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(97)

The notion of general-purpose AI models should be clearly defined and set apart from thenotion of AI systems to enable legal certainty. The definition should be based on the key
functional characteristics of a general-purpose AI model, in particular the generality andthe capability to competently perform a wide range of distinct tasks. These models are
typically trained on large amounts of data, through various methods, such as
self-supervised, unsupervised or reinforcement learning. General-purpose AI models may
be placed on the market in various ways, including through libraries, application
programming interfaces (APIs), as direct download, or as physical copy. These models
may be further modified or fine-tuned into new models. Although AI models are essential
components of AI systems, they do not constitute AI systems on their own. AI models
require the addition of further components, such as for example a user interface, to become
AI systems. AI models are typically integrated into and form part of AI systems. This
Regulation provides specific rules for general-purpose AI models and for general-purpose
AI models that pose systemic risks, which should apply also when these models areintegrated or form part of an AI system. It should be understood that the obligations for theproviders of general-purpose AI models should apply once the general-purpose AI models
are placed on the market.

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When the provider of a general-purpose AI model integrates an own model into its own AI
system that is made available on the market or put into service, that model should beconsidered to be placed on the market and, therefore, the obligations in this Regulation formodels should continue to apply in addition to those for AI systems. The obligations laid
down for models should in any case not apply when an own model is used for purelyinternal processes that are not essential for providing a product or a service to third parties
and the rights of natural persons are not affected. Considering their potential significantly
negative effects, the general-purpose AI models with systemic risk should always be
subject to the relevant obligations under this Regulation. The definition should not cover
AI models used before their placing on the market for the sole purpose of research,development and prototyping activities. This is without prejudice to the obligation tocomply with this Regulation when, following such activities, a model is placed on themarket.
(98)

Whereas the generality of a model could, inter alia, also be determined by a number ofparameters, models with at least a billion of parameters and trained with a large amount ofdata using self-supervision at scale should be considered to display significant generality
and to competently perform a wide range of distinctive tasks.

(99)

Large generative AI models are a typical example for a general-purpose AI model, giventhat they allow for flexible generation of content, such as in the form of text, audio, images
or video, that can readily accommodate a wide range of distinctive tasks.

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(100)

When a general-purpose AI model is integrated into or forms part of an AI system, thissystem should be considered to be general-purpose AI system when, due to thisintegration, this system has the capability to serve a variety of purposes. A general-purpose
AI system can be used directly, or it may be integrated into other AI systems.

(101)

Providers of general-purpose AI models have a particular role and responsibility along the
AI value chain, as the models they provide may form the basis for a range of downstream
systems, often provided by downstream providers that necessitate a good understanding of
the models and their capabilities, both to enable the integration of such models into theirproducts, and to fulfil their obligations under this or other regulations. Therefore,
proportionate transparency measures should be laid down, including the drawing up andkeeping up to date of documentation, and the provision of information on thegeneral-purpose AI model for its usage by the downstream providers. Technicaldocumentation should be prepared and kept up to date by the general-purpose AI model
provider for the purpose of making it available, upon request, to the AI Office and thenational competent authorities. The minimal set of elements to be included in such
documentation should be set out in specific annexes to this Regulation. The Commission
should be empowered to amend those annexes by means of delegated acts in light ofevolving technological developments.

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Software and data, including models, released under a free and open-source licence thatallows them to be openly shared and where users can freely access, use, modify andredistribute them or modified versions thereof, can contribute to research and innovation in
the market and can provide significant growth opportunities for the Union economy.
General-purpose AI models released under free and open-source licences should beconsidered to ensure high levels of transparency and openness if their parameters,
including the weights, the information on the model architecture, and the information onmodel usage are made publicly available. The licence should be considered to be free andopen-source also when it allows users to run, copy, distribute, study, change and improve
software and data, including models under the condition that the original provider of themodel is credited, the identical or comparable terms of distribution are respected.

(103)

Free and open-source AI components covers the software and data, including models andgeneral-purpose AI models, tools, services or processes of an AI system. Free andopen-source AI components can be provided through different channels, including theirdevelopment on open repositories. For the purposes of this Regulation, AI components thatare provided against a price or otherwise monetised, including through the provision oftechnical support or other services, including through a software platform, related to the AI
component, or the use of personal data for reasons other than exclusively for improving thesecurity, compatibility or interoperability of the software, with the exception oftransactions between microenterprises, should not benefit from the exceptions provided tofree and open-source AI components. The fact of making AI components available throughopen repositories should not, in itself, constitute a monetisation.

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EN(104)The providers of general-purpose AI models that are released under a free and open-source
licence, and whose parameters, including the weights, the information on the modelarchitecture, and the information on model usage, are made publicly available should be
subject to exceptions as regards the transparency-related requirements imposed on
general-purpose AI models, unless they can be considered to present a systemic risk, inwhich case the circumstance that the model is transparent and accompanied by an
open-source license should not be considered to be a sufficient reason to exclude
compliance with the obligations under this Regulation. In any case, given that the releaseof general-purpose AI models under free and open-source licence does not necessarily
reveal substantial information on the data set used for the training or fine-tuning of themodel and on how compliance of copyright law was thereby ensured, the exception
provided for general-purpose AI models from compliance with the transparency-related
requirements should not concern the obligation to produce a summary about the content
used for model training and the obligation to put in place a policy to comply with Union
copyright law, in particular to identify and comply with the reservation of rights pursuant
to Article 4(3) of Directive (EU) 2019/790 of the European Parliament and of theCouncil40.

40

Directive (EU) 2019/790 of the European Parliament and of the Council of 17 April 2019 on
copyright and related rights in the Digital Single Market and amending Directives 96/9/EC
and 2001/29/EC (OJ L 130, 17.5.2019, p. 92).

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(105)

General-purpose AI models, in particular large generative AI models, capable ofgenerating text, images, and other content, present unique innovation opportunities but also
challenges to artists, authors, and other creators and the way their creative content iscreated, distributed, used and consumed. The development and training of such models
require access to vast amounts of text, images, videos, and other data. Text and data
mining techniques may be used extensively in this context for the retrieval and analysis ofsuch content, which may be protected by copyright and related rights. Any use of copyrightprotected content requires the authorisation of the rightsholder concerned unless relevant
copyright exceptions and limitations apply. Directive (EU) 2019/790 introduced exceptions
and limitations allowing reproductions and extractions of works or other subject matter, forthe purpose of text and data mining, under certain conditions. Under these rules,
rightsholders may choose to reserve their rights over their works or other subject matter toprevent text and data mining, unless this is done for the purposes of scientific research.
Where the rights to opt out has been expressly reserved in an appropriate manner,providers of general-purpose AI models need to obtain an authorisation from rightsholders
if they want to carry out text and data mining over such works.

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(106)

Providers that place general-purpose AI models on the Union market should ensurecompliance with the relevant obligations in this Regulation. To that end, providers ofgeneral-purpose AI models should put in place a policy to comply with Union law on
copyright and related rights, in particular to identify and comply with the reservation ofrights expressed by rightsholders pursuant to Article 4(3) of Directive (EU) 2019/790. Any
provider placing a general-purpose AI model on the Union market should comply with thisobligation, regardless of the jurisdiction in which the copyright-relevant acts underpinning
the training of those general-purpose AI models take place. This is necessary to ensure alevel playing field among providers of general-purpose AI models where no provider
should be able to gain a competitive advantage in the Union market by applying lower
copyright standards than those provided in the Union.

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EN(107)In order to increase transparency on the data that is used in the pre-training and training ofgeneral-purpose AI models, including text and data protected by copyright law, it isadequate that providers of such models draw up and make publicly available a sufficiently
detailed summary of the content used for training the general-purpose AI model. While
taking into due account the need to protect trade secrets and confidential businessinformation, this summary should be generally comprehensive in its scope instead oftechnically detailed to facilitate parties with legitimate interests, including copyrightholders, to exercise and enforce their rights under Union law, for example by listing themain data collections or sets that went into training the model, such as large private or
public databases or data archives, and by providing a narrative explanation about other data
sources used. It is appropriate for the AI Office to provide a template for the summary,which should be simple, effective, and allow the provider to provide the required summaryin narrative form.

(108)

With regard to the obligations imposed on providers of general-purpose AI models to put
in place a policy to comply with Union copyright law and make publicly available asummary of the content used for the training, the AI Office should monitor whether theprovider has fulfilled those obligations without verifying or proceeding to a work-by-workassessment of the training data in terms of copyright compliance. This Regulation does notaffect the enforcement of copyright rules as provided for under Union law.

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(109)

Compliance with the obligations applicable to the providers of general-purpose AI models
should be commensurate and proportionate to the type of model provider, excluding theneed for compliance for persons who develop or use models for non-professional orscientific research purposes, who should nevertheless be encouraged to voluntarily comply
with these requirements. Without prejudice to Union copyright law, compliance with thoseobligations should take due account of the size of the provider and allow simplified waysof compliance for SMEs, including start-ups, that should not represent an excessive costand not discourage the use of such models. In the case of a modification or fine-tuning of amodel, the obligations for providers of general-purpose AI models should be limited to thatmodification or fine-tuning, for example by complementing the already existing technicaldocumentation with information on the modifications, including new training data sources,
as a means to comply with the value chain obligations provided in this Regulation.

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(110)

General-purpose AI models could pose systemic risks which include, but are not limited to,any actual or reasonably foreseeable negative effects in relation to major accidents,
disruptions of critical sectors and serious consequences to public health and safety; any
actual or reasonably foreseeable negative effects on democratic processes, public andeconomic security; the dissemination of illegal, false, or discriminatory content. Systemicrisks should be understood to increase with model capabilities and model reach, can arise
along the entire lifecycle of the model, and are influenced by conditions of misuse, model
reliability, model fairness and model security, the level of autonomy of the model, its
access to tools, novel or combined modalities, release and distribution strategies, thepotential to remove guardrails and other factors. In particular, international approaches
have so far identified the need to pay attention to risks from potential intentional misuse orunintended issues of control relating to alignment with human intent; chemical, biological,
radiological, and nuclear risks, such as the ways in which barriers to entry can be lowered,including for weapons development, design acquisition, or use; offensive cybercapabilities, such as the ways in vulnerability discovery, exploitation, or operational use
can be enabled; the effects of interaction and tool use, including for example the capacity
to control physical systems and interfere with critical infrastructure; risks from models of
making copies of themselves or ‘self-replicating’ or training other models; the ways inwhich models can give rise to harmful bias and discrimination with risks to individuals,
communities or societies; the facilitation of disinformation or harming privacy with threats
to democratic values and human rights; risk that a particular event could lead to a chain
reaction with considerable negative effects that could affect up to an entire city, an entire
domain activity or an entire community.

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(111)

It is appropriate to establish a methodology for the classification of general-purpose AI
models as general-purpose AI model with systemic risks. Since systemic risks result fromparticularly high capabilities, a general-purpose AI model should be considered to present
systemic risks if it has high-impact capabilities, evaluated on the basis of appropriatetechnical tools and methodologies, or significant impact on the internal market due to its
reach. High-impact capabilities in general-purpose AI models means capabilities thatmatch or exceed the capabilities recorded in the most advanced general-purpose AI
models. The full range of capabilities in a model could be better understood after its
placing on the market or when deployers interact with the model. According to the state of
the art at the time of entry into force of this Regulation, the cumulative amount ofcomputation used for the training of the general-purpose AI model measured in floating
point operations is one of the relevant approximations for model capabilities. The
cumulative amount of computation used for training includes the computation used acrossthe activities and methods that are intended to enhance the capabilities of the model prior
to deployment, such as pre-training, synthetic data generation and fine-tuning. Therefore,
an initial threshold of floating point operations should be set, which, if met by ageneral-purpose AI model, leads to a presumption that the model is a general-purpose AI
model with systemic risks. This threshold should be adjusted over time to reflect
technological and industrial changes, such as algorithmic improvements or increased
hardware efficiency, and should be supplemented with benchmarks and indicators formodel capability.

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To inform this, the AI Office should engage with the scientific community, industry, civilsociety and other experts. Thresholds, as well as tools and benchmarks for the assessmentof high-impact capabilities, should be strong predictors of generality, its capabilities andassociated systemic risk of general-purpose AI models, and could take into account theway the model will be placed on the market or the number of users it may affect. To
complement this system, there should be a possibility for the Commission to takeindividual decisions designating a general-purpose AI model as a general-purpose AI
model with systemic risk if it is found that such model has capabilities or an impact
equivalent to those captured by the set threshold. That decision should be taken on thebasis of an overall assessment of the criteria for the designation of a general-purpose AI
model with systemic risk set out in an annex to this Regulation, such as quality or size ofthe training data set, number of business and end users, its input and output modalities, its
level of autonomy and scalability, or the tools it has access to. Upon a reasoned request of
a provider whose model has been designated as a general-purpose AI model with systemic
risk, the Commission should take the request into account and may decide to reassess
whether the general-purpose AI model can still be considered to present systemic risks.

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EN(112)

It is also necessary to clarify a procedure for the classification of a general-purpose AI
model with systemic risks. A general-purpose AI model that meets the applicable thresholdfor high-impact capabilities should be presumed to be a general-purpose AI models withsystemic risk. The provider should notify the AI Office at the latest two weeks after therequirements are met or it becomes known that a general-purpose AI model will meet therequirements that lead to the presumption. This is especially relevant in relation to thethreshold of floating point operations because training of general-purpose AI models takes
considerable planning which includes the upfront allocation of compute resources and,
therefore, providers of general-purpose AI models are able to know if their model would
meet the threshold before the training is completed. In the context of that notification, theprovider should be able to demonstrate that, because of its specific characteristics, ageneral-purpose AI model exceptionally does not present systemic risks, and that it thus
should not be classified as a general-purpose AI model with systemic risks. That
information is valuable for the AI Office to anticipate the placing on the market ofgeneral-purpose AI models with systemic risks and the providers can start to engage with
the AI Office early on. That information is especially important with regard togeneral-purpose AI models that are planned to be released as open-source, given that, after
the open-source model release, necessary measures to ensure compliance with the
obligations under this Regulation may be more difficult to implement.

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(113)

If the Commission becomes aware of the fact that a general-purpose AI model meets therequirements to classify as a general-purpose AI model with systemic risk, which
previously had either not been known or of which the relevant provider has failed to notify
the Commission, the Commission should be empowered to designate it so. A system of
qualified alerts should ensure that the AI Office is made aware by the scientific panel ofgeneral-purpose AI models that should possibly be classified as general-purpose AI models
with systemic risk, in addition to the monitoring activities of the AI Office.

(114)

The providers of general-purpose AI models presenting systemic risks should be subject, in
addition to the obligations provided for providers of general-purpose AI models, toobligations aimed at identifying and mitigating those risks and ensuring an adequate levelof cybersecurity protection, regardless of whether it is provided as a standalone model orembedded in an AI system or a product. To achieve those objectives, this Regulation
should require providers to perform the necessary model evaluations, in particular prior toits first placing on the market, including conducting and documenting adversarial testing ofmodels, also, as appropriate, through internal or independent external testing. In addition,
providers of general-purpose AI models with systemic risks should continuously assess
and mitigate systemic risks, including for example by putting in place risk-management
policies, such as accountability and governance processes, implementing post-market
monitoring, taking appropriate measures along the entire model’s lifecycle and cooperatingwith relevant actors along the AI value chain.

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(115)

Providers of general-purpose AI models with systemic risks should assess and mitigate
possible systemic risks. If, despite efforts to identify and prevent risks related to a
general-purpose AI model that may present systemic risks, the development or use of themodel causes a serious incident, the general-purpose AI model provider should without
undue delay keep track of the incident and report any relevant information and possible
corrective measures to the Commission and national competent authorities. Furthermore,
providers should ensure an adequate level of cybersecurity protection for the model and its
physical infrastructure, if appropriate, along the entire model lifecycle. Cybersecurity
protection related to systemic risks associated with malicious use or attacks should duly
consider accidental model leakage, unauthorised releases, circumvention of safetymeasures, and defence against cyberattacks, unauthorised access or model theft. That
protection could be facilitated by securing model weights, algorithms, servers, and data
sets, such as through operational security measures for information security, specificcybersecurity policies, adequate technical and established solutions, and cyber and physicalaccess controls, appropriate to the relevant circumstances and the risks involved.

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(116)The AI Office should encourage and facilitate the drawing up, review and adaptation ofcodes of practice, taking into account international approaches. All providers ofgeneral-purpose AI models could be invited to participate. To ensure that the codes ofpractice reflect the state of the art and duly take into account a diverse set of perspectives,
the AI Office should collaborate with relevant national competent authorities, and could,
where appropriate, consult with civil society organisations and other relevant stakeholders
and experts, including the Scientific Panel, for the drawing up of such codes. Codes ofpractice should cover obligations for providers of general-purpose AI models and ofgeneral-purpose AI models presenting systemic risks. In addition, as regards systemicrisks, codes of practice should help to establish a risk taxonomy of the type and nature of
the systemic risks at Union level, including their sources. Codes of practice should also be
focused on specific risk assessment and mitigation measures.

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(117)

The codes of practice should represent a central tool for the proper compliance with the
obligations provided for under this Regulation for providers of general-purpose AI models.
Providers should be able to rely on codes of practice to demonstrate compliance with the
obligations. By means of implementing acts, the Commission may decide to approve a
code of practice and give it a general validity within the Union, or, alternatively, to provide
common rules for the implementation of the relevant obligations, if, by the time thisRegulation becomes applicable, a code of practice cannot be finalised or is not deemed
adequate by the AI Office. Once a harmonised standard is published and assessed as
suitable to cover the relevant obligations by the AI Office, compliance with a European
harmonised standard should grant providers the presumption of conformity. Providers ofgeneral-purpose AI models should furthermore be able to demonstrate compliance using
alternative adequate means, if codes of practice or harmonised standards are not available,or they choose not to rely on those.

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(118)

This Regulation regulates AI systems and AI models by imposing certain requirements andobligations for relevant market actors that are placing them on the market, putting into
service or use in the Union, thereby complementing obligations for providers ofintermediary services that embed such systems or models into their services regulated byRegulation (EU) 2022/2065. To the extent that such systems or models are embedded into
designated very large online platforms or very large online search engines, they are subject
to the risk-management framework provided for in Regulation (EU) 2022/2065.
Consequently, the corresponding obligations of this Regulation should be presumed to be
fulfilled, unless significant systemic risks not covered by Regulation (EU) 2022/2065
emerge and are identified in such models. Within this framework, providers of very large
online platforms and very large online search engines are obliged to assess potential
systemic risks stemming from the design, functioning and use of their services, including
how the design of algorithmic systems used in the service may contribute to such risks, aswell as systemic risks stemming from potential misuses. Those providers are also obliged
to take appropriate mitigating measures in observance of fundamental rights.

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(119)

Considering the quick pace of innovation and the technological evolution of digital
services in scope of different instruments of Union law in particular having in mind theusage and the perception of their recipients, the AI systems subject to this Regulation may
be provided as intermediary services or parts thereof within the meaning of Regulation(EU) 2022/2065, which should be interpreted in a technology-neutral manner. For
example, AI systems may be used to provide online search engines, in particular, to theextent that an AI system such as an online chatbot performs searches of, in principle, allwebsites, then incorporates the results into its existing knowledge and uses the updated
knowledge to generate a single output that combines different sources of information.

(120)

Furthermore, obligations placed on providers and deployers of certain AI systems in thisRegulation to enable the detection and disclosure that the outputs of those systems are
artificially generated or manipulated are particularly relevant to facilitate the effective
implementation of Regulation (EU) 2022/2065. This applies in particular as regards theobligations of providers of very large online platforms or very large online search engines
to identify and mitigate systemic risks that may arise from the dissemination of content thathas been artificially generated or manipulated, in particular risk of the actual or foreseeable
negative effects on democratic processes, civic discourse and electoral processes, including
through disinformation.

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(121)

Standardisation should play a key role to provide technical solutions to providers to ensurecompliance with this Regulation, in line with the state of the art, to promote innovation as
well as competitiveness and growth in the single market. Compliance with harmonised
standards as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012 of theEuropean Parliament and of the Council41, which are normally expected to reflect the stateof the art, should be a means for providers to demonstrate conformity with therequirements of this Regulation. A balanced representation of interests involving all
relevant stakeholders in the development of standards, in particular SMEs, consumer
organisations and environmental and social stakeholders in accordance with Articles 5
and 6 of Regulation (EU) No 1025/2012 should therefore be encouraged. In order tofacilitate compliance, the standardisation requests should be issued by the Commission
without undue delay. When preparing the standardisation request, the Commission should
consult the advisory forum and the Board in order to collect relevant expertise. However,in the absence of relevant references to harmonised standards, the Commission should be
able to establish, via implementing acts, and after consultation of the advisory forum,
common specifications for certain requirements under this Regulation.

41

Regulation (EU) No 1025/2012 of the European Parliament and of the Councilof 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC
and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of
the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of
the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).

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The common specification should be an exceptional fall back solution to facilitate theprovider’s obligation to comply with the requirements of this Regulation, when thestandardisation request has not been accepted by any of the European standardisation
organisations, or when the relevant harmonised standards insufficiently address
fundamental rights concerns, or when the harmonised standards do not comply with therequest, or when there are delays in the adoption of an appropriate harmonised standard.
Where such a delay in the adoption of a harmonised standard is due to the technicalcomplexity of that standard, this should be considered by the Commission before
contemplating the establishment of common specifications. When developing common
specifications, the Commission is encouraged to cooperate with international partners andinternational standardisation bodies.

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(122)

It is appropriate that, without prejudice to the use of harmonised standards and common
specifications, providers of a high-risk AI system that has been trained and tested on data
reflecting the specific geographical, behavioural, contextual or functional setting within
which the AI system is intended to be used, should be presumed to comply with therelevant measure provided for under the requirement on data governance set out in thisRegulation. Without prejudice to the requirements related to robustness and accuracy set
out in this Regulation, in accordance with Article 54(3) of Regulation (EU) 2019/881,
high-risk AI systems that have been certified or for which a statement of conformity has
been issued under a cybersecurity scheme pursuant to that Regulation and the references ofwhich have been published in the Official Journal of the European Union should bepresumed to comply with the cybersecurity requirement of this Regulation in so far as thecybersecurity certificate or statement of conformity or parts thereof cover the cybersecurity
requirement of this Regulation. This remains without prejudice to the voluntary nature ofthat cybersecurity scheme.

(123)

In order to ensure a high level of trustworthiness of high-risk AI systems, those systems
should be subject to a conformity assessment prior to their placing on the market or putting
into service.

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EN(124)

It is appropriate that, in order to minimise the burden on operators and avoid any possible
duplication, for high-risk AI systems related to products which are covered by existing
Union harmonisation legislation based on the New Legislative Framework, the complianceof those AI systems with the requirements of this Regulation should be assessed as part ofthe conformity assessment already provided for in that law. The applicability of therequirements of this Regulation should thus not affect the specific logic, methodology or
general structure of conformity assessment under the relevant Union harmonisation
legislation.

(125)

Given the complexity of high-risk AI systems and the risks that are associated with them, it
is important to develop an adequate conformity assessment procedure for high-risk AI
systems involving notified bodies, so-called third party conformity assessment. However,given the current experience of professional pre-market certifiers in the field of productsafety and the different nature of risks involved, it is appropriate to limit, at least in an
initial phase of application of this Regulation, the scope of application of third-party
conformity assessment for high-risk AI systems other than those related to products.
Therefore, the conformity assessment of such systems should be carried out as a generalrule by the provider under its own responsibility, with the only exception of AI systems
intended to be used for biometrics.

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(126)In order to carry out third-party conformity assessments when so required, notified bodies
should be notified under this Regulation by the national competent authorities, provided
that they comply with a set of requirements, in particular on independence, competence,
absence of conflicts of interests and suitable cybersecurity requirements. Notification of
those bodies should be sent by national competent authorities to the Commission and theother Member States by means of the electronic notification tool developed and managed
by the Commission pursuant to Article R23 of Annex I to Decision No 768/2008/EC.

(127)

In line with Union commitments under the World Trade Organization Agreement on
Technical Barriers to Trade, it is adequate to facilitate the mutual recognition ofconformity assessment results produced by competent conformity assessment bodies,
independent of the territory in which they are established, provided that those conformity
assessment bodies established under the law of a third country meet the applicablerequirements of this Regulation and the Union has concluded an agreement to that extent.
In this context, the Commission should actively explore possible international instruments
for that purpose and in particular pursue the conclusion of mutual recognition agreementswith third countries.

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(128)

In line with the commonly established notion of substantial modification for products
regulated by Union harmonisation legislation, it is appropriate that whenever a change
occurs which may affect the compliance of a high-risk AI system with this Regulation(e.g. change of operating system or software architecture), or when the intended purpose of
the system changes, that AI system should be considered to be a new AI system whichshould undergo a new conformity assessment. However, changes occurring to thealgorithm and the performance of AI systems which continue to ‘learn’ after being placedon the market or put into service, namely automatically adapting how functions are carriedout, should not constitute a substantial modification, provided that those changes have been
pre-determined by the provider and assessed at the moment of the conformity assessment.

(129)

High-risk AI systems should bear the CE marking to indicate their conformity with thisRegulation so that they can move freely within the internal market. For high-risk AI
systems embedded in a product, a physical CE marking should be affixed, and may becomplemented by a digital CE marking. For high-risk AI systems only provided digitally, a
digital CE marking should be used. Member States should not create unjustified obstacles
to the placing on the market or the putting into service of high-risk AI systems that comply
with the requirements laid down in this Regulation and bear the CE marking.

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(130)

Under certain conditions, rapid availability of innovative technologies may be crucial for
health and safety of persons, the protection of the environment and climate change and forsociety as a whole. It is thus appropriate that under exceptional reasons of public security
or protection of life and health of natural persons, environmental protection and theprotection of key industrial and infrastructural assets, market surveillance authorities could
authorise the placing on the market or the putting into service of AI systems which havenot undergone a conformity assessment. In duly justified situations, as provided for in thisRegulation, law enforcement authorities or civil protection authorities may put a specifichigh-risk AI system into service without the authorisation of the market surveillanceauthority, provided that such authorisation is requested during or after the use without
undue delay.

(131)

In order to facilitate the work of the Commission and the Member States in the AI field aswell as to increase the transparency towards the public, providers of high-risk AI systems
other than those related to products falling within the scope of relevant existing Union
harmonisation legislation, as well as providers who consider that an AI system listed in thehigh-risk use cases in an annex to this Regulation is not high-risk on the basis of aderogation, should be required to register themselves and information about their AI
system in an EU database, to be established and managed by the Commission. Before
using an AI system listed in the high-risk use cases in an annex to this Regulation,
deployers of high-risk AI systems that are public authorities, agencies or bodies, should
register themselves in such database and select the system that they envisage to use.

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Other deployers should be entitled to do so voluntarily. This section of the EU databaseshould be publicly accessible, free of charge, the information should be easily navigable,
understandable and machine-readable. The EU database should also be user-friendly, forexample by providing search functionalities, including through keywords, allowing thegeneral public to find relevant information to be submitted upon the registration ofhigh-risk AI systems and on the use case of high-risk AI systems, set out in an annex tothis Regulation, to which the high-risk AI systems correspond. Any substantial
modification of high-risk AI systems should also be registered in the EU database. For
high-risk AI systems in the area of law enforcement, migration, asylum and border control
management, the registration obligations should be fulfilled in a secure non-public sectionof the EU database. Access to the secure non-public section should be strictly limited to theCommission as well as to market surveillance authorities with regard to their national
section of that database. High-risk AI systems in the area of critical infrastructure should
only be registered at national level. The Commission should be the controller of the EU
database, in accordance with Regulation (EU) 2018/1725. In order to ensure the fullfunctionality of the EU database, when deployed, the procedure for setting the databaseshould include the development of functional specifications by the Commission and an
independent audit report. The Commission should take into account cybersecurity risks
when carrying out its tasks as data controller on the EU database. In order to maximise theavailability and use of the EU database by the public, the EU database, including theinformation made available through it, should comply with requirements under the
Directive (EU) 2019/882.

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EN(132)

Certain AI systems intended to interact with natural persons or to generate content may
pose specific risks of impersonation or deception irrespective of whether they qualify as
high-risk or not. In certain circumstances, the use of these systems should therefore be
subject to specific transparency obligations without prejudice to the requirements andobligations for high-risk AI systems and subject to targeted exceptions to take into accountthe special need of law enforcement. In particular, natural persons should be notified thatthey are interacting with an AI system, unless this is obvious from the point of view of anatural person who is reasonably well-informed, observant and circumspect taking into
account the circumstances and the context of use. When implementing that obligation, thecharacteristics of natural persons belonging to vulnerable groups due to their age ordisability should be taken into account to the extent the AI system is intended to interact
with those groups as well. Moreover, natural persons should be notified when they are
exposed to AI systems that, by processing their biometric data, can identify or infer theemotions or intentions of those persons or assign them to specific categories. Such specificcategories can relate to aspects such as sex, age, hair colour, eye colour, tattoos, personal
traits, ethnic origin, personal preferences and interests. Such information and notifications
should be provided in accessible formats for persons with disabilities.

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(133)

A variety of AI systems can generate large quantities of synthetic content that becomesincreasingly hard for humans to distinguish from human-generated and authentic content.
The wide availability and increasing capabilities of those systems have a significant impact
on the integrity and trust in the information ecosystem, raising new risks of misinformationand manipulation at scale, fraud, impersonation and consumer deception. In light of those
impacts, the fast technological pace and the need for new methods and techniques to trace
origin of information, it is appropriate to require providers of those systems to embed
technical solutions that enable marking in a machine readable format and detection that theoutput has been generated or manipulated by an AI system and not a human. Suchtechniques and methods should be sufficiently reliable, interoperable, effective and robust
as far as this is technically feasible, taking into account available techniques or a
combination of such techniques, such as watermarks, metadata identifications,
cryptographic methods for proving provenance and authenticity of content, logging
methods, fingerprints or other techniques, as may be appropriate. When implementing thisobligation, providers should also take into account the specificities and the limitations of
the different types of content and the relevant technological and market developments inthe field, as reflected in the generally acknowledged state of the art. Such techniques andmethods can be implemented at the level of the AI system or at the level of the AI model,
including general-purpose AI models generating content, thereby facilitating fulfilment of
this obligation by the downstream provider of the AI system. To remain proportionate, it isappropriate to envisage that this marking obligation should not cover AI systems
performing primarily an assistive function for standard editing or AI systems notsubstantially altering the input data provided by the deployer or the semantics thereof.

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(134)

Further to the technical solutions employed by the providers of the AI system, deployers
who use an AI system to generate or manipulate image, audio or video content that
appreciably resembles existing persons, objects, places, entities or events and would falsely
appear to a person to be authentic or truthful (deep fakes), should also clearly anddistinguishably disclose that the content has been artificially created or manipulated bylabelling the AI output accordingly and disclosing its artificial origin. Compliance with thistransparency obligation should not be interpreted as indicating that the use of the AI
system or its output impedes the right to freedom of expression and the right to freedom of
the arts and sciences guaranteed in the Charter, in particular where the content is part of anevidently creative, satirical, artistic, fictional or analogous work or programme, subject toappropriate safeguards for the rights and freedoms of third parties. In those cases, thetransparency obligation for deep fakes set out in this Regulation is limited to disclosure of
the existence of such generated or manipulated content in an appropriate manner that does
not hamper the display or enjoyment of the work, including its normal exploitation anduse, while maintaining the utility and quality of the work. In addition, it is also appropriate
to envisage a similar disclosure obligation in relation to AI-generated or manipulated text
to the extent it is published with the purpose of informing the public on matters of public
interest unless the AI-generated content has undergone a process of human review or
editorial control and a natural or legal person holds editorial responsibility for the
publication of the content.

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(135)

Without prejudice to the mandatory nature and full applicability of the transparency
obligations, the Commission may also encourage and facilitate the drawing up of codes ofpractice at Union level to facilitate the effective implementation of the obligations
regarding the detection and labelling of artificially generated or manipulated content,
including to support practical arrangements for making, as appropriate, the detection
mechanisms accessible and facilitating cooperation with other actors along the value chain,disseminating content or checking its authenticity and provenance to enable the public toeffectively distinguish AI-generated content.

(136)

The obligations placed on providers and deployers of certain AI systems in this Regulation
to enable the detection and disclosure that the outputs of those systems are artificiallygenerated or manipulated are particularly relevant to facilitate the effective implementationof Regulation (EU) 2022/2065. This applies in particular as regards the obligations ofproviders of very large online platforms or very large online search engines to identify andmitigate systemic risks that may arise from the dissemination of content that has been
artificially generated or manipulated, in particular the risk of the actual or foreseeable
negative effects on democratic processes, civic discourse and electoral processes, including
through disinformation. The requirement to label content generated by AI systems under
this Regulation is without prejudice to the obligation in Article 16(6) of Regulation(EU) 2022/2065 for providers of hosting services to process notices on illegal content
received pursuant to Article 16(1) of that Regulation and should not influence theassessment and the decision on the illegality of the specific content. That assessment
should be performed solely with reference to the rules governing the legality of thecontent.

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(137)

Compliance with the transparency obligations for the AI systems covered by thisRegulation should not be interpreted as indicating that the use of the AI system or its
output is lawful under this Regulation or other Union and Member State law and should be
without prejudice to other transparency obligations for deployers of AI systems laid downin Union or national law.

(138)

AI is a rapidly developing family of technologies that requires regulatory oversight and asafe and controlled space for experimentation, while ensuring responsible innovation andintegration of appropriate safeguards and risk mitigation measures. To ensure a legal
framework that promotes innovation, is future-proof and resilient to disruption,
Member States should ensure that their national competent authorities establish at least one
AI regulatory sandbox at national level to facilitate the development and testing ofinnovative AI systems under strict regulatory oversight before these systems are placed on
the market or otherwise put into service. Member States could also fulfil this obligation
through participating in already existing regulatory sandboxes or establishing jointly asandbox with one or more Member States’ competent authorities, insofar as thisparticipation provides equivalent level of national coverage for the participating
Member States. AI regulatory sandboxes could be established in physical, digital or hybrid
form and may accommodate physical as well as digital products. Establishing authorities
should also ensure that the AI regulatory sandboxes have the adequate resources for theirfunctioning, including financial and human resources.

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EN(139)The objectives of the AI regulatory sandboxes should be to foster AI innovation by
establishing a controlled experimentation and testing environment in the development andpre-marketing phase with a view to ensuring compliance of the innovative AI systems withthis Regulation and other relevant Union and national law. Moreover, the AI regulatory
sandboxes should aim to enhance legal certainty for innovators and the competentauthorities’ oversight and understanding of the opportunities, emerging risks and theimpacts of AI use, to facilitate regulatory learning for authorities and undertakings,
including with a view to future adaptions of the legal framework, to support cooperationand the sharing of best practices with the authorities involved in the AI regulatory sandbox,
and to accelerate access to markets, including by removing barriers for SMEs, including
start-ups. AI regulatory sandboxes should be widely available throughout the Union, andparticular attention should be given to their accessibility for SMEs, including start-ups. The
participation in the AI regulatory sandbox should focus on issues that raise legal
uncertainty for providers and prospective providers to innovate, experiment with AI in theUnion and contribute to evidence-based regulatory learning. The supervision of the AI
systems in the AI regulatory sandbox should therefore cover their development, training,
testing and validation before the systems are placed on the market or put into service, as
well as the notion and occurrence of substantial modification that may require a new
conformity assessment procedure. Any significant risks identified during the development
and testing of such AI systems should result in adequate mitigation and, failing that, in thesuspension of the development and testing process.

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Where appropriate, national competent authorities establishing AI regulatory sandboxes
should cooperate with other relevant authorities, including those supervising the protectionof fundamental rights, and could allow for the involvement of other actors within the AI
ecosystem such as national or European standardisation organisations, notified bodies,
testing and experimentation facilities, research and experimentation labs, European Digital
Innovation Hubs and relevant stakeholder and civil society organisations. To ensure
uniform implementation across the Union and economies of scale, it is appropriate toestablish common rules for the AI regulatory sandboxes’ implementation and a framework
for cooperation between the relevant authorities involved in the supervision of thesandboxes. AI regulatory sandboxes established under this Regulation should be without
prejudice to other law allowing for the establishment of other sandboxes aiming to ensurecompliance with law other than this Regulation. Where appropriate, relevant competentauthorities in charge of those other regulatory sandboxes should consider the benefits ofusing those sandboxes also for the purpose of ensuring compliance of AI systems with thisRegulation. Upon agreement between the national competent authorities and theparticipants in the AI regulatory sandbox, testing in real world conditions may also be
operated and supervised in the framework of the AI regulatory sandbox.

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(140)

This Regulation should provide the legal basis for the providers and prospective providers
in the AI regulatory sandbox to use personal data collected for other purposes fordeveloping certain AI systems in the public interest within the AI regulatory sandbox, only
under specified conditions, in accordance with Article 6(4) and Article 9(2), point (g), ofRegulation (EU) 2016/679, and Articles 5, 6 and 10 of Regulation (EU) 2018/1725, andwithout prejudice to Article 4(2) and Article 10 of Directive (EU) 2016/680. All otherobligations of data controllers and rights of data subjects under Regulations (EU) 2016/679
and (EU) 2018/1725 and Directive (EU) 2016/680 remain applicable. In particular, thisRegulation should not provide a legal basis in the meaning of Article 22(2), point (b) ofRegulation (EU) 2016/679 and Article 24(2), point (b) of Regulation (EU) 2018/1725.
Providers and prospective providers in the AI regulatory sandbox should ensure
appropriate safeguards and cooperate with the competent authorities, including byfollowing their guidance and acting expeditiously and in good faith to adequately mitigate
any identified significant risks to safety, health, and fundamental rights that may arise
during the development, testing and experimentation in that sandbox.

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(141)In order to accelerate the process of development and the placing on the market of thehigh-risk AI systems listed in an annex to this Regulation, it is important that providers orprospective providers of such systems may also benefit from a specific regime for testing
those systems in real world conditions, without participating in an AI regulatory sandbox.
However, in such cases, taking into account the possible consequences of such testing on
individuals, it should be ensured that appropriate and sufficient guarantees and conditions
are introduced by this Regulation for providers or prospective providers. Such guarantees
should include, inter alia, requesting informed consent of natural persons to participate in
testing in real world conditions, with the exception of law enforcement where the seekingof informed consent would prevent the AI system from being tested. Consent of subjects toparticipate in such testing under this Regulation is distinct from, and without prejudice to,consent of data subjects for the processing of their personal data under the relevant dataprotection law.

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It is also important to minimise the risks and enable oversight by competent authorities andtherefore require prospective providers to have a real-world testing plan submitted tocompetent market surveillance authority, register the testing in dedicated sections in the
EU database subject to some limited exceptions, set limitations on the period for which thetesting can be done and require additional safeguards for persons belonging to certain
vulnerable groups, as well as a written agreement defining the roles and responsibilities ofprospective providers and deployers and effective oversight by competent personnel
involved in the real world testing. Furthermore, it is appropriate to envisage additionalsafeguards to ensure that the predictions, recommendations or decisions of the AI system
can be effectively reversed and disregarded and that personal data is protected and isdeleted when the subjects have withdrawn their consent to participate in the testing without
prejudice to their rights as data subjects under the Union data protection law. As regards
transfer of data, it is also appropriate to envisage that data collected and processed for the
purpose of testing in real-world conditions should be transferred to third countries only
where appropriate and applicable safeguards under Union law are implemented, inparticular in accordance with bases for transfer of personal data under Union law on dataprotection, while for non-personal data appropriate safeguards are put in place inaccordance with Union law, such as Regulations (EU) 2022/86842 and (EU) 2023/285443of
the European Parliament and of the Council.

42

43Regulation (EU) 2022/868 of the European Parliament and of the Council of 30 May 2022
on European data governance and amending Regulation (EU) 2018/1724 (Data GovernanceAct) (OJ L 152, 3.6.2022, p. 1).
Regulation (EU) 2023/2854 of the European Parliament and of the Councilof 13 December 2023 on harmonised rules on fair access to and use of data and amending
Regulation (EU) 2017/2394 and Directive (EU) 2020/1828 (Data Act) (OJ L, 2023/2854,
22.12.2023, ELI: http://data.europa.eu/eli/reg/2023/2854/oj).

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EN(142)

To ensure that AI leads to socially and environmentally beneficial outcomes,
Member States are encouraged to support and promote research and development of AI
solutions in support of socially and environmentally beneficial outcomes, such as AI-based
solutions to increase accessibility for persons with disabilities, tackle socio-economic
inequalities, or meet environmental targets, by allocating sufficient resources, including
public and Union funding, and, where appropriate and provided that the eligibility andselection criteria are fulfilled, considering in particular projects which pursue suchobjectives. Such projects should be based on the principle of interdisciplinary cooperation
between AI developers, experts on inequality and non-discrimination, accessibility,
consumer, environmental, and digital rights, as well as academics.

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EN(143)In order to promote and protect innovation, it is important that the interests of SMEs,
including start-ups, that are providers or deployers of AI systems are taken into particular
account. To that end, Member States should develop initiatives, which are targeted at those
operators, including on awareness raising and information communication. Member Statesshould provide SMEs, including start-ups, that have a registered office or a branch in theUnion, with priority access to the AI regulatory sandboxes provided that they fulfil theeligibility conditions and selection criteria and without precluding other providers andprospective providers to access the sandboxes provided the same conditions and criteria are
fulfilled. Member States should utilise existing channels and where appropriate, establish
new dedicated channels for communication with SMEs, including start-ups, deployers,other innovators and, as appropriate, local public authorities, to support SMEs throughout
their development path by providing guidance and responding to queries about theimplementation of this Regulation. Where appropriate, these channels should work
together to create synergies and ensure homogeneity in their guidance to SMEs, including
start-ups, and deployers. Additionally, Member States should facilitate the participation of
SMEs and other relevant stakeholders in the standardisation development processes.
Moreover, the specific interests and needs of providers that are SMEs, including start-ups,
should be taken into account when notified bodies set conformity assessment fees. The
Commission should regularly assess the certification and compliance costs for SMEs,
including start-ups, through transparent consultations and should work with Member States
to lower such costs.

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For example, translation costs related to mandatory documentation and communication
with authorities may constitute a significant cost for providers and other operators, inparticular those of a smaller scale. Member States should possibly ensure that one of thelanguages determined and accepted by them for relevant providers’ documentation and forcommunication with operators is one which is broadly understood by the largest possible
number of cross-border deployers. In order to address the specific needs of SMEs,
including start-ups, the Commission should provide standardised templates for the areas
covered by this Regulation, upon request of the Board. Additionally, the Commission
should complement Member States’ efforts by providing a single information platform
with easy-to-use information with regards to this Regulation for all providers anddeployers, by organising appropriate communication campaigns to raise awareness about
the obligations arising from this Regulation, and by evaluating and promoting theconvergence of best practices in public procurement procedures in relation to AI systems.
Medium-sized enterprises which until recently qualified as small enterprises within themeaning of the Annex to Commission Recommendation 2003/361/EC44 should haveaccess to those support measures, as those new medium-sized enterprises may sometimes
lack the legal resources and training necessary to ensure proper understanding of, andcompliance with, this Regulation.

44

Commission Recommendation of 6 May 2003 concerning the definition of micro, small andmedium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

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(144)In order to promote and protect innovation, the AI-on-demand platform, all relevant Union
funding programmes and projects, such as Digital Europe Programme, Horizon Europe,
implemented by the Commission and the Member States at Union or national level should,
as appropriate, contribute to the achievement of the objectives of this Regulation.

(145)

In order to minimise the risks to implementation resulting from lack of knowledge andexpertise in the market as well as to facilitate compliance of providers, in particular SMEs,
including start-ups, and notified bodies with their obligations under this Regulation, theAI-on-demand platform, the European Digital Innovation Hubs and the testing andexperimentation facilities established by the Commission and the Member States at Unionor national level should contribute to the implementation of this Regulation. Within theirrespective mission and fields of competence, the AI-on-demand platform, the European
Digital Innovation Hubs and the testing and experimentation Facilities are able to provide
in particular technical and scientific support to providers and notified bodies.

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(146)

Moreover, in light of the very small size of some operators and in order to ensure
proportionality regarding costs of innovation, it is appropriate to allow microenterprises tofulfil one of the most costly obligations, namely to establish a quality management system,in a simplified manner which would reduce the administrative burden and the costs for
those enterprises without affecting the level of protection and the need for compliance withthe requirements for high-risk AI systems. The Commission should develop guidelines tospecify the elements of the quality management system to be fulfilled in this simplified
manner by microenterprises.

(147)

It is appropriate that the Commission facilitates, to the extent possible, access to testingand experimentation facilities to bodies, groups or laboratories established or accredited
pursuant to any relevant Union harmonisation legislation and which fulfil tasks in thecontext of conformity assessment of products or devices covered by that Union
harmonisation legislation. This is, in particular, the case as regards expert panels, expert
laboratories and reference laboratories in the field of medical devices pursuant toRegulations (EU) 2017/745 and (EU) 2017/746.

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EN(148)

This Regulation should establish a governance framework that both allows to coordinate
and support the application of this Regulation at national level, as well as build capabilities
at Union level and integrate stakeholders in the field of AI. The effective implementationand enforcement of this Regulation require a governance framework that allows tocoordinate and build up central expertise at Union level. The AI Office was established byCommission Decision45 and has as its mission to develop Union expertise and capabilities
in the field of AI and to contribute to the implementation of Union law on AI.
Member States should facilitate the tasks of the AI Office with a view to support thedevelopment of Union expertise and capabilities at Union level and to strengthen thefunctioning of the digital single market. Furthermore, a Board composed of representativesof the Member States, a scientific panel to integrate the scientific community and anadvisory forum to contribute stakeholder input to the implementation of this Regulation, atUnion and national level, should be established. The development of Union expertise andcapabilities should also include making use of existing resources and expertise, inparticular through synergies with structures built up in the context of the Union level
enforcement of other law and synergies with related initiatives at Union level, such as the
EuroHPC Joint Undertaking and the AI testing and experimentation facilities under the
Digital Europe Programme.

45

Commission Decision of 24.1.2024 establishing the European Artificial Intelligence OfficeC(2024) 390.

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(149)In order to facilitate a smooth, effective and harmonised implementation of this Regulationa Board should be established. The Board should reflect the various interests of the AI
eco-system and be composed of representatives of the Member States. The Board should
be responsible for a number of advisory tasks, including issuing opinions,recommendations, advice or contributing to guidance on matters related to theimplementation of this Regulation, including on enforcement matters, technicalspecifications or existing standards regarding the requirements established in thisRegulation and providing advice to the Commission and the Member States and theirnational competent authorities on specific questions related to AI. In order to give someflexibility to Member States in the designation of their representatives in the Board, such
representatives may be any persons belonging to public entities who should have therelevant competences and powers to facilitate coordination at national level and contributeto the achievement of the Board’s tasks. The Board should establish two standing
sub-groups to provide a platform for cooperation and exchange among market surveillanceauthorities and notifying authorities on issues related, respectively, to market surveillance
and notified bodies. The standing subgroup for market surveillance should act as theadministrative cooperation group (ADCO) for this Regulation within the meaning of
Article 30 of Regulation (EU) 2019/1020. In accordance with Article 33 of that
Regulation, the Commission should support the activities of the standing subgroup formarket surveillance by undertaking market evaluations or studies, in particular with a viewto identifying aspects of this Regulation requiring specific and urgent coordination amongmarket surveillance authorities. The Board may establish other standing or temporary
sub-groups as appropriate for the purpose of examining specific issues. The Board should
also cooperate, as appropriate, with relevant Union bodies, experts groups and networks
active in the context of relevant Union law, including in particular those active underrelevant Union law on data, digital products and services.

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(150)

With a view to ensuring the involvement of stakeholders in the implementation andapplication of this Regulation, an advisory forum should be established to advise andprovide technical expertise to the Board and the Commission. To ensure a varied andbalanced stakeholder representation between commercial and non-commercial interest and,within the category of commercial interests, with regards to SMEs and other undertakings,
the advisory forum should comprise inter alia industry, start-ups, SMEs, academia, civilsociety, including the social partners, as well as the Fundamental Rights Agency, ENISA,
the European Committee for Standardization (CEN), the European Committee forElectrotechnical Standardization (CENELEC) and the European Telecommunications
Standards Institute (ETSI).

(151)

To support the implementation and enforcement of this Regulation, in particular themonitoring activities of the AI Office as regards general-purpose AI models, a scientificpanel of independent experts should be established. The independent experts constituting
the scientific panel should be selected on the basis of up-to-date scientific or technicalexpertise in the field of AI and should perform their tasks with impartiality, objectivity andensure the confidentiality of information and data obtained in carrying out their tasks andactivities. To allow the reinforcement of national capacities necessary for the effective
enforcement of this Regulation, Member States should be able to request support from thepool of experts constituting the scientific panel for their enforcement activities.

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(152)In order to support adequate enforcement as regards AI systems and reinforce thecapacities of the Member States, Union AI testing support structures should be establishedand made available to the Member States.

(153)

Member States hold a key role in the application and enforcement of this Regulation. In
that respect, each Member State should designate at least one notifying authority and at
least one market surveillance authority as national competent authorities for the purpose of
supervising the application and implementation of this Regulation. Member States may
decide to appoint any kind of public entity to perform the tasks of the national competentauthorities within the meaning of this Regulation, in accordance with their specific nationalorganisational characteristics and needs. In order to increase organisation efficiency on theside of Member States and to set a single point of contact vis-à-vis the public and othercounterparts at Member State and Union levels, each Member State should designate amarket surveillance authority to act as a single point of contact.

(154)

The national competent authorities should exercise their powers independently, impartiallyand without bias, so as to safeguard the principles of objectivity of their activities and tasks
and to ensure the application and implementation of this Regulation. The members of theseauthorities should refrain from any action incompatible with their duties and should be
subject to confidentiality rules under this Regulation.

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EN(155)In order to ensure that providers of high-risk AI systems can take into account theexperience on the use of high-risk AI systems for improving their systems and the designand development process or can take any possible corrective action in a timely manner, allproviders should have a post-market monitoring system in place. Where relevant,post-market monitoring should include an analysis of the interaction with other AI systems
including other devices and software. Post-market monitoring should not cover sensitive
operational data of deployers which are law enforcement authorities. This system is also
key to ensure that the possible risks emerging from AI systems which continue to ‘learn’after being placed on the market or put into service can be more efficiently and timely
addressed. In this context, providers should also be required to have a system in place toreport to the relevant authorities any serious incidents resulting from the use of their AI
systems, meaning incident or malfunctioning leading to death or serious damage to health,serious and irreversible disruption of the management and operation of criticalinfrastructure, infringements of obligations under Union law intended to protect
fundamental rights or serious damage to property or the environment.

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EN(156)In order to ensure an appropriate and effective enforcement of the requirements andobligations set out by this Regulation, which is Union harmonisation legislation, thesystem of market surveillance and compliance of products established by Regulation(EU) 2019/1020 should apply in its entirety. Market surveillance authorities designatedpursuant to this Regulation should have all enforcement powers laid down in thisRegulation and in Regulation (EU) 2019/1020 and should exercise their powers and carryout their duties independently, impartially and without bias. Although the majority of AI
systems are not subject to specific requirements and obligations under this Regulation,market surveillance authorities may take measures in relation to all AI systems when theypresent a risk in accordance with this Regulation. Due to the specific nature of Union
institutions, agencies and bodies falling within the scope of this Regulation, it isappropriate to designate the European Data Protection Supervisor as a competent market
surveillance authority for them. This should be without prejudice to the designation ofnational competent authorities by the Member States. Market surveillance activities should
not affect the ability of the supervised entities to carry out their tasks independently, whensuch independence is required by Union law.

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(157)

This Regulation is without prejudice to the competences, tasks, powers and independenceof relevant national public authorities or bodies which supervise the application of Union
law protecting fundamental rights, including equality bodies and data protection
authorities. Where necessary for their mandate, those national public authorities or bodies
should also have access to any documentation created under this Regulation. A specificsafeguard procedure should be set for ensuring adequate and timely enforcement against
AI systems presenting a risk to health, safety and fundamental rights. The procedure forsuch AI systems presenting a risk should be applied to high-risk AI systems presenting arisk, prohibited systems which have been placed on the market, put into service or used inviolation of the prohibited practices laid down in this Regulation and AI systems whichhave been made available in violation of the transparency requirements laid down in thisRegulation and present a risk.

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(158)

Union financial services law includes internal governance and risk-management rules andrequirements which are applicable to regulated financial institutions in the course ofprovision of those services, including when they make use of AI systems. In order toensure coherent application and enforcement of the obligations under this Regulation andrelevant rules and requirements of the Union financial services legal acts, the competentauthorities for the supervision and enforcement of those legal acts, in particular competentauthorities as defined in Regulation (EU) No 575/2013 of the European Parliament and of
the Council46 and Directives 2008/48/EC47, 2009/138/EC48, 2013/36/EU49, 2014/17/EU50
and (EU) 2016/9751of the European Parliament and of the Council, should be designated,within their respective competences, as competent authorities for the purpose of
supervising the implementation of this Regulation, including for market surveillance
activities, as regards AI systems provided or used by regulated and supervised financial
institutions unless Member States decide to designate another authority to fulfil thesemarket surveillance tasks.

46

47

48

49

50

51

Regulation (EU) No 575/2013 of the European Parliament and of the Councilof 26 June 2013 on prudential requirements for credit institutions and investment firms andamending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1).
Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on
credit agreements for consumers and repealing Council Directive 87/102/EEC (OJ L 133,
22.5.2008, p. 66).
Directive 2009/138/EC of the European Parliament and of the Councilof 25 November 2009 on the taking-up and pursuit of the business of Insurance andReinsurance (Solvency II) (OJ L 335, 17.12.2009, p. 1).
Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 onaccess to the activity of credit institutions and the prudential supervision of credit
institutions and investment firms, amending Directive 2002/87/EC and repealing
Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).
Directive 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on
credit agreements for consumers relating to residential immovable property and amending
Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010 (OJ L 60,
28.2.2014, p. 34).
Directive (EU) 2016/97 of the European Parliament and of the Council of 20 January 2016
on insurance distribution (OJ L 26, 2.2.2016, p. 19).

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Those competent authorities should have all powers under this Regulation and Regulation(EU) 2019/1020 to enforce the requirements and obligations of this Regulation, including
powers to carry our ex post market surveillance activities that can be integrated, as
appropriate, into their existing supervisory mechanisms and procedures under the relevant
Union financial services law. It is appropriate to envisage that, when acting as market
surveillance authorities under this Regulation, the national authorities responsible for thesupervision of credit institutions regulated under Directive 2013/36/EU, which areparticipating in the Single Supervisory Mechanism established by Council Regulation(EU) No 1024/201352, should report, without delay, to the European Central Bank any
information identified in the course of their market surveillance activities that may be ofpotential interest for the European Central Bank’s prudential supervisory tasks as specified
in that Regulation. To further enhance the consistency between this Regulation and therules applicable to credit institutions regulated under Directive 2013/36/EU, it is also
appropriate to integrate some of the providers’ procedural obligations in relation to risk
management, post marketing monitoring and documentation into the existing obligations
and procedures under Directive 2013/36/EU. In order to avoid overlaps, limited
derogations should also be envisaged in relation to the quality management system ofproviders and the monitoring obligation placed on deployers of high-risk AI systems to theextent that these apply to credit institutions regulated by Directive 2013/36/EU. The same
regime should apply to insurance and re-insurance undertakings and insurance holding
companies under Directive 2009/138/EC and the insurance intermediaries under Directive(EU) 2016/97 and other types of financial institutions subject to requirements regarding
internal governance, arrangements or processes established pursuant to the relevant Union
financial services law to ensure consistency and equal treatment in the financial sector.

52

Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on theEuropean Central Bank concerning policies relating to the prudential supervision of credit
institutions (OJ L 287, 29.10.2013, p. 63).

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EN(159)

Each market surveillance authority for high-risk AI systems in the area of biometrics, as
listed in an annex to this Regulation insofar as those systems are used for the purposes oflaw enforcement, migration, asylum and border control management, or the administrationof justice and democratic processes, should have effective investigative and corrective
powers, including at least the power to obtain access to all personal data that are being
processed and to all information necessary for the performance of its tasks. The market
surveillance authorities should be able to exercise their powers by acting with complete
independence. Any limitations of their access to sensitive operational data under thisRegulation should be without prejudice to the powers conferred to them by Directive(EU) 2016/680. No exclusion on disclosing data to national data protection authorities
under this Regulation should affect the current or future powers of those authorities beyond
the scope of this Regulation.

(160)

The market surveillance authorities and the Commission should be able to propose joint
activities, including joint investigations, to be conducted by market surveillance authorities
or market surveillance authorities jointly with the Commission, that have the aim ofpromoting compliance, identifying non-compliance, raising awareness and providing
guidance in relation to this Regulation with respect to specific categories of high-risk AI
systems that are found to present a serious risk across two or more Member States. Joint
activities to promote compliance should be carried out in accordance with Article 9 ofRegulation (EU) 2019/1020. The AI Office should provide coordination support for joint
investigations.

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EN(161)

It is necessary to clarify the responsibilities and competences at Union and national level as
regards AI systems that are built on general-purpose AI models. To avoid overlapping
competences, where an AI system is based on a general-purpose AI model and the modeland system are provided by the same provider, the supervision should take place at Unionlevel through the AI Office, which should have the powers of a market surveillanceauthority within the meaning of Regulation (EU) 2019/1020 for this purpose. In all othercases, national market surveillance authorities remain responsible for the supervision of AI
systems. However, for general-purpose AI systems that can be used directly by deployers
for at least one purpose that is classified as high-risk, market surveillance authorities
should cooperate with the AI Office to carry out evaluations of compliance and inform theBoard and other market surveillance authorities accordingly. Furthermore, market
surveillance authorities should be able to request assistance from the AI Office where themarket surveillance authority is unable to conclude an investigation on a high-risk AI
system because of its inability to access certain information related to the general-purpose
AI model on which the high-risk AI system is built. In such cases, the procedure regarding
mutual assistance in cross-border cases in Chapter VI of Regulation (EU) 2019/1020
should apply mutatis mutandis.

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(162)

To make best use of the centralised Union expertise and synergies at Union level, thepowers of supervision and enforcement of the obligations on providers of general-purpose
AI models should be a competence of the Commission. The AI Office should be able tocarry out all necessary actions to monitor the effective implementation of this Regulation
as regards general-purpose AI models. It should be able to investigate possible
infringements of the rules on providers of general-purpose AI models both on its own
initiative, following the results of its monitoring activities, or upon request from market
surveillance authorities in line with the conditions set out in this Regulation. To support
effective monitoring of the AI Office, it should provide for the possibility that downstream
providers lodge complaints about possible infringements of the rules on providers ofgeneral-purpose AI models and systems.

(163)

With a view to complementing the governance systems for general-purpose AI models, thescientific panel should support the monitoring activities of the AI Office and may, incertain cases, provide qualified alerts to the AI Office which trigger follow-ups, such as
investigations. This should be the case where the scientific panel has reason to suspect thata general-purpose AI model poses a concrete and identifiable risk at Union level.
Furthermore, this should be the case where the scientific panel has reason to suspect that ageneral-purpose AI model meets the criteria that would lead to a classification as
general-purpose AI model with systemic risk. To equip the scientific panel with theinformation necessary for the performance of those tasks, there should be a mechanism
whereby the scientific panel can request the Commission to require documentation or
information from a provider.

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(164)The AI Office should be able to take the necessary actions to monitor the effective
implementation of and compliance with the obligations for providers of general-purpose
AI models laid down in this Regulation. The AI Office should be able to investigate
possible infringements in accordance with the powers provided for in this Regulation,
including by requesting documentation and information, by conducting evaluations, as well
as by requesting measures from providers of general-purpose AI models. When conducting
evaluations, in order to make use of independent expertise, the AI Office should be able toinvolve independent experts to carry out the evaluations on its behalf. Compliance with the
obligations should be enforceable, inter alia, through requests to take appropriate measures,
including risk mitigation measures in the case of identified systemic risks as well as
restricting the making available on the market, withdrawing or recalling the model. As asafeguard, where needed beyond the procedural rights provided for in this Regulation,
providers of general-purpose AI models should have the procedural rights provided for in
Article 18 of Regulation (EU) 2019/1020, which should apply mutatis mutandis, without
prejudice to more specific procedural rights provided for by this Regulation.

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(165)The development of AI systems other than high-risk AI systems in accordance with therequirements of this Regulation may lead to a larger uptake of ethical and trustworthy AI
in the Union. Providers of AI systems that are not high-risk should be encouraged to create
codes of conduct, including related governance mechanisms, intended to foster thevoluntary application of some or all of the mandatory requirements applicable to high-risk
AI systems, adapted in light of the intended purpose of the systems and the lower risk
involved and taking into account the available technical solutions and industry bestpractices such as model and data cards. Providers and, as appropriate, deployers of all AI
systems, high-risk or not, and AI models should also be encouraged to apply on a
voluntary basis additional requirements related, for example, to the elements of theUnion’s Ethics Guidelines for Trustworthy AI, environmental sustainability, AI literacy
measures, inclusive and diverse design and development of AI systems, including attention
to vulnerable persons and accessibility to persons with disability, stakeholders’participation with the involvement, as appropriate, of relevant stakeholders such as
business and civil society organisations, academia, research organisations, trade unions andconsumer protection organisations in the design and development of AI systems, anddiversity of the development teams, including gender balance. To ensure that the voluntary
codes of conduct are effective, they should be based on clear objectives and key
performance indicators to measure the achievement of those objectives. They should also
be developed in an inclusive way, as appropriate, with the involvement of relevant
stakeholders such as business and civil society organisations, academia, researchorganisations, trade unions and consumer protection organisation. The Commission may
develop initiatives, including of a sectoral nature, to facilitate the lowering of technicalbarriers hindering cross-border exchange of data for AI development, including on data
access infrastructure, semantic and technical interoperability of different types of data.

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(166)

It is important that AI systems related to products that are not high-risk in accordance withthis Regulation and thus are not required to comply with the requirements set out for
high-risk AI systems are nevertheless safe when placed on the market or put into service.
To contribute to this objective, Regulation (EU) 2023/988 of the European Parliament andof the Council53 would apply as a safety net.

(167)

In order to ensure trustful and constructive cooperation of competent authorities on Unionand national level, all parties involved in the application of this Regulation should respect
the confidentiality of information and data obtained in carrying out their tasks, inaccordance with Union or national law. They should carry out their tasks and activities insuch a manner as to protect, in particular, intellectual property rights, confidential businessinformation and trade secrets, the effective implementation of this Regulation, public andnational security interests, the integrity of criminal and administrative proceedings, and theintegrity of classified information.

53

Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023
on general product safety, amending Regulation (EU) No 1025/2012 of the European
Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament
and the Council, and repealing Directive 2001/95/EC of the European Parliament and of theCouncil and Council Directive 87/357/EEC (OJ L 135, 23.5.2023, p. 1).

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(168)

Compliance with this Regulation should be enforceable by means of the imposition ofpenalties and other enforcement measures. Member States should take all necessary
measures to ensure that the provisions of this Regulation are implemented, including bylaying down effective, proportionate and dissuasive penalties for their infringement, and torespect the ne bis in idem principle. In order to strengthen and harmonise administrative
penalties for infringement of this Regulation, the upper limits for setting the administrativefines for certain specific infringements should be laid down. When assessing the amount of
the fines, Member States should, in each individual case, take 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 to the size of the provider, inparticular if the provider is an SME, including a start-up. The European Data Protection
Supervisor should have the power to impose fines on Union institutions, agencies andbodies falling within the scope of this Regulation.

(169)

Compliance with the obligations on providers of general-purpose AI models imposed
under this Regulation should be enforceable, inter alia, by means of fines. To that end,
appropriate levels of fines should also be laid down for infringement of those obligations,
including the failure to comply with measures requested by the Commission in accordancewith this Regulation, subject to appropriate limitation periods in accordance with theprinciple of proportionality. All decisions taken by the Commission under this Regulation
are subject to review by the Court of Justice of the European Union in accordance with the
TFEU, including the unlimited jurisdiction of the Court of Justice with regard to penalties
pursuant to Article 261 TFEU.

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(170)

Union and national law already provide effective remedies to natural and legal persons
whose rights and freedoms are adversely affected by the use of AI systems. Without
prejudice to those remedies, any natural or legal person that has grounds to consider that
there has been an infringement of this Regulation should be entitled to lodge a complaint to
the relevant market surveillance authority.

(171)

Affected persons should have the right to obtain an explanation where a deployer’s
decision is based mainly upon the output from certain high-risk AI systems that fall within
the scope of this Regulation and where that decision produces legal effects or similarly
significantly affects those persons in a way that they consider to have an adverse impact on
their health, safety or fundamental rights. That explanation should be clear and meaningful
and should provide a basis on which the affected persons are able to exercise their rights.
The right to obtain an explanation should not apply to the use of AI systems for which
exceptions or restrictions follow from Union or national law and should apply only to theextent this right is not already provided for under Union law.

(172)

Persons acting as whistleblowers on the infringements of this Regulation should beprotected under the Union law. Directive (EU) 2019/1937 of the European Parliament andof the Council54 should therefore apply to the reporting of infringements of this Regulationand the protection of persons reporting such infringements.

54

Directive (EU) 2019/1937 of the European Parliament and of the Councilof 23 October 2019 on the protection of persons who report breaches of Union law(OJ L 305, 26.11.2019, p. 17).

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(173)In order to ensure that the regulatory framework can be adapted where necessary, thepower to adopt acts in accordance with Article 290 TFEU should be delegated to theCommission to amend the conditions under which an AI system is not to be considered tobe high-risk, the list of high-risk AI systems, the provisions regarding technicaldocumentation, the content of the EU declaration of conformity the provisions regarding
the conformity assessment procedures, the provisions establishing the high-risk AI systems
to which the conformity assessment procedure based on assessment of the quality
management system and assessment of the technical documentation should apply, thethreshold, benchmarks and indicators, including by supplementing those benchmarks andindicators, in the rules for the classification of general-purpose AI models with systemic
risk, the criteria for the designation of general-purpose AI models with systemic risk, thetechnical documentation for providers of general-purpose AI models and the transparency
information for providers of general-purpose AI models. It is of particular importance that
the Commission carry out appropriate consultations during its preparatory work, including
at expert level, and that those consultations be conducted in accordance with the principles
laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making55. In
particular, to ensure equal participation in the preparation of delegated acts, the European
Parliament and the Council receive all documents at the same time as Member States’
experts, and their experts systematically have access to meetings of Commission expert
groups dealing with the preparation of delegated acts.

55

OJ L 123, 12.5.2016, p. 1.

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EN(174)

Given the rapid technological developments and the technical expertise required toeffectively apply this Regulation, the Commission should evaluate and review thisRegulation by … [five years from the date of entry into force of this Regulation] and every
four years thereafter and report to the European Parliament and the Council. In addition,
taking into account the implications for the scope of this Regulation, the Commission
should carry out an assessment of the need to amend the list of high-risk AI systems andthe list of prohibited practices once a year. Moreover, by … [four years from the date ofentry into force of this Regulation] and every four years thereafter, the Commission should
evaluate and report to the European Parliament and to the Council on the need to amend
the list of high-risk areas headings in the annex to this Regulation, the AI systems within
the scope of the transparency obligations, the effectiveness of the supervision andgovernance system and the progress on the development of standardisation deliverables onenergy efficient development of general-purpose AI models, including the need for further
measures or actions. Finally, by … [four years from the date of entry into force of thisRegulation] and every three years thereafter, the Commission should evaluate the impact
and effectiveness of voluntary codes of conduct to foster the application of therequirements provided for high-risk AI systems in the case of AI systems other thanhigh-risk AI systems and possibly other additional requirements for such AI systems.

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(175)In order to ensure uniform conditions for the implementation of this Regulation,
implementing powers should be conferred on the Commission. Those powers should be
exercised in accordance with Regulation (EU) No 182/2011 of the European Parliamentand of the Council56.

(176)

Since the objective of this Regulation, namely to improve the functioning of the internalmarket and to promote the uptake of human centric and trustworthy AI, while ensuring ahigh level of protection of health, safety, fundamental rights enshrined in the Charter,
including democracy, the rule of law and environmental protection against harmful effectsof AI systems in the Union and supporting innovation, 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 ofsubsidiarity as set out in Article 5 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 toachieve that objective.

56

Regulation (EU) No 182/2011 of the European Parliament and of the Councilof 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).

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EN(177)In order to ensure legal certainty, ensure an appropriate adaptation period for operators andavoid disruption to the market, including by ensuring continuity of the use of AI systems, it
is appropriate that this Regulation applies to the high-risk AI systems that have been placedon the market or put into service before the general date of application thereof, only if,from that date, those systems are subject to significant changes in their design or intended
purpose. It is appropriate to clarify that, in this respect, the concept of significant change
should be understood as equivalent in substance to the notion of substantial modification,
which is used with regard only to high-risk AI systems pursuant to this Regulation. On an
exceptional basis and in light of public accountability, operators of AI systems which arecomponents of the large-scale IT systems established by the legal acts listed in an annex tothis Regulation and operators of high-risk AI systems that are intended to be used bypublic authorities should, respectively, take the necessary steps to comply with therequirements of this Regulation by end of 2030 and by … [six years from the date of entry
into force of this Regulation].

(178)

Providers of high-risk AI systems are encouraged to start to comply, on a voluntary basis,
with the relevant obligations of this Regulation already during the transitional period.

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(179)

This Regulation should apply from … [two years from the date of entry into force of thisRegulation]. However, taking into account the unacceptable risk associated with the use of
AI in certain ways, the prohibitions as well as the general provisions of this Regulation
should already apply from … [six months from the date of entry into force of thisRegulation]. While the full effect of those prohibitions follows with the establishment of
the governance and enforcement of this Regulation, anticipating the application of theprohibitions is important to take account of unacceptable risks and to have an effect onother procedures, such as in civil law. Moreover, the infrastructure related to thegovernance and the conformity assessment system should be operational before…
[two years from the date of entry into force of this Regulation], therefore the provisions on
notified bodies and governance structure should apply from … [12 months from the date ofentry into force of this Regulation]. Given the rapid pace of technological advancements
and adoption of general-purpose AI models, obligations for providers of general-purpose
AI models should apply from … [12 months from the date of entry into force of thisRegulation]. Codes of practice should be ready by … [9 months from the date of entry into
force of this Regulation] in view of enabling providers to demonstrate compliance on time.
The AI Office should ensure that classification rules and procedures are up to date in lightof technological developments. In addition, Member States should lay down and notify to
the Commission the rules on penalties, including administrative fines, and ensure that they
are properly and effectively implemented by the date of application of this Regulation.
Therefore the provisions on penalties should apply from … [12 months from the date ofentry into force of this Regulation].

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EN(180)The European Data Protection Supervisor and the European Data Protection Board wereconsulted in accordance with Article 42(1) and (2) of Regulation (EU) 2018/1725 anddelivered their joint opinion on 18 June 2021,

HAVE ADOPTED THIS REGULATION:

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Chapter I
General provisions

Article 1
Subject matter`
1.

The purpose of this Regulation is to improve the functioning of the internal market andpromote the uptake of human-centric and trustworthy artificial intelligence (AI), while
ensuring a high level of protection of health, safety, fundamental rights enshrined in theCharter, including democracy, the rule of law and environmental protection, against theharmful effects of AI systems in the Union and supporting innovation.

2.

This Regulation lays down:(a)harmonised rules for the placing on the market, the putting into service, and the useof AI systems in the Union;(b)

prohibitions of certain AI practices;(c)

specific requirements for high-risk AI systems and obligations for operators of such
systems;(d)harmonised transparency rules for certain AI systems;(e)harmonised rules for the placing on the market of general-purpose AI models;

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(f)

rules on market monitoring, market surveillance, governance and enforcement;(g)measures to support innovation, with a particular focus on SMEs, including start-ups.

Article 2
Scope
1.

This Regulation applies to:(a)providers placing on the market or putting into service AI systems or placing on themarket general-purpose AI models in the Union, irrespective of whether those
providers are established or located within the Union or in a third country;(b)

deployers of AI systems that have their place of establishment or are located within
the Union;(c)

providers and deployers of AI systems that have their place of establishment or are
located in a third country, where the output produced by the AI system is used in
the Union;(d)importers and distributors of AI systems;(e)product manufacturers placing on the market or putting into service an AI system
together with their product and under their own name or trademark;(f)authorised representatives of providers, which are not established in the Union;(g)affected persons that are located in the Union.

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2.

For AI systems classified as high-risk AI systems in accordance with Article 6(1) related to
products covered by the Union harmonisation legislation listed in Section B of Annex I,
only Article 6(1), Articles 102 to 109 and Article 112 apply. Article 57 applies only
in so far as the requirements for high-risk AI systems under this Regulation have been
integrated in that Union harmonisation legislation.

3.

This Regulation does not apply to areas outside the scope of Union law, and shall not, inany event, affect the competences of the Member States concerning national security,
regardless of the type of entity entrusted by the Member States with carrying out tasks inrelation to those competences.
This Regulation does not apply to AI systems where and in so far they are placed on themarket, put into service, or used with or without modification exclusively for military,defence or national security purposes, regardless of the type of entity carrying out those
activities.
This Regulation does not apply to AI systems which are not placed on the market or put
into service in the Union, where the output is used in the Union exclusively for military,defence or national security purposes, regardless of the type of entity carrying out those
activities.

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4.

This Regulation applies neither to public authorities in a third country nor to internationalorganisations falling within the scope of this Regulation pursuant to paragraph 1, where
those authorities or organisations use AI systems in the framework of international
cooperation or agreements for law enforcement and judicial cooperation with the Union orwith one or more Member States, provided that such a third country or internationalorganisation provides adequate safeguards with respect to the protection of fundamental
rights and freedoms of individuals.

5.

This Regulation shall not affect the application of the provisions on the liability ofproviders of intermediary services as set out in Chapter II of Regulation (EU) 2022/2065.

6.

This Regulation does not apply to AI systems or AI models, including their output,
specifically developed and put into service for the sole purpose of scientific research anddevelopment.

7.

Union law on the protection of personal data, privacy and the confidentiality ofcommunications applies to personal data processed in connection with the rights andobligations laid down in this Regulation. This Regulation shall not affect Regulation(EU) 2016/679 or (EU) 2018/1725, or Directive 2002/58/EC or (EU) 2016/680, without
prejudice to Article 10(5) and Article 59 of this Regulation.

8.

This Regulation does not apply to any research, testing or development activity regarding
AI systems or AI models prior to their being placed on the market or put into service. Such
activities shall be conducted in accordance with applicable Union law. Testing in realworld conditions shall not be covered by that exclusion.

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9.

This Regulation is without prejudice to the rules laid down by other Union legal acts
related to consumer protection and product safety.

10.

This Regulation does not apply to obligations of deployers who are natural persons using
AI systems in the course of a purely personal non-professional activity.

11.

This Regulation does not preclude the Union or Member States from maintaining or
introducing laws, regulations or administrative provisions which are more favourable toworkers in terms of protecting their rights in respect of the use of AI systems by
employers, or from encouraging or allowing the application of collective agreements which
are more favourable to workers.

12.

This Regulation does not apply to AI systems released under free and open-source
licences, unless they are placed on the market or put into service as high-risk AI systems oras an AI system that falls under Article 5 or 50.

Article 3
Definitions
For the purposes of this Regulation, the following definitions apply:(1)‘AI system’ means a machine-based system that is designed to operate with varying levelsof autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or
implicit objectives, infers, from the input it receives, how to generate outputs such aspredictions, content, recommendations, or decisions that can influence physical or virtualenvironments;

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(2)

‘risk’ means the combination of the probability of an occurrence of harm and the severityof that harm;(3)‘provider’ means a natural or legal person, public authority, agency or other body thatdevelops an AI system or a general-purpose AI model or that has an AI system or a
general-purpose AI model developed and places it on the market or puts the AI system into
service under its own name or trademark, whether for payment or free of charge;(4)‘deployer’ means a natural or legal person, public authority, agency or other body using an
AI system under its authority except where the AI system is used in the course of apersonal non-professional activity;(5)‘authorised representative’ means a natural or legal person located or established in theUnion who has received and accepted a written mandate from a provider of an AI systemor a general-purpose AI model to, respectively, perform and carry out on its behalf theobligations and procedures established by this Regulation;(6)‘importer’ means a natural or legal person located or established in the Union that placeson the market an AI system that bears the name or trademark of a natural or legal person
established in a third country;(7)‘distributor’ means a natural or legal person in the supply chain, other than the provider orthe importer, that makes an AI system available on the Union market;(8)‘operator’ means a provider, product manufacturer, deployer, authorised representative,
importer or distributor;

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(9)

‘placing on the market’ means the first making available of an AI system or a
general-purpose AI model on the Union market;(10)‘making available on the market’ means the supply of an AI system or a general-purpose
AI model for distribution or use on the Union market in the course of a commercial
activity, whether in return for payment or free of charge;(11)‘putting into service’ means the supply of an AI system for first use directly to the deployer
or for own use in the Union for its intended purpose;(12)‘intended purpose’ means the use for which an AI system is intended by the provider,including the specific context and conditions of use, as specified in the information
supplied by the provider in the instructions for use, promotional or sales materials andstatements, as well as in the technical documentation;(13)‘reasonably foreseeable misuse’ means the use of an AI system in a way that is not inaccordance with its intended purpose, but which may result from reasonably foreseeable
human behaviour or interaction with other systems, including other AI systems;(14)‘safety component’ means a component of a product or of an AI system which fulfils asafety function for that product or AI system, or the failure or malfunctioning of which
endangers the health and safety of persons or property;(15)‘instructions for use’ means the information provided by the provider to inform thedeployer of, in particular, an AI system’s intended purpose and proper use;

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(16)

‘recall of an AI system’ means any measure aiming to achieve the return to the provider ortaking out of service or disabling the use of an AI system made available to deployers;(17)‘withdrawal of an AI system’ means any measure aiming to prevent an AI system in the
supply chain being made available on the market;(18)‘performance of an AI system’ means the ability of an AI system to achieve its intended
purpose;(19)‘notifying authority’ means the national authority responsible for setting up and carryingout the necessary procedures for the assessment, designation and notification of conformity
assessment bodies and for their monitoring;(20)‘conformity assessment’ means the process of demonstrating whether the requirements set
out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled;(21)‘conformity assessment body’ means a body that performs third-party conformity
assessment activities, including testing, certification and inspection;(22)‘notified body’ means a conformity assessment body notified in accordance with thisRegulation and other relevant Union harmonisation legislation;(23)‘substantial modification’ means a change to an AI system after its placing on the market
or putting into service which is not foreseen or planned in the initial conformity assessment
carried out by the provider and as a result of which the compliance of the AI system withthe requirements set out in Chapter III, Section 2 is affected or results in a modification to
the intended purpose for which the AI system has been assessed;

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(24)

‘CE marking’ means a marking by which a provider indicates that an AI system is inconformity with the requirements set out in Chapter III, Section 2 and other applicable
Union harmonisation legislation providing for its affixing;(25)‘post-market monitoring system’ means all activities carried out by providers of AI
systems to collect and review experience gained from the use of AI systems they place on
the market or put into service for the purpose of identifying any need to immediately apply
any necessary corrective or preventive actions;(26)‘market surveillance authority’ means the national authority carrying out the activities andtaking the measures pursuant to Regulation (EU) 2019/1020;(27)‘harmonised standard’ means a harmonised standard as defined in Article 2(1), point (c), ofRegulation (EU) No 1025/2012;(28)‘common specification’ means a set of technical specifications as defined in Article 2,
point (4) of Regulation (EU) No 1025/2012, providing means to comply with certain
requirements established under this Regulation;(29)‘training data’ means data used for training an AI system through fitting its learnable
parameters;(30)‘validation data’ means data used for providing an evaluation of the trained AI system andfor tuning its non-learnable parameters and its learning process in order, inter alia, toprevent underfitting or overfitting;

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(31)

‘validation data set’ means a separate data set or part of the training data set, either as afixed or variable split;(32)‘testing data’ means data used for providing an independent evaluation of the AI system inorder to confirm the expected performance of that system before its placing on the market
or putting into service;(33)‘input data’ means data provided to or directly acquired by an AI system on the basis ofwhich the system produces an output;(34)‘biometric data’ means personal data resulting from specific technical processing relating
to the physical, physiological or behavioural characteristics of a natural person, such as
facial images or dactyloscopic data;(35)‘biometric identification’ means the automated recognition of physical, physiological,
behavioural, or psychological human features for the purpose of establishing the identity ofa natural person by comparing biometric data of that individual to biometric data of
individuals stored in a database;(36)‘biometric verification’ means the automated, one-to-one verification, including
authentication, of the identity of natural persons by comparing their biometric data topreviously provided biometric data;(37)‘special categories of personal data’ means the categories of personal data referred to in
Article 9(1) of Regulation (EU) 2016/679, Article 10 of Directive (EU) 2016/680 and
Article 10(1) of Regulation (EU) 2018/1725;

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(38)

‘sensitive operational data’ means operational data related to activities of prevention,
detection, investigation or prosecution of criminal offences, the disclosure of which could
jeopardise the integrity of criminal proceedings;(39)‘emotion recognition system’ means an AI system for the purpose of identifying or
inferring emotions or intentions of natural persons on the basis of their biometric data;(40)‘biometric categorisation system’ means an AI system for the purpose of assigning natural
persons to specific categories on the basis of their biometric data, unless it is ancillary toanother commercial service and strictly necessary for objective technical reasons;(41)‘remote biometric identification system’ means an AI system for the purpose of identifying
natural persons, without their active involvement, typically at a distance through thecomparison of a person’s biometric data with the biometric data contained in a reference
database;(42)‘real-time remote biometric identification system’ means a remote biometric identification
system, whereby the capturing of biometric data, the comparison and the identification all
occur without a significant delay, comprising not only instant identification, but also
limited short delays in order to avoid circumvention;(43)‘post remote biometric identification system’ means a remote biometric identification
system other than a real-time remote biometric identification system;

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(44)

‘publicly accessible space’ means any publicly or privately owned physical place
accessible to an undetermined number of natural persons, regardless of whether certain
conditions for access may apply, and regardless of the potential capacity restrictions;(45)‘law enforcement authority’ means:(a)any public authority competent for the prevention, investigation, detection orprosecution of criminal offences or the execution of criminal penalties, including thesafeguarding against and the prevention of threats to public security; or(b)

any other body or entity entrusted by Member State law to exercise public authorityand public powers for the purposes of the prevention, investigation, detection orprosecution of criminal offences or the execution of criminal penalties, including thesafeguarding against and the prevention of threats to public security;(46)‘law enforcement’ means activities carried out by law enforcement authorities or on theirbehalf for the prevention, investigation, detection or prosecution of criminal offences or the
execution of criminal penalties, including safeguarding against and preventing threats topublic security;(47)‘AI Office’ means the Commission’s function of contributing to the implementation,
monitoring and supervision of AI systems and general-purpose AI models, and AI
governance, provided for in Commission Decision of 24 January 2024; references in thisRegulation to the AI Office shall be construed as references to the Commission;

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(48)

‘national competent authority’ means a notifying authority or a market surveillanceauthority; as regards AI systems put into service or used by Union institutions, agencies,
offices and bodies, references to national competent authorities or market surveillanceauthorities in this Regulation shall be construed as references to the European Data
Protection Supervisor;(49)‘serious incident’ means an incident or malfunctioning of an AI system that directly or
indirectly leads to any of the following:(a)the death of a person, or serious harm to a person’s health;(b)a serious and irreversible disruption of the management or operation of criticalinfrastructure.

(c)the infringement of obligations under Union law intended to protect fundamental
rights;(d)(50)

serious harm to property or the environment;‘personal data’ means personal data as defined in Article 4, point (1), ofRegulation (EU) 2016/679;(51)‘non-personal data’ means data other than personal data as defined in Article 4, point (1),of Regulation (EU) 2016/679;(52)‘profiling’ means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679;

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(53)

‘real-world testing plan’ means a document that describes the objectives, methodology,
geographical, population and temporal scope, monitoring, organisation and conduct of
testing in real-world conditions;(54)‘sandbox plan’ means a document agreed between the participating provider and thecompetent authority describing the objectives, conditions, timeframe, methodology andrequirements for the activities carried out within the sandbox;(55)‘AI regulatory sandbox’ means a controlled framework set up by a competent authority
which offers providers or prospective providers of AI systems the possibility to develop,
train, validate and test, where appropriate in real-world conditions, an innovative AI
system, pursuant to a sandbox plan for a limited time under regulatory supervision;(56)‘AI literacy’ means skills, knowledge and understanding that allow providers, deployers
and affected persons, taking into account their respective rights and obligations in thecontext of this Regulation, to make an informed deployment of AI systems, as well as togain awareness about the opportunities and risks of AI and possible harm it can cause;(57)‘testing in real-world conditions’ means the temporary testing of an AI system for its
intended purpose in real-world conditions outside a laboratory or otherwise simulated
environment, with a view to gathering reliable and robust data and to assessing andverifying the conformity of the AI system with the requirements of this Regulation and it
does not qualify as placing the AI system on the market or putting it into service within themeaning of this Regulation, provided that all the conditions laid down in Article 57 or 60
are fulfilled;

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(58)

‘subject’, for the purpose of real-world testing, means a natural person who participates intesting in real-world conditions;(59)‘informed consent’ means a subject’s freely given, specific, unambiguous and voluntary
expression of his or her willingness to participate in a particular testing in real-world
conditions, after having been informed of all aspects of the testing that are relevant to thesubject’s decision to participate;(60)‘deep fake’ means AI-generated or manipulated image, audio or video content that
resembles existing persons, objects, places, entities or events and would falsely appear to aperson to be authentic or truthful;(61)‘widespread infringement’ means any act or omission contrary to Union law protecting theinterest of individuals, which:(a)has harmed or is likely to harm the collective interests of individuals residing in atleast two Member States other than the Member State in which:(i)the act or omission originated or took place;(ii)

the provider concerned, or, where applicable, its authorised representative islocated or established; or(iii) the deployer is established, when the infringement is committed by the
deployer;

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(b)

has caused, causes or is likely to cause harm to the collective interests of individuals
and has common features, including the same unlawful practice or the same interest
being infringed, and is occurring concurrently, committed by the same operator, in atleast three Member States;(62)‘critical infrastructure’ means critical infrastructure as defined in Article 2, point (4), of
Directive (EU) 2022/2557;(63)‘general-purpose AI model’ means an AI model, including where such an AI model istrained with a large amount of data using self-supervision at scale, that displays significant
generality and is capable of competently performing a wide range of distinct tasks
regardless of the way the model is placed on the market and that can be integrated into avariety of downstream systems or applications, except AI models that are used forresearch, development or prototyping activities before they are placed on the market;(64)‘high-impact capabilities’ means capabilities that match or exceed the capabilities recordedin the most advanced general-purpose AI models;(65)‘systemic risk’ means a risk that is specific to the high-impact capabilities ofgeneral-purpose AI models, having a significant impact on the Union market due to theirreach, or due to actual or reasonably foreseeable negative effects on public health, safety,
public security, fundamental rights, or the society as a whole, that can be propagated atscale across the value chain;

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(66)

‘general-purpose AI system’ means an AI system which is based on a general-purpose AI
model and which has the capability to serve a variety of purposes, both for direct use as
well as for integration in other AI systems;(67)‘floating-point operation’ means any mathematical operation or assignment involving
floating-point numbers, which are a subset of the real numbers typically represented oncomputers by an integer of fixed precision scaled by an integer exponent of a fixed base;(68)‘downstream provider’ means a provider of an AI system, including a general-purpose AI
system, which integrates an AI model, regardless of whether the AI model is provided bythemselves and vertically integrated or provided by another entity based on contractual
relations.

Article 4
AI literacy
Providers and deployers of AI systems shall take measures to ensure, to their best extent, asufficient level of AI literacy of their staff and other persons dealing with the operation and use of
AI systems on their behalf, taking into account their technical knowledge, experience, educationand training and the context the AI systems are to be used in, and considering the persons or groupsof persons on whom the AI systems are to be used.

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ENChapter II
Prohibited AI Practices

Article 5
Prohibited AI Practices
1.

The following AI practices shall be prohibited:(a)the placing on the market, the putting into service or the use of an AI system that
deploys subliminal techniques beyond a person’s consciousness or purposefully
manipulative or deceptive techniques, with the objective, or the effect of materiallydistorting the behaviour of a person or a group of persons by appreciably impairing
their ability to make an informed decision, thereby causing them to take a decisionthat they would not have otherwise taken in a manner that causes or is reasonably
likely to cause that person, another person or group of persons significant harm;(b)

the placing on the market, the putting into service or the use of an AI system that
exploits any of the vulnerabilities of a natural person or a specific group of persons
due to their age, disability or a specific social or economic situation, with theobjective, or the effect, of materially distorting the behaviour of that person or aperson belonging to that group in a manner that causes or is reasonably likely tocause that person or another person significant harm;

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(c)

the placing on the market, the putting into service or the use of AI systems for theevaluation or classification of natural persons or groups of persons over a certain
period of time based on their social behaviour or known, inferred or predictedpersonal or personality characteristics, with the social score leading to either or bothof the following:(i)

detrimental or unfavourable treatment of certain natural persons or groups of
persons in social contexts that are unrelated to the contexts in which the data
was originally generated or collected;(ii)

detrimental or unfavourable treatment of certain natural persons or groups of
persons that is unjustified or disproportionate to their social behaviour or its
gravity;(d)the placing on the market, the putting into service for this specific purpose, or the useof an AI system for making risk assessments of natural persons in order to assess or
predict the risk of a natural person committing a criminal offence, based solely on the
profiling of a natural person or on assessing their personality traits andcharacteristics; this prohibition shall not apply to AI systems used to support thehuman assessment of the involvement of a person in a criminal activity, which isalready based on objective and verifiable facts directly linked to a criminal activity;(e)the placing on the market, the putting into service for this specific purpose, or the useof AI systems that create or expand facial recognition databases through theuntargeted scraping of facial images from the internet or CCTV footage;

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(f)

the placing on the market, the putting into service for this specific purpose, or the useof AI systems to infer emotions of a natural person in the areas of workplace andeducation institutions, except where the use of the AI system is intended to be put inplace or into the market for medical or safety reasons;(g)the placing on the market, the putting into service for this specific purpose, or the useof biometric categorisation systems that categorise individually natural persons basedon their biometric data to deduce or infer their race, political opinions, trade union
membership, religious or philosophical beliefs, sex life or sexual orientation; thisprohibition does not cover any labelling or filtering of lawfully acquired biometric
datasets, such as images, based on biometric data or categorizing of biometric data in
the area of law enforcement;(h)the use of ‘real-time’ remote biometric identification systems in publicly accessible
spaces for the purposes of law enforcement, unless and in so far as such use is strictly
necessary for one of the following objectives:(i)the targeted search for specific victims of abduction, trafficking in humanbeings or sexual exploitation of human beings, as well as the search for missing
persons;(ii)

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(iii) the localisation or identification of a person suspected of having committed acriminal offence, for the purpose of conducting a criminal investigation orprosecution or executing a criminal penalty for offences referred to in Annex II
and punishable in the Member State concerned by a custodial sentence or adetention order for a maximum period of at least four years.
Point (h) of the first subparagraph is without prejudice to Article 9 of Regulation(EU) 2016/679 for the processing of biometric data for purposes other than law
enforcement.
2.

The use of ‘real-time’ remote biometric identification systems in publicly accessible spaces
for the purposes of law enforcement for any of the objectives referred to in paragraph 1,
first subparagraph, point (h), shall be deployed for the purposes set out in that point only toconfirm the identity of the specifically targeted individual, and it shall take into account thefollowing elements:(a)the nature of the situation giving rise to the possible use, in particular the seriousness,probability and scale of the harm that would be caused if the system were not used;(b)

the consequences of the use of the system for the rights and freedoms of all persons
concerned, in particular the seriousness, probability and scale of those consequences.

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In addition, the use of ‘real-time’ remote biometric identification systems in publicly
accessible spaces for the purposes of law enforcement for any of the objectives referred toin paragraph 1, first subparagraph, point (h), of this Article shall comply with necessary
and proportionate safeguards and conditions in relation to the use in accordance with thenational law authorising the use thereof, in particular as regards the temporal, geographic
and personal limitations. The use of the ‘real-time’ remote biometric identification system
in publicly accessible spaces shall be authorised only if the law enforcement authority hascompleted a fundamental rights impact assessment as provided for in Article 27 and has
registered the system in the EU database according to Article 49. However, in duly
justified cases of urgency, the use of such systems may be commenced without theregistration in the EU database, provided that such registration is completed without undue
delay.
3.

For the purposes of paragraph 1, first subparagraph, point (h) and paragraph 2, each use forthe purposes of law enforcement of a ‘real-time’ remote biometric identification system inpublicly accessible spaces shall be subject to a prior authorisation granted by a judicial
authority or an independent administrative authority whose decision is binding of theMember State in which the use is to take place, issued upon a reasoned request and inaccordance with the detailed rules of national law referred to in paragraph 5. However, in aduly justified situation of urgency, the use of such system may be commenced without an
authorisation provided that such authorisation is requested without undue delay, at thelatest within 24 hours. If such authorisation is rejected, the use shall be stopped withimmediate effect and all the data, as well as the results and outputs of that use shall be
immediately discarded and deleted.

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The competent judicial authority or an independent administrative authority whose
decision is binding shall grant the authorisation only where it is satisfied, on the basis ofobjective evidence or clear indications presented to it, that the use of the ‘real-time’ remotebiometric identification system concerned is necessary for, and proportionate to, achieving
one of the objectives specified in paragraph 1, first subparagraph, point (h), as identified in
the request and, in particular, remains limited to what is strictly necessary concerning theperiod of time as well as the geographic and personal scope. In deciding on the request,that authority shall take into account the elements referred to in paragraph 2. No decisionthat produces an adverse legal effect on a person may be taken based solely on the outputof the ‘real-time’ remote biometric identification system.
4.

Without prejudice to paragraph 3, each use of a ‘real-time’ remote biometric identification
system in publicly accessible spaces for law enforcement purposes shall be notified to therelevant market surveillance authority and the national data protection authority inaccordance with the national rules referred to in paragraph 5. The notification shall, as aminimum, contain the information specified under paragraph 6 and shall not includesensitive operational data.

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5.

A Member State may decide to provide for the possibility to fully or partially authorise theuse of ‘real-time’ remote biometric identification systems in publicly accessible spaces forthe purposes of law enforcement within the limits and under the conditions listed inparagraph 1, first subparagraph, point (h), and paragraphs 2 and 3. Member Statesconcerned shall lay down in their national law the necessary detailed rules for the request,
issuance and exercise of, as well as supervision and reporting relating to, the authorisations
referred to in paragraph 3. Those rules shall also specify in respect of which of theobjectives listed in paragraph 1, first subparagraph, point (h), including which of thecriminal offences referred to in point (h)(iii) thereof, the competent authorities may be
authorised to use those systems for the purposes of law enforcement. Member States shallnotify those rules to the Commission at the latest 30 days following the adoption thereof.
Member States may introduce, in accordance with Union law, more restrictive laws on theuse of remote biometric identification systems.

6.

National market surveillance authorities and the national data protection authorities ofMember States that have been notified of the use of ‘real-time’ remote biometricidentification systems in publicly accessible spaces for law enforcement purposes pursuant
to paragraph 4 shall submit to the Commission annual reports on such use. For that
purpose, the Commission shall provide Member States and national market surveillanceand data protection authorities with a template, including information on the number of thedecisions taken by competent judicial authorities or an independent administrative
authority whose decision is binding upon requests for authorisations in accordance withparagraph 3 and their result.

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7.

The Commission shall publish annual reports on the use of real-time remote biometricidentification systems in publicly accessible spaces for law enforcement purposes, basedon aggregated data in Member States on the basis of the annual reports referred to inparagraph 6. Those annual reports shall not include sensitive operational data of the related
law enforcement activities.

8.

This Article shall not affect the prohibitions that apply where an AI practice infringes other
Union law.

Chapter III
High-risk AI Systems
SECTION 1
CLASSIFICATION OF AI SYSTEMS AS HIGH-RISK

Article 6
Classification rules for high-risk AI systems
1.

Irrespective of whether an AI system is placed on the market or put into service
independently of the products referred to in points (a) and (b), that AI system shall beconsidered to be high-risk where both of the following conditions are fulfilled:(a)the AI system is intended to be used as a safety component of a product, or the AI
system is itself a product, covered by the Union harmonisation legislation listed in
Annex I;

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(b)

the product whose safety component pursuant to point (a) is the AI system, or the AI
system itself as a product, is required to undergo a third-party conformity
assessment, with a view to the placing on the market or the putting into service ofthat product pursuant to the Union harmonisation legislation listed in Annex I.

2.

In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in
Annex III shall be considered to be high-risk.

3.

By derogation from paragraph 2, an AI system referred to in Annex III shall not be
considered to be high-risk where it does not pose a significant risk of harm to the health,safety or fundamental rights of natural persons, including by not materially influencing theoutcome of decision making.
The first subparagraph shall apply where any of the following conditions is fulfilled:(a)the AI system is intended to perform a narrow procedural task;(b)

the AI system is intended to improve the result of a previously completed humanactivity;(c)the AI system is intended to detect decision-making patterns or deviations from priordecision-making patterns and is not meant to replace or influence the previously
completed human assessment, without proper human review; or(d)the AI system is intended to perform a preparatory task to an assessment relevant forthe purposes of the use cases listed in Annex III.

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Notwithstanding the first subparagraph, an AI system referred to in Annex III shall always
be considered to be high-risk where the AI system performs profiling of natural persons.
4.

A provider who considers that an AI system referred to in Annex III is not high-risk shalldocument its assessment before that system is placed on the market or put into service.
Such provider shall be subject to the registration obligation set out in Article 49(2). Upon
request of national competent authorities, the provider shall provide the documentation of
the assessment.

5.

The Commission shall, after consulting the European Artificial Intelligence Board (the‘Board’), and no later than … [18 months from the date of entry into force of thisRegulation], provide guidelines specifying the practical implementation of this Article inline with Article 96 together with a comprehensive list of practical examples of use casesof AI systems that are high-risk and not high-risk.

6.

The Commission is empowered to adopt delegated acts in accordance with Article 97 inorder to amend paragraph 3, second subparagraph, of this Article by adding new conditions
to those laid down therein, or by modifying them, where there is concrete and reliable
evidence of the existence of AI systems that fall under the scope of Annex III, but do notpose a significant risk of harm to the health, safety or fundamental rights of natural
persons.

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7.

The Commission shall adopt delegated acts in accordance with Article 97 in order toamend paragraph 3, second subparagraph, of this Article by deleting any of the conditions
laid down therein, where there is concrete and reliable evidence that this is necessary tomaintain the level of protection of health, safety and fundamental rights provided for bythis Regulation.

8.

Any amendment to the conditions laid down in paragraph 3, second subparagraph, adopted
in accordance with paragraphs 6 and 7 of this Article shall not decrease the overall level ofprotection of health, safety and fundamental rights provided for by this Regulation andshall ensure consistency with the delegated acts adopted pursuant to Article 7(1), and takeaccount of market and technological developments.

Article 7
Amendments to Annex III
1.

The Commission is empowered to adopt delegated acts in accordance with Article 97 toamend Annex III by adding or modifying use-cases of high-risk AI systems where both of
the following conditions are fulfilled:(a)the AI systems are intended to be used in any of the areas listed in Annex III;(b)

the AI systems pose a risk of harm to health and safety, or an adverse impact on
fundamental rights, and that risk is equivalent to, or greater than, the risk of harm orof adverse impact posed by the high-risk AI systems already referred to in Annex III.

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2.

When assessing the condition under paragraph 1, point (b), the Commission shall take into
account the following criteria:(a)the intended purpose of the AI system;(b)the extent to which an AI system has been used or is likely to be used;(c)the nature and amount of the data processed and used by the AI system, in particularwhether special categories of personal data are processed;(d)the extent to which the AI system acts autonomously and the possibility for a humanto override a decision or recommendations that may lead to potential harm;(e)the extent to which the use of an AI system has already caused harm to health andsafety, has had an adverse impact on fundamental rights or has given rise tosignificant concerns in relation to the likelihood of such harm or adverse impact, as
demonstrated, for example, by reports or documented allegations submitted tonational competent authorities or by other reports, as appropriate;(f)the potential extent of such harm or such adverse impact, in particular in terms of its
intensity and its ability to affect multiple persons or to disproportionately affect aparticular group of persons;(g)the extent to which persons who are potentially harmed or suffer an adverse impact
are dependent on the outcome produced with an AI system, in particular because forpractical or legal reasons it is not reasonably possible to opt-out from that outcome;

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(h)

the extent to which there is an imbalance of power, or the persons who arepotentially harmed or suffer an adverse impact are in a vulnerable position in relation
to the deployer of an AI system, in particular due to status, authority, knowledge,
economic or social circumstances, or age;(i)the extent to which the outcome produced involving an AI system is easily corrigibleor reversible, taking into account the technical solutions available to correct orreverse it, whereby outcomes having an adverse impact on health, safety or
fundamental rights, shall not be considered to be easily corrigible or reversible;(j)the magnitude and likelihood of benefit of the deployment of the AI system forindividuals, groups, or society at large, including possible improvements in productsafety;(k)

the extent to which existing Union law provides for:(i)effective measures of redress in relation to the risks posed by an AI system,with the exclusion of claims for damages;(ii)

effective measures to prevent or substantially minimise those risks.

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3.

The Commission is empowered to adopt delegated acts in accordance with Article 97 toamend the list in Annex III by removing high-risk AI systems where both of the following
conditions are fulfilled:(a)the high-risk AI system concerned no longer poses any significant risks tofundamental rights, health or safety, taking into account the criteria listed inparagraph 2;(b)the deletion does not decrease the overall level of protection of health, safety andfundamental rights under Union law.

SECTION 2
REQUIREMENTS FOR HIGH-RISK AI SYSTEMS

Article 8Compliance with the requirements
1.

High-risk AI systems shall comply with the requirements laid down in this Section, taking
into account their intended purpose as well as the generally acknowledged state of the art
on AI and AI-related technologies. The risk management system referred to in Article 9
shall be taken into account when ensuring compliance with those requirements.

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2.

Where a product contains an AI system, to which the requirements of this Regulation as
well as requirements of the Union harmonisation legislation listed in Section A of Annex I
apply, providers shall be responsible for ensuring that their product is fully compliant withall applicable requirements under applicable Union harmonisation legislation. In ensuring
the compliance of high-risk AI systems referred to in paragraph 1 with the requirements set
out in this Section, and in order to ensure consistency, avoid duplication and minimise
additional burdens, providers shall have a choice of integrating, as appropriate, thenecessary testing and reporting processes, information and documentation they provide
with regard to their product into documentation and procedures that already exist and are
required under the Union harmonisation legislation listed in Section A of Annex I.

Article 9
Risk management system
1.

A risk management system shall be established, implemented, documented and maintainedin relation to high-risk AI systems.

2.

The risk management system shall be understood as a continuous iterative process planned
and run throughout the entire lifecycle of a high-risk AI system, requiring regularsystematic review and updating. It shall comprise the following steps:(a)the identification and analysis of the known and the reasonably foreseeable risks thatthe high-risk AI system can pose to health, safety or fundamental rights when thehigh-risk AI system is used in accordance with its intended purpose;

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(b)

the estimation and evaluation of the risks that may emerge when the high-risk AI
system is used in accordance with its intended purpose, and under conditions ofreasonably foreseeable misuse;(c)the evaluation of other risks possibly arising, based on the analysis of data gatheredfrom the post-market monitoring system referred to in Article 72;(d)the adoption of appropriate and targeted risk management measures designed toaddress the risks identified pursuant to point (a).

3.

The risks referred to in this Article shall concern only those which may be reasonably
mitigated or eliminated through the development or design of the high-risk AI system, or
the provision of adequate technical information.

4.

The risk management measures referred to in paragraph 2, point (d), shall give due
consideration to the effects and possible interaction resulting from the combined
application of the requirements set out in this Section, with a view to minimising risks
more effectively while achieving an appropriate balance in implementing the measures tofulfil those requirements.

5.

The risk management measures referred to in paragraph 2, point (d), shall be such that therelevant residual risk associated with each hazard, as well as the overall residual risk of thehigh-risk AI systems is judged to be acceptable.

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In identifying the most appropriate risk management measures, the following shall beensured:(a)elimination or reduction of risks identified and evaluated pursuant to paragraph 2 in
as far as technically feasible through adequate design and development of thehigh-risk AI system;(b)where appropriate, implementation of adequate mitigation and control measures
addressing risks that cannot be eliminated;(c)provision of information required pursuant to Article 13 and, where appropriate,
training to deployers.

With a view to eliminating or reducing risks related to the use of the high-risk AI system,
due consideration shall be given to the technical knowledge, experience, education, thetraining to be expected by the deployer, and the presumable context in which the system isintended to be used.
6.

High-risk AI systems shall be tested for the purpose of identifying the most appropriate
and targeted risk management measures. Testing shall ensure that high-risk AI systems
perform consistently for their intended purpose and that they are in compliance with therequirements set out in this Section.

7.

Testing procedures may include testing in real-world conditions in accordancewith Article 60.

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8.

The testing of high-risk AI systems shall be performed, as appropriate, at any timethroughout the development process, and, in any event, prior to their being placed on themarket or put into service. Testing shall be carried out against prior defined metrics andprobabilistic thresholds that are appropriate to the intended purpose of the high-risk AI
system.

9.

When implementing the risk management system as provided for in paragraphs 1 to 7,
providers shall give consideration to whether in view of its intended purpose the high-risk
AI system is likely to have an adverse impact on persons under the age of 18 and, as
appropriate, other vulnerable groups.

10.

For providers of high-risk AI systems that are subject to requirements regarding internalrisk management processes under other relevant provisions of Union law, the aspects
provided in paragraphs 1 to 9 may be part of, or combined with, the risk management
procedures established pursuant to that law.

Article 10
Data and data governance1.

High-risk AI systems which make use of techniques involving the training of AI models
with data shall be developed on the basis of training, validation and testing data sets thatmeet the quality criteria referred to in paragraphs 2 to 5 whenever such data sets are used.

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2.

Training, validation and testing data sets shall be subject to data governance andmanagement practices appropriate for the intended purpose of the high-risk AI system.
Those practices shall concern in particular:(a)the relevant design choices;(b)data collection processes and the origin of data, and in the case of personal data, theoriginal purpose of the data collection;(c)relevant data-preparation processing operations, such as annotation, labelling,cleaning, updating, enrichment and aggregation;(d)the formulation of assumptions, in particular with respect to the information that thedata are supposed to measure and represent;(e)

an assessment of the availability, quantity and suitability of the data sets that areneeded;(f)

examination in view of possible biases that are likely to affect the health and safetyof persons, have a negative impact on fundamental rights or lead to discriminationprohibited under Union law, especially where data outputs influence inputs for future
operations;(g)appropriate measures to detect, prevent and mitigate possible biases identified
according to point (f);(h)

the identification of relevant data gaps or shortcomings that prevent compliance withthis Regulation, and how those gaps and shortcomings can be addressed.

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3.

Training, validation and testing data sets shall be relevant, sufficiently representative, andto the best extent possible, free of errors and complete in view of the intended purpose.
They shall have the appropriate statistical properties, including, where applicable, as
regards the persons or groups of persons in relation to whom the high-risk AI system isintended to be used. Those characteristics of the data sets may be met at the level ofindividual data sets or at the level of a combination thereof.

4.

Data sets shall take into account, to the extent required by the intended purpose, thecharacteristics or elements that are particular to the specific geographical, contextual,
behavioural or functional setting within which the high-risk AI system is intended to be
used.

5.

To the extent that it is strictly necessary for the purpose of ensuring bias detection andcorrection in relation to the high-risk AI systems in accordance with paragraph (2),points (f) and (g) of this Article, the providers of such systems may exceptionally process
special categories of personal data, subject to appropriate safeguards for the fundamental
rights and freedoms of natural persons. In addition to the provisions set out in Regulations(EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, all the following
conditions must be met in order for such processing to occur:(a)the bias detection and correction cannot be effectively fulfilled by processing otherdata, including synthetic or anonymised data;

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(b)

the special categories of personal data are subject to technical limitations on there-use of the personal data, and state-of-the-art security and privacy-preserving
measures, including pseudonymisation;(c)the special categories of personal data are subject to measures to ensure that thepersonal data processed are secured, protected, subject to suitable safeguards,
including strict controls and documentation of the access, to avoid misuse and ensurethat only authorised persons have access to those personal data with appropriate
confidentiality obligations;(d)the special categories of personal data are not to be transmitted, transferred orotherwise accessed by other parties;(e)the special categories of personal data are deleted once the bias has been corrected or
the personal data has reached the end of its retention period, whichever comes first;(f)

the records of processing activities pursuant to Regulations (EU) 2016/679 and(EU) 2018/1725 and Directive (EU) 2016/680 include the reasons why theprocessing of special categories of personal data was strictly necessary to detect andcorrect biases, and why that objective could not be achieved by processing
other data.

6.

For the development of high-risk AI systems not using techniques involving the training ofAI models, paragraphs 2 to 5 apply only to the testing data sets.

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Article 11
Technical documentation
1.

The technical documentation of a high-risk AI system shall be drawn up before that system
is placed on the market or put into service and shall be kept up-to date.
The technical documentation shall be drawn up in such a way as to demonstrate that thehigh-risk AI system complies with the requirements set out in this Section and to provide
national competent authorities and notified bodies with the necessary information in a clear
and comprehensive form to assess the compliance of the AI system with thoserequirements. It shall contain, at a minimum, the elements set out in Annex IV. SMEs,
including start-ups, may provide the elements of the technical documentation specified in
Annex IV in a simplified manner. To that end, the Commission shall establish a simplified
technical documentation form targeted at the needs of small and microenterprises. Wherean SME, including a start-up, opts to provide the information required in Annex IV in a
simplified manner, it shall use the form referred to in this paragraph. Notified bodies shallaccept the form for the purposes of the conformity assessment.

2.

Where a high-risk AI system related to a product covered by the Union harmonisation
legislation listed in Section A of Annex I is placed on the market or put into service, asingle set of technical documentation shall be drawn up containing all the information set
out in paragraph 1, as well as the information required under those legal acts.

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3.

The Commission is empowered to adopt delegated acts in accordance with Article 97 inorder to amend Annex IV, where necessary, to ensure that, in light of technical progress,
the technical documentation provides all the information necessary to assess thecompliance of the system with the requirements set out in this Section.

Article 12
Record-keeping
1.

High-risk AI systems shall technically allow for the automatic recording of events (logs)
over the lifetime of the system.

2.

In order to ensure a level of traceability of the functioning of a high-risk AI system that is
appropriate to the intended purpose of the system, logging capabilities shall enable therecording of events relevant for:(a)identifying situations that may result in the high-risk AI system presenting a risk
within the meaning of Article 79(1) or in a substantial modification;

3.

(b)

facilitating the post-market monitoring referred to in Article 72; and(c)monitoring the operation of high-risk AI systems referred to in Article 26(5).

For high-risk AI systems referred to in point 1 (a), of Annex III, the logging capabilities
shall provide, at a minimum:(a)recording of the period of each use of the system (start date and time and end date
and time of each use);

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(b)

the reference database against which input data has been checked by the system;(c)the input data for which the search has led to a match;(d)the identification of the natural persons involved in the verification of the results, as
referred to in Article 14(5).

Article 13
Transparency and provision of information to deployers
1.

High-risk AI systems shall be designed and developed in such a way as to ensure that theiroperation is sufficiently transparent to enable deployers to interpret a system’s output anduse it appropriately. An appropriate type and degree of transparency shall be ensured witha view to achieving compliance with the relevant obligations of the provider and deployer
set out in Section 3.

2.

High-risk AI systems shall be accompanied by instructions for use in an appropriate digitalformat or otherwise that include concise, complete, correct and clear information that isrelevant, accessible and comprehensible to deployers.

3.

The instructions for use shall contain at least the following information:(a)the identity and the contact details of the provider and, where applicable, of its
authorised representative;

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(b)

the characteristics, capabilities and limitations of performance of the high-risk AI
system, including:(i)

its intended purpose;(ii)

the level of accuracy, including its metrics, robustness and cybersecurity
referred to in Article 15 against which the high-risk AI system has been tested
and validated and which can be expected, and any known and foreseeable
circumstances that may have an impact on that expected level of accuracy,
robustness and cybersecurity;(iii) any known or foreseeable circumstance, related to the use of the high-risk AI
system in accordance with its intended purpose or under conditions ofreasonably foreseeable misuse, which may lead to risks to the health and safety
or fundamental rights referred to in Article 9(2);(iv) where applicable, the technical capabilities and characteristics of the high-risk
AI system to provide information that is relevant to explain its output;(v)

when appropriate, its performance regarding specific persons or groups of
persons on which the system is intended to be used;(vi) when appropriate, specifications for the input data, or any other relevant
information in terms of the training, validation and testing data sets used,taking into account the intended purpose of the high-risk AI system;

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(vii) where applicable, information to enable deployers to interpret the output of thehigh-risk AI system and use it appropriately;(c)the changes to the high-risk AI system and its performance which have been predetermined by the provider at the moment of the initial conformity assessment, if
any;

(d)

the human oversight measures referred to in Article 14, including the technicalmeasures put in place to facilitate the interpretation of the outputs of the high-risk AI
systems by the deployers;(e)the computational and hardware resources needed, the expected lifetime of thehigh-risk AI system and any necessary maintenance and care measures, including
their frequency, to ensure the proper functioning of that AI system, including as
regards software updates;(f)where relevant, a description of the mechanisms included within the high-risk AI
system that allows deployers to properly collect, store and interpret the logs inaccordance with Article 12.

Article 14
Human oversight1.

High-risk AI systems shall be designed and developed in such a way, including withappropriate human-machine interface tools, that they can be effectively overseen by natural
persons during the period in which they are in use.

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2.

Human oversight shall aim to prevent or minimise the risks to health, safety or
fundamental rights that may emerge when a high-risk AI system is used in accordance with
its intended purpose or under conditions of reasonably foreseeable misuse, in particularwhere such risks persist despite the application of other requirements set out inthis Section.

3.

The oversight measures shall be commensurate with the risks, level of autonomy andcontext of use of the high-risk AI system, and shall be ensured through either one or bothof the following types of measures:(a)measures identified and built, when technically feasible, into the high-risk AI systemby the provider before it is placed on the market or put into service;(b)measures identified by the provider before placing the high-risk AI system on themarket or putting it into service and that are appropriate to be implemented by the
deployer.

4.

For the purpose of implementing paragraphs 1, 2 and 3, the high-risk AI system shall be
provided to the deployer in such a way that natural persons to whom human oversight is
assigned are enabled, as appropriate and proportionate:(a)to properly understand the relevant capacities and limitations of the high-risk AI
system and be able to duly monitor its operation, including in view of detecting andaddressing anomalies, dysfunctions and unexpected performance;

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(b)

to remain aware of the possible tendency of automatically relying or over-relying on
the output produced by a high-risk AI system (automation bias), in particular for
high-risk AI systems used to provide information or recommendations for decisions
to be taken by natural persons;(c)to correctly interpret the high-risk AI system’s output, taking into account, forexample, the interpretation tools and methods available;(d)to decide, in any particular situation, not to use the high-risk AI system or tootherwise disregard, override or reverse the output of the high-risk AI system;(e)

to intervene in the operation of the high-risk AI system or interrupt the systemthrough a ‘stop’ button or a similar procedure that allows the system to come to ahalt in a safe state.

5.

For high-risk AI systems referred to in point 1(a) of Annex III, the measures referred to inparagraph 3 of this Article shall be such as to ensure that, in addition, no action or decision
is taken by the deployer on the basis of the identification resulting from the system unlessthat identification has been separately verified and confirmed by at least two natural
persons with the necessary competence, training and authority.
The requirement for a separate verification by at least two natural persons shall not apply
to high-risk AI systems used for the purposes of law enforcement, migration, bordercontrol or asylum, where Union or national law considers the application of thisrequirement to be disproportionate.

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Article 15
Accuracy, robustness and cybersecurity
1.

High-risk AI systems shall be designed and developed in such a way that they achieve anappropriate level of accuracy, robustness, and cybersecurity, and that they performconsistently in those respects throughout their lifecycle.

2.

To address the technical aspects of how to measure the appropriate levels of accuracy androbustness set out in paragraph 1 and any other relevant performance metrics, theCommission shall, in cooperation with relevant stakeholders and organisations such as
metrology and benchmarking authorities, encourage, as appropriate, the development ofbenchmarks and measurement methodologies.

3.

The levels of accuracy and the relevant accuracy metrics of high-risk AI systems shall bedeclared in the accompanying instructions of use.

4.

High-risk AI systems shall be as resilient as possible regarding errors, faults orinconsistencies that may occur within the system or the environment in which the system
operates, in particular due to their interaction with natural persons or other systems.
Technical and organisational measures shall be taken in this regard.
The robustness of high-risk AI systems may be achieved through technical redundancy
solutions, which may include backup or fail-safe plans.

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High-risk AI systems that continue to learn after being placed on the market or put into
service shall be developed in such a way as to eliminate or reduce as far as possible the riskof possibly biased outputs influencing input for future operations (feedback loops), and as
to ensure that any such feedback loops are duly addressed with appropriate mitigation
measures.
5.

High-risk AI systems shall be resilient against attempts by unauthorised third parties toalter their use, outputs or performance by exploiting system vulnerabilities.
The technical solutions aiming to ensure the cybersecurity of high-risk AI systems shall beappropriate to the relevant circumstances and the risks.
The technical solutions to address AI specific vulnerabilities shall include, whereappropriate, measures to prevent, detect, respond to, resolve and control for attacks trying
to manipulate the training data set (data poisoning), or pre-trained components used intraining (model poisoning), inputs designed to cause the AI model to make a mistake(adversarial examples or model evasion), confidentiality attacks or model flaws.

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SECTION 3
OBLIGATIONS OF PROVIDERS AND DEPLOYERS OF HIGH-RISK AI SYSTEMSAND OTHER PARTIES

Article 16
Obligations of providers of high-risk AI systems
Providers of high-risk AI systems shall:(a)ensure that their high-risk AI systems are compliant with the requirements set out in
Section 2;(b)

indicate on the high-risk AI system or, where that is not possible, on its packaging or its
accompanying documentation, as applicable, their name, registered trade name orregistered trade mark, the address at which they can be contacted;(c)have a quality management system in place which complies with Article 17;(d)keep the documentation referred to in Article 18;(e)when under their control, keep the logs automatically generated by their high-risk AI
systems as referred to in Article 19;(f)

ensure that the high-risk AI system undergoes the relevant conformity assessment
procedure as referred to in Article 43, prior to its being placed on the market or put into
service;

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(g)

draw up an EU declaration of conformity in accordance with Article 47;(h)affix the CE marking to the high-risk AI system or, where that is not possible, on its
packaging or its accompanying documentation, to indicate conformity with thisRegulation, in accordance with Article 48;(i)comply with the registration obligations referred to in Article 49(1);(j)

take the necessary corrective actions and provide information as required in Article 20;(k)upon a reasoned request of a national competent authority, demonstrate the conformity of
the high-risk AI system with the requirements set out in Section 2;(l)ensure that the high-risk AI system complies with accessibility requirements in accordancewith Directives (EU) 2016/2102 and (EU) 2019/882.

Article 17
Quality management system
1.

Providers of high-risk AI systems shall put a quality management system in place that
ensures compliance with this Regulation. That system shall be documented in a systematicand orderly manner in the form of written policies, procedures and instructions, and shall
include at least the following aspects:(a)a strategy for regulatory compliance, including compliance with conformity
assessment procedures and procedures for the management of modifications to thehigh-risk AI system;

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(b)

techniques, procedures and systematic actions to be used for the design, design
control and design verification of the high-risk AI system;(c)techniques, procedures and systematic actions to be used for the development,
quality control and quality assurance of the high-risk AI system;(d)examination, test and validation procedures to be carried out before, during and after
the development of the high-risk AI system, and the frequency with which they haveto be carried out;(e)technical specifications, including standards, to be applied and, where the relevant
harmonised standards are not applied in full or do not cover all of the relevant
requirements set out in Section 2, the means to be used to ensure that the high-risk AI
system complies with those requirements;(f)systems and procedures for data management, including data acquisition, datacollection, data analysis, data labelling, data storage, data filtration, data mining, data
aggregation, data retention and any other operation regarding the data that is
performed before and for the purpose of the placing on the market or the putting into
service of high-risk AI systems;(g)

the risk management system referred to in Article 9;(h)the setting-up, implementation and maintenance of a post-market monitoring system,in accordance with Article 72;

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(i)

procedures related to the reporting of a serious incident in accordance with
Article 73;(j)the handling of communication with national competent authorities, other relevant
authorities, including those providing or supporting the access to data, notified
bodies, other operators, customers or other interested parties;(k)systems and procedures for record-keeping of all relevant documentation andinformation;(l)resource management, including security-of-supply related measures;(m) an accountability framework setting out the responsibilities of the management andother staff with regard to all the aspects listed in this paragraph.
2.

The implementation of the aspects referred to in paragraph 1 shall be proportionate to thesize of the provider’s organisation. Providers shall, in any event, respect the degree ofrigour and the level of protection required to ensure the compliance of their high-risk AI
systems with this Regulation.

3.

Providers of high-risk AI systems that are subject to obligations regarding quality
management systems or an equivalent function under relevant sectoral Union law may
include the aspects listed in paragraph 1 as part of the quality management systems
pursuant to that law.

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4.

For providers that are financial institutions subject to requirements regarding their internal
governance, arrangements or processes under Union financial services law, the obligation
to put in place a quality management system, with the exception of paragraph 1,
points (g), (h) and (i) of this Article, shall be deemed to be fulfilled by complying with therules on internal governance arrangements or processes pursuant to the relevant Union
financial services law. To that end, any harmonised standards referred to in Article 40 shallbe taken into account.

Article 18
Documentation keeping
1.

The provider shall, for a period ending 10 years after the high-risk AI system has beenplaced on the market or put into service, keep at the disposal of the national competentauthorities:(a)the technical documentation referred to in Article 11;(b)

the documentation concerning the quality management system referred toin Article 17;(c)the documentation concerning the changes approved by notified bodies, whereapplicable;(d)the decisions and other documents issued by the notified bodies, where applicable;(e)the EU declaration of conformity referred to in Article 47.

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2.

Each Member State shall determine conditions under which the documentation referred toin paragraph 1 remains at the disposal of the national competent authorities for the period
indicated in that paragraph for the cases when a provider or its authorised representative
established on its territory goes bankrupt or ceases its activity prior to the end of that
period.

3.

Providers that are financial institutions subject to requirements regarding their internal
governance, arrangements or processes under Union financial services law shall maintainthe technical documentation as part of the documentation kept under the relevant Union
financial services law.

Article 19
Automatically generated logs
1.

Providers of high-risk AI systems shall keep the logs referred to in Article 12(1),automatically generated by their high-risk AI systems, to the extent such logs are under
their control. Without prejudice to applicable Union or national law, the logs shall be kept
for a period appropriate to the intended purpose of the high-risk AI system, of at least six
months, unless provided otherwise in the applicable Union or national law, in particular inUnion law on the protection of personal data.

2.

Providers that are financial institutions subject to requirements regarding their internal
governance, arrangements or processes under Union financial services law shall maintainthe logs automatically generated by their high-risk AI systems as part of the documentation
kept under the relevant financial services law.

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Article 20
Corrective actions and duty of information
1.

Providers of high-risk AI systems which consider or have reason to consider that ahigh-risk AI system that they have placed on the market or put into service is not in
conformity with this Regulation shall immediately take the necessary corrective actions tobring that system into conformity, to withdraw it, to disable it, or to recall it, as
appropriate. They shall inform the distributors of the high-risk AI system concerned and,
where applicable, the deployers, the authorised representative and importers accordingly.

2.

Where the high-risk AI system presents a risk within the meaning of Article 79(1) and theprovider becomes aware of that risk, it shall immediately investigate the causes, incollaboration with the reporting deployer, where applicable, and inform the market
surveillance authorities competent for the high-risk AI system concerned and, whereapplicable, the notified body that issued a certificate for that high-risk AI system inaccordance with Article 44, in particular, of the nature of the non-compliance and of any
relevant corrective action taken.

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Article 21
Cooperation with competent authorities
1.

Providers of high-risk AI systems shall, upon a reasoned request by a competent authority,
provide that authority all the information and documentation necessary to demonstrate theconformity of the high-risk AI system with the requirements set out in Section 2, in alanguage which can be easily understood by the authority in one of the official languagesof the institutions of the Union as indicated by the Member State concerned.

2.

Upon a reasoned request by a competent authority, providers shall also give the requesting
competent authority, as applicable, access to the automatically generated logs of thehigh-risk AI system referred to in Article 12(1), to the extent such logs are under theircontrol.

3.

Any information obtained by a competent authority pursuant to this Article shall be treatedin accordance with the confidentiality obligations set out in Article 78.

Article 22
Authorised representatives of providers of high-risk AI systems
1.

Prior to making their high-risk AI systems available on the Union market, providers
established in third countries shall, by written mandate, appoint an authorised
representative which is established in the Union.

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2.

The provider shall enable its authorised representative to perform the tasks specified in the
mandate received from the provider.

3.

The authorised representative shall perform the tasks specified in the mandate received
from the provider. It shall provide a copy of the mandate to the market surveillanceauthorities upon request, in one of the official languages of the institutions of the Union, as
indicated by the competent authority. For the purposes of this Regulation, the mandate
shall empower the authorised representative to carry out the following tasks:(a)verify that the EU declaration of conformity referred to in Article 47 and thetechnical documentation referred to in Article 11 have been drawn up and that an
appropriate conformity assessment procedure has been carried out by the provider;(b)keep at the disposal of the competent authorities and national authorities or bodies
referred to in Article 74(10), for a period of 10 years after the high-risk AI system
has been placed on the market or put into service, the contact details of the provider
that appointed the authorised representative, a copy of the EU declaration ofconformity referred to in Article 47, the technical documentation and, if applicable,
the certificate issued by the notified body;(c)provide a competent authority, upon a reasoned request, with all the information anddocumentation, including that referred to in point (b) of this subparagraph, necessary
to demonstrate the conformity of a high-risk AI system with the requirements set out
in Section 2, including access to the logs, as referred to in Article 12(1),automatically generated by the high-risk AI system, to the extent such logs are under
the control of the provider;

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(d)

cooperate with competent authorities, upon a reasoned request, in any action thelatter take in relation to the high-risk AI system, in particular to reduce and mitigate
the risks posed by the high-risk AI system;(e)where applicable, comply with the registration obligations referred to in
Article 49(1), or, if the registration is carried out by the provider itself, ensure thatthe information referred to in point 3 of Section A of Annex VIII is correct.

The mandate shall empower the authorised representative to be addressed, in addition to or
instead of the provider, by the competent authorities, on all issues related to ensuring
compliance with this Regulation.
4.

The authorised representative shall terminate the mandate if it considers or has reason toconsider the provider to be acting contrary to its obligations pursuant to this Regulation. In
such a case, it shall immediately inform the relevant market surveillance authority, as wellas, where applicable, the relevant notified body, about the termination of the mandate andthe reasons therefor.

Article 23
Obligations of importers
1.

Before placing a high-risk AI system on the market, importers shall ensure that the system
is in conformity with this Regulation by verifying that:(a)the relevant conformity assessment procedure referred to in Article 43 has been
carried out by the provider of the high-risk AI system;

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(b)

the provider has drawn up the technical documentation in accordance with Article 11
and Annex IV;(c)the system bears the required CE marking and is accompanied by the EU declarationof conformity referred to in Article 47 and instructions for use;(d)the provider has appointed an authorised representative in accordance with
Article 22(1).

2.

Where an importer has sufficient reason to consider that a high-risk AI system is not in
conformity with this Regulation, or is falsified, or accompanied by falsified
documentation, it shall not place the system on the market until it has been brought into
conformity. Where the high-risk AI system presents a risk within the meaning of
Article 79(1), the importer shall inform the provider of the system, the authorised
representative and the market surveillance authorities to that effect.

3.

Importers shall indicate their name, registered trade name or registered trade mark, and theaddress at which they can be contacted on the high-risk AI system and on its packaging or
its accompanying documentation, where applicable.

4.

Importers shall ensure that, while a high-risk AI system is under their responsibility,
storage or transport conditions, where applicable, do not jeopardise its compliance with therequirements set out in Section 2.

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5.

Importers shall keep, for a period of 10 years after the high-risk AI system has been placedon the market or put into service, a copy of the certificate issued by the notified body,where applicable, of the instructions for use, and of the EU declaration of conformity
referred to in Article 47.

6.

Importers shall provide the relevant competent authorities, upon a reasoned request, withall the necessary information and documentation, including that referred to in paragraph 5,
to demonstrate the conformity of a high-risk AI system with the requirements set out in
Section 2 in a language which can be easily understood by them. For this purpose, theyshall also ensure that the technical documentation can be made available to thoseauthorities.

7.

Importers shall cooperate with the relevant competent authorities in any action thoseauthorities take in relation to a high-risk AI system placed on the market by the importers,in particular to reduce and mitigate the risks posed by it.

Article 24
Obligations of distributors
1.

Before making a high-risk AI system available on the market, distributors shall verify thatit bears the required CE marking, that it is accompanied by a copy of the EU declaration ofconformity referred to in Article 47 and instructions for use, and that the provider and theimporter of that system, as applicable, have complied with their respective obligations aslaid down in Article 16, points (b) and (c) and Article 23(3).

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2.

Where a distributor considers or has reason to consider, on the basis of the information inits possession, that a high-risk AI system is not in conformity with the requirements set out
in Section 2, it shall not make the high-risk AI system available on the market until thesystem has been brought into conformity with those requirements. Furthermore, where thehigh-risk AI system presents a risk within the meaning of Article 79(1), the distributor
shall inform the provider or the importer of the system, as applicable, to that effect.

3.

Distributors shall ensure that, while a high-risk AI system is under their responsibility,
storage or transport conditions, where applicable, do not jeopardise the compliance of thesystem with the requirements set out in Section 2.

4.

A distributor that considers or has reason to consider, on the basis of the information in its
possession, a high-risk AI system which it has made available on the market not to be inconformity with the requirements set out in Section 2, shall take the corrective actions
necessary to bring that system into conformity with those requirements, to withdraw it orrecall it, or shall ensure that the provider, the importer or any relevant operator, as
appropriate, takes those corrective actions. Where the high-risk AI system presents a risk
within the meaning of Article 79(1), the distributor shall immediately inform the provider
or importer of the system and the authorities competent for the high-risk AI system
concerned, giving details, in particular, of the non-compliance and of any corrective
actions taken.

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5.

Upon a reasoned request from a relevant competent authority, distributors of a high-risk AI
system shall provide that authority with all the information and documentation regarding
their actions pursuant to paragraphs 1 to 4 necessary to demonstrate the conformity of thatsystem with the requirements set out in Section 2.

6.

Distributors shall cooperate with the relevant competent authorities in any action thoseauthorities take in relation to a high-risk AI system made available on the market by the
distributors, in particular to reduce or mitigate the risk posed by it.

Article 25
Responsibilities along the AI value chain
1.

Any distributor, importer, deployer or other third-party shall be considered to be a provider
of a high-risk AI system for the purposes of this Regulation and shall be subject to the
obligations of the provider under Article 16, in any of the following circumstances:(a)they put their name or trademark on a high-risk AI system already placed on themarket or put into service, without prejudice to contractual arrangements stipulatingthat the obligations are otherwise allocated;(b)

they make a substantial modification to a high-risk AI system that has already beenplaced on the market or has already been put into service in such a way that itremains a high-risk AI system pursuant to Article 6;

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(c)

they modify the intended purpose of an AI system, including a general-purpose AI
system, which has not been classified as high-risk and has already been placed on themarket or put into service in such a way that the AI system concerned becomes ahigh-risk AI system in accordance with Article 6.

2.

Where the circumstances referred to in paragraph 1 occur, the provider that initially placed
the AI system on the market or put it into service shall no longer be considered to be aprovider of that specific AI system for the purposes of this Regulation. That initial provider
shall closely cooperate with new providers and shall make available the necessary
information and provide the reasonably expected technical access and other assistance thatare required for the fulfilment of the obligations set out in this Regulation, in particularregarding the compliance with the conformity assessment of high-risk AI systems. This
paragraph shall not apply in cases where the initial provider has clearly specified that its AI
system is not to be changed into a high-risk AI system and therefore does not fall under the
obligation to hand over the documentation.

3.

In the case of high-risk AI systems that are safety components of products covered by theUnion harmonisation legislation listed in Section A of Annex I, the product manufacturer
shall be considered to be the provider of the high-risk AI system, and shall be subject to the
obligations under Article 16 under either of the following circumstances:(a)the high-risk AI system is placed on the market together with the product under thename or trademark of the product manufacturer;(b)the high-risk AI system is put into service under the name or trademark of the
product manufacturer after the product has been placed on the market.

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4.

The provider of a high-risk AI system and the third party that supplies an AI system, tools,
services, components, or processes that are used or integrated in a high-risk AI systemshall, by written agreement, specify the necessary information, capabilities, technicalaccess and other assistance based on the generally acknowledged state of the art, in orderto enable the provider of the high-risk AI system to fully comply with the obligations set
out in this Regulation. This paragraph shall not apply to third parties making accessible tothe public tools, services, processes, or components, other than general-purpose AI models,under a free and open-source licence.
The AI Office may develop and recommend voluntary model terms for contracts between
providers of high-risk AI systems and third parties that supply tools, services, components
or processes that are used for or integrated into high-risk AI systems. When developing
those voluntary model terms, the AI Office shall take into account possible contractual
requirements applicable in specific sectors or business cases. The voluntary model terms
shall be published and be available free of charge in an easily usable electronic format.

5.

Paragraphs 2 and 3 are without prejudice to the need to observe and protect intellectual
property rights, confidential business information and trade secrets in accordance with
Union and national law.

Article 26
Obligations of deployers of high-risk AI systems
1.

Deployers of high-risk AI systems shall take appropriate technical and organisational
measures to ensure they use such systems in accordance with the instructions for use
accompanying the systems, pursuant to paragraphs 3 and 6.

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2.

Deployers shall assign human oversight to natural persons who have the necessarycompetence, training and authority, as well as the necessary support.

3.

The obligations set out in paragraphs 1 and 2, are without prejudice to other deployer
obligations under Union or national law and to the deployer’s freedom to organise its own
resources and activities for the purpose of implementing the human oversight measuresindicated by the provider.

4.

Without prejudice to paragraphs 1 and 2, to the extent the deployer exercises control overthe input data, that deployer shall ensure that input data is relevant and sufficiently
representative in view of the intended purpose of the high-risk AI system.

5.

Deployers shall monitor the operation of the high-risk AI system on the basis of the
instructions for use and, where relevant, inform providers in accordance with Article 72.
Where deployers have reason to consider that the use of the high-risk AI system inaccordance with the instructions may result in that AI system presenting a risk within themeaning of Article 79(1), they shall, without undue delay, inform the provider or
distributor and the relevant market surveillance authority, and shall suspend the use of thatsystem. Where deployers have identified a serious incident, they shall also immediately
inform first the provider, and then the importer or distributor and the relevant market
surveillance authorities of that incident. If the deployer is not able to reach the provider,
Article 73 shall apply mutatis mutandis. This obligation shall not cover sensitive
operational data of deployers of AI systems which are law enforcement authorities.

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For deployers that are financial institutions subject to requirements regarding their internal
governance, arrangements or processes under Union financial services law, the monitoring
obligation set out in the first subparagraph shall be deemed to be fulfilled by complying
with the rules on internal governance arrangements, processes and mechanisms pursuant to
the relevant financial service law.
6.

Deployers of high-risk AI systems shall keep the logs automatically generated by thathigh-risk AI system to the extent such logs are under their control, for a period appropriate
to the intended purpose of the high-risk AI system, of at least six months, unless provided
otherwise in applicable Union or national law, in particular in Union law on the protectionof personal data.
Deployers that are financial institutions subject to requirements regarding their internal
governance, arrangements or processes under Union financial services law shall maintainthe logs as part of the documentation kept pursuant to the relevant Union financial service
law.

7.

Before putting into service or using a high-risk AI system at the workplace, deployers whoare employers shall inform workers’ representatives and the affected workers that they will
be subject to the use of the high-risk AI system. This information shall be provided, whereapplicable, in accordance with the rules and procedures laid down in Union and nationallaw and practice on information of workers and their representatives.

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8.

Deployers of high-risk AI systems that are public authorities, or Union institutions, bodies,
offices or agencies shall comply with the registration obligations referred to in Article 49.
When such deployers find that the high-risk AI system that they envisage using has notbeen registered in the EU database referred to in Article 71, they shall not use that systemand shall inform the provider or the distributor.

9.

Where applicable, deployers of high-risk AI systems shall use the information provided
under Article 13 of this Regulation to comply with their obligation to carry out a dataprotection impact assessment under Article 35 of Regulation (EU) 2016/679 or Article 27
of Directive (EU) 2016/680.

10.

Without prejudice to Directive (EU) 2016/680, in the framework of an investigation for thetargeted search of a person suspected or convicted of having committed a criminal offence,the deployer of a high-risk AI system for post-remote biometric identification shall request
an authorisation, ex ante, or without undue delay and no later than 48 hours, by a judicial
authority or an administrative authority whose decision is binding and subject to judicial
review, for the use of that system, except when it is used for the initial identification of apotential suspect based on objective and verifiable facts directly linked to the offence. Eachuse shall be limited to what is strictly necessary for the investigation of a specific criminal
offence.
If the authorisation requested pursuant to the first subparagraph is rejected, the use of the
post-remote biometric identification system linked to that requested authorisation shall be
stopped with immediate effect and the personal data linked to the use of the high-risk AI
system for which the authorisation was requested shall be deleted.

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In no case shall such high-risk AI system for post-remote biometric identification be used
for law enforcement purposes in an untargeted way, without any link to a criminal offence,a criminal proceeding, a genuine and present or genuine and foreseeable threat of acriminal offence, or the search for a specific missing person. It shall be ensured that nodecision that produces an adverse legal effect on a person may be taken by the law
enforcement authorities based solely on the output of such post-remote biometricidentification systems.
This paragraph is without prejudice to Article 9 of Regulation (EU) 2016/679 andArticle 10 of Directive (EU) 2016/680 for the processing of biometric data.
Regardless of the purpose or deployer, each use of such high-risk AI systems shall be
documented in the relevant police file and shall be made available to the relevant market
surveillance authority and the national data protection authority upon request, excluding
the disclosure of sensitive operational data related to law enforcement. This subparagraphshall be without prejudice to the powers conferred by Directive (EU) 2016/680 onsupervisory authorities.
Deployers shall submit annual reports to the relevant market surveillance and national dataprotection authorities on their use of post-remote biometric identification systems,
excluding the disclosure of sensitive operational data related to law enforcement. The
reports may be aggregated to cover more than one deployment.
Member States may introduce, in accordance with Union law, more restrictive laws on theuse of post-remote biometric identification systems.

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11.

Without prejudice to Article 50 of this Regulation, deployers of high-risk AI systems
referred to in Annex III that make decisions or assist in making decisions related to natural
persons shall inform the natural persons that they are subject to the use of the high-risk AI
system. For high-risk AI systems used for law enforcement purposes Article 13 of
Directive (EU) 2016/680 shall apply.

12.

Deployers shall cooperate with the relevant competent authorities in any action thoseauthorities take in relation to the high-risk AI system in order to implement
this Regulation.

Article 27
Fundamental rights impact assessment for high-risk AI systems
1.

Prior to deploying a high-risk AI system referred to in Article 6(2), with the exception ofhigh-risk AI systems intended to be used in the area listed in point 2 of Annex III,
deployers that are bodies governed by public law, or are private entities providing public
services, and deployers of high-risk AI systems referred to in points 5 (b) and (c) of
Annex III, shall perform an assessment of the impact on fundamental rights that the use ofsuch system may produce. For that purpose, deployers shall perform an assessment
consisting of:(a)a description of the deployer’s processes in which the high-risk AI system will be
used in line with its intended purpose;(b)a description of the period of time within which, and the frequency with which, eachhigh-risk AI system is intended to be used;

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(c)

the categories of natural persons and groups likely to be affected by its use in thespecific context;(d)the specific risks of harm likely to have an impact on the categories of natural
persons or groups of persons identified pursuant to point (c) of this paragraph, taking
into account the information given by the provider pursuant to Article 13;(e)a description of the implementation of human oversight measures, according to the
instructions for use;(f)the measures to be taken in the case of the materialisation of those risks, including
the arrangements for internal governance and complaint mechanisms.

2.

The obligation laid down in paragraph 1 applies to the first use of the high-risk AI system.
The deployer may, in similar cases, rely on previously conducted fundamental rights
impact assessments or existing impact assessments carried out by provider. If, during theuse of the high-risk AI system, the deployer considers that any of the elements listed inparagraph 1 has changed or is no longer up to date, the deployer shall take the necessary
steps to update the information.

3.

Once the assessment referred to in paragraph 1 of this Article has been performed, thedeployer shall notify the market surveillance authority of its results, submitting thefilled-out template referred to in paragraph 5 of this Article as part of the notification. In
the case referred to in Article 46(1), deployers may be exempt from that obligation to
notify.

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4.

If any of the obligations laid down in this Article is already met through the data protection
impact assessment conducted pursuant to Article 35 of Regulation (EU) 2016/679 or
Article 27 of Directive (EU) 2016/680, the fundamental rights impact assessment referred
to in paragraph 1 of this Article shall complement that data protection impact assessment.

5.

The AI Office shall develop a template for a questionnaire, including through an automatedtool, to facilitate deployers in complying with their obligations under this Article in a
simplified manner.

SECTION 4
NOTIFYING AUTHORITIES AND NOTIFIED BODIESArticle 28
Notifying authorities
1.

Each Member State shall designate or establish at least one notifying authority responsible
for setting up and carrying out the necessary procedures for the assessment, designationand notification of conformity assessment bodies and for their monitoring. Those
procedures shall be developed in cooperation between the notifying authorities of all
Member States.

2.

Member States may decide that the assessment and monitoring referred to in paragraph 1 isto be carried out by a national accreditation body within the meaning of, and in accordance
with, Regulation (EC) No 765/2008.

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3.

Notifying authorities shall be established, organised and operated in such a way that noconflict of interest arises with conformity assessment bodies, and that the objectivity andimpartiality of their activities are safeguarded.

4.

Notifying authorities shall be organised in such a way that decisions relating to thenotification of conformity assessment bodies are taken by competent persons different
from those who carried out the assessment of those bodies.

5.

Notifying authorities shall offer or provide neither any activities that conformity
assessment bodies perform, nor any consultancy services on a commercial or competitive
basis.

6.

Notifying authorities shall safeguard the confidentiality of the information that they obtain,in accordance with Article 78.

7.

Notifying authorities shall have an adequate number of competent personnel at theirdisposal for the proper performance of their tasks. Competent personnel shall have thenecessary expertise, where applicable, for their function, in fields such as information
technologies, AI and law, including the supervision of fundamental rights.

Article 29
Application of a conformity assessment body for notification
1.

Conformity assessment bodies shall submit an application for notification to the notifying
authority of the Member State in which they are established.

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2.

The application for notification shall be accompanied by a description of the conformity
assessment activities, the conformity assessment module or modules and the types of AI
systems for which the conformity assessment body claims to be competent, as well as byan accreditation certificate, where one exists, issued by a national accreditation bodyattesting that the conformity assessment body fulfils the requirements laid down in
Article 31.
Any valid document related to existing designations of the applicant notified body under
any other Union harmonisation legislation shall be added.

3.

Where the conformity assessment body concerned cannot provide an accreditation
certificate, it shall provide the notifying authority with all the documentary evidence
necessary for the verification, recognition and regular monitoring of its compliance withthe requirements laid down in Article 31.

4.

For notified bodies which are designated under any other Union harmonisation legislation,
all documents and certificates linked to those designations may be used to support theirdesignation procedure under this Regulation, as appropriate. The notified body shall update
the documentation referred to in paragraphs 2 and 3 of this Article whenever relevantchanges occur, in order to enable the authority responsible for notified bodies to monitor
and verify continuous compliance with all the requirements laid down in Article 31.

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Article 30
Notification procedure1.

Notifying authorities may notify only conformity assessment bodies which have satisfied
the requirements laid down in Article 31.

2.

Notifying authorities shall notify the Commission and the other Member States, using theelectronic notification tool developed and managed by the Commission, of eachconformity assessment body referred to in paragraph 1.

3.

The notification referred to in paragraph 2 of this Article shall include full details of theconformity assessment activities, the conformity assessment module or modules, the typesof AI systems concerned, and the relevant attestation of competence. Where a notification
is not based on an accreditation certificate as referred to in Article 29(2), the notifying
authority shall provide the Commission and the other Member States with documentary
evidence which attests to the competence of the conformity assessment body and to thearrangements in place to ensure that that body will be monitored regularly and willcontinue to satisfy the requirements laid down in Article 31.

4.

The conformity assessment body concerned may perform the activities of a notified body
only where no objections are raised by the Commission or the other Member States within
two weeks of a notification by a notifying authority where it includes an accreditation
certificate referred to in Article 29(2), or within two months of a notification by the
notifying authority where it includes documentary evidence referred to in Article 29(3).

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5.

Where objections are raised, the Commission shall, without delay, enter into consultations
with the relevant Member States and the conformity assessment body. In view thereof, theCommission shall decide whether the authorisation is justified. The Commission shalladdress its decision to the Member State concerned and to the relevant conformity
assessment body.

Article 31
Requirements relating to notified bodies
1.

A notified body shall be established under the national law of a Member State and shallhave legal personality.

2.

Notified bodies shall satisfy the organisational, quality management, resources and process
requirements that are necessary to fulfil their tasks, as well as suitable cybersecurity
requirements.

3.

The organisational structure, allocation of responsibilities, reporting lines and operation of
notified bodies shall ensure confidence in their performance, and in the results of theconformity assessment activities that the notified bodies conduct.

4.

Notified bodies shall be independent of the provider of a high-risk AI system in relation towhich they perform conformity assessment activities. Notified bodies shall also be
independent of any other operator having an economic interest in high-risk AI systems
assessed, as well as of any competitors of the provider. This shall not preclude the use of
assessed high-risk AI systems that are necessary for the operations of the conformity
assessment body, or the use of such high-risk AI systems for personal purposes.

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5.

Neither a conformity assessment body, its top-level management nor the personnel
responsible for carrying out its conformity assessment tasks shall be directly involved in
the design, development, marketing or use of high-risk AI systems, nor shall they represent
the parties engaged in those activities. They shall not engage in any activity that might
conflict with their independence of judgement or integrity in relation to conformity
assessment activities for which they are notified. This shall, in particular, apply to
consultancy services.

6.

Notified bodies shall be organised and operated so as to safeguard the independence,
objectivity and impartiality of their activities. Notified bodies shall document andimplement a structure and procedures to safeguard impartiality and to promote and apply
the principles of impartiality throughout their organisation, personnel and assessment
activities.

7.

Notified bodies shall have documented procedures in place ensuring that their personnel,
committees, subsidiaries, subcontractors and any associated body or personnel of externalbodies maintain, in accordance with Article 78, the confidentiality of the information
which comes into their possession during the performance of conformity assessment
activities, except when its disclosure is required by law. The staff of notified bodies shallbe bound to observe professional secrecy with regard to all information obtained incarrying out their tasks under this Regulation, except in relation to the notifying authoritiesof the Member State in which their activities are carried out.

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8.

Notified bodies shall have procedures for the performance of activities which take due
account of the size of a provider, the sector in which it operates, its structure, and thedegree of complexity of the AI system concerned.

9.

Notified bodies shall take out appropriate liability insurance for their conformity
assessment activities, unless liability is assumed by the Member State in which they are
established in accordance with national law or that Member State is itself directly
responsible for the conformity assessment.

10.

Notified bodies shall be capable of carrying out all their tasks under this Regulation withthe highest degree of professional integrity and the requisite competence in the specificfield, whether those tasks are carried out by notified bodies themselves or on their behalf
and under their responsibility.

11.

Notified bodies shall have sufficient internal competences to be able effectively to evaluate
the tasks conducted by external parties on their behalf. The notified body shall havepermanent availability of sufficient administrative, technical, legal and scientific personnel
who possess experience and knowledge relating to the relevant types of AI systems, data
and data computing, and relating to the requirements set out in Section 2.

12.

Notified bodies shall participate in coordination activities as referred to in Article 38. They
shall also take part directly, or be represented in, European standardisation organisations,or ensure that they are aware and up to date in respect of relevant standards.

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Article 32
Presumption of conformity with requirements relating to notified bodies
Where a conformity assessment body demonstrates its conformity with the criteria laid down in therelevant harmonised standards or parts thereof, the references of which have been published in the
Official Journal of the European Union, it shall be presumed to comply with the requirements set
out in Article 31 in so far as the applicable harmonised standards cover those requirements.

Article 33
Subsidiaries of notified bodies and subcontracting
1.

Where a notified body subcontracts specific tasks connected with the conformity
assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or thesubsidiary meets the requirements laid down in Article 31, and shall inform the notifying
authority accordingly.

2.

Notified bodies shall take full responsibility for the tasks performed by any subcontractors
or subsidiaries.

3.

Activities may be subcontracted or carried out by a subsidiary only with the agreement of
the provider. Notified bodies shall make a list of their subsidiaries publicly available.

4.

The relevant documents concerning the assessment of the qualifications of thesubcontractor or the subsidiary and the work carried out by them under this Regulation
shall be kept at the disposal of the notifying authority for a period of five years from thetermination date of the subcontracting.

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Article 34
Operational obligations of notified bodies
1.

Notified bodies shall verify the conformity of high-risk AI systems in accordance with theconformity assessment procedures set out in Article 43.

2.

Notified bodies shall avoid unnecessary burdens for providers when performing theiractivities, and take due account of the size of the provider, the sector in which it operates,
its structure and the degree of complexity of the high-risk AI system concerned, inparticular in view of minimising administrative burdens and compliance costs for
micro- and small enterprises within the meaning of Recommendation 2003/361/EC. The
notified body shall, nevertheless, respect the degree of rigour and the level of protection
required for the compliance of the high-risk AI system with the requirements of thisRegulation.

3.

Notified bodies shall make available and submit upon request all relevant documentation,
including the providers’ documentation, to the notifying authority referred to in Article 28
to allow that authority to conduct its assessment, designation, notification and monitoring
activities, and to facilitate the assessment outlined in this Section.

Article 35
Identification numbers and lists of notified bodies
1.

The Commission shall assign a single identification number to each notified body, even
where a body is notified under more than one Union act.

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2.

The Commission shall make publicly available the list of the bodies notified under thisRegulation, including their identification numbers and the activities for which they havebeen notified. The Commission shall ensure that the list is kept up to date.

Article 36
Changes to notifications
1.

The notifying authority shall notify the Commission and the other Member States of any
relevant changes to the notification of a notified body via the electronic notification toolreferred to in Article 30(2).

2.

The procedures laid down in Articles 29 and 30 shall apply to extensions of the scope ofthe notification.
For changes to the notification other than extensions of its scope, the procedures laid downin paragraphs (3) to (9) shall apply.

3.

Where a notified body decides to cease its conformity assessment activities, it shall informthe notifying authority and the providers concerned as soon as possible and, in the case of aplanned cessation, at least one year before ceasing its activities. The certificates of thenotified body may remain valid for a period of nine months after cessation of the notified
body’s activities, on condition that another notified body has confirmed in writing that it
will assume responsibilities for the high-risk AI systems covered by those certificates. The
latter notified body shall complete a full assessment of the high-risk AI systems affected by
the end of that nine-month-period before issuing new certificates for those systems. Where
the notified body has ceased its activity, the notifying authority shall withdraw thedesignation.

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4.

Where a notifying authority has sufficient reason to consider that a notified body no longer
meets the requirements laid down in Article 31, or that it is failing to fulfil its obligations,the notifying authority shall without delay investigate the matter with the utmost diligence.
In that context, it shall inform the notified body concerned about the objections raised andgive it the possibility to make its views known. If the notifying authority comes to theconclusion that the notified body no longer meets the requirements laid down in Article 31
or that it is failing to fulfil its obligations, it shall restrict, suspend or withdraw thedesignation as appropriate, depending on the seriousness of the failure to meet thoserequirements or fulfil those obligations. It shall immediately inform the Commission andthe other Member States accordingly.

5.

Where its designation has been suspended, restricted, or fully or partially withdrawn, thenotified body shall inform the providers concerned within 10 days.

6.

In the event of the restriction, suspension or withdrawal of a designation, the notifying
authority shall take appropriate steps to ensure that the files of the notified body concerned
are kept, and to make them available to notifying authorities in other Member States and tomarket surveillance authorities at their request.

7.

In the event of the restriction, suspension or withdrawal of a designation, the notifying
authority shall:(a)assess the impact on the certificates issued by the notified body;(b)submit a report on its findings to the Commission and the other Member States
within three months of having notified the changes to the designation;

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(c)

require the notified body to suspend or withdraw, within a reasonable period of time
determined by the authority, any certificates which were unduly issued, in order toensure the continuing conformity of high-risk AI systems on the market;(d)inform the Commission and the Member States about certificates the suspension orwithdrawal of which it has required;(e)provide the national competent authorities of the Member State in which the provider
has its registered place of business with all relevant information about the certificatesof which it has required the suspension or withdrawal; that authority shall take theappropriate measures, where necessary, to avoid a potential risk to health, safety or
fundamental rights.

8.

With the exception of certificates unduly issued, and where a designation has beensuspended or restricted, the certificates shall remain valid in one of the following
circumstances:(a)the notifying authority has confirmed, within one month of the suspension or
restriction, that there is no risk to health, safety or fundamental rights in relation tocertificates affected by the suspension or restriction, and the notifying authority hasoutlined a timeline for actions to remedy the suspension or restriction; or

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(b)

the notifying authority has confirmed that no certificates relevant to the suspension
will be issued, amended or re-issued during the course of the suspension or
restriction, and states whether the notified body has the capability of continuing tomonitor and remain responsible for existing certificates issued for the period of thesuspension or restriction; in the event that the notifying authority determines that the
notified body does not have the capability to support existing certificates issued, theprovider of the system covered by the certificate shall confirm in writing to thenational competent authorities of the Member State in which it has its registeredplace of business, within three months of the suspension or restriction, that anotherqualified notified body is temporarily assuming the functions of the notified body tomonitor and remain responsible for the certificates during the period of suspension or
restriction.

9.

With the exception of certificates unduly issued, and where a designation has been
withdrawn, the certificates shall remain valid for a period of nine months under thefollowing circumstances:(a)the national competent authority of the Member State in which the provider of thehigh-risk AI system covered by the certificate has its registered place of business has
confirmed that there is no risk to health, safety or fundamental rights associated withthe high-risk AI systems concerned; and(b)another notified body has confirmed in writing that it will assume immediate
responsibility for those AI systems and completes its assessment within 12 months of
the withdrawal of the designation.

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In the circumstances referred to in the first subparagraph, the national competent authorityof the Member State in which the provider of the system covered by the certificate has its
place of business may extend the provisional validity of the certificates for additional
periods of three months, which shall not exceed 12 months in total.
The national competent authority or the notified body assuming the functions of thenotified body affected by the change of designation shall immediately inform theCommission, the other Member States and the other notified bodies thereof.

Article 37
Challenge to the competence of notified bodies
1.

The Commission shall, where necessary, investigate all cases where there are reasons to
doubt the competence of a notified body or the continued fulfilment by a notified body of
the requirements laid down in Article 31 and of its applicable responsibilities.

2.

The notifying authority shall provide the Commission, on request, with all relevant
information relating to the notification or the maintenance of the competence of thenotified body concerned.

3.

The Commission shall ensure that all sensitive information obtained in the course of its
investigations pursuant to this Article is treated confidentially in accordancewith Article 78.

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4.

Where the Commission ascertains that a notified body does not meet or no longer meetsthe requirements for its notification, it shall inform the notifying Member State accordingly
and request it to take the necessary corrective measures, including the suspension orwithdrawal of the notification if necessary. Where the Member State fails to take thenecessary corrective measures, the Commission may, by means of an implementing act,
suspend, restrict or withdraw the designation. That implementing act shall be adopted inaccordance with the examination procedure referred to in Article 98(2).

Article 38
Coordination of notified bodies
1.

The Commission shall ensure that, with regard to high-risk AI systems, appropriate
coordination and cooperation between notified bodies active in the conformity assessment
procedures pursuant to this Regulation are put in place and properly operated in the formof a sectoral group of notified bodies.

2.

Each notifying authority shall ensure that the bodies notified by it participate in the workof a group referred to in paragraph 1, directly or through designated representatives.

3.

The Commission shall provide for the exchange of knowledge and best practices between
notifying authorities.

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Article 39
Conformity assessment bodies of third countries
Conformity assessment bodies established under the law of a third country with which the Union
has concluded an agreement may be authorised to carry out the activities of notified bodies under
this Regulation, provided that they meet the requirements laid down in Article 31 or they ensure an
equivalent level of compliance.

SECTION 5
STANDARDS, CONFORMITY ASSESSMENT, CERTIFICATES, REGISTRATION

Article 40
Harmonised standards and standardisation deliverables
1.

High-risk AI systems or general-purpose AI models which are in conformity withharmonised standards or parts thereof the references of which have been published in the
Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012
shall be presumed to be in conformity with the requirements set out in Section 2 of this
Chapter or, as applicable, with the obligations set out in of Chapter V, Sections 2 and 3, of
this Regulation, to the extent that those standards cover those requirements or obligations.

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2.

In accordance with Article 10 of Regulation (EU) (No) 1025/2012, the Commission shallissue, without undue delay, standardisation requests covering all requirements set out in
Section 2 of this Chapter and, as applicable, standardisation requests covering obligations
set out in Chapter V, Sections 2 and 3, of this Regulation. The standardisation request shallalso ask for deliverables on reporting and documentation processes to improve AI systems’
resource performance, such as reducing the high-risk AI system’s consumption of energy
and of other resources during its lifecycle, and on the energy-efficient development ofgeneral-purpose AI models. When preparing a standardisation request, the Commission
shall consult the Board and relevant stakeholders, including the advisory forum.
When issuing a standardisation request to European standardisation organisations, theCommission shall specify that standards have to be clear, consistent, including with thestandards developed in the various sectors for products covered by the existing Union
harmonisation legislation listed in Annex I, and aiming to ensure that high-risk AI systems
or general-purpose AI models placed on the market or put into service in the Union meetthe relevant requirements or obligations laid down in this Regulation.
The Commission shall request the European standardisation organisations to provide
evidence of their best efforts to fulfil the objectives referred to in the first and the second
subparagraph of this paragraph in accordance with Article 24 ofRegulation (EU) No 1025/2012.

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3.

The participants in the standardisation process shall seek to promote investment andinnovation in AI, including through increasing legal certainty, as well as thecompetitiveness and growth of the Union market, to contribute to strengthening global
cooperation on standardisation and taking into account existing international standards inthe field of AI that are consistent with Union values, fundamental rights and interests, andto enhance multi-stakeholder governance ensuring a balanced representation of interests
and the effective participation of all relevant stakeholders in accordance with Articles 5, 6,
and 7 of Regulation (EU) No 1025/2012.

Article 41
Common specifications
1.

The Commission may adopt, implementing acts establishing common specifications for therequirements set out in Section 2 of this Chapter or, as applicable, for the obligations set
out in Sections 2 and 3 of Chapter V where the following conditions have been fulfilled:(a)the Commission has requested, pursuant to Article 10(1) of Regulation(EU) No 1025/2012, one or more European standardisation organisations to draft a
harmonised standard for the requirements set out in Section 2 of this Chapter, or, as
applicable, for the obligations set out in Sections 2 and 3 of Chapter V, and:(i)the request has not been accepted by any of the European standardisation
organisations; or

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(ii)

the harmonised standards addressing that request are not delivered within thedeadline set in accordance with Article 10(1) ofRegulation (EU) No 1025/2012; or(iii) the relevant harmonised standards insufficiently address fundamental rights
concerns; or(iv) the harmonised standards do not comply with the request; and(b)no reference to harmonised standards covering the requirements referred to in
Section 2 of this Chapter or, as applicable, the obligations referred to in Sections 2
and 3 of Chapter V has been published in the Official Journal of the European Unionin accordance with Regulation (EU) No 1025/2012, and no such reference is
expected to be published within a reasonable period.

When drafting the common specifications, the Commission shall consult the advisory
forum referred to in Article 67.
The implementing acts referred to in the first subparagraph of this paragraph shall be
adopted in accordance with the examination procedure referred to in Article 98(2).
2.

Before preparing a draft implementing act, the Commission shall inform the committee
referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers the conditions
laid down in paragraph 1 of this Article to be fulfilled.

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3.

High-risk AI systems or general-purpose AI models which are in conformity with thecommon specifications referred to in paragraph 1, or parts of those specifications, shall be
presumed to be in conformity with the requirements set out in Section 2of this Chapter or,
as applicable, to comply with the obligations referred to in Sections 2 and 3 of Chapter V,
to the extent those common specifications cover those requirements or those obligations.

4.

Where a harmonised standard is adopted by a European standardisation organisation andproposed to the Commission for the publication of its reference in the Official Journal of
the European Union, the Commission shall assess the harmonised standard in accordancewith Regulation (EU) No 1025/2012. When reference to a harmonised standard is
published in the Official Journal of the European Union, the Commission shall repeal theimplementing acts referred to in paragraph 1, or parts thereof which cover the samerequirements set out in Section 2 of this Chapter or, as applicable, the same obligations set
out in Sections 2 and 3 of Chapter V.

5.

Where providers of high-risk AI systems or general-purpose AI models do not comply
with the common specifications referred to in paragraph 1, they shall duly justify that they
have adopted technical solutions that meet the requirements referred to in Section 2 of this
Chapter or, as applicable, comply with the obligations set out in Sections 2 and 3 ofChapter V to a level at least equivalent thereto.

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6.

Where a Member State considers that a common specification does not entirely meet therequirements set out in Section 2 or, as applicable, comply with obligations set out in
Sections 2 and 3 of Chapter V, it shall inform the Commission thereof with a detailed
explanation. The Commission shall assess that information and, if appropriate, amend theimplementing act establishing the common specification concerned.

Article 42
Presumption of conformity with certain requirements
1.

High-risk AI systems that have been trained and tested on data reflecting the specificgeographical, behavioural, contextual or functional setting within which they are intended
to be used shall be presumed to comply with the relevant requirements laid downin Article 10(4).

2.

High-risk AI systems that have been certified or for which a statement of conformity has
been issued under a cybersecurity scheme pursuant to Regulation (EU) 2019/881 and thereferences of which have been published in the Official Journal of the European Union
shall be presumed to comply with the cybersecurity requirements set out in Article 15 ofthis Regulation in so far as the cybersecurity certificate or statement of conformity or parts
thereof cover those requirements.

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Article 43
Conformity assessment1.

For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating thecompliance of a high-risk AI system with the requirements set out in Section 2, theprovider has applied harmonised standards referred to in Article 40, or, where applicable,
common specifications referred to in Article 41, the provider shall opt for one of thefollowing conformity assessment procedures based on:(a)the internal control referred to in Annex VI; or(b)

the assessment of the quality management system and the assessment of the technicaldocumentation, with the involvement of a notified body, referred to in Annex VII.

In demonstrating the compliance of a high-risk AI system with the requirements set out in
Section 2, the provider shall follow the conformity assessment procedure set out inAnnex VII where:(a)harmonised standards referred to in Article 40 do not exist, and common
specifications referred to in Article 41 are not available;(b)the provider has not applied, or has applied only part of, the harmonised standard;(c)the common specifications referred to in point (a) exist, but the provider has notapplied them;

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(d)

one or more of the harmonised standards referred to in point (a) has been publishedwith a restriction, and only on the part of the standard that was restricted.

For the purposes of the conformity assessment procedure referred to in Annex VII, theprovider may choose any of the notified bodies. However, where the high-risk AI system isintended to be put into service by law enforcement, immigration or asylum authorities orby Union institutions, bodies, offices or agencies, the market surveillance authority
referred to in Article 74(8) or (9), as applicable, shall act as a notified body.
2.

For high-risk AI systems referred to in points 2 to 8 of Annex III, providers shall follow
the conformity assessment procedure based on internal control as referred to in Annex VI,
which does not provide for the involvement of a notified body.

3.

For high-risk AI systems covered by the Union harmonisation legislation listed in
Section A of Annex I, the provider shall follow the relevant conformity assessment
procedure as required under those legal acts. The requirements set out in Section 2 of this
Chapter shall apply to those high-risk AI systems and shall be part of that assessment.
Points 4.3., 4.4., 4.5. and the fifth paragraph of point 4.6 of Annex VII shall also apply.
For the purposes of that assessment, notified bodies which have been notified under thoselegal acts shall be entitled to control the conformity of the high-risk AI systems with therequirements set out in Section 2, provided that the compliance of those notified bodies
with requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in thecontext of the notification procedure under those legal acts.

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Where a legal act listed in Section A of Annex I enables the product manufacturer to opt
out from a third-party conformity assessment, provided that that manufacturer has applied
all harmonised standards covering all the relevant requirements, that manufacturer may usethat option only if it has also applied harmonised standards or, where applicable, common
specifications referred to in Article 41, covering all requirements set out in Section 2 ofthis Chapter.
4.

High-risk AI systems that have already been subject to a conformity assessment procedure
shall undergo a new conformity assessment procedure in the event of a substantial
modification, regardless of whether the modified system is intended to be further
distributed or continues to be used by the current deployer.
For high-risk AI systems that continue to learn after being placed on the market or put into
service, changes to the high-risk AI system and its performance that have been
pre-determined by the provider at the moment of the initial conformity assessment and arepart of the information contained in the technical documentation referred to in point 2(f) ofAnnex IV, shall not constitute a substantial modification.

5.

The Commission is empowered to adopt delegated acts in accordance with Article 97 inorder to amend Annexes VI and VII by updating them in light of technical progress.

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6.

The Commission is empowered to adopt delegated acts in accordance with Article 97 inorder to amend paragraphs 1 and 2 of this Article in order to subject high-risk AI systems
referred to in points 2 to 8 of Annex III to the conformity assessment procedure referred toin Annex VII or parts thereof. The Commission shall adopt such delegated acts taking into
account the effectiveness of the conformity assessment procedure based on internal control
referred to in Annex VI in preventing or minimising the risks to health and safety andprotection of fundamental rights posed by such systems, as well as the availability ofadequate capacities and resources among notified bodies.

Article 44
Certificates
1.

Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in alanguage which can be easily understood by the relevant authorities in the Member State inwhich the notified body is established.

2.

Certificates shall be valid for the period they indicate, which shall not exceed five years forAI systems covered by Annex I, and four years for AI systems covered by Annex III. At
the request of the provider, the validity of a certificate may be extended for further periods,
each not exceeding five years for AI systems covered by Annex I, and four years for AI
systems covered by Annex III, based on a re-assessment in accordance with the applicableconformity assessment procedures. Any supplement to a certificate shall remain valid,
provided that the certificate which it supplements is valid.

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3.

Where a notified body finds that an AI system no longer meets the requirements set out in
Section 2, it shall, taking account of the principle of proportionality, suspend or withdraw
the certificate issued or impose restrictions on it, unless compliance with thoserequirements is ensured by appropriate corrective action taken by the provider of thesystem within an appropriate deadline set by the notified body. The notified body shallgive reasons for its decision.
An appeal procedure against decisions of the notified bodies, including on conformity
certificates issued, shall be available.

Article 45
Information obligations of notified bodies
1.

Notified bodies shall inform the notifying authority of the following:(a)any Union technical documentation assessment certificates, any supplements to thosecertificates, and any quality management system approvals issued in accordance withthe requirements of Annex VII;(b)

any refusal, restriction, suspension or withdrawal of a Union technicaldocumentation assessment certificate or a quality management system approvalissued in accordance with the requirements of Annex VII;(c)

any circumstances affecting the scope of or conditions for notification;

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(d)

any request for information which they have received from market surveillanceauthorities regarding conformity assessment activities;(e)on request, conformity assessment activities performed within the scope of theirnotification and any other activity performed, including cross-border activities andsubcontracting.

2.

Each notified body shall inform the other notified bodies of:(a)quality management system approvals which it has refused, suspended or withdrawn,
and, upon request, of quality system approvals which it has issued;(b)Union technical documentation assessment certificates or any supplements thereto
which it has refused, withdrawn, suspended or otherwise restricted, and, uponrequest, of the certificates and/or supplements thereto which it has issued.

3.

Each notified body shall provide the other notified bodies carrying out similar conformity
assessment activities covering the same types of AI systems with relevant information on
issues relating to negative and, on request, positive conformity assessment results.

4.

Notified bodies shall safeguard the confidentiality of the information that they obtain, in
accordance with Article 78.

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Article 46
Derogation from conformity assessment procedure1.

By way of derogation from Article 43 and upon a duly justified request, any market
surveillance authority may authorise the placing on the market or the putting into service ofspecific high-risk AI systems within the territory of the Member State concerned, for
exceptional reasons of public security or the protection of life and health of persons,environmental protection or the protection of key industrial and infrastructural assets. Thatauthorisation shall be for a limited period while the necessary conformity assessment
procedures are being carried out, taking into account the exceptional reasons justifying thederogation. The completion of those procedures shall be undertaken without undue delay.

2.

In a duly justified situation of urgency for exceptional reasons of public security or in thecase of specific, substantial and imminent threat to the life or physical safety of natural
persons, law-enforcement authorities or civil protection authorities may put a specifichigh-risk AI system into service without the authorisation referred to in paragraph 1,
provided that such authorisation is requested during or after the use without undue delay. If
the authorisation referred to in paragraph 1 is refused, the use of the high-risk AI systemshall be stopped with immediate effect and all the results and outputs of such use shall be
immediately discarded.

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3.

The authorisation referred to in paragraph 1 shall be issued only if the market surveillanceauthority concludes that the high-risk AI system complies with the requirements ofSection 2. The market surveillance authority shall inform the Commission and the otherMember States of any authorisation issued pursuant to paragraphs 1 and 2. This obligation
shall not cover sensitive operational data in relation to the activities of law-enforcement
authorities.

4.

Where, within 15 calendar days of receipt of the information referred to in paragraph 3, noobjection has been raised by either a Member State or the Commission in respect of an
authorisation issued by a market surveillance authority of a Member State in accordancewith paragraph 1, that authorisation shall be deemed justified.

5.

Where, within 15 calendar days of receipt of the notification referred to in paragraph 3,
objections are raised by a Member State against an authorisation issued by a market
surveillance authority of another Member State, or where the Commission considers theauthorisation to be contrary to Union law, or the conclusion of the Member States
regarding the compliance of the system as referred to in paragraph 3 to be unfounded, theCommission shall, without delay, enter into consultations with the relevant Member State.
The operators concerned shall be consulted and have the possibility to present their views.
Having regard thereto, the Commission shall decide whether the authorisation is justified.
The Commission shall address its decision to the Member State concerned and to therelevant operators.

6.

Where the Commission considers the authorisation unjustified, it shall be withdrawn by themarket surveillance authority of the Member State concerned.

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7.

For high-risk AI systems related to products covered by Union harmonisation legislation
listed in Section A of Annex I, only the derogations from the conformity assessment
established in that Union harmonisation legislation shall apply.

Article 47
EU declaration of conformity
1.

The provider shall draw up a written machine readable, physical or electronically signed
EU declaration of conformity for each high-risk AI system, and keep it at the disposal of
the national competent authorities for 10 years after the high-risk AI system has beenplaced on the market or put into service. The EU declaration of conformity shall identify
the high-risk AI system for which it has been drawn up. A copy of the EU declaration ofconformity shall be submitted to the relevant national competent authorities upon request.

2.

The EU declaration of conformity shall state that the high-risk AI system concerned meetsthe requirements set out in Section 2. The EU declaration of conformity shall contain theinformation set out in Annex V, and shall be translated into a language that can be easily
understood by the national competent authorities of the Member States in which thehigh-risk AI system is placed on the market or made available.

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3.

Where high-risk AI systems are subject to other Union harmonisation legislation which
also requires an EU declaration of conformity, a single EU declaration of conformity shallbe drawn up in respect of all Union law applicable to the high-risk AI system. The
declaration shall contain all the information required to identify the Union harmonisation
legislation to which the declaration relates.

4.

By drawing up the EU declaration of conformity, the provider shall assume responsibility
for compliance with the requirements set out in Section 2. The provider shall keep the EU
declaration of conformity up-to-date as appropriate.

5.

The Commission is empowered to adopt delegated acts in accordance with Article 97 inorder to amend Annex V by updating the content of the EU declaration of conformity set
out in that Annex, in order to introduce elements that become necessary in light oftechnical progress.

Article 48
CE marking
1.

The CE marking shall be subject to the general principles set out in Article 30 ofRegulation (EC) No 765/2008.

2.

For high-risk AI systems provided digitally, a digital CE marking shall be used, only if it
can easily be accessed via the interface from which that system is accessed or via an easily
accessible machine-readable code or other electronic means.

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3.

The CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems.
Where that is not possible or not warranted on account of the nature of the high-risk AI
system, it shall be affixed to the packaging or to the accompanying documentation, as
appropriate.

4.

Where applicable, the CE marking shall be followed by the identification number of thenotified body responsible for the conformity assessment procedures set out in Article 43.
The identification number of the notified body shall be affixed by the body itself or, under
its instructions, by the provider or by the provider’s authorised representative. The
identification number shall also be indicated in any promotional material which mentions
that the high-risk AI system fulfils the requirements for CE marking.

5.

Where high-risk AI systems are subject to other Union law which also provides for theaffixing of the CE marking, the CE marking shall indicate that the high-risk AI system also
fulfil the requirements of that other law.

Article 49
Registration
1.

Before placing on the market or putting into service a high-risk AI system listed in
Annex III, with the exception of high-risk AI systems referred to in point 2 of Annex III,the provider or, where applicable, the authorised representative shall register themselves
and their system in the EU database referred to in Article 71.

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2.

Before placing on the market or putting into service an AI system for which the provider
has concluded that it is not high-risk according to Article 6(3), that provider or, whereapplicable, the authorised representative shall register themselves and that system in the
EU database referred to in Article 71.

3.

Before putting into service or using a high-risk AI system listed in Annex III, with the
exception of high-risk AI systems listed in point 2 of Annex III, deployers that are publicauthorities, Union institutions, bodies, offices or agencies or persons acting on their behalf
shall register themselves, select the system and register its use in the EU database referred
to in Article 71.

4.

For high-risk AI systems referred to in points 1, 6 and 7 of Annex III, in the areas of law
enforcement, migration, asylum and border control management, the registration referred
to in paragraphs 1, 2 and 3 of this Article shall be in a secure non-public section of the EU
database referred to in Article 71 and shall include only the following information, as
applicable, referred to in:(a)section A, points 1 to 10, of Annex VIII, with the exception of points 6, 8 and 9;(b)

Section B, points 1 to 5, and points 8 and 9 of Annex VIII;(c)

section C, points 1 to 3, of Annex VIII;(d)points 1, 2, 3 and 5, of Annex IX.

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ENOnly the Commission and national authorities referred to in Article 74(8) shall have accessto the respective restricted sections of the EU database listed in the first subparagraph ofthis paragraph.
5.

High-risk AI systems referred to in point 2 of Annex III shall be registered at national
level.

Chapter IV
Transparency obligations for providers and deployersof certain AI systems

Article 50
Transparency obligations for providers and deployers of certain AI systems
1.

Providers shall ensure that AI systems intended to interact directly with natural persons aredesigned and developed in such a way that the natural persons concerned are informed thatthey are interacting with an AI system, unless this is obvious from the point of view of anatural person who is reasonably well-informed, observant and circumspect, taking into
account the circumstances and the context of use. This obligation shall not apply to AI
systems authorised by law to detect, prevent, investigate or prosecute criminal offences,subject to appropriate safeguards for the rights and freedoms of third parties, unless thosesystems are available for the public to report a criminal offence.

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2.

Providers of AI systems, including general-purpose AI systems, generating synthetic
audio, image, video or text content, shall ensure that the outputs of the AI system aremarked in a machine-readable format and detectable as artificially generated ormanipulated. Providers shall ensure their technical solutions are effective, interoperable,robust and reliable as far as this is technically feasible, taking into account the specificities
and limitations of various types of content, the costs of implementation and the generally
acknowledged state of the art, as may be reflected in relevant technical standards. Thisobligation shall not apply to the extent the AI systems perform an assistive function forstandard editing or do not substantially alter the input data provided by the deployer or thesemantics thereof, or where authorised by law to detect, prevent, investigate or prosecutecriminal offences.

3.

Deployers of an emotion recognition system or a biometric categorisation system shallinform the natural persons exposed thereto of the operation of the system, and shall process
the personal data in accordance with Regulations (EU) 2016/679 and (EU) 2018/1725 andDirective (EU) 2016/680, as applicable. This obligation shall not apply to AI systems used
for biometric categorisation and emotion recognition, which are permitted by law to detect,prevent or investigate criminal offences, subject to appropriate safeguards for the rights
and freedoms of third parties, and in accordance with Union law.

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4.

Deployers of an AI system that generates or manipulates image, audio or video content
constituting a deep fake, shall disclose that the content has been artificially generated ormanipulated. This obligation shall not apply where the use is authorised by law to detect,prevent, investigate or prosecute criminal offence. Where the content forms part of anevidently artistic, creative, satirical, fictional or analogous work or programme, thetransparency obligations set out in this paragraph are limited to disclosure of the existenceof such generated or manipulated content in an appropriate manner that does not hamper
the display or enjoyment of the work.
Deployers of an AI system that generates or manipulates text which is published with the
purpose of informing the public on matters of public interest shall disclose that the text has
been artificially generated or manipulated. This obligation shall not apply where the use isauthorised by law to detect, prevent, investigate or prosecute criminal offences or where
the AI-generated content has undergone a process of human review or editorial control andwhere a natural or legal person holds editorial responsibility for the publication of thecontent.

5.

The information referred to in paragraphs 1 to 4 shall be provided to the natural persons
concerned in a clear and distinguishable manner at the latest at the time of the firstinteraction or exposure. The information shall conform to the applicable accessibility
requirements.

6.

Paragraphs 1 to 4 shall not affect the requirements and obligations set out in Chapter III,and shall be without prejudice to other transparency obligations laid down in Union or
national law for deployers of AI systems.

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7.

The AI Office shall encourage and facilitate the drawing up of codes of practice at Unionlevel to facilitate the effective implementation of the obligations regarding the detection
and labelling of artificially generated or manipulated content. The Commission may adopt
implementing acts to approve those codes of practice in accordance with the procedure laid
down in Article 56 (6). If it deems the code is not adequate, the Commission may adopt an
implementing act specifying common rules for the implementation of those obligations inaccordance with the examination procedure laid down in Article 98(2).

Chapter V
General-purpose AI models

Section 1
Classification rules

Article 51
Classification of general-purpose AI models as general-purpose AI models with systemic risk
1.

A general-purpose AI model shall be classified as a general-purpose AI model withsystemic risk if it meets any of the following conditions:(a)it has high impact capabilities evaluated on the basis of appropriate technical tools
and methodologies, including indicators and benchmarks;

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(b)

based on a decision of the Commission, ex officio or following a qualified alert fromthe scientific panel, it has capabilities or an impact equivalent to those set out inpoint (a) having regard to the criteria set out in Annex XIII.

2.

A general-purpose AI model shall be presumed to have high impact capabilities pursuant
to paragraph 1, point (a), when the cumulative amount of computation used for its training
measured in floating point operations is greater than 1025.

3.

The Commission shall adopt delegated acts in accordance with Article 97 to amend thethresholds listed in paragraphs 1 and 2 of this Article, as well as to supplement benchmarks
and indicators in light of evolving technological developments, such as algorithmic
improvements or increased hardware efficiency, when necessary, for these thresholds toreflect the state of the art.

Article 52
Procedure
1.

Where a general-purpose AI model meets the condition referred to in Article 51(1),point (a), the relevant provider shall notify the Commission without delay and in any event
within two weeks after that requirement is met or it becomes known that it will be met.
That notification shall include the information necessary to demonstrate that the relevant
requirement has been met. If the Commission becomes aware of a general-purpose AI
model presenting systemic risks of which it has not been notified, it may decide to
designate it as a model with systemic risk.

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2.

The provider of a general-purpose AI model that meets the condition referred to in
Article 51(1), point (a), may present, with its notification, sufficiently substantiatedarguments to demonstrate that, exceptionally, although it meets that requirement, thegeneral-purpose AI model does not present, due to its specific characteristics, systemicrisks and therefore should not be classified as a general-purpose AI model with systemic
risk.

3.

Where the Commission concludes that the arguments submitted pursuant to paragraph 2
are not sufficiently substantiated and the relevant provider was not able to demonstrate thatthe general-purpose AI model does not present, due to its specific characteristics, systemicrisks, it shall reject those arguments, and the general-purpose AI model shall be considered
to be a general-purpose AI model with systemic risk.

4.

The Commission may designate a general-purpose AI model as presenting systemic risks,
ex officio or following a qualified alert from the scientific panel pursuant to Article 90(1),point (a), on the basis of criteria set out in Annex XIII.
The Commission is empowered to adopt delegated acts in accordance with Article 97 inorder to amend Annex XIII by specifying and updating the criteria set out in that Annex.

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5.

Upon a reasoned request of a provider whose model has been designated as a
general-purpose AI model with systemic risk pursuant to paragraph 4, the Commission
shall take the request into account and may decide to reassess whether the general-purpose
AI model can still be considered to present systemic risks on the basis of the criteria set out
in Annex XIII. Such a request shall contain objective, detailed and new reasons that havearisen since the designation decision. Providers may request reassessment at the earliest six
months after the designation decision. Where the Commission, following its reassessment,
decides to maintain the designation as a general-purpose AI model with systemic risk,
providers may request reassessment at the earliest six months after that decision.

6.

The Commission shall ensure that a list of general-purpose AI models with systemic risk ispublished and shall keep that list up to date, without prejudice to the need to observe andprotect intellectual property rights and confidential business information or trade secrets inaccordance with Union and national law.

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SECTION 2
OBLIGATIONS FOR PROVIDERS OF GENERAL-PURPOSE AI MODELS

Article 53
Obligations for providers of general-purpose AI models
1.

Providers of general-purpose AI models shall:(a)draw up and keep up-to-date the technical documentation of the model, including its
training and testing process and the results of its evaluation, which shall contain, at aminimum, the information set out in Annex XI for the purpose of providing it, uponrequest, to the AI Office and the national competent authorities;(b)

draw up, keep up-to-date and make available information and documentation toproviders of AI systems who intend to integrate the general-purpose AI model into
their AI systems. Without prejudice to the need to observe and protect intellectual
property rights and confidential business information or trade secrets in accordancewith Union and national law, the information and documentation shall:(i)enable providers of AI systems to have a good understanding of the capabilities
and limitations of the general-purpose AI model and to comply with their
obligations pursuant to this Regulation; and(ii)

contain, at a minimum, the elements set out in Annex XII;

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(c)

put in place a policy to comply with Union law on copyright and related rights, andin particular to identify and comply with, including through state-of-the-art
technologies, a reservation of rights expressed pursuant to Article 4(3) of
Directive (EU) 2019/790;(d)draw up and make publicly available a sufficiently detailed summary about thecontent used for training of the general-purpose AI model, according to a template
provided by the AI Office.

2.

The obligations set out in paragraph 1, points (a) and (b), shall not apply to providers of AI
models that are released under a free and open-source licence that allows for the access,usage, modification, and distribution of the model, and whose parameters, including theweights, the information on the model architecture, and the information on model usage,
are made publicly available. This exception shall not apply to general-purpose AI models
with systemic risks.

3.

Providers of general-purpose AI models shall cooperate as necessary with the Commission
and the national competent authorities in the exercise of their competences and powers
pursuant to this Regulation.

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4.

Providers of general-purpose AI models may rely on codes of practice within the meaningof Article 56 to demonstrate compliance with the obligations set out in paragraph 1 of this
Article, until a harmonised standard is published. Compliance with European harmonised
standards grants providers the presumption of conformity to the extent that those standards
cover those obligations. Providers of general-purpose AI models who do not adhere to an
approved code of practice or do not comply with a European harmonised standard shalldemonstrate alternative adequate means of compliance for assessment by the Commission.

5.

For the purpose of facilitating compliance with Annex XI, in particular points 2 (d) and (e)thereof, the Commission is empowered to adopt delegated acts in accordance with
Article 97 to detail measurement and calculation methodologies with a view to allowing
for comparable and verifiable documentation.

6.

The Commission is empowered to adopt delegated acts in accordance with Article 97(2) toamend Annexes XI and XII in light of evolving technological developments.

7.

Any information or documentation obtained pursuant to this Article, including trade
secrets, shall be treated in accordance with the confidentiality obligations set out
in Article 78.

Article 54
Authorised representatives of providers of general-purpose AI models
1.

Prior to placing a general-purpose AI model on the Union market, providers established inthird countries shall, by written mandate, appoint an authorised representative which isestablished in the Union.

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2.

The provider shall enable its authorised representative to perform the tasks specified in the
mandate received from the provider.

3.

The authorised representative shall perform the tasks specified in the mandate received
from the provider. It shall provide a copy of the mandate to the AI Office upon request, in
one of the official languages of the institutions of the Union. For the purposes of thisRegulation, the mandate shall empower the authorised representative to carry out thefollowing tasks:(a)verify that the technical documentation specified in Annex XI has been drawn up andall obligations referred to in Article 53 and, where applicable, Article 55 have been
fulfilled by the provider;(b)keep a copy of the technical documentation specified in Annex XI at the disposal of
the AI Office and national competent authorities, for a period of 10 years after thegeneral-purpose AI model has been placed on the market, and the contact details of
the provider that appointed the authorised representative;(c)provide the AI Office, upon a reasoned request, with all the information anddocumentation, including that referred to in point (b), necessary to demonstratecompliance with the obligations in this Chapter;(d)cooperate with the AI Office and competent authorities, upon a reasoned request, in
any action they take in relation to the general-purpose AI model, including when themodel is integrated into AI systems placed on the market or put into service inthe Union.

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4.

The mandate shall empower the authorised representative to be addressed, in addition to or
instead of the provider, by the AI Office or the competent authorities, on all issues related
to ensuring compliance with this Regulation.

5.

The authorised representative shall terminate the mandate if it considers or has reason toconsider the provider to be acting contrary to its obligations pursuant to this Regulation. In
such a case, it shall also immediately inform the AI Office about the termination of themandate and the reasons therefor.

6.

The obligation set out in this Article shall not apply to providers of general-purpose AI
models that are released under a free and open-source licence that allows for the access,usage, modification, and distribution of the model, and whose parameters, including theweights, the information on the model architecture, and the information on model usage,
are made publicly available, unless the general-purpose AI models present systemic risks.

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SECTION 3
OBLIGATIONS OF PROVIDERS OF GENERAL-PURPOSE AI MODELS
WITH SYSTEMIC RISK

Article 55
Obligations of providers of general-purpose AI models with systemic risk
1.

In addition to the obligations listed in Articles 53 and 54, providers of general-purpose AI
models with systemic risk shall:(a)perform model evaluation in accordance with standardised protocols and tools
reflecting the state of the art, including conducting and documenting adversarial
testing of the model with a view to identifying and mitigating systemic risks;(b)assess and mitigate possible systemic risks at Union level, including their sources,that may stem from the development, the placing on the market, or the use ofgeneral-purpose AI models with systemic risk;(c)keep track of, document, and report, without undue delay, to the AI Office and, as
appropriate, to national competent authorities, relevant information about serious
incidents and possible corrective measures to address them;(d)ensure an adequate level of cybersecurity protection for the general-purpose AI
model with systemic risk and the physical infrastructure of the model.

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2.

Providers of general-purpose AI models with systemic risk may rely on codes of practicewithin the meaning of Article 56 to demonstrate compliance with the obligations set out inparagraph 1 of this Article, until a harmonised standard is published. Compliance with
European harmonised standards grants providers the presumption of conformity to theextent that those standards cover those obligations. Providers of general-purpose AI
models with systemic risks who do not adhere to an approved code of practice or do notcomply with a European harmonised standard shall demonstrate alternative adequatemeans of compliance for assessment by the Commission.

3.

Any information or documentation obtained pursuant to this Article, including trade
secrets, shall be treated in accordance with the confidentiality obligations set out
in Article 78.

SECTION 4
CODES OF PRACTICE

Article 56
Codes of practice1.

The AI Office shall encourage and facilitate the drawing up of codes of practice at Unionlevel in order to contribute to the proper application of this Regulation, taking into accountinternational approaches.

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2.

The AI Office and the Board shall aim to ensure that the codes of practice cover at least the
obligations provided for in Articles 53 and 55, including the following issues:(a)the means to ensure that the information referred to in Article 53(1), points (a)and (b), is kept up to date in light of market and technological developments;(b)

the adequate level of detail for the summary about the content used for training;(c)the identification of the type and nature of the systemic risks at Union level,
including their sources, where appropriate;(d)the measures, procedures and modalities for the assessment and management of thesystemic risks at Union level, including the documentation thereof, which shall be
proportionate to the risks, take into consideration their severity and probability andtake into account the specific challenges of tackling those risks in light of thepossible ways in which such risks may emerge and materialise along the AI value
chain.

3.

The AI Office may invite all providers of general-purpose AI models, as well as relevant
national competent authorities, to participate in the drawing-up of codes of practice. Civil
society organisations, industry, academia and other relevant stakeholders, such as
downstream providers and independent experts, may support the process.

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4.

The AI Office and the Board shall aim to ensure that the codes of practice clearly set out
their specific objectives and contain commitments or measures, including key performanceindicators as appropriate, to ensure the achievement of those objectives, and that they takedue account of the needs and interests of all interested parties, including affected persons,at Union level.

5.

The AI Office shall aim to ensure that participants to the codes of practice report regularly
to the AI Office on the implementation of the commitments and the measures taken andtheir outcomes, including as measured against the key performance indicators as
appropriate. Key performance indicators and reporting commitments shall reflect
differences in size and capacity between various participants.

6.

The AI Office and the Board shall regularly monitor and evaluate the achievement of theobjectives of the codes of practice by the participants and their contribution to the proper
application of this Regulation. The AI Office and the Board shall assess whether the codesof practice cover the obligations provided for in Articles 53 and 55, and shall regularly
monitor and evaluate the achievement of their objectives. They shall publish theirassessment of the adequacy of the codes of practice.
The Commission may, by way of an implementing act, approve a code of practice and giveit a general validity within the Union. That implementing act shall be adopted inaccordance with the examination procedure referred to in Article 98(2).

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7.

The AI Office may invite all providers of general-purpose AI models to adhere to thecodes of practice. For providers of general-purpose AI models not presenting systemicrisks this adherence may be limited to the obligations provided for in Article 53, unlessthey declare explicitly their interest to join the full code.

8.

The AI Office shall, as appropriate, also encourage and facilitate the review and adaptationof the codes of practice, in particular in light of emerging standards. The AI Office shallassist in the assessment of available standards.

9.

Codes of practice shall be ready at the latest by … [nine months from the date of entry into
force of this Regulation]. The AI Office shall take the necessary steps, including inviting
providers pursuant to paragraph 7.
If, by … [12 months from the date of entry into force], a code of practice cannot be
finalised, or if the AI Office deems it is not adequate following its assessment underparagraph 6 of this Article, the Commission may provide, by means of implementing acts,
common rules for the implementation of the obligations provided for in Articles 53 and 55,
including the issues set out in paragraph 2 of this Article. Those implementing acts shall be
adopted in accordance with the examination procedure referred to in Article 98(2).

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ENChapter VI
Measures in support of innovation

Article 57
AI regulatory sandboxes
1.

Member States shall ensure that their competent authorities establish at least one AI
regulatory sandbox at national level, which shall be operational by … [24 months from thedate of entry into force of this Regulation]. That sandbox may also be established jointlywith the competent authorities of other Member States. The Commission may provide
technical support, advice and tools for the establishment and operation of AI regulatory
sandboxes.
The obligation under the first subparagraph may also be fulfilled by participating in anexisting sandbox in so far as that participation provides an equivalent level of national
coverage for the participating Member States.

2.

Additional AI regulatory sandboxes at regional or local level, or established jointly withthe competent authorities of other Member States may also be established.

3.

The European Data Protection Supervisor may also establish an AI regulatory sandbox forUnion institutions, bodies, offices and agencies, and may exercise the roles and the tasks ofnational competent authorities in accordance with this Chapter.

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4.

Member States shall ensure that the competent authorities referred to in paragraphs 1 and 2
allocate sufficient resources to comply with this Article effectively and in a timely manner.
Where appropriate, national competent authorities shall cooperate with other relevant
authorities, and may allow for the involvement of other actors within the AI ecosystem.
This Article shall not affect other regulatory sandboxes established under Union or nationallaw. Member States shall ensure an appropriate level of cooperation between theauthorities supervising those other sandboxes and the national competent authorities.

5.

AI regulatory sandboxes established under paragraph 1 shall provide for a controlledenvironment that fosters innovation and facilitates the development, training, testing andvalidation of innovative AI systems for a limited time before their being placed on themarket or put into service pursuant to a specific sandbox plan agreed between the providers
or prospective providers and the competent authority. Such sandboxes may include testingin real world conditions supervised therein.

6.

Competent authorities shall provide, as appropriate, guidance, supervision and support
within the AI regulatory sandbox with a view to identifying risks, in particular to
fundamental rights, health and safety, testing, mitigation measures, and their effectivenessin relation to the obligations and requirements of this Regulation and, where relevant, other
Union and national law supervised within the sandbox.

7.

Competent authorities shall provide providers and prospective providers participating in
the AI regulatory sandbox with guidance on regulatory expectations and how to fulfil therequirements and obligations set out in this Regulation.

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ENUpon request of the provider or prospective provider of the AI system, the competentauthority shall provide a written proof of the activities successfully carried out in the
sandbox. The competent authority shall also provide an exit report detailing the activities
carried out in the sandbox and the related results and learning outcomes. Providers may use
such documentation to demonstrate their compliance with this Regulation through theconformity assessment process or relevant market surveillance activities. In this regard, theexit reports and the written proof provided by the national competent authority shall betaken positively into account by market surveillance authorities and notified bodies, with aview to accelerating conformity assessment procedures to a reasonable extent.
8.

Subject to the confidentiality provisions in Article 78, and with the agreement of theprovider or prospective provider, the Commission and the Board shall be authorised toaccess the exit reports and shall take them into account, as appropriate, when exercising
their tasks under this Regulation. If both the provider or prospective provider and thenational competent authority explicitly agree, the exit report may be made publicly
available through the single information platform referred to in this Article.

9.

The establishment of AI regulatory sandboxes shall aim to contribute to the following
objectives:(a)

improving legal certainty to achieve regulatory compliance with this Regulation or,
where relevant, other applicable Union and national law;(b)

supporting the sharing of best practices through cooperation with the authorities
involved in the AI regulatory sandbox;

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(c)

fostering innovation and competitiveness and facilitating the development of an AI
ecosystem;(d)contributing to evidence-based regulatory learning;(e)facilitating and accelerating access to the Union market for AI systems, in particularwhen provided by SMEs, including start-ups.

10.

National competent authorities shall ensure that, to the extent the innovative AI systems
involve the processing of personal data or otherwise fall under the supervisory remit ofother national authorities or competent authorities providing or supporting access to data,
the national data protection authorities and those other national or competent authorities
are associated with the operation of the AI regulatory sandbox and involved in the
supervision of those aspects to the extent of their respective tasks and powers.

11.

The AI regulatory sandboxes shall not affect the supervisory or corrective powers of thecompetent authorities supervising the sandboxes, including at regional or local level. Any
significant risks to health and safety and fundamental rights identified during thedevelopment and testing of such AI systems shall result in an adequate mitigation. National
competent authorities shall have the power to temporarily or permanently suspend thetesting process, or the participation in the sandbox if no effective mitigation is possible,
and shall inform the AI Office of such decision. National competent authorities shall
exercise their supervisory powers within the limits of the relevant law, using theirdiscretionary powers when implementing legal provisions in respect of a specific AI
regulatory sandbox project, with the objective of supporting innovation in AI in the Union.

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12.

Providers and prospective providers participating in the AI regulatory sandbox shallremain liable under applicable Union and national liability law for any damage inflicted on
third parties as a result of the experimentation taking place in the sandbox. However,provided that the prospective providers observe the specific plan and the terms andconditions for their participation and follow in good faith the guidance given by thenational competent authority, no administrative fines shall be imposed by the authorities
for infringements of this Regulation. Where other competent authorities responsible forother Union and national law were actively involved in the supervision of the AI system inthe sandbox and provided guidance for compliance, no administrative fines shall be
imposed regarding that law.

13.

The AI regulatory sandboxes shall be designed and implemented in such a way that, where
relevant, they facilitate cross-border cooperation between national competent authorities.

14.

National competent authorities shall coordinate their activities and cooperate within theframework of the Board.

15.

National competent authorities shall inform the AI Office and the Board of theestablishment of a sandbox, and may ask them for support and guidance. The AI Officeshall make publicly available a list of planned and existing sandboxes and keep it up todate in order to encourage more interaction in the AI regulatory sandboxes andcross-border cooperation.

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16.

National competent authorities shall submit annual reports to the AI Office and to theBoard, from one year after the establishment of the AI regulatory sandbox and every year
thereafter until its termination, and a final report. Those reports shall provide informationon the progress and results of the implementation of those sandboxes, including bestpractices, incidents, lessons learnt and recommendations on their setup and, where
relevant, on the application and possible revision of this Regulation, including its delegatedand implementing acts, and on the application of other Union law supervised by thecompetent authorities within the sandbox. The national competent authorities shall makethose annual reports or abstracts thereof available to the public, online. The Commission
shall, where appropriate, take the annual reports into account when exercising its tasks
under this Regulation.

17.

The Commission shall develop a single and dedicated interface containing all relevant
information related to AI regulatory sandboxes to allow stakeholders to interact with AI
regulatory sandboxes and to raise enquiries with competent authorities, and to seek
non-binding guidance on the conformity of innovative products, services, business models
embedding AI technologies, in accordance with Article 62(1), point (c). The Commission
shall proactively coordinate with national competent authorities, where relevant.

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Article 58
Detailed arrangements for, and functioning of, AI regulatory sandboxes
1.

In order to avoid fragmentation across the Union, the Commission shall adopt
implementing acts specifying the detailed arrangements for the establishment,
development, implementation, operation and supervision of the AI regulatory sandboxes.
The implementing acts shall include common principles on the following issues:(a)eligibility and selection criteria for participation in the AI regulatory sandbox;(b)

procedures for the application, participation, monitoring, exiting from andtermination of the AI regulatory sandbox, including the sandbox plan and the exit
report;(c)the terms and conditions applicable to the participants.

Those implementing acts shall be adopted in accordance with the examination procedurereferred to in Article 98(2).
2.

The implementing acts referred to in paragraph 1 shall ensure:(a)that AI regulatory sandboxes are open to any applying provider or prospective
provider of an AI system who fulfils eligibility and selection criteria, which shall betransparent and fair, and that national competent authorities inform applicants of
their decision within three months of the application;

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(b)

that AI regulatory sandboxes allow broad and equal access and keep up with demandfor participation; providers and prospective providers may also submit applications
in partnerships with deployers and other relevant third parties;(c)that the detailed arrangements for, and conditions concerning AI regulatory
sandboxes support, to the best extent possible, flexibility for national competentauthorities to establish and operate their AI regulatory sandboxes;(d)that access to the AI regulatory sandboxes is free of charge for SMEs, including
start-ups, without prejudice to exceptional costs that national competent authorities
may recover in a fair and proportionate manner;(e)that they facilitate providers and prospective providers, by means of the learning
outcomes of the AI regulatory sandboxes, in complying with conformity assessment
obligations under this Regulation and the voluntary application of the codes ofconduct referred to in Article 95;(f)that AI regulatory sandboxes facilitate the involvement of other relevant actors
within the AI ecosystem, such as notified bodies and standardisation organisations,
SMEs, including start-ups, enterprises, innovators, testing and experimentation
facilities, research and experimentation labs and European Digital Innovation Hubs,
centres of excellence, individual researchers, in order to allow and facilitate
cooperation with the public and private sectors;

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(g)

that procedures, processes and administrative requirements for application, selection,
participation and exiting the AI regulatory sandbox are simple, easily intelligible, andclearly communicated in order to facilitate the participation of SMEs, including
start-ups, with limited legal and administrative capacities and are streamlined acrossthe Union, in order to avoid fragmentation and that participation in an AI regulatory
sandbox established by a Member State, or by the European Data Protection
Supervisor is mutually and uniformly recognised and carries the same legal effects
across the Union;(h)that participation in the AI regulatory sandbox is limited to a period that is
appropriate to the complexity and scale of the project and that may be extended by
the national competent authority;(i)that AI regulatory sandboxes facilitate the development of tools and infrastructure fortesting, benchmarking, assessing and explaining dimensions of AI systems relevant
for regulatory learning, such as accuracy, robustness and cybersecurity, as well as
measures to mitigate risks to fundamental rights and society at large.

3.

Prospective providers in the AI regulatory sandboxes, in particular SMEs and start-ups,
shall be directed, where relevant, to pre-deployment services such as guidance on theimplementation of this Regulation, to other value-adding services such as help withstandardisation documents and certification, testing and experimentation facilities,
European Digital Innovation Hubs and centres of excellence.

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4.

Where national competent authorities consider authorising testing in real world conditions
supervised within the framework of an AI regulatory sandbox to be established under this
Article, they shall specifically agree the terms and conditions of such testing and, inparticular, the appropriate safeguards with the participants, with a view to protecting
fundamental rights, health and safety. Where appropriate, they shall cooperate with othernational competent authorities with a view to ensuring consistent practices acrossthe Union.

Article 59
Further processing of personal data for developing certain AI systems
in the public interest in the AI regulatory sandbox
1.

In the AI regulatory sandbox, personal data lawfully collected for other purposes may beprocessed solely for the purpose of developing, training and testing certain AI systems inthe sandbox when all of the following conditions are met:(a)

AI systems shall be developed for safeguarding substantial public interest by a publicauthority or another natural or legal person and in one or more of the following areas:(i)public safety and public health, including disease detection, diagnosis
prevention, control and treatment and improvement of health care systems;(ii)

a high level of protection and improvement of the quality of the environment,
protection of biodiversity, protection against pollution, green transition
measures, climate change mitigation and adaptation measures;

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(iii) energy sustainability;(iv) safety and resilience of transport systems and mobility, critical infrastructureand networks;(v)(b)

efficiency and quality of public administration and public services;the data processed are necessary for complying with one or more of the requirements
referred to in Chapter III, Section 2 where those requirements cannot effectively be
fulfilled by processing anonymised, synthetic or other non-personal data;(c)there are effective monitoring mechanisms to identify if any high risks to the rights
and freedoms of the data subjects, as referred to in Article 35 of Regulation(EU) 2016/679 and in Article 39 of Regulation (EU) 2018/1725, may arise during thesandbox experimentation, as well as response mechanisms to promptly mitigate thoserisks and, where necessary, stop the processing;(d)any personal data to be processed in the context of the sandbox are in a functionallyseparate, isolated and protected data processing environment under the control of theprospective provider and only authorised persons have access to those data;(e)providers can further share the originally collected data only in accordance with
Union data protection law; any personal data created in the sandbox cannot be sharedoutside the sandbox;

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(f)

any processing of personal data in the context of the sandbox neither leads tomeasures or decisions affecting the data subjects nor does it affect the application of
their rights laid down in Union law on the protection of personal data;(g)

any personal data processed in the context of the sandbox are protected by means ofappropriate technical and organisational measures and deleted once the participationin the sandbox has terminated or the personal data has reached the end of its retention
period;(h)the logs of the processing of personal data in the context of the sandbox are kept forthe duration of the participation in the sandbox, unless provided otherwise by Unionor national law;(i)a complete and detailed description of the process and rationale behind the training,
testing and validation of the AI system is kept together with the testing results as partof the technical documentation referred to in Annex IV;(j)a short summary of the AI project developed in the sandbox, its objectives andexpected results is published on the website of the competent authorities; thisobligation shall not cover sensitive operational data in relation to the activities of law
enforcement, border control, immigration or asylum authorities.

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2.

For the purposes of the prevention, investigation, detection or prosecution of criminal
offences or the execution of criminal penalties, including safeguarding against andpreventing threats to public security, under the control and responsibility of law
enforcement authorities, the processing of personal data in AI regulatory sandboxes shallbe based on a specific Union or national law and subject to the same cumulative conditions
as referred to in paragraph 1.

3.

Paragraph 1 is without prejudice to Union or national law which excludes processing of
personal data for other purposes than those explicitly mentioned in that law, as well as toUnion or national law laying down the basis for the processing of personal data which isnecessary for the purpose of developing, testing or training of innovative AI systems or
any other legal basis, in compliance with Union law on the protection of personal data.

Article 60
Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
1.

Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
may be conducted by providers or prospective providers of high-risk AI systems listed in
Annex III, in accordance with this Article and the real-world testing plan referred to in this
Article, without prejudice to the prohibitions under Article 5.
The Commission shall, by means of implementing acts, specify the detailed elements of
the real-world testing plan. Those implementing acts shall be adopted in accordance withthe examination procedure referred to in Article 98(2).

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This paragraph shall be without prejudice to Union or national law on the testing in realworld conditions of high-risk AI systems related to products covered by Union
harmonisation legislation listed in Annex I.
2.

Providers or prospective providers may conduct testing of high-risk AI systems referred toin Annex III in real world conditions at any time before the placing on the market or theputting into service of the AI system on their own or in partnership with one or more
deployers or prospective deployers.

3.

The testing of high-risk AI systems in real world conditions under this Article shall be
without prejudice to any ethical review that is required by Union or national law.

4.

Providers or prospective providers may conduct the testing in real world conditions only
where all of the following conditions are met:(a)the provider or prospective provider has drawn up a real-world testing plan andsubmitted it to the market surveillance authority in the Member State where thetesting in real world conditions is to be conducted;(b)

the market surveillance authority in the Member State where the testing in real world
conditions is to be conducted has approved the testing in real world conditions andthe real-world testing plan; where the market surveillance authority has not provided
an answer within 30 days, the testing in real world conditions and the real-world
testing plan shall be understood to have been approved; where national law does notprovide for a tacit approval, the testing in real world conditions shall remain subject
to an authorisation;

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(c)

the provider or prospective provider, with the exception of providers or prospective
providers of high-risk AI systems referred to in points 1, 6 and 7 of Annex III in theareas of law enforcement, migration, asylum and border control management, andhigh-risk AI systems referred to in point 2 of Annex III has registered the testing inreal world conditions in accordance with Article 71(4) with a Union-wide unique
single identification number and with the information specified in Annex IX; theprovider or prospective provider of high-risk AI systems referred to in points 1, 6
and 7 of Annex III in the areas of law enforcement, migration, asylum and bordercontrol management, has registered the testing in real-world conditions in the secure
non-public section of the EU database according to Article 49(4), point (d), with aUnion-wide unique single identification number and with the information specified
therein; the provider or prospective provider of high-risk AI systems referred to inpoint 2 of Annex III has registered the testing in real-world conditions in accordancewith Article 49(5);(d)

the provider or prospective provider conducting the testing in real world conditions isestablished in the Union or has appointed a legal representative who is established in
the Union;(e)data collected and processed for the purpose of the testing in real world conditions
shall be transferred to third countries only provided that appropriate and applicablesafeguards under Union law are implemented;

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(f)

the testing in real world conditions does not last longer than necessary to achieve its
objectives and in any case not longer than six months, which may be extended for an
additional period of six months, subject to prior notification by the provider orprospective provider to the market surveillance authority, accompanied by an
explanation of the need for such an extension;(g)

the subjects of the testing in real world conditions who are persons belonging tovulnerable groups due to their age or disability, are appropriately protected;(h)where a provider or prospective provider organises the testing in real world
conditions in cooperation with one or more deployers or prospective deployers, thelatter have been informed of all aspects of the testing that are relevant to theirdecision to participate, and given the relevant instructions for use of the AI systemreferred to in Article 13; the provider or prospective provider and the deployer orprospective deployer shall conclude an agreement specifying their roles andresponsibilities with a view to ensuring compliance with the provisions for testing inreal world conditions under this Regulation and under other applicable Union andnational law;(i)the subjects of the testing in real world conditions have given informed consent inaccordance with Article 61, or in the case of law enforcement, where the seeking of
informed consent would prevent the AI system from being tested, the testing itself
and the outcome of the testing in the real world conditions shall not have any
negative effect on the subjects, and their personal data shall be deleted after the test
is performed;

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(j)

the testing in real world conditions is effectively overseen by the provider orprospective provider, as well as by deployers or prospective deployers throughpersons who are suitably qualified in the relevant field and have the necessary
capacity, training and authority to perform their tasks;(k)the predictions, recommendations or decisions of the AI system can be effectively
reversed and disregarded.

5.

Any subjects of the testing in real world conditions, or their legally designatedrepresentative, as appropriate, may, without any resulting detriment and without having toprovide any justification, withdraw from the testing at any time by revoking their informed
consent and may request the immediate and permanent deletion of their personal data. The
withdrawal of the informed consent shall not affect the activities already carried out.

6.

In accordance with Article 75, Member States shall confer on their market surveillanceauthorities the powers of requiring providers and prospective providers to provide
information, of carrying out unannounced remote or on-site inspections, and of performing
checks on the conduct of the testing in real world conditions and the related high-risk AI
systems. Market surveillance authorities shall use those powers to ensure the safe
development of testing in real world conditions.

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7.

Any serious incident identified in the course of the testing in real world conditions shall bereported to the national market surveillance authority in accordance with Article 73. The
provider or prospective provider shall adopt immediate mitigation measures or, failing that,shall suspend the testing in real world conditions until such mitigation takes place, orotherwise terminate it. The provider or prospective provider shall establish a procedure forthe prompt recall of the AI system upon such termination of the testing in real world
conditions.

8.

Providers or prospective providers shall notify the national market surveillance authority in
the Member State where the testing in real world conditions is to be conducted of thesuspension or termination of the testing in real world conditions and of the final outcomes.

9.

The provider or prospective provider shall be liable under applicable Union and national
liability law for any damage caused in the course of their testing in real world conditions.

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Article 61
Informed consent to participate in testing in real world conditions
outside AI regulatory sandboxes
1.

For the purpose of testing in real world conditions under Article 60, freely-given informed
consent shall be obtained from the subjects of testing prior to their participation in suchtesting and after their having been duly informed with concise, clear, relevant, andunderstandable information regarding:(a)the nature and objectives of the testing in real world conditions and the possible
inconvenience that may be linked to their participation;(b)

the conditions under which the testing in real world conditions is to be conducted,
including the expected duration of the subject or subjects’ participation;(c)their rights, and the guarantees regarding their participation, in particular their rightto refuse to participate in, and the right to withdraw from, testing in real world
conditions at any time without any resulting detriment and without having to provide
any justification;(d)the arrangements for requesting the reversal or the disregarding of the predictions,recommendations or decisions of the AI system;(e)

the Union-wide unique single identification number of the testing in real world
conditions in accordance with Article 60(4) point (c), and the contact details of theprovider or its legal representative from whom further information can be obtained.

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2.

The informed consent shall be dated and documented and a copy shall be given to thesubjects of testing or their legal representative.

Article 62
Measures for providers and deployers, in particular SMEs, including start-ups
1.

Member States shall undertake the following actions:(a)provide SMEs, including start-ups, having a registered office or a branch in theUnion, with priority access to the AI regulatory sandboxes, to the extent that they
fulfil the eligibility conditions and selection criteria; the priority access shall notpreclude other SMEs, including start-ups, other than those referred to in thisparagraph from access to the AI regulatory sandbox, provided that they also fulfil theeligibility conditions and selection criteria;(b)organise specific awareness raising and training activities on the application of thisRegulation tailored to the needs of SMEs including start-ups, deployers and, as
appropriate, local public authorities;(c)utilise existing dedicated channels and where appropriate, establish new ones forcommunication with SMEs including start-ups, deployers, other innovators and, as
appropriate, local public authorities to provide advice and respond to queries about
the implementation of this Regulation, including as regards participation in AI
regulatory sandboxes;

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(d)

facilitate the participation of SMEs and other relevant stakeholders in thestandardisation development process.

2.

The specific interests and needs of the SME providers, including start-ups, shall be taken
into account when setting the fees for conformity assessment under Article 43, reducing
those fees proportionately to their size, market size and other relevant indicators.

3.

The AI Office shall undertake the following actions:(a)provide standardised templates for areas covered by this Regulation, as specified by
the Board in its request;(b)develop and maintain a single information platform providing easy to use
information in relation to this Regulation for all operators across the Union;(c)organise appropriate communication campaigns to raise awareness about the
obligations arising from this Regulation;(d)evaluate and promote the convergence of best practices in public procurement
procedures in relation to AI systems.

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Article 63
Derogations for specific operators
1.

Microenterprises within the meaning of Recommendation 2003/361/EC may comply withcertain elements of the quality management system required by Article 17 of thisRegulation in a simplified manner, provided that they do not have partner enterprises orlinked enterprises within the meaning of that Recommendation. For that purpose, theCommission shall develop guidelines on the elements of the quality management system
which may be complied with in a simplified manner considering the needs ofmicroenterprises, without affecting the level of protection or the need for compliance withthe requirements in respect of high-risk AI systems.

2.

Paragraph 1 of this Article shall not be interpreted as exempting those operators from
fulfilling any other requirements or obligations laid down in this Regulation, including
those established in Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73.

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Chapter VII
Governance
SECTION 1
GOVERNANCE AT UNION LEVEL

Article 64
AI Office1.

The Commission shall develop Union expertise and capabilities in the field of AI throughthe AI Office.

2.

Member States shall facilitate the tasks entrusted to the AI Office, as reflected inthis Regulation.

Article 65
Establishment and structure of the European Artificial Intelligence Board
1.

A European Artificial Intelligence Board (the ‘Board’) is hereby established.

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2.

The Board shall be composed of one representative per Member State. The European Data
Protection Supervisor shall participate as observer. The AI Office shall also attend theBoard’s meetings, without taking part in the votes. Other national and Union authorities,
bodies or experts may be invited to the meetings by the Board on a case by case basis,
where the issues discussed are of relevance for them.

3.

Each representative shall be designated by their Member State for a period of three years,
renewable once.

4.

Member States shall ensure that their representatives on the Board:(a)have the relevant competences and powers in their Member State so as to contributeactively to the achievement of the Board’s tasks referred to in Article 66;(b)

are designated as a single contact point vis-à-vis the Board and, where appropriate,taking into account Member States’ needs, as a single contact point for stakeholders;(c)are empowered to facilitate consistency and coordination between national
competent authorities in their Member State as regards the implementation of thisRegulation, including through the collection of relevant data and information for the
purpose of fulfilling their tasks on the Board.

5.

The designated representatives of the Member States shall adopt the Board’s rules ofprocedure by a two-thirds majority. The rules of procedure shall, in particular, lay down
procedures for the selection process, the duration of the mandate of, and specifications of
the tasks of, the Chair, detailed arrangements for voting, and the organisation of theBoard’s activities and those of its sub-groups.

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6.

The Board shall establish two standing sub-groups to provide a platform for cooperationand exchange among market surveillance authorities and notifying authorities about issues
related to market surveillance and notified bodies respectively.
The standing sub-group for market surveillance should act as the administrative
cooperation group (ADCO) for this Regulation within the meaning of Article 30 ofRegulation (EU) 2019/1020.
The Board may establish other standing or temporary sub-groups as appropriate for the
purpose of examining specific issues. Where appropriate, representatives of the advisory
forum referred to in Article 67 may be invited to such sub-groups or to specific meetings ofthose subgroups as observers.

7.

The Board shall be organised and operated so as to safeguard the objectivity andimpartiality of its activities.

8.

The Board shall be chaired by one of the representatives of the Member States. The AI
Office shall provide the secretariat for the Board, convene the meetings upon request of the
Chair, and prepare the agenda in accordance with the tasks of the Board pursuant to thisRegulation and its rules of procedure.

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Article 66
Tasks of the Board
The Board shall advise and assist the Commission and the Member States in order to facilitate theconsistent and effective application of this Regulation. To that end, the Board may in particular:(a)contribute to the coordination among national competent authorities responsible for theapplication of this Regulation and, in cooperation with and subject to the agreement of themarket surveillance authorities concerned, support joint activities of market surveillanceauthorities referred to in Article 74(11);(b)

collect and share technical and regulatory expertise and best practices among
Member States;(c)

provide advice on the implementation of this Regulation, in particular as regards theenforcement of rules on general-purpose AI models;(d)contribute to the harmonisation of administrative practices in the Member States, including
in relation to the derogation from the conformity assessment procedures referred to in
Article 46, the functioning of AI regulatory sandboxes, and testing in real world conditions
referred to in Articles 57, 59 and 60;

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(e)

at the request of the Commission or on its own initiative, issue recommendations andwritten opinions on any relevant matters related to the implementation of this Regulationand to its consistent and effective application, including:(i)on the development and application of codes of conduct and codes of practicepursuant to this Regulation, as well as of the Commission’s guidelines;(ii)

the evaluation and review of this Regulation pursuant to Article 112, including as
regards the serious incident reports referred to in Article 73, and the functioning of
the EU database referred to in Article 71, the preparation of the delegated or
implementing acts, and as regards possible alignments of this Regulation with theUnion harmonisation legislation listed in Annex I;(iii) on technical specifications or existing standards regarding the requirements set out in
Chapter III, Section 2;(iv) on the use of harmonised standards or common specifications referred to in
Articles 40 and 41;(v)

trends, such as European global competitiveness in AI, the uptake of AI in the Union,
and the development of digital skills;(vi) trends on the evolving typology of AI value chains, in particular on the resulting
implications in terms of accountability;

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(vii) on the potential need for amendment to Annex III in accordance with Article 7, andon the potential need for possible revision of Article 5 pursuant to Article 112, taking
into account relevant available evidence and the latest developments in technology;(f)support the Commission in promoting AI literacy, public awareness and understanding of
the benefits, risks, safeguards and rights and obligations in relation to the use of AI
systems;(g)facilitate the development of common criteria and a shared understanding among market
operators and competent authorities of the relevant concepts provided for in thisRegulation, including by contributing to the development of benchmarks;(h)cooperate, as appropriate, with other Union institutions, bodies, offices and agencies, aswell as relevant Union expert groups and networks, in particular in the fields of productsafety, cybersecurity, competition, digital and media services, financial services, consumer
protection, data and fundamental rights protection;(i)contribute to effective cooperation with the competent authorities of third countries andwith international organisations;(j)assist national competent authorities and the Commission in developing the organisational
and technical expertise required for the implementation of this Regulation, including bycontributing to the assessment of training needs for staff of Member States involved in
implementing this Regulation;

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(k)

assist the AI Office in supporting national competent authorities in the establishment anddevelopment of AI regulatory sandboxes, and facilitate cooperation andinformation-sharing among AI regulatory sandboxes;(l)contribute to, and provide relevant advice on, the development of guidance documents;(m)advise the Commission in relation to international matters on AI;(n)provide opinions to the Commission on the qualified alerts regarding general-purpose AI
models;(o)receive opinions by the Member States on qualified alerts regarding general-purpose AI
models, and on national experiences and practices on the monitoring and enforcement ofAI systems, in particular systems integrating the general-purpose AI models.

Article 67
Advisory forum
1.

An advisory forum shall be established to provide technical expertise and advise the Boardand the Commission, and to contribute to their tasks under this Regulation.

2.

The membership of the advisory forum shall represent a balanced selection of
stakeholders, including industry, start-ups, SMEs, civil society and academia. The
membership of the advisory forum shall be balanced with regard to commercial andnon-commercial interests and, within the category of commercial interests, with regard to
SMEs and other undertakings.

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3.

The Commission shall appoint the members of the advisory forum, in accordance with thecriteria set out in paragraph 2, from amongst stakeholders with recognised expertise in thefield of AI.

4.

The term of office of the members of the advisory forum shall be two years, which may be
extended by up to no more than four years.

5.

The Fundamental Rights Agency, ENISA, the European Committee for Standardization(CEN), the European Committee for Electrotechnical Standardization (CENELEC), andthe European Telecommunications Standards Institute (ETSI) shall be permanent membersof the advisory forum.

6.

The advisory forum shall draw up its rules of procedure. It shall elect two co-chairs fromamong its members, in accordance with criteria set out in paragraph 2. The term of officeof the co-chairs shall be two years, renewable once.

7.

The advisory forum shall hold meetings at least twice a year. The advisory forum may
invite experts and other stakeholders to its meetings.

8.

The advisory forum may prepare opinions, recommendations and written contributions at
the request of the Board or the Commission.

9.

The advisory forum may establish standing or temporary sub-groups as appropriate for the
purpose of examining specific questions related to the objectives of this Regulation.

10.

The advisory forum shall prepare an annual report on its activities. That report shall bemade publicly available.

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Article 68
Scientific panel of independent experts
1.

The Commission shall, by means of an implementing act, make provisions on theestablishment of a scientific panel of independent experts (the ‘scientific panel’) intended
to support the enforcement activities under this Regulation. That implementing act shall be
adopted in accordance with the examination procedure referred to in Article 98(2).

2.

The scientific panel shall consist of experts selected by the Commission on the basis of
up-to-date scientific or technical expertise in the field of AI necessary for the tasks set out
in paragraph 3, and shall be able to demonstrate meeting all of the following conditions:(a)having particular expertise and competence and scientific or technical expertise in
the field of AI;(b)

independence from any provider of AI systems or general-purpose AI models;(c)an ability to carry out activities diligently, accurately and objectively.

The Commission, in consultation with the Board, shall determine the number of experts on
the panel in accordance with the required needs and shall ensure fair gender andgeographical representation.

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3.

The scientific panel shall advise and support the AI Office, in particular with regard to thefollowing tasks:(a)supporting the implementation and enforcement of this Regulation as regards
general-purpose AI models and systems, in particular by:(i)alerting the AI Office of possible systemic risks at Union level ofgeneral-purpose AI models, in accordance with Article 90;(ii)

contributing to the development of tools and methodologies for evaluating
capabilities of general-purpose AI models and systems, including throughbenchmarks;(iii) providing advice on the classification of general-purpose AI models withsystemic risk;(iv) providing advice on the classification of various general-purpose AI models
and systems;(v)

contributing to the development of tools and templates;(b)

supporting the work of market surveillance authorities, at their request;(c)supporting cross-border market surveillance activities as referred to in Article 74(11),without prejudice to the powers of market surveillance authorities;

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(d)

supporting the AI Office in carrying out its duties in the context of the Union
safeguard procedure pursuant to Article 81.

4.

The experts on the scientific panel shall perform their tasks with impartiality andobjectivity, and shall ensure the confidentiality of information and data obtained incarrying out their tasks and activities. They shall neither seek nor take instructions fromanyone when exercising their tasks under paragraph 3. Each expert shall draw up adeclaration of interests, which shall be made publicly available. The AI Office shallestablish systems and procedures to actively manage and prevent potential conflicts ofinterest.

5.

The implementing act referred to in paragraph 1 shall include provisions on the conditions,procedures and detailed arrangements for the scientific panel and its members to issue
alerts, and to request the assistance of the AI Office for the performance of the tasks of thescientific panel.

Article 69
Access to the pool of experts by the Member States
1.

Member States may call upon experts of the scientific panel to support their enforcement
activities under this Regulation.

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2.

The Member States may be required to pay fees for the advice and support provided by theexperts. The structure and the level of fees as well as the scale and structure of recoverable
costs shall be set out in the implementing act referred to in Article 68(1), taking into
account the objectives of the adequate implementation of this Regulation,
cost-effectiveness and the necessity of ensuring effective access to experts for all
Member States.

3.

The Commission shall facilitate timely access to the experts by the Member States, as
needed, and ensure that the combination of support activities carried out by Union AI
testing support pursuant to Article 84 and experts pursuant to this Article is efficiently
organised and provides the best possible added value.

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SECTION 2NATIONAL COMPETENT AUTHORITIESArticle 70
Designation of national competent authorities and single points of contact
1.

Each Member State shall establish or designate as national competent authorities at least
one notifying authority and at least one market surveillance authority for the purposes ofthis Regulation. Those national competent authorities shall exercise their powers
independently, impartially and without bias so as to safeguard the objectivity of theiractivities and tasks, and to ensure the application and implementation of this Regulation.
The members of those authorities shall refrain from any action incompatible with theirduties. Provided that those principles are observed, such activities and tasks may be
performed by one or more designated authorities, in accordance with the organisational
needs of the Member State.

2.

Member States shall communicate to the Commission the identity of the notifying
authorities and the market surveillance authorities and the tasks of those authorities, as wellas any subsequent changes thereto. Member States shall make publicly available
information on how competent authorities and single points of contact can be contacted,
through electronic communication means by … [12 months from the date of entry into
force of this Regulation]. Member States shall designate a market surveillance authority to
act as the single point of contact for this Regulation, and shall notify the Commission of
the identity of the single point of contact. The Commission shall make a list of the single
points of contact publicly available.

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3.

Member States shall ensure that their national competent authorities are provided withadequate technical, financial and human resources, and with infrastructure to fulfil theirtasks effectively under this Regulation. In particular, the national competent authorities
shall have a sufficient number of personnel permanently available whose competences andexpertise shall include an in-depth understanding of AI technologies, data and data
computing, personal data protection, cybersecurity, fundamental rights, health and safety
risks and knowledge of existing standards and legal requirements. Member States shallassess and, if necessary, update competence and resource requirements referred to in thisparagraph on an annual basis.

4.

National competent authorities shall take appropriate measures to ensure an adequate levelof cybersecurity.

5.

When performing their tasks, the national competent authorities shall act in accordancewith the confidentiality obligations set out in Article 78.

6.

By … [one year from the date of entry into force of this Regulation], and once every two
years thereafter, Member States shall report to the Commission on the status of thefinancial and human resources of the national competent authorities, with an assessment of
their adequacy. The Commission shall transmit that information to the Board for
discussion and possible recommendations.

7.

The Commission shall facilitate the exchange of experience between national competentauthorities.

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8.

National competent authorities may provide guidance and advice on the implementation ofthis Regulation, in particular to SMEs including start-ups, taking into account the guidance
and advice of the Board and the Commission, as appropriate. Whenever national
competent authorities intend to provide guidance and advice with regard to an AI system inareas covered by other Union law, the national competent authorities under that Union law
shall be consulted, as appropriate.

9.

Where Union institutions, bodies, offices or agencies fall within the scope of thisRegulation, the European Data Protection Supervisor shall act as the competent authority
for their supervision.

Chapter VIII
EU database for high-risk AI systems

Article 71
EU database for high-risk AI systems listed in Annex III
1.

The Commission shall, in collaboration with the Member States, set up and maintain an
EU database containing information referred to in paragraphs 2 and 3 of this Article
concerning high-risk AI systems referred to in Article 6(2) which are registered inaccordance with Articles 49 and 60 and AI systems that are not considered as high-risk
pursuant to Article 6(3) and which are registered in accordance with Article 6(4) and
Article 49. When setting the functional specifications of such database, the Commission
shall consult the relevant experts, and when updating the functional specifications of suchdatabase, the Commission shall consult the Board.

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2.

The data listed in Sections A and B of Annex VIII shall be entered into the EU database by
the provider or, where applicable, by the authorised representative.

3.

The data listed in Section C of Annex VIII shall be entered into the EU database by the
deployer who is, or who acts on behalf of, a public authority, agency or body, in
accordance with Article 49(3) and (4).

4.

With the exception of the section referred to in Article 49(4) and Article 60(4), point (c),the information contained in the EU database registered in accordance with Article 49 shallbe accessible and publicly available in a user-friendly manner. The information should be
easily navigable and machine-readable. The information registered in accordance with
Article 60 shall be accessible only to market surveillance authorities and the Commission,
unless the prospective provider or provider has given consent for also making theinformation accessible the public.

5.

The EU database shall contain personal data only in so far as necessary for collecting andprocessing information in accordance with this Regulation. That information shall include
the names and contact details of natural persons who are responsible for registering thesystem and have the legal authority to represent the provider or the deployer, as applicable.

6.

The Commission shall be the controller of the EU database. It shall make available toproviders, prospective providers and deployers adequate technical and administrative
support. The EU database shall comply with the applicable accessibility requirements.

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ENChapter IX
Post-market monitoring, information sharing and market surveillance
SECTION 1
POST-MARKET MONITORING

Article 72
Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
1.

Providers shall establish and document a post-market monitoring system in a manner thatis proportionate to the nature of the AI technologies and the risks of the high-risk AI
system.

2.

The post-market monitoring system shall actively and systematically collect, document andanalyse relevant data which may be provided by deployers or which may be collected
through other sources on the performance of high-risk AI systems throughout their
lifetime, and which allow the provider to evaluate the continuous compliance of AI
systems with the requirements set out in Chapter III, Section 2. Where relevant,post-market monitoring shall include an analysis of the interaction with other AI systems.
This obligation shall not cover sensitive operational data of deployers which arelaw-enforcement authorities.

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3.

The post-market monitoring system shall be based on a post-market monitoring plan. The
post-market monitoring plan shall be part of the technical documentation referred to in
Annex IV. The Commission shall adopt an implementing act laying down detailed
provisions establishing a template for the post-market monitoring plan and the list ofelements to be included in the plan by … [18 months after the entry into force of thisRegulation]. That implementing act shall be adopted in accordance with the examination
procedure referred to in Article 98(2).

4.

For high-risk AI systems covered by the Union harmonisation legislation listed in Section
A of Annex I, where a post-market monitoring system and plan are already establishedunder that legislation, in order to ensure consistency, avoid duplications and minimise
additional burdens, providers shall have a choice of integrating, as appropriate, thenecessary elements described in paragraphs 1, 2 and 3 using the template referred inparagraph 3 into systems and plans already existing under that legislation, provided that itachieves an equivalent level of protection.
The first subparagraph of this paragraph shall also apply to high-risk AI systems referred toin point 5 of Annex III placed on the market or put into service by financial institutions
that are subject to requirements under Union financial services law regarding their internal
governance, arrangements or processes.

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SECTION 2
SHARING OF INFORMATION ON SERIOUS INCIDENTS

Article 73
Reporting of serious incidents
1.

Providers of high-risk AI systems placed on the Union market shall report any serious
incident to the market surveillance authorities of the Member States where that incident
occurred.

2.

The report referred to in paragraph 1 shall be made immediately after the provider has
established a causal link between the AI system and the serious incident or the reasonable
likelihood of such a link, and, in any event, not later than 15 days after the provider or,
where applicable, the deployer, becomes aware of the serious incident.
The period for the reporting referred to in the first subparagraph shall take account of theseverity of the serious incident.

3.

Notwithstanding paragraph 2 of this Article, in the event of a widespread infringement or aserious incident as defined in Article 3, point (49) (b), the report referred to in paragraph 1of this Article shall be provided immediately, and not later than two days after the provider
or, where applicable, the deployer becomes aware of that incident.

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4.

Notwithstanding paragraph 2, in the event of the death of a person, the report shall be
provided immediately after the provider or the deployer has established, or as soon as it
suspects, a causal relationship between the high-risk AI system and the serious incident,
but not later than 10 days after the date on which the provider or, where applicable, thedeployer becomes aware of the serious incident.

5.

Where necessary to ensure timely reporting, the provider or, where applicable, thedeployer, may submit an initial report that is incomplete, followed by a complete report.

6.

Following the reporting of a serious incident pursuant to paragraph 1, the provider shall,
without delay, perform the necessary investigations in relation to the serious incident andthe AI system concerned. This shall include a risk assessment of the incident, andcorrective action.
The provider shall cooperate with the competent authorities, and where relevant with thenotified body concerned, during the investigations referred to in the first subparagraph, andshall not perform any investigation which involves altering the AI system concerned in a
way which may affect any subsequent evaluation of the causes of the incident, prior to
informing the competent authorities of such action.

7.

Upon receiving a notification related to a serious incident referred to in Article 3,
point (49)(c), the relevant market surveillance authority shall inform the national publicauthorities or bodies referred to in Article 77(1). The Commission shall develop dedicatedguidance to facilitate compliance with the obligations set out in paragraph 1 of this Article.
That guidance shall be issued by … [12 months after the entry into force of thisRegulation], and shall be assessed regularly.

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8.

The market surveillance authority shall take appropriate measures, as provided for in
Article 19 of Regulation (EU) 2019/1020, within seven days from the date it received thenotification referred to in paragraph 1 of this Article, and shall follow the notification
procedures as provided in that Regulation.

9.

For high-risk AI systems referred to in Annex III that are placed on the market or put into
service by providers that are subject to Union legislative instruments laying down reporting
obligations equivalent to those set out in this Regulation, the notification of serious
incidents shall be limited to those referred to in Article 3, point (49)(c).

10.

For high-risk AI systems which are safety components of devices, or are themselvesdevices, covered by Regulations (EU) 2017/745 and (EU) 2017/746, the notification ofserious incidents shall be limited to those referred to in Article 3, point (49)(c) of thisRegulation, and shall be made to the national competent authority chosen for that purposeby the Member States where the incident occurred.

11.

National competent authorities shall immediately notify the Commission of any serious
incident, whether or not they have taken action on it, in accordance with Article 20 ofRegulation (EU) 2019/1020.

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SECTION 3
ENFORCEMENT

Article 74
Market surveillance and control of AI systems in the Union market
1.

Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. For the
purposes of the effective enforcement of this Regulation:(a)any reference to an economic operator under Regulation (EU) 2019/1020 shall be
understood as including all operators identified in Article 2(1) of this Regulation;(b)

any reference to a product under Regulation (EU) 2019/1020 shall be understood as
including all AI systems falling within the scope of this Regulation.

2.

As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020,
the market surveillance authorities shall report annually to the Commission and relevant
national competition authorities any information identified in the course of market
surveillance activities that may be of potential interest for the application of Union law oncompetition rules. They shall also annually report to the Commission about the use ofprohibited practices that occurred during that year and about the measures taken.

3.

For high-risk AI systems related to products covered by the Union harmonisation
legislation listed in Section A of Annex I, the market surveillance authority for the
purposes of this Regulation shall be the authority responsible for market surveillance
activities designated under those legal acts.

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ENBy derogation from the first subparagraph, and in appropriate circumstances,
Member States may designate another relevant authority to act as a market surveillanceauthority, provided they ensure coordination with the relevant sectoral market surveillanceauthorities responsible for the enforcement of the Union harmonisation legislation listed
in Annex I.
4.

The procedures referred to in Articles 79 to 83 of this Regulation shall not apply to AI
systems related to products covered by the Union harmonisation legislation listed in
section A of Annex I, where such legal acts already provide for procedures ensuring anequivalent level of protection and having the same objective. In such cases, the relevant
sectoral procedures shall apply instead.

5.

Without prejudice to the powers of market surveillance authorities under Article 14 ofRegulation (EU) 2019/1020, for the purpose of ensuring the effective enforcement of thisRegulation, market surveillance authorities may exercise the powers referred to in
Article 14(4), points (d) and (j), of that Regulation remotely, as appropriate.

6.

For high-risk AI systems placed on the market, put into service, or used by financial
institutions regulated by Union financial services law, the market surveillance authority forthe purposes of this Regulation shall be the relevant national authority responsible for thefinancial supervision of those institutions under that legislation in so far as the placing on
the market, putting into service, or the use of the AI system is in direct connection with theprovision of those financial services.

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7.

By way of derogation from paragraph 6, in appropriate circumstances, and provided thatcoordination is ensured, another relevant authority may be identified by the Member Stateas market surveillance authority for the purposes of this Regulation.
National market surveillance authorities supervising regulated credit institutions regulated
under Directive 2013/36/EU, which are participating in the Single Supervisory Mechanism
established by Regulation (EU) No 1024/2013, should report, without delay, to theEuropean Central Bank any information identified in the course of their market
surveillance activities that may be of potential interest for the prudential supervisory tasksof the European Central Bank specified in that Regulation.

8.

For high-risk AI systems listed in point 1 of Annex III to this Regulation, in so far as thesystems are used for law enforcement purposes, border management and justice anddemocracy, and for high-risk AI systems listed in points 6, 7 and 8 of Annex III to thisRegulation, Member States shall designate as market surveillance authorities for the
purposes of this Regulation either the competent data protection supervisory authorities
under Regulation (EU) 2016/679 or Directive (EU) 2016/680, or any other authority
designated pursuant to the same conditions laid down in Articles 41 to 44 of Directive(EU) 2016/680. Market surveillance activities shall in no way affect the independence of
judicial authorities, or otherwise interfere with their activities when acting in their judicial
capacity.

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9.

Where Union institutions, bodies, offices or agencies fall within the scope of thisRegulation, the European Data Protection Supervisor shall act as their market surveillanceauthority, except in relation to the Court of Justice of the European Union acting in its
judicial capacity.

10.

Member States shall facilitate coordination between market surveillance authorities
designated under this Regulation and other relevant national authorities or bodies which
supervise the application of Union harmonisation legislation listed in Annex I, or in other
Union law, that might be relevant for the high-risk AI systems referred to in Annex III.

11.

Market surveillance authorities and the Commission shall be able to propose joint
activities, including joint investigations, to be conducted by either market surveillanceauthorities or market surveillance authorities jointly with the Commission, that have theaim of promoting compliance, identifying non-compliance, raising awareness or providing
guidance in relation to this Regulation with respect to specific categories of high-risk AI
systems that are found to present a serious risk across two or more Member States inaccordance with Article 9 of Regulation (EU) 2019/1020. The AI Office shall provide
coordination support for joint investigations.

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12.

Without prejudice to the powers provided for under Regulation (EU) 2019/1020, andwhere relevant and limited to what is necessary to fulfil their tasks, the market surveillanceauthorities shall be granted full access by providers to the documentation as well as thetraining, validation and testing data sets used for the development of high-risk AI systems,
including, where appropriate and subject to security safeguards, through application
programming interfaces (API) or other relevant technical means and tools enabling remote
access.

13.

Market surveillance authorities shall be granted access to the source code of the high-risk
AI system upon a reasoned request and only when both of the following conditions are
fulfilled:(a)access to source code is necessary to assess the conformity of a high-risk AI systemwith the requirements set out in Chapter III, Section 2; and,(b)testing or auditing procedures and verifications based on the data and documentation
provided by the provider have been exhausted or proved insufficient.

14.

Any information or documentation obtained by market surveillance authorities shall betreated in accordance with the confidentiality obligations set out in Article 78.

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Article 75
Mutual assistance, market surveillance and control of general-purpose AI systems
1.

Where an AI system is based on a general-purpose AI model, and the model and thesystem are developed by the same provider, the AI Office shall have powers to monitor
and supervise compliance of that AI system with obligations under this Regulation. To
carry out its monitoring and supervision tasks, the AI Office shall have all the powers of amarket surveillance authority provided for in this Section and Regulation (EU) 2019/1020.

2.

Where the relevant market surveillance authorities have sufficient reason to consider
general-purpose AI systems that can be used directly by deployers for at least one purposethat is classified as high-risk pursuant to this Regulation to be non-compliant with therequirements laid down in this Regulation, they shall cooperate with the AI Office to carryout compliance evaluations, and shall inform the Board and other market surveillanceauthorities accordingly.

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3.

Where a market surveillance authority is unable to conclude its investigation of thehigh-risk AI system because of its inability to access certain information related to thegeneral-purpose AI model despite having made all appropriate efforts to obtain that
information, it may submit a reasoned request to the AI Office, by which access to that
information shall be enforced. In that case, the AI Office shall supply to the applicant
authority without delay, and in any event within 30 days, any information that the AI
Office considers to be relevant in order to establish whether a high-risk AI system is
non-compliant. Market surveillance authorities shall safeguard the confidentiality of theinformation that they obtain in accordance with Article 78 of this Regulation. The
procedure provided for in Chapter VI of Regulation (EU) 2019/1020 shall apply
mutatis mutandis.

Article 76
Supervision of testing in real world conditions by market surveillance authorities
1.

Market surveillance authorities shall have competences and powers to ensure that testing inreal world conditions is in accordance with this Regulation.

2.

Where testing in real world conditions is conducted for AI systems that are supervised
within an AI regulatory sandbox under Article 58, the market surveillance authorities shallverify the compliance with Article 60 as part of their supervisory role for the AI regulatory
sandbox. Those authorities may, as appropriate, allow the testing in real world conditions
to be conducted by the provider or prospective provider, in derogation from the conditions
set out in Article 60(4), points (f) and (g).

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3.

Where a market surveillance authority has been informed by the prospective provider, theprovider or any third party of a serious incident or has other grounds for considering thatthe conditions set out in Articles 60 and 61 are not met, it may take either of the following
decisions on its territory, as appropriate:(a)to suspend or terminate the testing in real world conditions;(b)to require the provider or prospective provider and the deployer or prospective
deployer to modify any aspect of the testing in real world conditions.

4.

Where a market surveillance authority has taken a decision referred to in paragraph 3 ofthis Article, or has issued an objection within the meaning of Article 60(4), point (b), thedecision or the objection shall indicate the grounds therefor and how the provider orprospective provider can challenge the decision or objection.

5.

Where applicable, where a market surveillance authority has taken a decision referred to inparagraph 3, it shall communicate the grounds therefor to the market surveillanceauthorities of other Member States in which the AI system has been tested in accordancewith the testing plan.

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Article 77
Powers of authorities protecting fundamental rights
1.

National public authorities or bodies which supervise or enforce the respect of obligations
under Union law protecting fundamental rights, including the right to non-discrimination,
in relation to the use of high-risk AI systems referred to in Annex III shall have the power
to request and access any documentation created or maintained under this Regulation inaccessible language and format when access to that documentation is necessary for
effectively fulfilling their mandates within the limits of their jurisdiction. The relevantpublic authority or body shall inform the market surveillance authority of theMember State concerned of any such request.

2.

By … [three months after the entry into force of this Regulation], each Member State shallidentify the public authorities or bodies referred to in paragraph 1 and make a list of thempublicly available. Member States shall notify the list to the Commission and to the otherMember States, and shall keep the list up to date.

3.

Where the documentation referred to in paragraph 1 is insufficient to ascertain whether an
infringement of obligations under Union law protecting fundamental rights has occurred,
the public authority or body referred to in paragraph 1 may make a reasoned request to themarket surveillance authority, to organise testing of the high-risk AI system throughtechnical means. The market surveillance authority shall organise the testing with the close
involvement of the requesting public authority or body within a reasonable time following
the request.

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4.

Any information or documentation obtained by the national public authorities or bodies
referred to in paragraph 1 of this Article pursuant to this Article shall be treated inaccordance with the confidentiality obligations set out in Article 78.

Article 78
Confidentiality
1.

The Commission, market surveillance authorities and notified bodies and any other naturalor legal person involved in the application of this Regulation shall, in accordance with
Union or national law, respect the confidentiality of information and data obtained incarrying out their tasks and activities in such a manner as to protect, in particular:(a)the intellectual property rights and confidential business information or trade secretsof a natural or legal person, including source code, except in the cases referred to in
Article 5 of Directive (EU) 2016/943 of the European Parliament and of
the Council57;(b)

the effective implementation of this Regulation, in particular for the purposes ofinspections, investigations or audits;

57

(c)

public and national security interests;(d)the conduct of criminal or administrative proceedings;

Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on
the protection of undisclosed know-how and business information (trade secrets) against
their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).

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(e)
2.

information classified pursuant to Union or national law.

The authorities involved in the application of this Regulation pursuant to paragraph 1 shallrequest only data that is strictly necessary for the assessment of the risk posed by AI
systems and for the exercise of their powers in accordance with this Regulation and with
Regulation (EU) 2019/1020. They shall put in place adequate and effective cybersecurity
measures to protect the security and confidentiality of the information and data obtained,
and shall delete the data collected as soon as it is no longer needed for the purpose forwhich it was obtained, in accordance with applicable Union or national law.

3.

Without prejudice to paragraphs 1 and 2, information exchanged on a confidential basis
between the national competent authorities or between national competent authorities andthe Commission shall not be disclosed without prior consultation of the originating
national competent authority and the deployer when high-risk AI systems referred to inpoint 1, 6 or 7 of Annex III are used by law enforcement, border control, immigration or
asylum authorities and when such disclosure would jeopardise public and national security
interests. This exchange of information shall not cover sensitive operational data in relation
to the activities of law enforcement, border control, immigration or asylum authorities.

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AI systems referred to in point 1, 6 or 7 of Annex III, the technical documentation referred
to in Annex IV shall remain within the premises of those authorities. Those authorities
shall ensure that the market surveillance authorities referred to in Article 74(8) and (9), as
applicable, can, upon request, immediately access the documentation or obtain a copy
thereof. Only staff of the market surveillance authority holding the appropriate level of
security clearance shall be allowed to access that documentation or any copy thereof.
4.

Paragraphs 1, 2 and 3 shall not affect the rights or obligations of the Commission,
Member States and their relevant authorities, as well as those of notified bodies, withregard to the exchange of information and the dissemination of warnings, including in thecontext of cross-border cooperation, nor shall they affect the obligations of the parties
concerned to provide information under criminal law of the Member States.

5.

The Commission and Member States may exchange, where necessary and in accordancewith relevant provisions of international and trade agreements, confidential information
with regulatory authorities of third countries with which they have concluded bilateral or
multilateral confidentiality arrangements guaranteeing an adequate level of confidentiality.

Article 79
Procedure at national level for dealing with AI systems presenting a risk
1.

AI systems presenting a risk shall be understood as a ‘product presenting a risk’ as definedin Article 3, point 19 of Regulation (EU) 2019/1020, in so far as they present risks to thehealth or safety, or to fundamental rights, of persons.

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2.

Where the market surveillance authority of a Member State has sufficient reason toconsider an AI system to present a risk as referred to in paragraph 1 of this Article, it shallcarry out an evaluation of the AI system concerned in respect of its compliance with all therequirements and obligations laid down in this Regulation. Particular attention shall begiven to AI systems presenting a risk to vulnerable groups. Where risks to fundamental
rights are identified, the market surveillance authority shall also inform and fully cooperatewith the relevant national public authorities or bodies referred to in Article 77(1). The
relevant operators shall cooperate as necessary with the market surveillance authority andwith the other national public authorities or bodies referred to in Article 77(1).
Where, in the course of that evaluation, the market surveillance authority or, whereapplicable the market surveillance authority in cooperation with the national publicauthority referred to in Article 77(1), finds that the AI system does not comply with therequirements and obligations laid down in this Regulation, it shall without undue delay
require the relevant operator to take all appropriate corrective actions to bring the AI
system into compliance, to withdraw the AI system from the market, or to recall it within aperiod the market surveillance authority may prescribe, and in any event within the shorterof 15 working days, or as provided for in the relevant Union harmonisation legislation.
The market surveillance authority shall inform the relevant notified body accordingly.
Article 18 of Regulation (EU) 2019/1020 shall apply to the measures referred to in thesecond subparagraph of this paragraph.

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3.

Where the market surveillance authority considers that the non-compliance is not restricted
to its national territory, it shall inform the Commission and the other Member States
without undue delay of the results of the evaluation and of the actions which it has required
the operator to take.

4.

The operator shall ensure that all appropriate corrective action is taken in respect of all theAI systems concerned that it has made available on the Union market.

5.

Where the operator of an AI system does not take adequate corrective action within the
period referred to in paragraph 2, the market surveillance authority shall take allappropriate provisional measures to prohibit or restrict the AI system’s being madeavailable on its national market or put into service, to withdraw the product or the
standalone AI system from that market or to recall it. That authority shall without undue
delay notify the Commission and the other Member States of those measures.

6.

The notification referred to in paragraph 5 shall include all available details, in particular
the information necessary for the identification of the non-compliant AI system, the originof the AI system and the supply chain, the nature of the non-compliance alleged and therisk involved, the nature and duration of the national measures taken and the arguments put
forward by the relevant operator. In particular, the market surveillance authorities shallindicate whether the non-compliance is due to one or more of the following:(a)non-compliance with the prohibition of the AI practices referred to in Article 5;(b)a failure of a high-risk AI system to meet requirements set out in Chapter III,
Section 2;

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(c)

shortcomings in the harmonised standards or common specifications referred to in
Articles 40 and 41 conferring a presumption of conformity;(d)7.

non-compliance with Article 50.

The market surveillance authorities other than the market surveillance authority of theMember State initiating the procedure shall, without undue delay, inform the Commission
and the other Member States of any measures adopted and of any additional information attheir disposal relating to the non-compliance of the AI system concerned, and, in the eventof disagreement with the notified national measure, of their objections.

8.

Where, within three months of receipt of the notification referred to in paragraph 5 of this
Article, no objection has been raised by either a market surveillance authority of a
Member State or by the Commission in respect of a provisional measure taken by a market
surveillance authority of another Member State, that measure shall be deemed justified.
This shall be without prejudice to the procedural rights of the concerned operator inaccordance with Article 18 of Regulation (EU) 2019/1020. The three-month period
referred to in this paragraph shall be reduced to 30 days in the event of non-compliancewith the prohibition of the AI practices referred to in Article 5 of this Regulation.

9.

The market surveillance authorities shall ensure that appropriate restrictive measures aretaken in respect of the product or the AI system concerned, such as withdrawal of the
product or the AI system from their market, without undue delay.

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Article 80
Procedure for dealing with AI systems classified by the provider as
non-high-risk in application of Annex III
1.

Where a market surveillance authority has sufficient reason to consider that an AI systemclassified by the provider as non-high-risk pursuant to Article 6(3) is indeed high-risk, themarket surveillance authority shall carry out an evaluation of the AI system concerned in
respect of its classification as a high-risk AI system based on the conditions set out in
Article 6(3) and the Commission guidelines.

2.

Where, in the course of that evaluation, the market surveillance authority finds that the AI
system concerned is high-risk, it shall without undue delay require the relevant provider totake all necessary actions to bring the AI system into compliance with the requirements
and obligations laid down in this Regulation, as well as take appropriate corrective action
within a period the market surveillance authority may prescribe.

3.

Where the market surveillance authority considers that the use of the AI system concerned
is not restricted to its national territory, it shall inform the Commission and the otherMember States without undue delay of the results of the evaluation and of the actions
which it has required the provider to take.

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4.

The provider shall ensure that all necessary action is taken to bring the AI system into
compliance with the requirements and obligations laid down in this Regulation. Where theprovider of an AI system concerned does not bring the AI system into compliance withthose requirements and obligations within the period referred to in paragraph 2 of this
Article, the provider shall be subject to fines in accordance with Article 99.

5.

The provider shall ensure that all appropriate corrective action is taken in respect of all theAI systems concerned that it has made available on the Union market.

6.

Where the provider of the AI system concerned does not take adequate corrective action
within the period referred to in paragraph 2 of this Article, Article 79(5) to (9) shall apply.

7.

Where, in the course of the evaluation pursuant to paragraph 1 of this Article, the market
surveillance authority establishes that the AI system was misclassified by the provider as
non-high-risk in order to circumvent the application of requirements in Chapter III,
Section 2, the provider shall be subject to fines in accordance with Article 99.

8.

In exercising their power to monitor the application of this Article, and in accordance with
Article 11 of Regulation (EU) 2019/1020, market surveillance authorities may perform
appropriate checks, taking into account in particular information stored in the EU databasereferred to in Article 71 of this Regulation.

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Article 81
Union safeguard procedure
1.

Where, within three months of receipt of the notification referred to in Article 79(5), or
within 30 days in the case of non-compliance with the prohibition of the AI practices
referred to in Article 5, objections are raised by the market surveillance authority of a
Member State to a measure taken by another market surveillance authority, or where theCommission considers the measure to be contrary to Union law, the Commission shallwithout undue delay enter into consultation with the market surveillance authority of therelevant Member State and the operator or operators, and shall evaluate the national
measure. On the basis of the results of that evaluation, the Commission shall, within six
months, or within 60 days in the case of non-compliance with the prohibition of the AI
practices referred to in Article 5, starting from the notification referred to in Article 79(5),decide whether the national measure is justified and shall notify its decision to the market
surveillance authority of the Member State concerned. The Commission shall also informall other market surveillance authorities of its decision.

2.

Where the Commission considers the measure taken by the relevant Member State to bejustified, all Member States shall ensure that they take appropriate restrictive measures inrespect of the AI system concerned, such as requiring the withdrawal of the AI systemfrom their market without undue delay, and shall inform the Commission accordingly.
Where the Commission considers the national measure to be unjustified, the Member State
concerned shall withdraw the measure and shall inform the Commission accordingly.

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3.

Where the national measure is considered justified and the non-compliance of the AI
system is attributed to shortcomings in the harmonised standards or common specifications
referred to in Articles 40 and 41 of this Regulation, the Commission shall apply theprocedure provided for in Article 11 of Regulation (EU) No 1025/2012.

Article 82
Compliant AI systems which present a risk
1.

Where, having performed an evaluation under Article 79, after consulting the relevant
national public authority referred to in Article 77(1), the market surveillance authority of a
Member State finds that although a high-risk AI system complies with this Regulation, it
nevertheless presents a risk to the health or safety of persons, to fundamental rights, or toother aspects of public interest protection, it shall require the relevant operator to take allappropriate measures to ensure that the AI system concerned, when placed on the market
or put into service, no longer presents that risk without undue delay, within a period it may
prescribe.

2.

The provider or other relevant operator shall ensure that corrective action is taken in
respect of all the AI systems concerned that it has made available on the Union market
within the timeline prescribed by the market surveillance authority of the Member Statereferred to in paragraph 1.

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3.

The Member States shall immediately inform the Commission and the otherMember States of a finding under paragraph 1. That information shall include all available
details, in particular the data necessary for the identification of the AI system concerned,
the origin and the supply chain of the AI system, the nature of the risk involved and thenature and duration of the national measures taken.

4.

The Commission shall without undue delay enter into consultation with the Member Statesconcerned and the relevant operators, and shall evaluate the national measures taken. On
the basis of the results of that evaluation, the Commission shall decide whether themeasure is justified and, where necessary, propose other appropriate measures.

5.

The Commission shall immediately communicate its decision to the Member Statesconcerned and to the relevant operators. It shall also inform the other Member States.

Article 83
Formal non-compliance
1.

Where the market surveillance authority of a Member State makes one of the following
findings, it shall require the relevant provider to put an end to the non-complianceconcerned, within a period it may prescribe:(a)the CE marking has been affixed in violation of Article 48;(b)

the CE marking has not been affixed;(c)the EU declaration of conformity referred to in Article 47 has not been drawn up;

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(d)

the EU declaration of conformity referred to in Article 47 has not been drawn up
correctly;

2.

(e)

the registration in the EU database referred to in Article 71 has not been carried out;(f)where applicable, no authorised representative has been appointed;(g)

technical documentation is not available.

Where the non-compliance referred to in paragraph 1 persists, the market surveillanceauthority of the Member State concerned shall take appropriate and proportionate measures
to restrict or prohibit the high-risk AI system being made available on the market or toensure that it is recalled or withdrawn from the market without delay.

Article 84
Union AI testing support structures
1.

The Commission shall designate one or more Union AI testing support structures toperform the tasks listed under Article 21(6) of Regulation (EU) 2019/1020 in the areaof AI.

2.

Without prejudice to the tasks referred to in paragraph 1, Union AI testing support
structures shall also provide independent technical or scientific advice at the request of theBoard, the Commission, or of market surveillance authorities.

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SECTION 4
REMEDIES

Article 85
Right to lodge a complaint with a market surveillance authority
Without prejudice to other administrative or judicial remedies, any natural or legal person having
grounds to consider that there has been an infringement of the provisions of this Regulation may
submit complaints to the relevant market surveillance authority.
In accordance with Regulation (EU) 2019/1020, such complaints shall be taken into account for the
purpose of conducting market surveillance activities, and shall be handled in line with the dedicatedprocedures established therefor by the market surveillance authorities.

Article 86
Right to explanation of individual decision-making
1.

Any affected person subject to a decision which is taken by the deployer on the basis of theoutput from a high-risk AI system listed in Annex III, with the exception of systems listed
under point 2 thereof, and which produces legal effects or similarly significantly affects
that person in a way that they consider to have an adverse impact on their health, safety or
fundamental rights shall have the right to obtain from the deployer clear and meaningful
explanations of the role of the AI system in the decision-making procedure and the mainelements of the decision taken.

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2.

Paragraph 1 shall not apply to the use of AI systems for which exceptions from, or
restrictions to, the obligation under that paragraph follow from Union or national law incompliance with Union law.

3.

This Article shall apply only to the extent that the right referred to in paragraph 1 is nototherwise provided for under Union law.

Article 87
Reporting of infringements and protection of reporting persons
Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and theprotection of persons reporting such infringements.

SECTION 5
SUPERVISION, INVESTIGATION, ENFORCEMENT AND MONITORINGIN RESPECT OF PROVIDERS OF GENERAL-PURPOSE AI MODELS

Article 88
Enforcement of the obligations of providers of general-purpose AI models
1.

The Commission shall have exclusive powers to supervise and enforce Chapter V, taking
into account the procedural guarantees under Article 94. The Commission shall entrust theimplementation of these tasks to the AI Office, without prejudice to the powers oforganisation of the Commission and the division of competences between Member States
and the Union based on the Treaties.

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2.

Without prejudice to Article 75(3), market surveillance authorities may request theCommission to exercise the powers laid down in this Section, where that is necessary andproportionate to assist with the fulfilment of their tasks under this Regulation.

Article 89
Monitoring actions
1.

For the purpose of carrying out the tasks assigned to it under this Section, the AI Office
may take the necessary actions to monitor the effective implementation and compliancewith this Regulation by providers of general-purpose AI models, including their adherence
to approved codes of practice.

2.

Downstream providers shall have the right to lodge a complaint alleging an infringementof this Regulation. A complaint shall be duly reasoned and indicate at least:(a)the point of contact of the provider of the general-purpose AI model concerned;(b)a description of the relevant facts, the provisions of this Regulation concerned, andthe reason why the downstream provider considers that the provider of thegeneral-purpose AI model concerned infringed this Regulation;(c)any other information that the downstream provider that sent the request considers
relevant, including, where appropriate, information gathered on its own initiative.

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Article 90
Alerts of systemic risks by the scientific panel
1.

The scientific panel may provide a qualified alert to the AI Office where it has reason tosuspect that:

2.

(a)

a general-purpose AI model poses concrete identifiable risk at Union level; or,(b)a general-purpose AI model meets the conditions referred to in Article 51.

Upon such qualified alert, the Commission, through the AI Office and after having
informed the Board, may exercise the powers laid down in this Section for the purpose of
assessing the matter. The AI Office shall inform the Board of any measure according to
Articles 91 to 94.

3.

A qualified alert shall be duly reasoned and indicate at least:(a)the point of contact of the provider of the general-purpose AI model with systemicrisk concerned;(b)a description of the relevant facts and the reasons for the alert by the scientific panel;(c)any other information that the scientific panel considers to be relevant, including,where appropriate, information gathered on its own initiative.

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Article 91
Power to request documentation and information
1.

The Commission may request the provider of the general-purpose AI model concerned toprovide the documentation drawn up by the provider in accordance with Articles 53
and 55, or any additional information that is necessary for the purpose of assessing
compliance of the provider with this Regulation.

2.

Before sending the request for information, the AI Office may initiate a structured dialogue
with the provider of the general-purpose AI model.

3.

Upon a duly substantiated request from the scientific panel, the Commission may issue arequest for information to a provider of a general-purpose AI model, where the access to
information is necessary and proportionate for the fulfilment of the tasks of the scientificpanel under Article 68(2).

4.

The request for information shall state the legal basis and the purpose of the request,
specify what information is required, set a period within which the information is to beprovided, and indicate the fines provided for in Article 101 for supplying incorrect,
incomplete or misleading information.

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5.

The provider of the general-purpose AI model concerned, or its representative shall supply
the information requested. In the case of legal persons, companies or firms, or where theprovider has no legal personality, the persons authorised to represent them by law or by
their statutes, shall supply the information requested on behalf of the provider of thegeneral-purpose AI model concerned. Lawyers duly authorised to act may supply
information on behalf of their clients. The clients shall nevertheless remain fully
responsible if the information supplied is incomplete, incorrect or misleading.

Article 92
Power to conduct evaluations
1.

The AI Office, after consulting the Board, may conduct evaluations of the general-purpose
AI model concerned:(a)to assess compliance of the provider with obligations under this Regulation, where
the information gathered pursuant to Article 91 is insufficient; or,(b)

to investigate systemic risks at Union level of general-purpose AI models withsystemic risk, in particular following a qualified alert from the scientific panel inaccordance with Article 90(1), point (a).

2.

The Commission may decide to appoint independent experts to carry out evaluations on its
behalf, including from the scientific panel established pursuant to Article 68. Independent
experts appointed for this task shall meet the criteria outlined in Article 68(2).

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3.

For the purposes of paragraph 1, the Commission may request access to thegeneral-purpose AI model concerned through APIs or further appropriate technical means
and tools, including source code.

4.

The request for access shall state the legal basis, the purpose and reasons of the request andset the period within which the access is to be provided, and the fines provided for in
Article 101 for failure to provide access.

5.

The providers of the general-purpose AI model concerned or its representative shall supply
the information requested. In the case of legal persons, companies or firms, or where theprovider has no legal personality, the persons authorised to represent them by law or by
their statutes, shall provide the access requested on behalf of the provider of thegeneral-purpose AI model concerned.

6.

The Commission shall adopt implementing acts setting out the detailed arrangements andthe conditions for the evaluations, including the detailed arrangements for involving
independent experts, and the procedure for the selection thereof. Those implementing acts
shall be adopted in accordance with the examination procedure referred to in Article 98(2).

7.

Prior to requesting access to the general-purpose AI model concerned, the AI Office may
initiate a structured dialogue with the provider of the general-purpose AI model to gather
more information on the internal testing of the model, internal safeguards for preventing
systemic risks, and other internal procedures and measures the provider has taken to
mitigate such risks.

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Article 93
Power to request measures
1.

Where necessary and appropriate, the Commission may request providers to:(a)take appropriate measures to comply with the obligations set out in Articles 53
and 54;(b)

implement mitigation measures, where the evaluation carried out in accordance with
Article 92 has given rise to serious and substantiated concern of a systemic risk atUnion level;(c)2.

restrict the making available on the market, withdraw or recall the model.

Before a measure is requested, the AI Office may initiate a structured dialogue with theprovider of the general-purpose AI model.

3.

If, during the structured dialogue referred to in paragraph 2, the provider of thegeneral-purpose AI model with systemic risk offers commitments to implement mitigation
measures to address a systemic risk at Union level, the Commission may, by decision,
make those commitments binding and declare that there are no further grounds for action.

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Article 94
Procedural rights of economic operators of the general-purpose AI model
Article 18 of Regulation (EU) 2019/1020 shall apply mutatis mutandis to the providers of thegeneral-purpose AI model, without prejudice to more specific procedural rights provided for inthis Regulation.

Chapter X
Codes of conduct and guidelines

Article 95
Codes of conduct for voluntary application of specific requirements
1.

The AI Office and the Member States shall encourage and facilitate the drawing up ofcodes of conduct, including related governance mechanisms, intended to foster thevoluntary application to AI systems, other than high-risk AI systems, of some or all of therequirements set out in Chapter III, Section 2 taking into account the available technicalsolutions and industry best practices allowing for the application of such requirements.

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2.

The AI Office and the Member States shall facilitate the drawing up of codes of conduct
concerning the voluntary application, including by deployers, of specific requirements to
all AI systems, on the basis of clear objectives and key performance indicators to measure
the achievement of those objectives, including elements such as, but not limited to:(a)applicable elements provided for in Union ethical guidelines for trustworthy AI;(b)assessing and minimising the impact of AI systems on environmental sustainability,
including as regards energy-efficient programming and techniques for the efficientdesign, training and use of AI;(c)promoting AI literacy, in particular that of persons dealing with the development,
operation and use of AI;(d)facilitating an inclusive and diverse design of AI systems, including through theestablishment of inclusive and diverse development teams and the promotion of
stakeholders’ participation in that process;(e)assessing and preventing the negative impact of AI systems on vulnerable persons orgroups of vulnerable persons, including as regards accessibility for persons with adisability, as well as on gender equality.

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3.

Codes of conduct may be drawn up by individual providers or deployers of AI systems or
by organisations representing them or by both, including with the involvement of any
interested stakeholders and their representative organisations, including civil society
organisations and academia. Codes of conduct may cover one or more AI systems taking
into account the similarity of the intended purpose of the relevant systems.

4.

The AI Office and the Member States shall take into account the specific interests andneeds of SMEs, including start-ups, when encouraging and facilitating the drawing up ofcodes of conduct.

Article 96
Guidelines from the Commission on the implementation of this Regulation
1.

The Commission shall develop guidelines on the practical implementation of thisRegulation, and in particular on:(a)

the application of the requirements and obligations referred to in Articles 8 to 15 andin Article 25;(b)

the prohibited practices referred to in Article 5;(c)the practical implementation of the provisions related to substantial modification;(d)the practical implementation of transparency obligations laid down in Article 50;

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(e)

detailed information on the relationship of this Regulation with the Union
harmonisation legislation listed in Annex I, as well as with other relevant Union law,
including as regards consistency in their enforcement;(f)the application of the definition of an AI system as set out in Article 3, point (1).

When issuing such guidelines, the Commission shall pay particular attention to the needsof SMEs including start-ups, of local public authorities and of the sectors most likely to beaffected by this Regulation.
The guidelines referred to in the first subparagraph of this paragraph shall take due accountof the generally acknowledged state of the art on AI, as well as of relevant harmonised
standards and common specifications that are referred to in Articles 40 and 41, or of thoseharmonised standards or technical specifications that are set out pursuant to Union
harmonisation law.
2.

At the request of the Member States or the AI Office, or on its own initiative, theCommission shall update guidelines previously adopted when deemed necessary.

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ENChapter XIDelegation of power and committee procedure

Article 97
Exercise of the delegation
1.

The power to adopt delegated acts is conferred on the Commission subject to theconditions laid down in this Article.

2.

The power to adopt delegated acts referred to in Article 6(6) and (7), Article 7(1) and (3),Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and
Article 53(5) and (6) shall be conferred on the Commission for a period of five years
from … [date of entry into force of this Regulation]. The Commission shall draw up areport in respect of the delegation of power not later than nine months before the end of the
five-year period. The delegation of power shall be tacitly extended for periods of an
identical duration, unless the European Parliament or the Council opposes such extension
not later than three months before the end of each period.

3.

The delegation of power referred to in Article 6(6) and (7), Article 7(1) and (3),Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and
Article 53(5) and (6) may be revoked at any time by the European Parliament or by theCouncil. A decision of revocation shall put an end to the delegation of power specified inthat 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 thevalidity of any delegated acts already in force.

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4.

Before adopting a delegated act, the Commission shall consult experts designated by each
Member State in accordance with the principles laid down in the Interinstitutional
Agreement of 13 April 2016 on Better Law-Making.

5.

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to theEuropean Parliament and to the Council.

6.

Any delegated act adopted pursuant to Article 6(6) or (7), Article 7(1) or (3), Article 11(3),Article 43(5) or (6), Article 47(5), Article 51(3), Article 52(4) or Article 53(5) or (6) shallenter into force only if no objection has been expressed by either the European Parliamentor 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 98
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 shallapply.

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Penalties

Article 99
Penalties
1.

In accordance with the terms and conditions laid down in this Regulation, Member Statesshall lay down the rules on penalties and other enforcement measures, which may also
include warnings and non-monetary measures, applicable to infringements of thisRegulation by operators, and shall take all measures necessary to ensure that they areproperly and effectively implemented, thereby taking into account the guidelines issued by
the Commission pursuant to Article 96. The penalties provided for shall be effective,
proportionate and dissuasive. They shall take into account the interests of SMEs, including
start-ups, and their economic viability.

2.

The Member States shall, without delay and at the latest by the date of entry into
application, notify the Commission of the rules on penalties and of other enforcement
measures referred to in paragraph 1, and shall notify it, without delay, of any subsequent
amendment to them.

3.

Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be
subject to administrative fines of up to 35 000 000 EUR or, if the offender is anundertaking, up to 7 % of its total worldwide annual turnover for the preceding financial
year, whichever is higher.

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4.

Non-compliance with any of the following provisions related to operators or notified
bodies, other than those laid down in Articles 5, shall be subject to administrative fines of
up to 15 000 000 EUR or, if the offender is an undertaking, up to 3 % of its total
worldwide annual turnover for the preceding financial year, whichever is higher:(a)obligations of providers pursuant to Article 16;(b)obligations of authorised representatives pursuant to Article 22;(c)obligations of importers pursuant to Article 23;(d)obligations of distributors pursuant to Article 24;(e)obligations of deployers pursuant to Article 26;(f)requirements and obligations of notified bodies pursuant to Article 31,
Article 33(1), (3) and (4) or Article 34;(g)5.

transparency obligations for providers and deployers pursuant to Article 50.

The supply of incorrect, incomplete or misleading information to notified bodies or
national competent authorities in reply to a request shall be subject to administrative finesof up to 7 500 000 EUR or, if the offender is an undertaking, up to 1 % of its total
worldwide annual turnover for the preceding financial year, whichever is higher.

6.

In the case of SMEs, including start-ups, each fine referred to in this Article shall be up to
the percentages or amount referred to in paragraphs 3, 4 and 5, whichever thereof is lower.

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7.

When deciding whether to impose an administrative fine and when deciding on the amountof the administrative fine in each individual case, all relevant circumstances of the specificsituation shall be taken into account and, as appropriate, regard shall be given to thefollowing:(a)the nature, gravity and duration of the infringement and of its consequences, taking
into account the purpose of the AI system, as well as, where appropriate, the number
of affected persons and the level of damage suffered by them;(b)whether administrative fines have already been applied by other market surveillanceauthorities to the same operator for the same infringement;(c)whether administrative fines have already been applied by other authorities to thesame operator for infringements of other Union or national law, when such
infringements result from the same activity or omission constituting a relevant
infringement of this Regulation;(d)the size, the annual turnover and market share of the operator committing theinfringement;(e)

any other aggravating or mitigating factor applicable to the circumstances of thecase, such as financial benefits gained, or losses avoided, directly or indirectly, fromthe infringement;(f)the degree of cooperation with the national competent authorities, in order to remedy
the infringement and mitigate the possible adverse effects of the infringement;

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(g)

the degree of responsibility of the operator taking into account the technical andorganisational measures implemented by it;(h)the manner in which the infringement became known to the national competentauthorities, in particular whether, and if so to what extent, the operator notified theinfringement;(i)

the intentional or negligent character of the infringement;(j)

any action taken by the operator to mitigate the harm suffered by the affected
persons.

8.

Each Member State shall lay down rules on to what extent administrative fines may be
imposed on public authorities and bodies established in that Member State.

9.

Depending on the legal system of the Member States, the rules on administrative fines may
be applied in such a manner that the fines are imposed by competent national courts or byother bodies, as applicable in those Member States. The application of such rules in thoseMember States shall have an equivalent effect.

10.

The exercise of powers under this Article shall be subject to appropriate procedural
safeguards in accordance with Union and national law, including effective judicial
remedies and due process.

11.

Member States shall, on an annual basis, report to the Commission about theadministrative fines they have issued during that year, in accordance with this Article, andabout any related litigation or judicial proceedings.

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Article 100
Administrative fines on Union institutions, bodies, offices and agencies
1.

The European Data Protection Supervisor may impose administrative fines on Union
institutions, bodies, offices and agencies falling within the scope of this Regulation. When
deciding whether to impose an administrative fine and when deciding on the amount of theadministrative fine in each individual case, all relevant circumstances of the specificsituation shall be taken into account and due regard shall be given to the following:(a)the nature, gravity and duration of the infringement and of its consequences, taking
into account the purpose of the AI system concerned, as well as, where appropriate,
the number of affected persons and the level of damage suffered by them;(b)

the degree of responsibility of the Union institution, body, office or agency, taking
into account technical and organisational measures implemented by them;(c)any action taken by the Union institution, body, office or agency to mitigate thedamage suffered by affected persons;(d)the degree of cooperation with the European Data Protection Supervisor in order toremedy the infringement and mitigate the possible adverse effects of theinfringement, including compliance with any of the measures previously ordered by
the European Data Protection Supervisor against the Union institution, body, officeor agency concerned with regard to the same subject matter;

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(e)

any similar previous infringements by the Union institution, body, office or agency;(f)the manner in which the infringement became known to the European Data
Protection Supervisor, in particular whether, and if so to what extent, the Union
institution, body, office or agency notified the infringement;(g)2.

the annual budget of the Union institution, body, office or agency.

Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be
subject to administrative fines of up to EUR 1 500 000.

3.

The non-compliance of the AI system with any requirements or obligations under thisRegulation, other than those laid down in Article 5, shall be subject to administrative finesof up to EUR 750 000.

4.

Before taking decisions pursuant to this Article, the European Data Protection Supervisor
shall give the Union institution, body, office or agency which is the subject of theproceedings conducted by the European Data Protection Supervisor the opportunity of
being heard on the matter regarding the possible infringement. The European Data
Protection Supervisor shall base his or her decisions only on elements and circumstanceson which the parties concerned have been able to comment. Complainants, if any, shall be
associated closely with the proceedings.

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5.

The rights of defence of the parties concerned shall be fully respected in the proceedings.
They shall be entitled to have access to the European Data Protection Supervisor’s file,
subject to the legitimate interest of individuals or undertakings in the protection of theirpersonal data or business secrets.

6.

Funds collected by imposition of fines in this Article shall contribute to the general budgetof the Union. The fines shall not affect the effective operation of the Union institution,
body, office or agency fined.

7.

The European Data Protection Supervisor shall, on an annual basis, notify the Commissionof the administrative fines it has imposed pursuant to this Article and of any litigation or
judicial proceedings it has initiated.

Article 101
Fines for providers of general-purpose AI models
1.

The Commission may impose on providers of general-purpose AI models fines notexceeding 3 % of their annual total worldwide turnover in the preceding financial year or
EUR 15 000 000, whichever is higher., when the Commission finds that the provider
intentionally or negligently:(a)infringed the relevant provisions of this Regulation;(b)failed to comply with a request for a document or for information pursuant to
Article 91, or supplied incorrect, incomplete or misleading information;

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(c)

failed to comply with a measure requested under Article 93;(d)failed to make available to the Commission access to the general-purpose AI modelor general-purpose AI model with systemic risk with a view to conducting anevaluation pursuant to Article 92.

In fixing the amount of the fine or periodic penalty payment, regard shall be had to thenature, gravity and duration of the infringement, taking due account of the principles of
proportionality and appropriateness. The Commission shall also into account commitments
made in accordance with Article 93(3) or made in relevant codes of practice in accordancewith Article 56.
2.

Before adopting the decision pursuant to paragraph 1, the Commission shall communicate
its preliminary findings to the provider of the general-purpose AI model and give it anopportunity to be heard.

3.

Fines imposed in accordance with this Article shall be effective, proportionate anddissuasive.

4.

Information on fines imposed under this Article shall also be communicated to the Board
as appropriate.

5.

The Court of Justice of the European Union shall have unlimited jurisdiction to review
decisions of the Commission fixing a fine under this Article. It may cancel, reduce or
increase the fine imposed.

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6.

The Commission shall adopt implementing acts containing detailed arrangements andprocedural safeguards for proceedings in view of the possible adoption of decisions
pursuant to paragraph 1 of this Article. Those implementing acts shall be adopted inaccordance with the examination procedure referred to in Article 98(2).

Chapter XIII
Final provisions

Article 102
Amendment to Regulation (EC) No 300/2008
In Article 4(3) of Regulation (EC) No 300/2008, the following subparagraph is added:‘When adopting detailed measures related to technical specifications and procedures for approval
and use of security equipment concerning Artificial Intelligence systems within the meaning ofRegulation (EU) 2024/… of the European Parliament and of the Council*+, the requirements set out
in Chapter III, Section 2, of that Regulation shall be taken into account.
________________*

Regulation (EU) 2024/… of the European Parliament and of the Council of … laying down
harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008,(EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and(EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828(Artificial Intelligence Act) (OJ L, …, ELI: …).’+

OJ: Please insert in the text the number of this Regulation (2021/0106(COD)) and complete
the corresponding footnote.

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Article 103
Amendment to Regulation (EU) No 167/2013
In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added:‘When adopting delegated acts pursuant to the first subparagraph concerning artificial intelligencesystems which are safety components within the meaning of Regulation (EU) 2024/… of theEuropean Parliament and of the Council*+, the requirements set out in Chapter III, Section 2, of that
Regulation shall be taken into account.
________________*+

Regulation (EU) 2024/… of the European Parliament and of the Council of … laying down
harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008,(EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and(EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828(Artificial Intelligence Act) (OJ L, …, ELI: …).’

OJ: Please insert in the text the number of this Regulation (2021/0106(COD)) and complete
the corresponding footnote.

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Amendment to Regulation (EU) No 168/2013
In Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added:‘When adopting delegated acts pursuant to the first subparagraph concerning Artificial Intelligencesystems which are safety components within the meaning of Regulation (EU) 2024/… of theEuropean Parliament and of the Council*+, the requirements set out in Chapter III, Section 2, of that
Regulation shall be taken into account.
________________*

Regulation (EU) 2024/… of the European Parliament and of the Council of … laying down
harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008,(EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and(EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828(Artificial Intelligence Act) (OJ L, …, ELI: …).’+

OJ: Please insert in the text the number of this Regulation (2021/0106(COD)) and complete
the corresponding footnote.

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Article 105
Amendment to Directive 2014/90/EU
In Article 8 of Directive 2014/90/EU, the following paragraph is added:‘5.

For Artificial Intelligence systems which are safety components within the meaning ofRegulation (EU) 2024/… of the European Parliament and of the Council*+, when carryingout its activities pursuant to paragraph 1 and when adopting technical specifications andtesting standards in accordance with paragraphs 2 and 3, the Commission shall take into
account the requirements set out in Chapter III, Section 2, of that Regulation.

________________*+

Regulation (EU) 2024/… of the European Parliament and of the Council of … laying down
harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008,(EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and(EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828(Artificial Intelligence Act) (OJ L, …, ELI: …).’

OJ: Please insert in the text the number of this Regulation (2021/0106(COD)) and complete
the corresponding footnote.

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Article 106
Amendment to Directive (EU) 2016/797
In Article 5 of Directive (EU) 2016/797, the following paragraph is added:‘12.

When adopting delegated acts pursuant to paragraph 1 and implementing acts pursuant toparagraph 11 concerning Artificial Intelligence systems which are safety components
within the meaning of Regulation (EU) 2024/… of the European Parliament and of theCouncil*+, the requirements set out in Chapter III, Section 2, of that Regulation shall betaken into account.

________________*

Regulation (EU) 2024/… of the European Parliament and of the Council of … laying down
harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008,(EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and(EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828(Artificial Intelligence Act) (OJ L, …, ELI: …).’+

OJ: Please insert in the text the number of this Regulation (2021/0106(COD)) and complete
the corresponding footnote.

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Article 107
Amendment to Regulation (EU) 2018/858
In Article 5 of Regulation (EU) 2018/858 the following paragraph is added:‘4.

When adopting delegated acts pursuant to paragraph 3 concerning Artificial Intelligencesystems which are safety components within the meaning of Regulation (EU) 2024/… of
the European Parliament and of the Council*+, the requirements set out in Chapter III,
Section 2, of that Regulation shall be taken into account.

________________*

Regulation (EU) 2024/… of the European Parliament and of the Council of … laying down
harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008,(EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and(EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828(Artificial Intelligence Act) (OJ L, …, ELI: …).’+

OJ: Please insert in the text the number of this Regulation (2021/0106(COD)) and complete
the corresponding footnote.

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Article 108
Amendments to Regulation (EU) 2018/1139
Regulation (EU) 2018/1139 is amended as follows:(1)

in Article 17, the following paragraph is added:‘3.

Without prejudice to paragraph 2, when adopting implementing acts pursuant toparagraph 1 concerning Artificial Intelligence systems which are safety components
within the meaning of Regulation (EU) 2024/… of the European Parliament and of
the Council*+, the requirements set out in Chapter III, Section 2, of that Regulation
shall be taken into account.

________________*(2)

Regulation (EU) 2024/… of the European Parliament and of the Council of … laying
down harmonised rules on artificial intelligence and amending Regulations(EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858,(EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797
and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, …, ELI: …).’;in Article 19, the following paragraph is added:‘4.

When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial
Intelligence systems which are safety components within the meaning of Regulation(EU) 2024/…++, the requirements set out in Chapter III, Section 2, of that Regulation
shall be taken into account.’;+++

OJ: Please insert in the text the number of this Regulation (2021/0106(COD)) and complete
the corresponding footnote.
OJ: Please insert the number of this Regulation (2021/0106(COD)).

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(3)

in Article 43, the following paragraph is added:‘4.

When adopting implementing acts pursuant to paragraph 1 concerning Artificial
Intelligence systems which are safety components within the meaning of Regulation(EU) 2024/…+, the requirements set out in Chapter III, Section 2, of that Regulation
shall be taken into account.’;(4)

in Article 47, the following paragraph is added:‘3.

When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial
Intelligence systems which are safety components within the meaning of Regulation(EU) 2024/…+, the requirements set out in Chapter III, Section 2, of that Regulation
shall be taken into account.’;(5)

in Article 57, the following subparagraph is added:‘When adopting those implementing acts concerning Artificial Intelligence systems which
are safety components within the meaning of Regulation (EU) 2024/…+, the requirements
set out in Chapter III, Section 2, of that Regulation shall be taken into account.’;(6)

in Article 58, the following paragraph is added:‘3.

When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial
Intelligence systems which are safety components within the meaning of Regulation(EU) 2024/…+, the requirements set out in Chapter III, Section 2, of that Regulation
shall be taken into account.’.

+

OJ: Please insert the number of this Regulation (2021/0106(COD)).

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Article 109
Amendment to Regulation (EU) 2019/2144
In Article 11 of Regulation (EU) 2019/2144, the following paragraph is added:‘3.

When adopting the implementing acts pursuant to paragraph 2, concerning artificial
intelligence systems which are safety components within the meaning of Regulation(EU) 2024/… of the European Parliament and of the Council*+, the requirements set out in
Chapter III, Section 2, of that Regulation shall be taken into account.

________________*+

Regulation (EU) 2024/… of the European Parliament and of the Council of … laying down
harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008,(EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and(EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828(Artificial Intelligence Act) (OJ L, …, ELI: …).’

OJ: Please insert in the text the number of this Regulation (2021/0106(COD)) and complete
the corresponding footnote.

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Article 110
Amendment to Directive (EU) 2020/1828
In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council58, thefollowing point is added:‘(68)

Regulation (EU) 2024/… of the European Parliament and of the Council of … + laying
down harmonised rules on artificial intelligence and amending Regulations(EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858,(EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and(EU) 2020/1828 (Artificial Intelligence Act) (OJ L, …, ELI: …)’.

Article 111
AI systems already placed on the market or put into service
and general-purpose AI models already placed on the marked
1.

Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a),AI systems which are components of the large-scale IT systems established by the legal
acts listed in Annex X that have been placed on the market or put into service before …
[36 months from the date of entry into force of this Regulation] shall be brought into
compliance with this Regulation by 31 December 2030.

58+

Directive (EU) 2020/1828 of the European Parliament and of the Councilof 25 November 2020 on representative actions for the protection of the collective interestsof consumers and repealing Directive 2009/22/EC (OJ L 409, 4.12.2020, p. 1).
OJ: Please insert in the text the date and the number of this Regulation (2021/0106(COD)).

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The requirements laid down in this Regulation shall be taken into account in the evaluationof each large-scale IT system established by the legal acts listed in Annex X to beundertaken as provided for in those legal acts and where those legal acts are replaced oramended.
2.

Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a),this Regulation shall apply to operators of high-risk AI systems, other than the systems
referred to in paragraph 1 of this Article, that have been placed on the market or put into
service before … [24 months from the date of entry into force of this Regulation], only if,
as from that date, those systems are subject to significant changes in their designs. In any
case, the providers and deployers of high-risk AI systems intended to be used by publicauthorities shall take the necessary steps to comply with the requirements and obligationsof this Regulation by …[six years from the date of entry into force of this Regulation].

3.

Providers of general-purpose AI models that have been placed on the market before …
[12 months from the date of entry into force of this Regulation] shall take the necessary
steps in order to comply with the obligations laid down in this Regulation by …
[36 months from the date of entry into force of this Regulation].

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Article 112
Evaluation and review
1.

The Commission shall assess the need for amendment of the list set out in Annex III and of
the list of prohibited AI practices laid down in Article 5, once a year following the entry
into force of this Regulation, and until the end of the period of the delegation of power laid
down in Article 97. The Commission shall submit the findings of that assessment to theEuropean Parliament and the Council.

2.

By … [four years from the date of entry into force of this Regulation] and every four years
thereafter, the Commission shall evaluate and report to the European Parliament and to theCouncil on the following:(a)the need for amendments extending existing area headings or adding new area
headings in Annex III;(b)amendments to the list of AI systems requiring additional transparency measures in
Article 50;(c)amendments enhancing the effectiveness of the supervision and governance system.

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3.

By … [five years from the date of entry into force of this Regulation] and every four years
thereafter, the Commission shall submit a report on the evaluation and review of thisRegulation to the European Parliament and to the Council. The report shall include anassessment with regard to the structure of enforcement and the possible need for a Union
agency to resolve any identified shortcomings. On the basis of the findings, that reportshall, where appropriate, be accompanied by a proposal for amendment of this Regulation.
The reports shall be made public.

4.

The reports referred to in paragraph 2 shall pay specific attention to the following:(a)the status of the financial, technical and human resources of the national competentauthorities in order to effectively perform the tasks assigned to them under
this Regulation;(b)

the state of penalties, in particular administrative fines as referred to in Article 99(1),applied by Member States for infringements of this Regulation;(c)adopted harmonised standards and common specifications developed to support thisRegulation;(d)the number of undertakings that enter the market after the entry into application ofthis Regulation, and how many of them are SMEs.

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5.

By … [four years from the date of entry into force of this Regulation], the Commission
shall evaluate the functioning of the AI Office, whether the AI Office has been given
sufficient powers and competences to fulfil its tasks, and whether it would be relevant andneeded for the proper implementation and enforcement of this Regulation to upgrade the
AI Office and its enforcement competences and to increase its resources. The Commission
shall submit a report on its evaluation to the European Parliament and to the Council.

6.

By … [four years from the date of entry into force of this Regulation] and every four years
thereafter, the Commission shall submit a report on the review of the progress on thedevelopment of standardisation deliverables on the energy-efficient development ofgeneral-purpose AI models, and asses the need for further measures or actions, including
binding measures or actions. The report shall be submitted to the European Parliament andto the Council, and it shall be made public.

7.

By … [four years from the date of entry into force of this Regulation] and every three
years thereafter, the Commission shall evaluate the impact and effectiveness of voluntary
codes of conduct to foster the application of the requirements set out in Chapter III,
Section 2 for AI systems other than high-risk AI systems and possibly other additional
requirements for AI systems other than high-risk AI systems, including as regards
environmental sustainability.

8.

For the purposes of paragraphs 1 to 7, the Board, the Member States and national
competent authorities shall provide the Commission with information upon its request andwithout undue delay.

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9.

In carrying out the evaluations and reviews referred to in paragraphs 1 to 7, theCommission shall take into account the positions and findings of the Board, of theEuropean Parliament, of the Council, and of other relevant bodies or sources.

10.

The Commission shall, if necessary, submit appropriate proposals to amend thisRegulation, in particular taking into account developments in technology, the effect of AI
systems on health and safety, and on fundamental rights, and in light of the state ofprogress in the information society.

11.

To guide the evaluations and reviews referred to in paragraphs 1 to 7 of this Article, theAI Office shall undertake to develop an objective and participative methodology for theevaluation of risk levels based on the criteria outlined in the relevant Articles and theinclusion of new systems in:(a)the list set out in Annex III, including the extension of existing area headings or the
addition of new area headings in that Annex;(b)the list of prohibited practices set out in Article 5; and(c)the list of AI systems requiring additional transparency measures pursuant
to Article 50.

12.

Any amendment to this Regulation pursuant to paragraph 10, or relevant delegated or
implementing acts, which concerns sectoral Union harmonisation legislation listed in
Section B of Annex I shall take into account the regulatory specificities of each sector, andthe existing governance, conformity assessment and enforcement mechanisms andauthorities established therein.

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13.

By … [seven years from the date of entry into force of this Regulation], the Commission
shall carry out an assessment of the enforcement of this Regulation and shall report on it to
the European Parliament, the Council and the European Economic and Social Committee,
taking into account the first years of application of this Regulation. On the basis of thefindings, that report shall, where appropriate, be accompanied by a proposal for
amendment of this Regulation with regard to the structure of enforcement and the need fora Union agency to resolve any identified shortcomings.

Article 113
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the
Official Journal of the European Union.
It shall apply from … [24 months from the date of entry into force of this Regulation].
However:(a)

Chapters I and II shall apply from … [six months from the date of entry into force of
this Regulation];(b)

Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply
from … [12 months from the date of entry into force of this Regulation], with the
exception of Article 101;

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(c)

Article 6(1) and the corresponding obligations in this Regulation shall apply from …
[36 months from the date of entry into force of this Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at …,

For the European Parliament

For the Council

The President

The President

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ANNEX I
List of Union harmonisation legislation
Section A. List of Union harmonisation legislation based on the New Legislative Framework
1.

Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on
machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24) [as repealed by
the Machinery Regulation];2.

Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on
the safety of toys (OJ L 170, 30.6.2009, p. 1);

3.

Directive 2013/53/EU of the European Parliament and of the Councilof 20 November 2013 on recreational craft and personal watercraft and repealing
Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90);

4.

Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014
on the harmonisation of the laws of the Member States relating to lifts and safety
components for lifts (OJ L 96, 29.3.2014, p. 251);

5.

Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014
on the harmonisation of the laws of the Member States relating to equipment andprotective systems intended for use in potentially explosive atmospheres (OJ L 96,
29.3.2014, p. 309);

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6.

Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on
the harmonisation of the laws of the Member States relating to the making available on themarket of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014,
p. 62);

7.

Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on
the harmonisation of the laws of the Member States relating to the making available on themarket of pressure equipment (OJ L 189, 27.6.2014, p. 164);8.

Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016
on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1);

9.

Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016
on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81,
31.3.2016, p. 51);

10.

Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016
on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81,
31.3.2016, p. 99);

11.

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017
on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC
and 93/42/EEC (OJ L 117, 5.5.2017, p. 1);

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12.

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017
on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission
Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
Section B. List of other Union harmonisation legislation

13.

Regulation (EC) No 300/2008 of the European Parliament and of the Councilof 11 March 2008 on common rules in the field of civil aviation security and repealing
Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72);

14.

Regulation (EU) No 168/2013 of the European Parliament and of the Councilof 15 January 2013 on the approval and market surveillance of two- or three-wheel
vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52);

15.

Regulation (EU) No 167/2013 of the European Parliament and of the Councilof 5 February 2013 on the approval and market surveillance of agricultural and forestry
vehicles (OJ L 60, 2.3.2013, p. 1);

16.

Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on
marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014,
p. 146);17.

Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016
on the interoperability of the rail system within the European Union (OJ L 138, 26.5.2016,p. 44);

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18.

Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018
on the approval and market surveillance of motor vehicles and their trailers, and ofsystems, components and separate technical units intended for such vehicles, amending
Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC(OJ L 151, 14.6.2018, p. 1);

19.

Regulation (EU) 2019/2144 of the European Parliament and of the Councilof 27 November 2019 on type-approval requirements for motor vehicles and their trailers,and systems, components and separate technical units intended for such vehicles, asregards their general safety and the protection of vehicle occupants and vulnerable road
users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council
and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of
the European Parliament and of the Council and Commission Regulations(EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010,(EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011,(EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012,(EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325,
16.12.2019, p. 1);

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20.

Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018
on common rules in the field of civil aviation and establishing a European Union Aviation
Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008,(EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of theEuropean Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and(EC) No 216/2008 of the European Parliament and of the Council and Council Regulation(EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1), in so far as the design, production andplacing on the market of aircrafts referred to in Article 2(1), points (a) and (b) thereof,
where it concerns unmanned aircraft and their engines, propellers, parts and equipment tocontrol them remotely, are concerned.

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5ENANNEX II
List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)
Criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii):–

terrorism,–

trafficking in human beings,–

sexual exploitation of children, and child pornography,–

illicit trafficking in narcotic drugs or psychotropic substances,–

illicit trafficking in weapons, munitions or explosives,–murder, grievous bodily injury,–

illicit trade in human organs or tissue,–

illicit trafficking in nuclear or radioactive materials,–

kidnapping, illegal restraint or hostage-taking,–crimes within the jurisdiction of the International Criminal Court,–

unlawful seizure of aircraft or ships,

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–

rape,

–

environmental crime,–

organised or armed robbery,–sabotage,–participation in a criminal organisation involved in one or more of the offences listed
above.

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2EN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 thesole 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 orcharacteristics;(c)2.

AI systems intended to be used for emotion recognition.

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 ofwater, gas, heating or electricity.

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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 thoseoutcomes are used to steer the learning process of natural persons in educational andvocational 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 orwithin 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, inparticular to place targeted job advertisements, to analyse and filter job applications,and to evaluate candidates;

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(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 andbenefits:(a)

AI systems intended to be used by public authorities or on behalf of publicauthorities to evaluate the eligibility of natural persons for essential public assistancebenefits 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.

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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 thevictim 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 orprosecution 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 notsolely 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 pastcriminal behaviour of natural persons or groups;

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(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 prosecutionof criminal offences.

7.

Migration, asylum and border control management, in so far as their use is permitted underrelevant 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;

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(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 orborder 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 orreferendum or the voting behaviour of natural persons in the exercise of their vote inelections 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.

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6ENANNEX IV
Technical documentation referred to in Article 11(1)The technical documentation referred to in Article 11(1) shall contain at least the following
information, as applicable to the relevant AI system:
1.

A general description of the AI system including:(a)

its intended purpose, the name of the provider and the version of the system
reflecting its relation to previous versions;(b)

how the AI system interacts with, or can be used to interact with, hardware orsoftware, including with other AI systems, that are not part of the AI system itself,
where applicable;(c)the versions of relevant software or firmware, and any requirements related toversion updates;(d)the description of all the forms in which the AI system is placed on the market or put
into service, such as software packages embedded into hardware, downloads,
or APIs;(e)the description of the hardware on which the AI system is intended to run;(f)where the AI system is a component of products, photographs or illustrations
showing external features, the marking and internal layout of those products;

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(g)

a basic description of the user-interface provided to the deployer;(h)instructions for use for the deployer, and a basic description of the user-interface
provided to the deployer, where applicable;

2.

A detailed description of the elements of the AI system and of the process for its
development, including:(a)the methods and steps performed for the development of the AI system, including,where relevant, recourse to pre-trained systems or tools provided by third parties andhow those were used, integrated or modified by the provider;(b)the design specifications of the system, namely the general logic of the AI systemand of the algorithms; the key design choices including the rationale and assumptions
made, including with regard to persons or groups of persons in respect of who, thesystem is intended to be used; the main classification choices; what the system isdesigned to optimise for, and the relevance of the different parameters; thedescription of the expected output and output quality of the system; the decisions
about any possible trade-off made regarding the technical solutions adopted tocomply with the requirements set out in Chapter III, Section 2;(c)the description of the system architecture explaining how software components build
on or feed into each other and integrate into the overall processing; the computational
resources used to develop, train, test and validate the AI system;

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(d)

where relevant, the data requirements in terms of datasheets describing the training
methodologies and techniques and the training data sets used, including a generaldescription of these data sets, information about their provenance, scope and main
characteristics; how the data was obtained and selected; labelling procedures (e.g. forsupervised learning), data cleaning methodologies (e.g. outliers detection);(e)assessment of the human oversight measures needed in accordance with Article 14,
including an assessment of the technical measures needed to facilitate theinterpretation of the outputs of AI systems by the deployers, in accordance with
Article 13(3), point (d);(f)

where applicable, a detailed description of pre-determined changes to the AI system
and its performance, together with all the relevant information related to the technicalsolutions adopted to ensure continuous compliance of the AI system with therelevant requirements set out in Chapter III, Section 2;(g)

the validation and testing procedures used, including information about the validationand testing data used and their main characteristics; metrics used to measureaccuracy, robustness and compliance with other relevant requirements set out in
Chapter III, Section 2, as well as potentially discriminatory impacts; test logs and alltest reports dated and signed by the responsible persons, including with regard to
pre-determined changes as referred to under point (f);(h)

cybersecurity measures put in place;

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3.

Detailed information about the monitoring, functioning and control of the AI system, inparticular with regard to: its capabilities and limitations in performance, including thedegrees of accuracy for specific persons or groups of persons on which the system isintended to be used and the overall expected level of accuracy in relation to its intended
purpose; the foreseeable unintended outcomes and sources of risks to health and safety,
fundamental rights and discrimination in view of the intended purpose of the AI system;
the human oversight measures needed in accordance with Article 14, including thetechnical measures put in place to facilitate the interpretation of the outputs of AI systems
by the deployers; specifications on input data, as appropriate;

4.

A description of the appropriateness of the performance metrics for the specific AI system;

5.

A detailed description of the risk management system in accordance with Article 9;6.

A description of relevant changes made by the provider to the system through its lifecycle;

7.

A list of the harmonised standards applied in full or in part the references of which havebeen published in the Official Journal of the European Union; where no such harmonised
standards have been applied, a detailed description of the solutions adopted to meet therequirements set out in Chapter III, Section 2, including a list of other relevant standards
and technical specifications applied;8.

A copy of the EU declaration of conformity referred to in Article 47;

9.

A detailed description of the system in place to evaluate the AI system performance in the
post-market phase in accordance with Article 72, including the post-market monitoringplan referred to in Article 72(3).

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ANNEX V
EU declaration of conformity
The EU declaration of conformity referred to in Article 47, shall contain all of the following
information:
1.

AI system name and type and any additional unambiguous reference allowing theidentification and traceability of the AI system;

2.

The name and address of the provider or, where applicable, of their authorised
representative;

3.

A statement that the EU declaration of conformity referred to in Article 47 is issued under
the sole responsibility of the provider;4.

A statement that the AI system is in conformity with this Regulation and, if applicable,with any other relevant Union law that provides for the issuing of the EU declaration ofconformity referred to in Article 47;

5.

Where an AI system involves the processing of personal data, a statement that that AI
system complies with Regulations (EU) 2016/679 and (EU) 2018/1725 andDirective (EU) 2016/680;

6.

References to any relevant harmonised standards used or any other common specificationin relation to which conformity is declared;

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7.

Where applicable, the name and identification number of the notified body, a descriptionof the conformity assessment procedure performed, and identification of the certificate
issued;8.

The place and date of issue of the declaration, the name and function of the person who
signed it, as well as an indication for, or on behalf of whom, that person signed, asignature.

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Conformity assessment procedure based on internal control
1.

The conformity assessment procedure based on internal control is the conformity
assessment procedure based on points 2, 3 and 4.

2.

The provider verifies that the established quality management system is in compliance withthe requirements of Article 17.

3.

The provider examines the information contained in the technical documentation in order
to assess the compliance of the AI system with the relevant essential requirements set out
in Chapter III, Section 2.

4.

The provider also verifies that the design and development process of the AI system and its
post-market monitoring as referred to in Article 72 is consistent with the technicaldocumentation.

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ANNEX VII
Conformity based on an assessment of the quality management system
and an assessment of the technical documentation
1.

Introduction
Conformity based on an assessment of the quality management system and an assessmentof the technical documentation is the conformity assessment procedure based on points 2
to 5.

2.

Overview
The approved quality management system for the design, development and testing of AI
systems pursuant to Article 17 shall be examined in accordance with point 3 and shall be
subject to surveillance as specified in point 5. The technical documentation of the AI
system shall be examined in accordance with point 4.

3.

Quality management system

3.1.

The application of the provider shall include:(a)the name and address of the provider and, if the application is lodged by anauthorised representative, also their name and address;(b)

the list of AI systems covered under the same quality management system;(c)the technical documentation for each AI system covered under the same quality
management system;

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(d)

the documentation concerning the quality management system which shall cover all
the aspects listed under Article 17;(e)a description of the procedures in place to ensure that the quality management systemremains adequate and effective;(f)a written declaration that the same application has not been lodged with any othernotified body.

3.2.

The quality management system shall be assessed by the notified body, which shalldetermine whether it satisfies the requirements referred to in Article 17.
The decision shall be notified to the provider or its authorised representative.
The notification shall contain the conclusions of the assessment of the quality management
system and the reasoned assessment decision.

3.3.

The quality management system as approved shall continue to be implemented andmaintained by the provider so that it remains adequate and efficient.

3.4.

Any intended change to the approved quality management system or the list of AI systems
covered by the latter shall be brought to the attention of the notified body by the provider.
The proposed changes shall be examined by the notified body, which shall decide whether
the modified quality management system continues to satisfy the requirements referred toin point 3.2 or whether a reassessment is necessary.

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The notified body shall notify the provider of its decision. The notification shall containthe conclusions of the examination of the changes and the reasoned assessment decision.
4.

Control of the technical documentation.

4.1.

In addition to the application referred to in point 3, an application with a notified body of
their choice shall be lodged by the provider for the assessment of the technicaldocumentation relating to the AI system which the provider intends to place on the market
or put into service and which is covered by the quality management system referred tounder point 3.

4.2.

The application shall include:(a)the name and address of the provider;(b)a written declaration that the same application has not been lodged with any othernotified body;

(c)
4.3.

the technical documentation referred to in Annex IV.

The technical documentation shall be examined by the notified body. Where relevant, andlimited to what is necessary to fulfil its tasks, the notified body shall be granted full accessto the training, validation, and testing data sets used, including, where appropriate andsubject to security safeguards, through API or other relevant technical means and tools
enabling remote access.

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4.4.

In examining the technical documentation, the notified body may require that the provider
supply further evidence or carry out further tests so as to enable a proper assessment of theconformity of the AI system with the requirements set out in Chapter III, Section 2. Where
the notified body is not satisfied with the tests carried out by the provider, the notified
body shall itself directly carry out adequate tests, as appropriate.

4.5.

Where necessary to assess the conformity of the high-risk AI system with the requirements
set out in Chapter III, Section 2, after all other reasonable means to verify conformity havebeen exhausted and have proven to be insufficient, and upon a reasoned request, thenotified body shall also be granted access to the training and trained models of the AI
system, including its relevant parameters. Such access shall be subject to existing Union
law on the protection of intellectual property and trade secrets.

4.6.

The decision of the notified body shall be notified to the provider or its authorised
representative. The notification shall contain the conclusions of the assessment of thetechnical documentation and the reasoned assessment decision.
Where the AI system is in conformity with the requirements set out in Chapter III,
Section 2, the notified body shall issue a Union technical documentation assessment
certificate. The certificate shall indicate the name and address of the provider, theconclusions of the examination, the conditions (if any) for its validity and the datanecessary for the identification of the AI system.
The certificate and its annexes shall contain all relevant information to allow theconformity of the AI system to be evaluated, and to allow for control of the AI system
while in use, where applicable.

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Where the AI system is not in conformity with the requirements set out in Chapter III,
Section 2, the notified body shall refuse to issue a Union technical documentationassessment certificate and shall inform the applicant accordingly, giving detailed reasonsfor its refusal.
Where the AI system does not meet the requirement relating to the data used to train it,
re-training of the AI system will be needed prior to the application for a new conformity
assessment. In this case, the reasoned assessment decision of the notified body refusing toissue the Union technical documentation assessment certificate shall contain specificconsiderations on the quality data used to train the AI system, in particular on the reasonsfor non-compliance.
4.7.

Any change to the AI system that could affect the compliance of the AI system with therequirements or its intended purpose shall be assessed by the notified body which issued
the Union technical documentation assessment certificate. The provider shall inform such
notified body of its intention to introduce any of the abovementioned changes, or if it
otherwise becomes aware of the occurrence of such changes. The intended changes shallbe assessed by the notified body, which shall decide whether those changes require a new
conformity assessment in accordance with Article 43(4) or whether they could be
addressed by means of a supplement to the Union technical documentation assessment
certificate. In the latter case, the notified body shall assess the changes, notify the providerof its decision and, where the changes are approved, issue to the provider a supplement to
the Union technical documentation assessment certificate.

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5.

Surveillance of the approved quality management system.

5.1.

The purpose of the surveillance carried out by the notified body referred to in Point 3 is tomake sure that the provider duly complies with the terms and conditions of the approved
quality management system.

5.2.

For assessment purposes, the provider shall allow the notified body to access the premises
where the design, development, testing of the AI systems is taking place. The provider
shall further share with the notified body all necessary information.

5.3.

The notified body shall carry out periodic audits to make sure that the provider maintains
and applies the quality management system and shall provide the provider with an audit
report. In the context of those audits, the notified body may carry out additional tests of the
AI systems for which a Union technical documentation assessment certificate was issued.

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Information to be submitted upon the registrationof high-risk AI systems in accordance with Article 49
Section A - Information to be submitted by providers of high-risk AI systems
in accordance with Article 49(1)The following information shall be provided and thereafter kept up to date with regard to high-risk
AI systems to be registered in accordance with Article 49(1):1.

The name, address and contact details of the provider;

2.

Where submission of information is carried out by another person on behalf of theprovider, the name, address and contact details of that person;

3.

The name, address and contact details of the authorised representative, where applicable;

4.

The AI system trade name and any additional unambiguous reference allowing theidentification and traceability of the AI system;

5.

A description of the intended purpose of the AI system and of the components andfunctions supported through this AI system;

6.

A basic and concise description of the information used by the system (data, inputs) and its
operating logic;

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7.

The status of the AI system (on the market, or in service; no longer placed on the market/inservice, recalled);

8.

The type, number and expiry date of the certificate issued by the notified body and thename or identification number of that notified body, where applicable;

9.

A scanned copy of the certificate referred to in point 8, where applicable;

10.

Any Member States in which the AI system has been placed on the market, put into service
or made available in the Union;

11.

A copy of the EU declaration of conformity referred to in Article 47;

12.

Electronic instructions for use; this information shall not be provided for high-risk AI
systems in the areas of law enforcement or migration, asylum and border control
management referred to in Annex III, points 1, 6 and 7;

13.

A URL for additional information (optional).

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2ENSection B - Information to be submitted by providers of high-risk AI systems
in accordance with Article 49(2)The following information shall be provided and thereafter kept up to date with regard to AI
systems to be registered in accordance with Article 49(2):1.

The name, address and contact details of the provider;

2.

Where submission of information is carried out by another person on behalf of theprovider, the name, address and contact details of that person;

3.

The name, address and contact details of the authorised representative, where applicable;

4.

The AI system trade name and any additional unambiguous reference allowing theidentification and traceability of the AI system;

5.

A description of the intended purpose of the AI system;

6.

The condition or conditions under Article 6(3)based on which the AI system is considered
to be not-high-risk;

7.

A short summary of the grounds on which the AI system is considered to be not-high-risk
in application of the procedure under Article 6(3);8.

The status of the AI system (on the market, or in service; no longer placed on the market/inservice, recalled);

9.

Any Member States in which the AI system has been placed on the market, put into service
or made available in the Union.

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Section C - Information to be submitted by deployers of high-risk AI systems
in accordance with Article 49(3)The following information shall be provided and thereafter kept up to date with regard to high-risk
AI systems to be registered in accordance with Article 49:
1.

The name, address and contact details of the deployer;

2.

The name, address and contact details of the person submitting information on behalf ofthe deployer;

3.

The URL of the entry of the AI system in the EU database by its provider;4.

A summary of the findings of the fundamental rights impact assessment conducted inaccordance with Article 27;

5.

A summary of the data protection impact assessment carried out in accordance with
Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680 as
specified in Article 26(8) of this Regulation, where applicable.

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ANNEX IX
Information to be submitted upon the registration of high-risk AI systems listed in Annex III
in relation to testing in real world conditions in accordance with Article 60
The following information shall be provided and thereafter kept up to date with regard to testing inreal world conditions to be registered in accordance with Article 60:
1.

A Union-wide unique single identification number of the testing in real world conditions;2.

The name and contact details of the provider or prospective provider and of the deployers
involved in the testing in real world conditions;3.

A brief description of the AI system, its intended purpose, and other information necessary
for the identification of the system;

4.

A summary of the main characteristics of the plan for testing in real world conditions;

5.

Information on the suspension or termination of the testing in real world conditions.

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ANNEX X
Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice1.

Schengen Information System(a)

Regulation (EU) 2018/1860 of the European Parliament and of the Councilof 28 November 2018 on the use of the Schengen Information System for the returnof illegally staying third-country nationals (OJ L 312, 7.12.2018, p. 1).

(b)Regulation (EU) 2018/1861 of the European Parliament and of the Councilof 28 November 2018 on the establishment, operation and use of the Schengen
Information System (SIS) in the field of border checks, and amending theConvention implementing the Schengen Agreement, and amending and repealing
Regulation (EC) No 1987/2006 (OJ L 312, 7.12.2018, p. 14).

(c)Regulation (EU) 2018/1862 of the European Parliament and of the Councilof 28 November 2018 on the establishment, operation and use of the Schengen
Information System (SIS) in the field of police cooperation and judicial cooperationin criminal matters, amending and repealing Council Decision 2007/533/JHA, andrepealing Regulation (EC) No 1986/2006 of the European Parliament and of theCouncil and Commission Decision 2010/261/EU (OJ L 312, 7.12.2018, p. 56).

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2.

Visa Information System(a)

Regulation (EU) 2021/1133 of the European Parliament and of the Councilof 7 July 2021 amending Regulations (EU) No 603/2013, (EU) 2016/794,(EU) 2018/1862, (EU) 2019/816 and (EU) 2019/818 as regards the establishment of
the conditions for accessing other EU information systems for the purposes of the
Visa Information System (OJ L 248, 13.7.2021, p. 1).

(b)Regulation (EU) 2021/1134 of the European Parliament and of the Councilof 7 July 2021 amending Regulations (EC) No 767/2008, (EC) No 810/2009,(EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1860,(EU) 2018/1861, (EU) 2019/817 and (EU) 2019/1896 of the European Parliamentand of the Council and repealing Council Decisions 2004/512/EC and2008/633/JHA, for the purpose of reforming the Visa Information System (OJ L 248,
13.7.2021, p. 11).

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3.

Eurodac
Regulation (EU) 2024/… of the European Parliament and of the Council on theestablishment of ‘Eurodac’ for the comparison of biometric data in order to effectively
apply Regulations (EU) 2024/… and (EU) 2024/… of the European Parliament and of theCouncil and Council Directive 2001/55/EC and to identify illegally staying third-country
nationals and stateless persons and on requests for the comparison with Eurodac data by
Member States’ law enforcement authorities and Europol for law enforcement purposes,
amending Regulations (EU) 2018/1240 and (EU) 2019/818 of the European Parliamentand of the Council and repealing Regulation (EU) No 603/2013 of the European
Parliament and of the Council+.

4.

Entry/Exit System
Regulation (EU) 2017/2226 of the European Parliament and of the Councilof 30 November 2017 establishing an Entry/Exit System (EES) to register entry and exit
data and refusal of entry data of third-country nationals crossing the external borders of theMember States and determining the conditions for access to the EES for law enforcement
purposes, and amending the Convention implementing the Schengen Agreement andRegulations (EC) No 767/2008 and (EU) No 1077/2011 (OJ L 327, 9.12.2017, p. 20).

+

OJ: Please insert in the text the number of the Regulation contained in document
PE-CONS 15/24 (2016/0132 (COD)) and insert the number, date, title and OJ reference ofthat Regulation in the footnote.

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5.

European Travel Information and Authorisation System(a)

Regulation (EU) 2018/1240 of the European Parliament and of the Councilof 12 September 2018 establishing a European Travel Information and Authorisation
System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014,(EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236, 19.9.2018, p. 1).

(b)Regulation (EU) 2018/1241 of the European Parliament and of the Councilof 12 September 2018 amending Regulation (EU) 2016/794 for the purpose of
establishing a European Travel Information and Authorisation System (ETIAS)(OJ L 236, 19.9.2018, p. 72).

6.

European Criminal Records Information System on third-country nationals and statelesspersons
Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019
establishing a centralised system for the identification of Member States holding
conviction information on third-country nationals and stateless persons (ECRIS-TCN) to
supplement the European Criminal Records Information System and amending Regulation(EU) 2018/1726 (OJ L 135, 22.5.2019, p. 1).

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7.

Interoperability(a)Regulation (EU) 2019/817 of the European Parliament and of the Councilof 20 May 2019 on establishing a framework for interoperability between EU
information systems in the field of borders and visa and amending Regulations(EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240,(EU) 2018/1726 and (EU) 2018/1861 of the European Parliament and of the Council
and Council Decisions 2004/512/EC and 2008/633/JHA (OJ L 135, 22.5.2019,p. 27).

(b)Regulation (EU) 2019/818 of the European Parliament and of the Councilof 20 May 2019 on establishing a framework for interoperability between EU
information systems in the field of police and judicial cooperation, asylum andmigration and amending Regulations (EU) 2018/1726, (EU) 2018/1862 and(EU) 2019/816 (OJ L 135, 22.5.2019, p. 85).

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Technical documentation referred to in Article 53(1), point (a) - technical documentation
for providers of general-purpose AI models
Section 1
Information to be provided by all providers of general-purpose AI models
The technical documentation referred to in Article 53(1), point (a) shall contain at least thefollowing information as appropriate to the size and risk profile of the model:
1.

A general description of the general-purpose AI model including:(a)the tasks that the model is intended to perform and the type and nature of AI systems
in which it can be integrated;(b)

the acceptable use policies applicable;(c)the date of release and methods of distribution;(d)the architecture and number of parameters;(e)the modality (e.g. text, image) and format of inputs and outputs;(f)the licence.

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2.

A detailed description of the elements of the model referred to in point 1, and relevant
information of the process for the development, including the following elements:(a)the technical means (e.g. instructions of use, infrastructure, tools) required for thegeneral-purpose AI model to be integrated in AI systems;(b)

the design specifications of the model and training process, including training
methodologies and techniques, the key design choices including the rationale andassumptions made; what the model is designed to optimise for and the relevance ofthe different parameters, as applicable;(c)information on the data used for training, testing and validation, where applicable,
including the type and provenance of data and curation methodologies (e.g. cleaning,filtering etc), the number of data points, their scope and main characteristics; how thedata was obtained and selected as well as all other measures to detect theunsuitability of data sources and methods to detect identifiable biases, whereapplicable;(d)the computational resources used to train the model (e.g. number of floating point
operations), training time, and other relevant details related to the training;(e)known or estimated energy consumption of the model.

With regard to point (e), where the energy consumption of the model is unknown, theenergy consumption may be based on information about computational resources used.

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Additional information to be provided
by providers of general-purpose AI models with systemic risk
1.

A detailed description of the evaluation strategies, including evaluation results, on the basisof available public evaluation protocols and tools or otherwise of other evaluation
methodologies. Evaluation strategies shall include evaluation criteria, metrics and themethodology on the identification of limitations.

2.

Where applicable, a detailed description of the measures put in place for the purpose of
conducting internal and/or external adversarial testing (e.g., red teaming), model
adaptations, including alignment and fine-tuning.

3.

Where applicable, a detailed description of the system architecture explaining how
software components build or feed into each other and integrate into the overall processing.

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3ENANNEX XIITransparency information referred to in Article 53(1), point (b)- technical documentation for providers of general-purpose AI models
to downstream providers that integrate the model into their AI system
The information referred to in Article 53(1), point (b) shall contain at least the following:
1.

A general description of the general-purpose AI model including:(a)the tasks that the model is intended to perform and the type and nature of AI systems
into which it can be integrated;(b)

the acceptable use policies applicable;(c)the date of release and methods of distribution;(d)

how the model interacts, or can be used to interact, with hardware or software that is
not part of the model itself, where applicable;(e)the versions of relevant software related to the use of the general-purpose AI model,
where applicable;(f)the architecture and number of parameters;(g)

the modality (e.g., text, image) and format of inputs and outputs;(h)the licence for the model.

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2.

A description of the elements of the model and of the process for its development,
including:(a)the technical means (e.g., instructions for use, infrastructure, tools) required for thegeneral-purpose AI model to be integrated into AI systems;(b)

the modality (e.g., text, image, etc.) and format of the inputs and outputs and theirmaximum size (e.g., context window length, etc.);(c)

information on the data used for training, testing and validation, where applicable,
including the type and provenance of data and curation methodologies.

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Criteria for the designation of general-purpose AI models
with systemic risk referred to in Article 51
For the purpose of determining that a general-purpose AI model has capabilities or an impact
equivalent to those set out in Article 51(1), point (a), the Commission shall take into account thefollowing criteria:(a)the number of parameters of the model;(b)

the quality or size of the data set, for example measured through tokens;(c)the amount of computation used for training the model, measured in floating point
operations or indicated by a combination of other variables such as estimated cost of
training, estimated time required for the training, or estimated energy consumption for the
training;(d)the input and output modalities of the model, such as text to text (large language models),
text to image, multi-modality, and the state of the art thresholds for determining
high-impact capabilities for each modality, and the specific type of inputs and outputs(e.g. biological sequences);(e)the benchmarks and evaluations of capabilities of the model, including considering thenumber of tasks without additional training, adaptability to learn new, distinct tasks, its
level of autonomy and scalability, the tools it has access to;

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(f)

whether it has a high impact on the internal market due to its reach, which shall be
presumed when it has been made available to at least 10 000 registered business users
established in the Union;(g)

the number of registered end-users.

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