Council of theEuropean Union
Brussels, 25 November 2022
(OR. en)14954/22
Interinstitutional File:
2021/0106(COD)

LIMITETELECOM 472
JAI 1494
COPEN 396
CYBER 374
DATAPROTECT 320
EJUSTICE 89
COSI 293
IXIM 267
ENFOPOL 569
RELEX 1556
MI 843
COMPET 918
CODEC 1773

NOTE
From:
To:

Permanent Representatives Committee (Part 1)
CouncilNo. prev. doc.:
No. Cion doc.:

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8115/21

Subject:

Proposal for a Regulation of the European Parliament and of the Council
laying down harmonised rules on artificial intelligence (Artificial IntelligenceAct) and amending certain Union legislative acts
- General approachI.

INTRODUCTION

1.

The Commission adopted the proposal for a Regulation laying down harmonised rules on
artificial intelligence (Artificial Intelligence Act) on 21 April 2021.

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The objectives of the Commission proposal are to ensure that AI systems placed on the Union
market and used in the Union are safe and respect existing law on fundamental rights andUnion values, to ensure legal certainty in view of facilitating investment and innovation in AI,
to enhance governance and effective enforcement of existing law on fundamental rights andsafety, and to facilitate the development of a single market for lawful, safe and trustworthy AI
applications, while preventing market fragmentation.

II.

WORK IN THE OTHER INSTITUTIONS

3.

In the European Parliament, the discussions are led by the Committee on Internal Market andConsumer Protection (IMCO; rapporteur: Brando Benifei, S&D, Italy) and the Committee on
Civil Liberties, Justice and Home Affairs (LIBE; rapporteur: Dragos Tudorache, Renew,
Romania) under a joint committee procedure. The Legal Affairs Committee (JURI), theCommittee on Industry, Research and Energy (ITRE) and the Committee on Culture and
Education (CULT) are associated to the legislative work with shared and/or exclusivecompetences. The two co-rapporteurs unveiled their draft report in April 2022, and the voteon the joint IMCO-LIBE report is scheduled for the first quarter of 2023.

4.

The European Economic and Social Committee delivered its opinion on the proposal on 22
September 2021, while the European Committee of the Regions followed with its opinion on
2 December 2021.

5.

On 18 June 2021 the European Data Protection Board (EDPB) and the European Data
Protection Supervisor (EDPS) issued a joint opinion on the proposal.

6.

The European Central Bank (ECB) issued its opinion on 29 December 2021 and presented itin the Working Party on Telecommunications and Information Society (hereinafter: WP
TELECOM) on 10 February 2022.

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III. STATE OF PLAY IN THE COUNCIL
1.

In the Council, the examination of the proposal has been carried out in the WP TELECOM.
The WP TELECOM started discussing the proposal under the Portuguese Presidency, withseveral meetings and workshops held between April and June 2021. The work on the proposal
continued under the Slovenian Presidency, which drafted the first, partial compromise
proposal covering Articles 1-7 and Annexes I-III. Additionally, the Slovenian Presidency
organised a half a day informal Council of telecom ministers devoted exclusively to the AI
Act proposal, during which the ministers confirmed their support for the horizontal andhuman-centric approach to regulating AI. The French Presidency continued the examination
process and by the end of its term it redrafted the remaining parts of the text (Articles 8-85
and Annexes IV-IX) and presented the entire first consolidated compromise proposal on the
AI Act on 17 June 2022.

2.

On 5 July 2022, the Czech Presidency held a policy debate in WP TELECOM on the basis ofa policy options paper, the outcomes of which were used to prepare the second compromise
text. Based on the reactions of the delegations to this compromise, the Czech Presidency
prepared the third compromise text, which was presented and discussed in WP TELECOM
on 22 and 29 September 2022. After these discussions, the delegations were asked to provide
further written comments, which were used by the Czech Presidency to draft the fourthcompromise proposal. Based on the discussions of the fourth compromise proposal held in
WP TELECOM on 25 October 2022 and 8 November 2022, as well as taking into accountfinal written remarks from the Member States, the Czech Presidency has prepared the final
version of the compromise text, which can be found in the Annex. On 18 November the
Coreper examined this compromise proposal and unanimously agreed to submit it to theTTE (Telecommunications) Council, without any changes, in view of a general approachat its meeting on 6 December 2022.

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IV.

MAIN ELEMENTS OF THE COMPROMISE PROPOSAL

1.

Definition of an AI system, prohibited AI practices, list of high-risk AI use cases inAnnex III, and classification of AI systems as high risk
1.1

In order to ensure that the definition of an AI system provides sufficiently clear criteria

for distinguishing AI from more classical software systems, the compromise text narrows
down the definition in Article 3(1) to systems developed through machine learning
approaches and logic- and knowledge-based approaches.
1.2

As regards the delegation of powers to the Commission in relation to the updates of thedefinition of an AI system, Annex I and the corresponding empowerment for the Commission
to update it by means of delegated acts has been deleted. Instead, new Recitals 6a and 6b
have been added to clarify what should be understood by machine learning approaches andlogic- and knowledge-based approaches. To ensure that the AI Act remains flexible and future
proof, a possibility to adopt implementing acts to further specify and update techniques undermachine learning approaches and logic- and knowledge-based approaches has been added in
Article 4.
1.3

Concerning prohibited AI practices, in Article 5 the compromise text contains theextension of the prohibition of using AI for social scoring also to private actors. Furthermore,
the provision prohibiting the use of AI systems that exploit the vulnerabilities of a specificgroup of persons now also covers persons who are vulnerable due to their social or economic
situation. As regards the prohibition of the use of ‘real-time’ remote biometric identification
systems in publicly accessible spaces by law enforcement authorities, the compromise text
clarifies the objectives where such use is considered to be strictly necessary for law
enforcement purposes and for which law enforcement authorities should therefore be
exceptionally allowed to use such systems.

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1.4

As regards the list of high-risk AI use cases in Annex III, three of them have been

deleted (deep fake detection by law enforcement authorities, crime analytics, verification of
the authenticity of travel documents), two have been added (critical digital infrastructure andlife and health insurance) and others have been fine-tuned. At the same time, Article 7(1) has
been modified in order to provide for a possibility not only to add high-risk use cases to thelist by means of delegated acts, but also delete them. In order to ensure that fundamental
rights are adequately protected in case of such deletions, additional provisions have been
added in Article 7(3), specifying the conditions which would need to be fulfilled before adelegated act can be adopted.
1.5Regarding the classification of AI systems as high risk, the compromise proposal now

includes an additional horizontal layer on top of the high-risk classification made in Annex
III, in order to ensure that AI systems that are not likely to cause serious fundamental rights
violations or other significant risks are not captured. More specifically, Article 6(3) contains
new provisions according to which the significance of the output of the AI system in respectof the relevant action or a decision to be taken should also be taken into account whenclassifying AI systems as high risk. The significance of the output of an AI system would beassessed based on whether or not it is purely accessory in respect of the relevant action ordecision to be taken.

2.

Requirements for high-risk AI systems and responsibilities of various actors in the AI
value chain
2.1

Many of the requirements for high-risk AI systems, as provided in Chapter 2 of Title

III of the proposal, have been clarified and adjusted in such a way that they are more
technically feasible and less burdensome for stakeholders to comply with, for example as
regards the quality of data, or in relation to the technical documentation that should be drawn
up by SMEs to demonstrate that their high-risk AI systems comply with the requirements.

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In view of the fact that AI systems are developed and distributed through complex value

chains, the compromise text includes changes clarifying the allocation of responsibilities androles. For example, some additional provisions in Articles 13 and 14 have been added thatallow for more effective cooperation between providers and users. The compromise text also
aims to clarify the relationship between the responsibilities under the AI Act and those that
already exist under other legislation, such as the relevant Union data protection or sectorial
legislation, including as regards the sector of financial services. Furthermore, the new Article
23a indicates more clearly the situations in which other actors in the value chain are obliged
to take on the responsibilities of a provider.
3.

General purpose AI systems
3.1

A new Title IA has been added to account for situations where AI systems can be used

for many different purposes (general purpose AI), and where there may be circumstanceswhere general purpose AI technology gets integrated into another system which may become
high-risk. The compromise text specifies in Article 4b(1) that certain requirements for highrisk AI systems would also apply to general purpose AI systems. However, instead of direct
application of these requirements, an implementing act would specify how they should beapplied in relation to general purpose AI systems, based on a consultation and detailed impact
assessment and taking into account specific characteristics of these systems and related value
chain, technical feasibility and market and technological developments. The use of an
implementing act will ensure that the Member States will be properly involved and will keep
the final say on how the requirements will be applied in this context.
3.2

Moreover, the compromise text of Article 4b(5) also includes a possibility to adopt

further implementing acts which would lay down the modalities of cooperation between
providers of general purpose AI systems and other providers intending to put into service orplace such systems on the Union market as high-risk AI systems, in particular as regards theprovision of information.

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4.

Clarification of the scope of the proposed AI Act and provisions relating to law
enforcement authorities
4.1

In Article 2 an explicit reference has been made to the exclusion of national security,

defence and military purposes from the scope of the AI Act. Similarly, it has been clarified
that the AI Act should not apply to AI systems and their outputs used for the sole purpose of
research and development and to obligations of people using AI for non-professional
purposes, which would fall outside the scope of the AI Act, except for the transparency
obligations.
4.2

In order to take into account the particular specificities of law enforcement authorities, anumber of changes has been made to provisions relating to the use of AI systems for law
enforcement purposes. Notably, some of the related definitions in Article 3, such as ‘remotebiometric identification system’ and ‘real-time remote biometric identification system’, havebeen fine-tuned in order to clarify what situations would fall under the related prohibition andhigh-risk use case and what situations would not. The compromise proposal also contains
other modifications that are, subject to appropriate safeguards, meant to ensure appropriate
level of flexibility in the use of high-risk AI systems by law enforcement authorities or reflect
on the need to respect the confidentiality of sensitive operational data in relation to theiractivities.

5.

Conformity assessments, governance framework, market surveillance, enforcement andpenalties
5.1

In order to simplify the compliance framework for the AI Act, the compromise text

contains a number of clarifications and simplifications to the provisions on the conformity
assessment procedures. The provisions related to market surveillance have also been clarified
and simplified in order to make them more effective and easier to implement, taking into
account the need for a proportionate approach in this respect. Moreover, Article 41 has beenthoroughly reviewed in order to limit the Commission’s discretion with regard to the adoptionof implementing acts establishing common technical specifications for the requirements forhigh-risk AI systems and general purpose AI systems.

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The compromise text also substantially modifies the provisions concerning the AI

Board ('the Board'), with the objectives to ensure its greater autonomy and to strengthen its
role in the governance architecture for the AIA. In this context, Articles 56 and 58 have beenrevised in order to strengthen the role of the Board in such a way that it should be in a better
position to provide support to the Member States in the implementation and enforcement of
the AI Act. More specifically, the tasks of the Board have been extended and its composition
has been specified. In order to ensure the involvement of the stakeholders in relation to allissues related to the implementation of the AI Act, including the preparation of implementing
and delegates acts, a new requirement has been added for the Board to create a permanentsubgroup serving as a platform for a wide range of stakeholders. Two other standing subgroups for market surveillance authorities and notifying authorities should also be established
to reinforce the consistency of governance and enforcement of the AI Act across the Union.
5.3

To further improve the governance framework, the compromise text includes new

Articles 68a and 68b. Article 68a includes a requirement for the Commission to designate
one or more Union testing facilities in the area of artificial intelligence, which should provide
independent technical or scientific advice at the request of the Board or market surveillanceauthorities, while Article 68b creates an obligation for the Commission to create a central
pool of independent experts to support the enforcement activities required under the AI Act.
Finally, there is also a new Article 58a laying down an obligation for the Commission to
produce guidance on the application of the AI Act.
5.4

As regards the penalties for infringements of the provisions of the AI Act, in Article 71

the compromise text provides for more proportionate caps on the amount of administrativefines for SMEs and start-ups. Moreover, in Article 71(6) four more criteria have been addedfor deciding on the amount of administrative fines in order to further safeguard their overall
proportionality.

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6.

Transparency and other provisions in favour of the affected persons

6.1

The compromise proposal includes a number of changes that increase the transparency

with regard to the use of high-risk AI systems. Notably, Article 51 has been updated toindicate that certain users of high-risk of AI system that are public authorities, agencies orbodies will also be obliged to register in the EU database for high-risk AI systems listed in
Annex III. Moreover, the newly added Article 52(2a) puts emphasis on an obligation forusers of an emotion recognition system to inform natural persons when they are being
exposed to such a system.
6.2

The compromise proposal also makes it clear in the newly added Article 63(11) that anatural or legal person who has reasons to consider that there has been an infringement of theprovisions of the AI Act may make a complaint to the relevant market surveillance authority
and may expect that such a complaint will be handled in line with the dedicated procedures ofthat authority.

7.

Measures in support of innovation
7.1

With the objective to create a legal framework that is more innovation-friendly and inorder to promote evidence-based regulatory learning, the provisions concerning measures insupport of innovation in Article 53 have been substantially modified in the compromise text.
Notably, it has been clarified that AI regulatory sandboxes, which are supposed to establish acontrolled environment for the development, testing and validation of innovative AI systems
under the direct supervision and guidance by the national competent authorities, should also
allow for testing of innovative AI systems in real world conditions. Furthermore, newprovisions in Articles 54a and 54b have been added allowing unsupervised real world testingof AI systems, under specific conditions and safeguards. In both cases the compromise text
clarifies how these new rules are to be interpreted in relation to other existing, sectoral
legislation on regulatory sandboxes.

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7.2

Finally, in order to alleviate the administrative burden for smaller companies, in Article

55 the compromise text includes a list of actions to be undertaken by the Commission to
support such operators, and in Article 55a it provides for some limited and clearly specified
derogations.

V.

CONCLUSION

1.

In the light of the above, the Council is invited to:–

examine the compromise text set out in the Annex to this note;–

confirm a general approach on the proposal for a Regulation laying down harmonised
rules on artificial intelligence (Artificial Intelligence Act) at the meeting of the TTE(Telecommunications) Council on 6 December 2022.

__________

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ANNEX
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILLAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE(ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNIONLEGISLATIVE ACTS
(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,
Having regard to the opinion of the European Economic and Social Committee1,
Having regard to the opinion of the Committee of the Regions2,
Having regard to the opinion of the European Central Bank3,
Acting in accordance with the ordinary legislative procedure,
Whereas:1
2
3

OJ C […], […], p. […].
OJ C […], […], p. […].
Reference to ECB opinion

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(1)The purpose of this Regulation is to improve the functioning of the internal market by laying
down a uniform legal framework in particular for the development, marketing and use of
artificial intelligence in conformity with Union values. This Regulation pursues a number ofoverriding reasons of public interest, such as a high level of protection of health, safety andfundamental rights, and it ensures the free movement of AI-based goods and services crossborder, thus preventing Member States from imposing restrictions on the development,
marketing and use of AI systems, unless explicitly authorised by this Regulation.

(2)

Artificial intelligence systems (AI systems) can be easily deployed in multiple sectors of theeconomy and society, including cross border, and circulate throughout the Union. Certain
Member States have already explored the adoption of national rules to ensure that artificial
intelligence is safe and is developed and used in compliance with fundamental rights
obligations. Differing national rules may lead to fragmentation of the internal market anddecrease legal certainty for operators that develop, import or use AI systems. A consistentand high level of protection throughout the Union should therefore be ensured, while
divergences hampering the free circulation of AI systems and related products and services
within the internal market should be prevented, by laying down uniform obligations for
operators and guaranteeing the uniform protection of overriding reasons of public interest
and of rights of persons throughout the internal market based on 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 ‘real-time’ remote biometricidentification in publicly accessible spaces for the purpose of law enforcement, it isappropriate to base this Regulation, in as far as those specific rules are concerned, on Article
16 of the TFEU. In light of those specific rules and the recourse to Article 16 TFEU, it isappropriate to consult the European Data Protection Board.

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(3)Artificial intelligence is a fast evolving family of technologies that can contribute to a widearray of economic 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
artificial intelligence can provide key competitive advantages to companies and supportsocially and environmentally beneficial outcomes, for example in healthcare, farming,
education and training, infrastructure management, energy, transport and logistics, public
services, security, justice, resource and energy efficiency, and climate change mitigation andadaptation.

(4)

At the same time, depending on the circumstances regarding its specific application and use,
artificial intelligence may generate risks and cause harm to public interests and rights thatare protected by Union law. Such harm might be material or immaterial.

(5)

A Union legal framework laying down harmonised rules on artificial intelligence istherefore needed to foster the development, use and uptake of artificial intelligence in theinternal market that at the same time meets a high level of protection of public interests,
such as health and safety and the protection of fundamental rights, as recognised andprotected by Union law. To achieve that objective, rules regulating the placing on the market
and putting into service of certain AI systems should be laid down, thus ensuring the smoothfunctioning of the internal market and allowing those systems to benefit from the principleof free movement of goods and services. By laying down those rules and building on thework of the High-level Expert Group on Artificial Intelligence as reflecetd in the Guidelines
for Trustworthy Artificial Intelligence in the EU, this Regulation supports the objective of
the Union of being a global leader in the development of secure, trustworthy and ethicalartificial intelligence as stated by the European Council4, and it ensures the protection of
ethical principles, as specifically requested by the European Parliament5.

45European 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 the Commission on a frameworkof ethical aspects of artificial intelligence, robotics and related technologies, 2020/2012(INL).

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LIMITEEN(5a)The harmonised rules on the placing on the market, putting into service and use of AI
systems laid down in this Regulation should apply across sectors and, in line with its New
Legislative Framework approach, should be without prejudice to existing Union law,notably on data protection, consumer protection, fundamental rights, employment andproduct safety, to which this Regulation is complementary. As a consequence all rights andremedies afforded by such Union law to consumers and other persons who may be
negatively impacted by AI systems, including as regards the compensation of possible
damages pursuant to 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 for defective products, remain unaffected and fully applicable. On top of that, thisRegulation aims to strengthen the effectiveness of such existing rights and remedies by
establishing specific requirements and obligations, including in respect of 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 laws, in compliance with Union law, having the effectof limiting the use of certain AI systems where such laws fall outside the scope of thisRegulation or pursue other legitimate public interest objectives than those pursued by thisRegulation. For example, national labour law and the laws on the protection of minors (i.e.
persons below the age of 18) taking into account the United Nations General Comment No
25 (2021) on children’s rights, insofar as they are not specific to AI systems and pursue
other legimitate public interest objectives, should not be affected by this Regulation.

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(6)The notion of AI system should be clearly defined to ensure legal certainty, while providing
the flexibility to accommodate future technological developments. The definition should bebased on key functional characteristics of artificial intelligence such as its learning,
reasoning or modelling capabilities, distinguishing it from simpler software systems andprogramming approaches. In particular, for the purposes of this Regulation AI systems
should have the ability, on the basis of machine and/or human-based data and inputs, to infer
the way to achieve a set of final objectives given to them by humans, using machine learning
and/or logic- and knowledge based approaches and to produce outputs such as content for
generative AI systems (e.g. text, video or images), predictions, recommendations or
decisions, influencing the environment with which the system interacts, be it in a physical ordigital dimension. A system that uses rules defined solely by natural persons toautomatically execute operations should not be considered an AI system. AI systems can be
designed to operate with varying levels of autonomy and 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 serve the functionality of the product without being integrated
therein (non-embedded). The concept of the autonomy of an AI system relates to the degree
to which such a system functions without human involvement.

(6a)Machine learning approaches focus on the development of systems capable of learning andinferring from data to solve an application problem without being explicitly programmedwith a set of step-by-step instructions from input to output. Learning refers to thecomputational process of optimizing from data the parameters of the model, which is amathematical construct generating an output based on input data. The range of problems
addressed by machine learning typically involves tasks for which other approaches fail,either because there is no suitable formalisation of the problem, or because the resolution of
the problem is intractable with non-learning approaches. Machine learning approaches
include for instance supervised, unsupervised and reinforcement learning, using a variety ofmethods including deep learning with neural networks, statistical techniques for learningand inference (including for instance logistic regression, Bayesian estimation) and searchand optimisation methods.

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(6b)Logic- and knowledge based approaches focus on the development of systems with logicalreasoning capabilities on knowledge to solve an application problem. Such systems typicallyinvolve a knowledge base and an inference engine that generates outputs by reasoning on
the knowledge base. The knowledge base, which is usually encoded by human experts,
represents entities and logical relationships relevant for the application problem throughformalisms based on rules, ontologies, or knowledge graphs. The inference engine acts on
the knowledge base and extracts new information through operations such as sorting,searching, matching or chaining. Logic- and knowledge based approaches include for
instance knowledge representation, inductive (logic) programming, knowledge bases,
inference and deductive engines, (symbolic) reasoning, expert systems and search andoptimisation methods.

(6c) In order to ensure uniform conditions for the implementation of this Regulation as regards
machine learning approaches and logic- and knowledged based approaches and to takeaccount of market and technological developments, implementing powers should beconferred on the Commission.
(6d)

The notion of ‘user’ referred to in this Regulation should be interpreted as any natural or
legal person, including a public authority, agency or other body, using an AI system underwhose authority the system is used. Depending on the type of AI system, the use of thesystem may affect persons other than the user.

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LIMITEEN(7)The notion of biometric data used in this Regulation should be interpreted consistently with
the notion of biometric data as defined in Article 4(14) of Regulation (EU) 2016/679 of theEuropean Parliament and of the Council6, Article 3(18) of Regulation (EU) 2018/1725 of theEuropean Parliament and of the Council7 and Article 3(13) of Directive (EU) 2016/680 of
the European Parliament and of the Council8.

6

7

8

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protectionof natural persons with regard to the processing of personal data and on the free movement of such data, andrepealing 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 Council of 23 October 2018 on theprotection of natural persons with regard to the processing of personal data by the Union institutions, bodies,
offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 andDecision 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 ofnatural persons with regard to the processing of personal data by competent authorities for the purposes of theprevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties,
and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (Law
Enforcement Directive) (OJ L 119, 4.5.2016, p. 89).

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LIMITEEN(8)The notion of remote biometric identification system as used in this Regulation should be
defined functionally, as an AI system intended for the identification of natural persons
typically at a distance, without their active involvement, through the comparison of aperson’s biometric data with the biometric data contained in a reference data repository,
irrespectively of the particular technology, processes or types of biometric data used. Suchremote biometric identification systems are typically used to perceive (scan) multiple
persons or their behaviour simultaneously in order to facilitate significantly theidentification of a number of persons without their active involvement. Such a definition
excludes verification/authentication systems whose sole purpose would be to confirm that a
specific natural person is the person he or she claims to be, as well as systems that are used
to confirm the identity of a natural person for the sole purpose of having access to a service,a device or premises. This exclusion is justified by the fact that such systems are likely tohave a minor impact on fundamental rights of natural persons compared to remote biometricidentification systems which may be used for the processing of the biometric data of a large
number of persons. In the case of ‘real-time’ systems, the capturing of the biometric data,
the comparison and the identification occur all instantaneously, near-instantaneously or inany 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 inquestion 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 havealready 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 the system
in respect of the natural persons concerned.

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(9)For the purposes of this Regulation the notion of publicly accessible space should beunderstood as referring to any physical place that is accessible to an undetermined numberof natural persons, and irrespective of whether the place in question is privately or publicly
owned. and irrepective of the activity for which the place may be used, such as commerce(for instance, shops, restaurants, cafés), services (for instance, banks, professional activities,
hospitality), sport (for instance, swimming pools, gyms, stadiums), transport (for instance,bus, metro and railway stations, airports, means of transport ), entertainment (for instance,cinemas, theatres, museums, concert and conference halls) leisure or otherwise (for instance,
public roads and squares, parks, forests, playgrounds). A place should be classified as
publicly accessible also if, regardless of potential capacity or security restrictions, access issubject to certain predetermined conditions, which can be fulfilled by an undetermined
number of persons, such as purchase of a ticket or title of transport, prior registration or
having a certain age. By contrast, a place should not be considered publicly accessible ifaccess is limited to specific and defined 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 the relevant authority on the place. The factual possibility of access alone(e.g. an unlocked door, an open gate in a fence) does not imply that the place is publicly
accessible in the presence of indications or circumstances suggesting the contrary (e.g. signs
prohibiting or restricting access). Company and factory premises as well as offices andworkplaces that are intended to be accessed only by relevant employees and service
providers are places that are not publicly accessible. Publicly accessible spaces should notinclude prisons or border control areas. Some other areas may be composed of both not
publicly accessible and publicly accessible areas, such as the hallway of a private residentialbuilding necessary to access a doctor's office or an airport. Online spaces are not covered
either, as they are not physical spaces. Whether a given space is accessible to the publicshould however be determined on a case-by-case basis, having regard to the specificities of
the individual situation at hand.

(10)

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 users of AI systems establishedwithin the Union.

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(11)In light of their digital nature, certain AI systems should fall within the scope of thisRegulation even when they are neither placed on the market, nor put into service, nor usedin the Union. This is the case for example of an operator established in the Union that
contracts certain services to an operator established outside the Union in relation to an
activity to be performed by an AI system that would qualify as high-risk. In thosecircumstances, the AI system used by the operator outside the Union could process data
lawfully collected in and transferred from the Union, and provide to the contracting operator
in the Union the output of 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 thecircumvention of this Regulation and to ensure an effective protection of natural persons
located in the Union, this Regulation should also apply to providers and users of AI systems
that are established in a third country, to the extent the output produced by those systems isused in the Union. Nonetheless, to take into account existing arrangements and special needs
for future cooperation with foreign partners with whom information and evidence is
exchanged, this Regulation should not apply to public authorities of a third country andinternational organisations when acting in the framework of international agreements
concluded at national or European level for law enforcement and judicial cooperation with
the Union or with its Member States. Such agreements have been concluded bilaterally
between Member States and third countries or between the European Union, Europol andother EU agencies and third countries and international organisations. Recipient Member
States authorities and Union institutions, offices, bodies and bodies making use of suchoutputs in the Union remain accountable to ensure their use comply with Union law. When
those international agreements are revised or new ones are concluded in the future, thecontracting parties should undertake the utmost effort to align those agreements with therequirements of this Regulation.

(12)

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

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(-12a) If and insofar AI systems are placed on the market, put into service, or used with or without
modification of such systems for military, defence or national security purposes, thoseshould be excluded from the scope of this Regulation regardless of which type of entity 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 specifities of the Member States’ and the common Union defence policy covered by
Chapter 2 of Title V of the Treaty on European Union (TEU) that are subject to public
international law, which is therefore the more appropriate legal framework for the regulationof AI systems in the context of the use of lethal force and other AI systems in the context ofmilitary and defence activities. As regards national security purposes, the exclusion isjustified both by the fact that national security remains the sole responsibility of Member
States in accordance with Article 4(2) TEU and by the specific nature and operational needsof national 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 system for other than military, defence or
national security purposes should ensure compliance of the system with this Regulation,
unless the system is already compliant with this Regulation. AI systems placed on themarket or put into service for an excluded (i.e. military, defence or national security) and
one or more non excluded purposes (e.g. civilian purposes, law enforcement, etc.), fallwithin the scope of this Regulation and providers of those systems should ensure compliancewith this Regulation. In those cases, the fact that an AI system may fall within 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 carrying out 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 the market for civilian
or law enforcement purposes which is used with or without modification for military,defence or national security purposes should not fall within the scope of this Regulation,
regardless of the type of entity carrying out those activities.

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(12a) This Regulation should be without prejudice to the provisions regarding the liability ofintermediary service providers set out in Directive 2000/31/EC of the European Parliamentand of the Council [as amended by the Digital Services Act].
(12b) This Regulation should not undermine research and development activity and should respect
freedom of science. It is therefore necessary to exclude from its scope AI systems
specifically developed and put into service for the sole purpose of scientific research anddevelopment and to ensure that the Regulation does not otherwise affect scientific researchand development activity on AI systems. As regards product oriented research activity byproviders, the provisions of this Regulation should also not apply. This is without prejudice
to the obligation to comply with this Regulation when an AI system falling into the scope of
this Regulation is placed on the market or put into service as a result of such research anddevelopment activity and to the application of provisions on regulatory sandboxes andtesting in real world conditions. Furthermore, without prejudice to the foregoing regarding
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
reaserch and development activity should remain subject to the provisions of thisRegulation. Under all circumstances, any research and development activity should be
carried out in accordance with recognised ethical and professional standards for scientificresearch.

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(12c) In the light of the nature and complexity of the value chain for AI systems, it is essential toclarify the role of actors who may contribute to the development of AI systems, notably
high-risk AI systems. In particular, it is necessary to clarify that general purpose AI systems
are AI systems that are intended by the provider to perform generally applicable functions,such as image/speech recognition, and in a plurality of contexts. They may be used as highrisk AI systems by themselves or be components of other high risk AI systems. Therefore,
due to their particular nature and in order to ensure a fair sharing of responsibilities along
the AI value chain, such systems should be subject to proportionate and more specificrequirements and obligations under this Regulation while ensuring a high level of protectionof fundamental rights, health and safety. In addition, the providers of general purpose AI
systems, irrespective of whether they may be used as high-risk AI systems as such by otherproviders or as components of high-risk AI systems, should cooperate, as appropriate, withthe providers of the respective high-risk AI systems to enable their compliance with therelevant obligations under this Regulation and with the competent authorities establishedunder this Regulation. In order to take into account the specific characteristics of general
purpose AI systems and the fast evolving market and technological developments in thefield, implementing powers should be conferred on the Commission to specify and adapt theapplication of the requirements established under this Regulation to general purpose AI
systems and to specify the information to be shared by the providers of general purpose AI
systems in order to enable the providers of the respective high-risk AI system to comply
with their obligations under this Regulation.

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(13)In order to ensure a consistent and high level of protection of public interests as regards
health, safety and fundamental rights, common normative standards for all high-risk AI
systems should be established. Those standards should be consistent with the Charter offundamental rights of the European Union (the Charter) and should be non-discriminatory
and in line with the Union’s international trade commitments.

(14)

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 the typeand content of such rules to the intensity and scope of the risks that AI systems can generate.
It is therefore necessary to prohibit certain artificial intelligence practices, to lay down
requirements for high-risk AI systems and obligations for the relevant operators, and to lay
down transparency obligations for certain AI systems.

(15)

Aside from the many beneficial uses of artificial intelligence, that technology can also be
misused and provide novel and powerful tools for manipulative, exploitative and social
control practices. Such practices are particularly harmful and should be prohibited because
they contradict Union values of respect for human dignity, freedom, equality, democracy
and the rule of law and Union fundamental rights, including the right to non-discrimination,
data protection and privacy and the rights of the child.

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(16)AI-enabled manipulative techniques can be used to persuade persons to engage in unwanted
behaviours, or to deceive them by nudging them into decisions in a way that subverts andimpairs their autonomy, decision-making and free choices. The placing on the market,
putting into service or use of certain AI systems materially distorting human behaviour,whereby physical or psychological harms are likely to occur, are particularly dangerous andshould therefore be forbidden. Such AI systems deploy subliminal components such as
audio, image, video stimuli that persons cannot perceive as those stimuli are beyond humanperception or other subliminal techniques that subvert or impair person’s autonomy,
decision-making or free choices in ways that people are not consciously aware of, or even if
aware not able to control or resist, for example in cases of machine-brain interfaces orvirtual reality. In addition, AI systems may also otherwise exploit vulnerabilities of a
specific group of persons due to their age, disability within the meaning of Directive (EU)2019/882, or a specific social or economic situation that is likely to make those persons
more vulnerable to exploitation such as persons living in extreme poverty, ethnic or
religious minorities. Such AI systems can be placed on the market, put into service or usedwith the objective to or the effect of materially distorting the behaviour of a person and in amanner that causes or is reasonably likely to cause physical or phycological harm to that or
another person or groups of persons, including harms that may be accumulated over time.
The intention to distort the behaviour may not be presumed if the distortion results fromfactors external to the AI system which are outside of the control of the provider or the user,
meaning factors that may not be reasonably foreseen and mitigated by the provider or theuser of the AI system. In any case, it is not necessary for the provider or the user to have theintention to cause the physical or psychological harm, as long as 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, notably that unfair
commercial practices leading to economic or financial harms to consumers are prohibited
under all circumstances, irrespective of whether they are put in place through AI systems orotherwise. The prohibitions of manipulative and exploitative practices in this Regulation
should not affect lawful practices in the context of medical treatment such as psychologicaltreatment of a mental disease or physical rehabilitation, when those practices are carried out
in accordance with the applicable medical standards and legislation. In addition, common
and legitimate commercial practices that are in compliance with the applicable law should
not in themselves be regarded as constituting harmful manipulative AI practices.

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(17)AI systems providing social scoring of natural persons by public authorities or by private
actors may lead to discriminatory outcomes and the exclusion of certain groups. They may
violate the right to dignity and non-discrimination and the values of equality and justice.
Such AI systems evaluate or classify natural persons based on their social behaviour inmultiple contexts or known or predicted personal or personality characteristics. The socialscore obtained from such AI systems may lead to the detrimental or unfavourable treatmentof 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 treatmentthat is disproportionate or unjustified to the gravity of their social behaviour. AI systems
entailing such unacceptable scoring practices should be therefore prohibited. This
prohibition should not affect lawful evaluation practices of natural persons done for one ormore specific purpose in compliance with the law.

(18)

The use of AI systems for ‘real-time’ remote biometric identification of natural persons inpublicly accessible spaces for the purpose of law enforcement is considered particularly
intrusive in the rights and freedoms of the concerned persons, to the extent that it may affectthe private 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. In
addition, the immediacy of the impact and the limited opportunities for further checks orcorrections in relation to the use of such systems operating in ‘real-time’ carry heightenedrisks for the rights and freedoms of the persons that are concerned by law enforcement
activities.

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LIMITEEN(19)The use of those systems for the purpose of law enforcement should therefore be prohibited,
except in exhaustively listed and narrowly defined situations, where the use is strictly
necessary to achieve a substantial public interest, the importance of which outweighs therisks. Those situations involve the search for potential victims of crime, including missing
children; certain threats to the life or physical safety of natural persons or of a terrorist
attack; and the detection, localisation, identification or prosecution of perpetrators orsuspects of the criminal offences referred to in Council Framework Decision 2002/584/JHA9
if those criminal offences are punishable in the Member State concerned by a custodial
sentence or a detention order for a maximum period of at least three years and as they aredefined in the law of that Member State. Such threshold for the custodial sentence or
detention order in accordance with national law contributes to ensure that the offence should
be serious enough to potentially justify the use of ‘real-time’ remote biometric identification
systems. Moreover, of the 32 criminal offences listed in the Council Framework Decision
2002/584/JHA, some are in practice likely to be more relevant than others, in that therecourse to ‘real-time’ remote biometric identification will foreseeably be necessary andproportionate to highly varying degrees for the practical pursuit of the detection,
localisation, identification or prosecution of a perpetrator or suspect of the different criminal
offences listed and having regard to the likely differences in the seriousness, probability andscale of the harm or possible negative consequences. In addition, this Regulation shouldpreserve the ability for law enforcement, border control, immigration or asylum authorities
to carry out identity checks in the presence of the person that is concerned in accordancewith the conditions set out in Union and national law for such checks. In particular, law
enforcement, border control, immigration or asylum authorities should be able to use
information systems, in accordance with Union or national law, to identify a person who,
during an identity check, either refuses to be identified or is unable to state or prove his or
her identity, without being required by this Regulation to obtain prior authorisation. 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.

9

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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(20)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 subject to appropriate limits
in time and space, having regard in particular to the evidence or indications regarding thethreats, the victims or perpetrator. The reference database of persons should be appropriate
for each use case in each of the situations mentioned above.

(21)

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. Such authorisation should in principle be obtained prior to the use of thesystem with a view to identify a person or persons. Exceptions to this rule should be allowedin duly justified situations of urgency, that is, situations where the need to use the systems inquestion is such as to make it effectively and objectively impossible to obtain an
authorisation before commencing the use. In such situations of urgency, the use should be
restricted to the absolute minimum necessary and be subject to appropriate safeguards andconditions, as determined in national law and specified in the context of each individual
urgent use case by the law enforcement authority itself. In addition, the law enforcement
authority should in such situations seek to obtain an authorisation as soon as possible, whilst
providing the reasons for not having been able to request it earlier.

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(22)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 in question 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 to provide
for such a possibility at all or to only provide for such a possibility in respect of some of theobjectives capable of justifying authorised use identified in this Regulation.

(23)

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 only be possible in as far as it
is compatible with the framework set by this Regulation, without there being scope, outsidethat 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 this context, this Regulation is notintended to provide the legal basis for the processing of personal data under Article 8 of
Directive 2016/680. However, the use of ‘real-time’ remote biometric identification systems
in publicly accessible spaces for purposes other than law enforcement, including bycompetent authorities, should not be covered by the specific framework regarding such use
for the purpose of law enforcement set by this Regulation. Such use for purposes other thanlaw 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 effect to it.

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(24)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 other thanlaw enforcement, Article 9(1) of Regulation (EU) 2016/679 and Article 10(1) of Regulation(EU) 2018/1725 prohibit the processing of biometric data for the purpose of uniquely
identifying a natural person, unless one of the situations in the respective second paragraphsof those two articles applies.

(25)

In accordance with Article 6a of Protocol No 21 on the position of the United Kingdom andIreland 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), point (d), (2), (3) and(4) of this Regulation adopted on the basis of Article 16 of the TFEU which relate to theprocessing 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 in criminal matters or
police cooperation which require compliance with the provisions laid down on the basis of
Article 16 of the TFEU.

(26)

In accordance with Articles 2 and 2a of Protocol No 22 on the position of Denmark, annexedto the TEU and TFEU, Denmark is not bound by rules laid down in Article 5(1), point (d),(2), (3) and (4) of this Regulation adopted on the basis of Article 16 of the TFEU, or subject
to their application, 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 ofPart Three of the TFEU.

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(27)High-risk AI systems should only be placed on the Union market or put into service if they
comply with certain mandatory requirements. Those requirements should ensure that highrisk AI systems available in the Union or whose output is otherwise used in the Union do notpose unacceptable risks to important Union public interests as recognised and protected byUnion law. AI systems identified as high-risk should be limited to those that have asignificant harmful impact on the health, safety and fundamental rights of persons in theUnion and such limitation minimises any potential restriction to international trade, if any.

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(28)AI systems could produce adverse outcomes to health and safety of persons, in particularwhen such systems operate as components of products. Consistently with the objectives ofUnion harmonisation legislation to facilitate the free movement of products in the internalmarket and to ensure that only safe and otherwise compliant products find their way into themarket, it is important that the safety risks that may be generated by a product as a whole
due to its digital components, including AI systems, are duly prevented and mitigated. For
instance, increasingly autonomous robots, whether in the context of manufacturing or
personal assistance and care should be able to safely operate and performs their functions incomplex environments. Similarly, in the health sector where the stakes for life and health areparticularly high, increasingly sophisticated diagnostics systems and systems supporting
human decisions should be reliable and accurate. The extent of the adverse impact caused by
the AI system on the fundamental rights protected by the Charter is of particular relevancewhen classifying an AI system as high-risk. Those rights include the right to human dignity,
respect for private and family life, protection of personal data, freedom of expression andinformation, freedom of assembly and of association, and non-discrimination, consumer
protection, workers’ rights, rights of persons with disabilities, right to an effective remedy
and to a fair trial, right of defence and the presumption of innocence, right to goodadministration. In addition to those rights, it is important to highlight that children havespecific rights as enshrined in Article 24 of the EU Charter and in the United Nations
Convention on the Rights of the Child (further elaborated in the UNCRC General Comment
No. 25 as regards the digital environment), both of which require consideration of thechildren’s vulnerabilities and provision of such protection and care as necessary for theirwell-being. The fundamental right to a high level of environmental protection enshrined in
the Charter and implemented in Union policies should also be considered when assessing theseverity of the harm that an AI system can cause, including in relation to the health andsafety of persons.

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LIMITEEN(29)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 300/2008of the European Parliament and of the Council10, Regulation (EU) No 167/2013 of theEuropean Parliament and of the Council11, Regulation (EU) No 168/2013 of the European
Parliament and of the Council12, Directive 2014/90/EU of the European Parliament and of
the Council13, Directive (EU) 2016/797 of the European Parliament and of the Council14,
Regulation (EU) 2018/858 of the European Parliament and of the Council15, Regulation(EU) 2018/1139 of the European Parliament and of the Council16, and Regulation (EU)2019/2144 of the European Parliament and of the Council17, it is appropriate to amend thoseacts to ensure that the Commission takes into account, on the basis of the technical andregulatory specificities of each sector, and without interfering with existing governance,
conformity assessment and enforcement mechanisms and authorities established therein, themandatory requirements for high-risk AI systems laid down in this Regulation when
adopting any relevant future delegated or implementing acts on the basis of those acts.

10

11
12
13
14
15

16

17

Regulation (EC) No 300/2008 of the European Parliament and of the Council of 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 Council of 5 February 2013 on theapproval 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 Council of 15 January 2013 on theapproval 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 theinteroperability of the rail system within the European Union (OJ L 138, 26.5.2016, p. 44).
Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval andmarket surveillance of motor vehicles and their trailers, and of systems, components and separate technicalunits intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 andrepealing 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 the European 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 Council of 27 November 2019 on typeapproval requirements for motor vehicles and their trailers, and systems, components and separate technicalunits intended for such vehicles, as regards their general safety and the protection of vehicle occupants andvulnerable 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 the European Parliamentand 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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LIMITEEN(30)As regards AI systems that are safety components of products, or which are themselves
products, falling within the scope of certain Union harmonisation legislation, it isappropriate to classify them as high-risk under this Regulation if the product in question
undergoes the conformity assessment procedure with a third-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 potentiallyexplosive atmospheres, radio equipment, pressure equipment, recreational craft equipment,
cableway installations, appliances burning gaseous fuels, medical devices, and in vitro
diagnostic medical devices.

(31)

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 ‘high-risk’ under the criteria established in therelevant Union harmonisation legislation that applies to the product. This is notably the casefor Regulation (EU) 2017/745 of the European Parliament and of the Council18 andRegulation (EU) 2017/746 of the European Parliament and of the Council19, where a thirdparty conformity assessment is provided for medium-risk and high-risk products.

18

19

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 and Regulation (EC) No 1223/2009 andrepealing Council Directives 90/385/EEC and 93/42/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).

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LIMITEEN(32)As regards high-risk AI systems other than those that are safety components of products, or
which are themselves products, it is appropriate to classify them as high-risk if, in the lightof their intended purpose, they pose a high risk of harm to the health and safety or thefundamental rights of persons, taking into account both the severity of the possible harm andits probability of occurrence, and they are used in a number of specifically pre-defined areas
specified in the Regulation. The identification of those systems is based on the same
methodology and criteria envisaged also for any future amendments of the list of high-risk
AI systems. It is also important to clarify that within the high-risk scenarios referred to in
Annex III there may be systems that do not lead to a significant risk to the legal interests
protected under those scenarios, taking into account the output produced by the AI system.
Therefore only when such output has a high degree of importance (i.e. is not purely
accessory) in respect of the relevant action or decision so as to generate a significant risk to
the legal interests protected, the AI system generating such output should be considered as
high-risk. For instance, when the information provided by an AI systems to the humanconsists of the profiling of natural persons within the meaning of of Article 4(4) Regulation(EU) 2016/679 and Article 3(4) of Directive (EU) 2016/680 and Article 3(5) of Regulation(EU) 2018/1725, such information should not typically be considered of accessory nature in
the context of high risk AI systems as referred to in Annex III. However, if the output of the
AI system has only negligible or minor relevance for human action or decision, it may beconsidered purely accessory, including for example, AI systems used for translation for
informative purposes or for the management of documents.

(33)

Technical inaccuracies of AI systems intended for the remote biometric identification ofnatural persons can lead to biased results and entail discriminatory effects. This isparticularly relevant when it comes to age, ethnicity, race, sex or disabilities. Therefore,‘real-time’ and ‘post’ remote biometric identification systems should be classified as highrisk. In view of the risks that they pose, both types of remote biometric identification
systems should be subject to specific requirements on logging capabilities and humanoversight.

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(34)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 Annex I point 8 of the
Directive on the resilience of critical entities, road traffic and the supply of water, gas,
heating and electricity, since their failure or malfunctioning may put at risk the life andhealth of persons at large scale and lead to appreciable disruptions in the ordinary conduct ofsocial and economic activities. Safety components of critical infrastructure, including
critical digital infrastrucure, are systems used to directly protect the physical integrity ofcritical infrastructure or health and safety of persons and property but which are notnecessary in order for the system to function. Failure or malfunctioning of such components
might directly lead to risks to the physical integrity of critical infrastructure and thus to risks
to health and safety of persons and property. Components intended to be used solely forcybersecurity 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.

(35)

AI systems used in education or vocational training, notably for determining access,admission or assigning persons to educational and vocational training institutions orprogrammes at all levels or to evaluate learning outcomes of persons should be consideredhigh-risk, since they may determine the educational and professional course of a person’slife and therefore affect their ability to secure their livelihood. When improperly designed
and used, such systems may violate the right to education and training as well as the rightnot to be discriminated against and perpetuate historical patterns of discrimination.

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(36)AI systems used in employment, workers management and access to self-employment,
notably for the recruitment and selection of persons, for making decisions on promotion andtermination and for task allocation based on individual behavior or personal traits or
characteristics, monitoring or evaluation of persons in work-related contractual
relationships, should also be classified as high-risk, since those systems may appreciably
impact future career prospects and livelihoods of these persons. Relevant work-related
contractual relationships should involve employees and persons providing services throughplatforms as referred to in the Commission Work Programme 2021. Such persons should in
principle not be considered users within the meaning of this Regulation. Throughout therecruitment process and in the evaluation, promotion, or retention of persons in work-related
contractual relationships, such systems may perpetuate historical patterns of discrimination,for example against women, certain age groups, persons with disabilities, or persons ofcertain racial or ethnic origins or sexual orientation. AI systems used to monitor the
performance and behaviour of these persons may also impact their rights to data protection
and privacy.

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(37)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, AI
systems used to evaluate the credit score or creditworthiness of natural persons should beclassified as high-risk AI systems, since they determine those persons’ access to financial
resources or essential services such as housing, electricity, and telecommunication services.
AI systems used for this purpose may lead to discrimination of persons or groups andperpetuate historical patterns of discrimination, for example based on racial or ethnic
origins, disabilities, age, sexual orientation, or create new forms of discriminatory impacts.
Considering the very limited scale of the impact and the available alternatives on the market,
it is appropriate to exempt AI systems for the purpose of creditworthiness assessment andcredit scoring when put into service by micro or small entreprises, as defined in the Annex
of Commission Recommendation 2003/361/EC for their own use. Natural persons applying
for or receiving essential public assistance benefits and services from public authorities 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 andservices should be denied, reduced, revoked or reclaimed by authorities, including whether
beneficiaries are legitimately entitled to such benefits or services, those systems may have asignificant impact on persons’ livelihood and may infringe their fundamental rights, such as
the right to social protection, non-discrimination, human dignity or an effective remedy.
Those systems should therefore be classified as high-risk. Nonetheless, this Regulation
should not hamper the development and use of innovative approaches in the public
administration, which would stand to benefit from a wider use of compliant and safe AI
systems, provided that those systems do not entail a high risk to legal and natural persons.
Finally, AI systems used to dispatch or establish priority in the dispatching of emergency
first response services should also be classified as high-risk since they make decisions invery critical situations for the life and health of persons and their property. AI systems arealso increasingly used for risk assessment in relation to natural persons and pricing in thecase of life and health insurance which, if not duly designed, developed and used, can leadto serious consequences for people’s life and health, including financial exclusion anddiscrimination. To ensure a consistent approach within the financial services sector, theabove mentioned exception for micro or small enterprises for their own use should apply,
insofar as they themselves provide and put into service an AI system for the purpose of
selling their own insurance products.

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38)

Actions by law enforcement authorities involving certain uses of AI systems arecharacterised by a significant degree of power imbalance and may lead to surveillance, arrest
or deprivation of a natural person’s liberty as well as other adverse impacts on fundamental
rights guaranteed in the Charter. In particular, if the AI system is not trained with highquality data, does not meet adequate requirements in terms of its accuracy or robustness, oris not properly designed and tested before being put on the market or otherwise put into
service, it may single out people in a discriminatory or otherwise incorrect or unjust manner.
Furthermore, the exercise of important procedural fundamental rights, such as the right to aneffective remedy and to a fair trial as well as the right of defence and the presumption of
innocence, could be hampered, in particular, where such AI systems are not sufficiently
transparent, explainable and documented. It is therefore appropriate to classify as high-risk a
number of AI systems intended to be used in the law enforcement context where accuracy,
reliability and transparency is particularly important to avoid adverse impacts, retain publictrust and ensure accountability and effective redress. In view of the nature of the activities inquestion and the risks relating thereto, those high-risk AI systems should include inparticular AI systems intended to be used by law enforcement authorities for individual risk
assessments, polygraphs and similar tools or to detect the emotional state of natural person,for the evaluation of the reliability of evidence in criminal proceedings, for predicting theoccurrence or reoccurrence of an actual or potential criminal offence based on profiling of
natural persons, or assessing personality traits and characteristics or past criminal behaviourof natural persons or groups, for profiling in the course of detection, investigation orprosecution of criminal offences. AI systems specifically intended to be used foradministrative proceedings by tax and customs authorities as well as by financial
intelligence units carrying out adminstrative tasks analysing information pursuant to Unionanti-money laundering legislation should not be considered high-risk AI systems used bylaw enforcement authorities for the purposes of prevention, detection, investigation andprosecution of criminal offences.

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(39)AI systems used in migration, asylum and border control management affect people who areoften 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 important toguarantee the respect of the fundamental rights of the affected persons, notably their rights
to free movement, non-discrimination, protection of private life and personal data,international protection and good administration. It is therefore appropriate to classify as
high-risk AI systems intended to be used by the competent public authorities charged withtasks in the fields of migration, asylum and border control management as polygraphs andsimilar tools or to detect the emotional state of a natural person; 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 of applications for
asylum, visa and residence permits and associated complaints with regard to the objective toestablish the eligibility of the natural persons applying for a status. AI systems in the area of
migration, asylum and border control management covered by this Regulation should
comply with the relevant procedural requirements set by the Directive 2013/32/EU of theEuropean Parliament and of the Council20, the Regulation (EC) No 810/2009 of theEuropean Parliament and of the Council21 and other relevant legislation.

20
21

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

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(40)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, rule of law, individual freedoms as well as the right to an effective remedy andto a fair trial. In particular, to address the risks of potential biases, errors and opacity, it isappropriate to qualify as high-risk AI systems intended to assist judicial authorities ininterpreting facts and the law and in applying the law to a concrete set of facts. Suchqualification should not extend, however, to AI systems intended for purely ancillaryadministrative 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.

(41)

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

(42)

To mitigate the risks from high-risk AI systems placed or otherwise put into service on theUnion market, certain mandatory requirements should apply, taking into account theintended purpose of the use of the system and according to the risk management system tobe established by the provider. In particular, the risk management system should consist of acontinuous iterative process planned and run throughout the entire lifecycle of a high-risk AI
system. This process should ensure that the provider identifies and analyses the risks to thehealth, safety and fundamental rights of the persons who may be affected by the system inlight of its intended purpose, including the possible risks arising from the interaction
between the AI system and the environment within which it operates, and accordingly
adopts suitable risk management measures in the light of state of the art.

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(43)Requirements should apply to high-risk AI systems as regards the quality of data sets used,technical documentation and record-keeping, transparency and the provision of information
to users, human oversight, and robustness, accuracy and cybersecurity. Those requirements
are necessary to effectively mitigate the risks for health, safety and fundamental rights, asapplicable in the light of the intended purpose of the system, and no other less trade
restrictive measures are reasonably available, thus avoiding unjustified restrictions to trade.

(44)

High data quality is essential for the performance of many AI systems, especially whentechniques 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 the source of
discrimination prohibited by Union law. High quality training, validation and testing data
sets require the implementation of appropriate data governance and management practices.
Training, validation and testing data sets should be sufficiently relevant, representative andhave the appropriate statistical properties, including as regards the persons or groups of
persons on which the high-risk AI system is intended to be used. These datasets should also
be as free of errors and complete as possible in view of the intended purpose of the AI
system, taking into account, in a proportionate manner, technical feasibility and state of theart, the availability of data and the implementation of appropriate risk management measures
so that possible shortcomings of the datasets are duly addressed. The requirement for thedatasets to be complete and free of errors should not affect the use of privacy-preserving
techniques in the context of the the development and testing of AI systems. Training,validation and testing data sets should take into account, to the extent required by theirintended purpose, the features, characteristics or elements that are particular to the specificgeographical, behavioural or functional setting or context within which the AI system isintended to be used. In order to protect the right of others from the discrimination that might
result from the bias in AI systems, the providers should be able to process also special
categories of personal data, as a matter of substantial public interest within the meaning of
Article 9(2)(g) of Regulation (EU) 2016/679 and Article 10(2)g) of Regulation (EU)2018/1725, in order to ensure the bias monitoring, detection and correction in relation tohigh-risk AI systems.

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(44a) When applying the principles referred to in Article 5(1)(c) of Regulation 2016/679 andArticle 4(1)(c) of Regulation 2018/1725, in particular the principle of data minimisation, inregard to training, validation and testing data sets under this Regulation, due regard should
be had to the full life cycle of the AI system.
(45)

For the development of high-risk AI systems, certain actors, such as providers, notified
bodies and other relevant entities, such as digital innovation hubs, testing experimentation
facilities and researchers, should be able to access and use high quality datasets within theirrespective fields of activities which are related to this Regulation. European common data
spaces established by the Commission and the facilitation of data sharing between
businesses and with government in the public interest will be instrumental to provide
trustful, accountable and non-discriminatory access to high 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 health data and the training of artificial
intelligence algorithms on those datasets, 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 ofAI systems.

(46)

Having information on how high-risk AI systems have been developed and how they
perform throughout their lifecycle is essential to verify compliance with the requirements
under this Regulation. This requires keeping records and the availability of a technicaldocumentation, containing information which is necessary to assess the compliance of the
AI system with the relevant requirements. Such information should include the generalcharacteristics, capabilities and limitations of the system, algorithms, data, training, testingand validation processes used as well as documentation on the relevant risk management
system. The technical documentation should be kept up to date. Furthermore, providers orusers should keep logs automatically generated by the high-risk AI system, including for
instance output data, start date and time etc., to the extent that such a system and the related
logs are under their control, for a period that is appropriate to enable them to fulfil their
obligations.

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(47)To address the opacity that may make certain AI systems incomprehensible to or too
complex for natural persons, a certain degree of transparency should be required for highrisk AI systems. Users should be able to interpret the system output and use it appropriately.
High-risk AI systems should therefore be accompanied by relevant documentation andinstructions of use and include concise and clear information, including in relation topossible risks to fundamental rights and discrimination of the persons who may be affectedby the system in light of its intended purpose, where appropriate. To facilitate theunderstanding of the instructions of use by users, they should contain illustrative examples,
as appropriate.

(48)

High-risk AI systems should be designed and developed in such a way that natural persons
can oversee their functioning. For this purpose, appropriate human oversight measures
should be identified by the provider of the system before its placing on the market or putting
into service. In particular, where appropriate, such measures should guarantee that thesystem is subject to in-built operational constraints that cannot be overridden by the systemitself and is responsive to the human operator, and that the natural persons to whom humanoversight has been assigned have the necessary competence, training and authority to carryout that role. Considering the significant consequences for persons in case of incorrect
matches by certain biometric identification systems, it is appropriate to provide for anenhanced human oversight requirement for those systems so that no action or decision may
be taken by the user on the basis of the identification resulting from the system unless thishas been separately verified and confirmed by at least two natural 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 or delays and it could be sufficientthat the separate verifications by the different persons are automatically recorded in the logs
generated by the system.

(49)

High-risk AI systems should perform consistently throughout their lifecycle and meet anappropriate level of accuracy, robustness and cybersecurity in accordance with the generally
acknowledged state of the art. The level of accuracy and accuracy metrics should becommunicated to the users.

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LIMITEEN(50)The 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). High-risk AI systems should therefore be
designed and developed with appropriate technical solutions to prevent or minimize that
harmful or otherwise undesirable behaviour, such as for instance mechanisms enabling thesystem to safely interrupt its operation (fail-safe plans) in the presence of certain anomalies
or when operation takes place outside certain predetermined boundaries. 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.

(51)

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 exploit vulnerabilities in the AI system’s digitalassets or the underlying ICT infrastructure. To ensure a level of cybersecurity appropriate to
the risks, suitable measures 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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(52)As part of Union harmonisation legislation, rules applicable to the placing on the market,
putting into service and use of high-risk AI systems should be laid down consistently with
Regulation (EC) No 765/2008 of the European Parliament and of the Council22 setting out
the requirements for accreditation and the market surveillance of products, Decision No
768/2008/EC of the European Parliament and of the Council23 on a common framework forthe marketing of products and Regulation (EU) 2019/1020 of the European Parliament andof the Council24 on market surveillance and compliance of products (‘New Legislative
Framework for the marketing of products’).

(52a) In line with New Legislative Framework principles, specific obligations for relevant
operators within the AI value chain should be set to ensure legal certainty and facilitate
compliance with this Regulation. In certain situations those operators could act in more than
one role at the same time and should therefore fufil cumulatively all relevant obligations
associated with those roles. For example, an operator could act as a distributor and an
importer at the same time.
(53)

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

22

23

24

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out therequirements for accreditation and market surveillance relating to the marketing of products and repealing
Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
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 and Regulations (EC) No
765/2008 and (EU) No 305/2011 (Text with EEA relevance) (OJ L 169, 25.6.2019, p. 1–44).

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(54)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. Public authorities
which put into service high-risk AI systems for their own use may adopt and implement therules 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 thesector and the competences and organisation of the public authority in question.

(54a) To ensure legal certainty, it is necessary to clarify that, under certain specific conditions, any
natural or legal person should be considered a provider of a new high-risk AI system andtherefore assume all the relevant obligations. For example, this would be the case if that
person puts its name or trademark on a high-risk AI system already placed on the market or
put into service, or if that person modifies the intended purpose of an AI system which is nothigh-risk and is already placed on the market or put into service, in a way that makes themodified system a high-risk AI system. These provisions should apply without prejudice tomore specific provisions established in certain New Legislative Framework sectorial
legislation with which this Regulation should apply jointly. For example, Article 16,
paragraph 2 of Regulation 745/2017, establishing that certain changes should not be
considered modifications of a device that could affect its compliance with the applicablerequirements, should continue to apply to high-risk AI systems that are medical devices
within the meaning of that Regulation.
(55)

Where a high-risk AI system that is a safety component of a product which is covered by arelevant New Legislative Framework sectorial legislation is not placed on the market or put
into service independently from the product, the product manufacturer as defined under the
relevant New Legislative Framework legislation should comply with the obligations of theprovider established in this Regulation and notably ensure that the AI system embedded in
the final product complies with the requirements of this Regulation.

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(56)To enable enforcement of this Regulation and create a level-playing field for operators, andtaking 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, where an importercannot be identified, providers established outside the Union shall, by written mandate,appoint an authorised representative established in the Union.

(56a) For providers who are not established in the Union, the authorised representative plays apivotal role in ensuring the compliance of the high-risk AI systems placed on the market or
put into service in the Union by those providers and in serving as their contact person
established in the Union. Given that pivotal role, and in order to ensure that responsibility is
assumed for the purposes of enforcement of this Regulation, it is appropriate to make theauthorised representative jointly and severally liable with the provider for defective highrisk AI systems. The liability of the authorised representative provided for in this Regulation
is without prejudice to the provisions of Directive 85/374/EEC on liability for defective
products.
(57)[deleted](58)

Given the nature of AI systems and the risks to safety and fundamental rights possibly
associated with their use, including as regard the need to ensure proper monitoring of theperformance of an AI system in a real-life setting, it is appropriate to set specificresponsibilities for users. Users should in particular use high-risk AI systems in accordancewith the instructions of use and certain other obligations should be provided for with regard
to monitoring of the functioning of the AI systems and with regard to record-keeping, as
appropriate. These obligations should be without prejudice to other user obligations inrelation to high-risk AI systems under Union or national law, and should not apply where
the use is made in the course of a personal non-professional activity.

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(58a) It is appropriate to clarify that this Regulation does not affect the obligations of providers
and users of AI systems in their role as data controllers or processors stemming from Union
law on the protection of personal data in so far as the design, the development or the use of
AI systems involves the processing of personal data. It is also appropriate to clarify that data
subjects continue to enjoy all the rights and guarantees awarded to them by such Union law,
including the rights related to solely automated individual decision-making, including
profiling. Harmonised rules for the placing on the market, the putting into service and theuse of AI systems established under this Regulation should facilitate the effective
implementation and 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.
(59)[deleted](60)[deleted]

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(61)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. Compliance withharmonised standards as defined in Regulation (EU) No 1025/2012 of the European
Parliament and of the Council25, which are normally expected to reflect the state of theart,should be a means for providers to demonstrate conformity with the requirements of thisRegulation. However, in the absence of relevant references to harmonised standards, theCommission should be able to establish, via implementing acts, common specifications forcertain requirements under this Regulation as an exceptional fall back solution to facilitate
the provider’s obligation to comply with the requirements of this Regulation, when thestandardisation process is blocked or when there are delays in the establishment of an
appropriate harmonised standard. If such delay is due to the technical complexity of thestandard in question, this should be considered by the Commission before contemplating theestablishment of common specifications. An appropriate involvement of small and medium
enterprises in the elaboration of standards supporting the implementation of this Regulation
is essential to promote innovation and competitiveness in the field of artificial intelligencewithin the Union. Such involvement should be appropriately ensured in accordance with
Article 5 and 6 of Regulation 1025/2012.

25

Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 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 theEuropean 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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(61a) It is appropriate that, without prejudice to the use of harmonised standards and common
specifications, providers benefit from a presumption of conformity with the relevant
requirement on data when their high-risk AI system has been trained and tested on data
reflecting the specific geographical, behavioural or functional setting within which the AI
system is intended to be used. Similarly, in line with Article 54(3) of Regulation (EU)2019/881 of the European Parliament and of the Council, high-risk AI systems that havebeen certified or for which a statement of conformity has been issued under a cybersecurity
scheme pursuant to that Regulation and the references of which have been published in the
Official Journal of the European Union should be presumed to be in compliance with thecybersecurity requirement of this Regulation. This remains without prejudice to thevoluntary nature of that cybersecurity scheme.
(62)

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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(63)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 following the New Legislative Framework approach, thecompliance of those AI systems with the requirements of this Regulation should be assessedas part of the conformity assessment already foreseen under that legislation. The
applicability of the requirements of this Regulation should thus not affect the specific logic,
methodology or general structure of conformity assessment under the relevant specific New
Legislative Framework legislation. This approach is fully reflected in the interplay between
this Regulation and the [Machinery Regulation]. While safety risks of AI systems ensuringsafety functions in machinery are addressed by the requirements of this Regulation, certain
specific requirements in the [Machinery Regulation] will ensure the safe integration of the
AI system into the overall machinery, so as not to compromise the safety of the machinery
as a whole. The [Machinery Regulation] applies the same definition of AI system as thisRegulation. With regard to high-risk AI systems related to products covered by Regulations
745/2017 and 746/2017 on medical devices, the applicability of the requirements of thisRegulation should be without prejudice and take into account the risk management logic andbenefit-risk assessment performed under the medical device framework.

(64)

Given the more extensive experience of professional pre-market certifiers in the field of
product safety 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 general ruleby the provider under its own responsibility, with the only exception of AI systems intended
to be used for the remote biometric identification of persons, for which the involvement of a
notified body in the conformity assessment should be foreseen, to the extent they are notprohibited.

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(65)In order to carry out third-party conformity assessment for AI systems intended to be used
for the remote biometric identification of persons, notified bodies should be notified under
this Regulation by the national competent authorities, provided they are compliant with a setof requirements, notably on independence, competence and absence of conflicts of interests.
Notification of those bodies should be sent by national competent authorities to theCommission and the other Member States by means of the electronic notification tool
developed and managed by the Commission pursuant to Article R23 of Decision 768/2008.

(66)

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 thesystem changes, that AI system should be considered a new AI system which should
undergo a new conformity assessment. However, changes occuring to the algorithm and theperformance of AI systems which continue to ‘learn’ after being placed on the market or put
into service (i.e. automatically adapting how functions are carried out) should not constitutea substantial modification, provided that those changes have been pre-determined by theprovider and assessed at the moment of the conformity assessment.

(67)

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. Member States should
not create unjustified obstacles to the placing on the market or putting into service of highrisk AI systems that comply with the requirements laid down in this Regulation and bear the
CE marking.

(68)

Under certain conditions, rapid availability of innovative technologies may be crucial for
health and safety of persons and for society as a whole. It is thus appropriate that under
exceptional reasons of public security or protection of life and health of natural persons andthe protection of industrial and commercial property, Member States could authorise theplacing on the market or putting into service of AI systems which have not undergone a
conformity assessment.

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(69)In order to facilitate the work of the Commission and the Member States in the artificial
intelligence field as well as to increase the transparency towards the public, providers ofhigh-risk AI systems other than those related to products falling within the scope of relevant
existing Union harmonisation legislation, should be required to register themselves andinformation about their high-risk AI system in a EU database, to be established and managed
by the Commission. Before using a high-risk AI system listed in Annex III, users of highrisk AI systems that are public authorities, agencies or bodies, with the exception of law
enforcement, border control, immigration or asylum authorities, and authorities that areusers of high-risk AI systems in the area of critical infrastructure shall also registerthemselves in such database and select the system that they envisage to use. The
Commission should be the controller of that database, in accordance with Regulation (EU)2018/1725 of the European Parliament and of the Council26. In order to ensure the fullfunctionality of the database, when deployed, the procedure for setting the database should
include the elaboration of functional specifications by the Commission and an independent
audit report.

26

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protectionof natural persons with regard to the processing of personal data and on the free movement of such data, andrepealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

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(70)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 tospecific transparency obligations without prejudice to the requirements and obligations forhigh-risk AI systems. In particular, natural persons should be notified that they areinteracting with an AI system, unless this is obvious from the point of view of a natural
person who is reasonably well-informed, observant and circumspect taking into account thecircumstances and the context of use. When implementing such obligation, thecharacteristics of individuals belonging to vulnerable groups due to their age or disability
should be taken into account to the extent the AI system is intended to interact with thosegroups as well. Moreover, natural persons should be notified when they are exposed tosystems that, by processing their biometric data, can identify or infer the emotions or
intentions of those persons or assign them to specific categories. Such specific categories
can relate to aspects such as sex, age, hair colour, eye colour, tatoos, personal traits, ethnic
origin, personal preferences and interests or to other aspects such as sexual or politicalorientation. Such information and notifications should be provided in accessible formats for
persons with disabilities. Further, users, who use an AI system to generate or manipulate
image, audio or video content that appreciably resembles existing persons, places or events
and would falsely appear to a person to be authentic, should disclose that the content has
been artificially created or manipulated by labelling the artificial intelligence output
accordingly and disclosing its artificial origin. The compliance with the information
obligations referred to above should not be interpreted as indicating that the use of thesystem 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 users of AI systems
laid down in Union or national law. Furthermore it should also not be interpreted asindicating that the use of the 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 of Funadamental
Rights of the EU, in particular where the content is part of an evidently creative, satirical,
artistic or fictional work or programme, subject to appropriate safeguards for the rights andfreedoms of third parties.

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(71)

Artificial intelligence is a rapidly developing family of technologies that requires novel
forms of regulatory oversight and a safe space for experimentation, while ensuring
responsible innovation and integration of appropriate safeguards and risk mitigation
measures. To ensure a legal framework that is innovation-friendly, future-proof and resilient
to disruption, national competent authorities from one or more Member States should be
encouraged to establish artificial intelligence regulatory sandboxes to facilitate thedevelopment and testing of innovative AI systems under strict regulatory oversight before
these systems are placed on the market or otherwise put into service.

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LIMITEEN(72)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 Member States legislation; to enhance legal
certainty for innovators and the competent authorities’ oversight and understanding of theopportunities, emerging risks and the impacts of AI use, and to accelerate access to markets,
including by removing barriers for small and medium enterprises (SMEs), including startups. 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 wellas the notion and occurrence of substantial modification that may require a new conformity
assessment procedure. Where appropriate, national competent authorities establishing AI
regulatory sandboxes should cooperate with other relevant authorities, including those
supervising the protection of fundamental rights, and could allow for the involvement ofother actors within the AI ecosystem such as national or European standardisation
organisations, notified bodies, testing and experimentation facilities, research andexperimentation labs, innovation hubs and relevant stakeholder and civil society
organisations. To ensure uniform implementation across the Union and economies of scale,
it is appropriate to establish common rules for the regulatory sandboxes’ implementation
and a framework for cooperation between the relevant authorities involved in the
supervision of the sandboxes. AI regulatory sandboxes established under this Regulation
should be without prejudice to other legislation allowing for the establishment of othersandboxes aiming at ensuring compliance with legislation other that this Regulation. Where
appropriate, relevant competent authorities in charge of those other regulatory sandboxes
should consider the benefits of using those sandboxes also for the purpose of ensuring
compliance of AI systems with this Regulation. Upon agreement between the national
competent authorities and the participants 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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(-72a) This Regulation should provide the legal basis for the participants in the AI regulatory
sandbox to use personal data collected for other purposes for developing certain AI systems
in the public interest within the AI regulatory sandbox, in line with Article 6(4) and 9(2)(g)of Regulation (EU) 2016/679, and Article 5 and 10 of Regulation (EU) 2018/1725, andwithout prejudice to Articles 4(2) and 10 of Directive (EU) 2016/680. All other obligationsof data controllers and rights of data subjects under Regulation (EU) 2016/679, Regulation(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)(b) of Regulation(EU) 2016/679 and Article 24(2)(b) of Regulation (EU) 2018/1725. Participants in the
sandbox should ensure appropriate safeguards and cooperate with the competent authorities,
including by following their guidance and acting expeditiously and in good faith to mitigate
any high-risks to safety and fundamental rights that may arise during the development andexperimentation in the sandbox. The conduct of the participants in the sandbox should betaken into account when competent authorities decide whether to impose an administrative
fine under Article 83(2) of Regulation 2016/679 and Article 57 of Directive 2016/680.
(72a) In order to accelerate the process of development and placing on the market of high-risk AI
systems listed in Annex III, it is important that providers or prospective 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 andtaking into account the possible consequences of such testing on individuals, it should beensured that appropriate and sufficient guarantees and conditions are introduced by theRegulation for providers or prospective providers. Such guarantees should include, among
others, requesting informed consent of natural persons to participate in testing in real world
conditions, with the exception of law enforcement in cases where the seeking of informed
consent would prevent the AI system from being tested. Consent of subjects to participate insuch 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 data protection law.

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(73)In order to promote and protect innovation, it is important that the interests of SME
providers and users of AI systems are taken into particular account. To this objective,
Member States should develop initiatives, which are targeted at those operators, including
on awareness raising and information communication. Moreover, the specific interests andneeds of SME providers shall be taken into account when notified bodies set conformity
assessment fees. Translation costs related to mandatory documentation and communication
with authorities may constitute a significant cost for providers and other operators, notably
those of a smaller scale. Member States should possibly ensure that one of the languages
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 users.

(73a) In order to promote and protect innovation, the AI-on demand platform, all relevant EU
funding programmes and projects, such as Digital Europe Programme, Horizon Europe,
implemented by the Commission and the Member States at national or EU level should
contribute to the achievement of the objectives of this Regulation.
(74)

In particular, in order to minimise the risks to implementation resulting from lack ofknowledge and expertise in the market as well as to facilitate compliance of providers,notably SMEs, and notified bodies with their obligations under this Regulation, the AI-on
demand platform, the European Digital Innovation Hubs and the Testing andExperimentation Facilities established by the Commission and the Member States at national
or EU level should possibly contribute to the implementation of this Regulation. Within
their respective mission and fields of competence, they may provide in particular technicaland scientific support to providers and notified bodies.

(74a) Moreover, in order to ensure proportionality considering the very small size of some
operators regarding costs of innovation, it is appropriate to exempt microenterprises fromthe most costly obligations, such as to establish a quality management system which would
reduce the administrative burden and the costs for those enterprises without affecting thelevel of protection and the need for compliance with the requirements for high-risk AI
systems.

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(75)It is appropriate that the Commission facilitates, to the extent possible, access to Testing andExperimentation 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 notably the case for expert panels, expert laboratories andreference laboratories in the field of medical devices pursuant to Regulation (EU) 2017/745
and Regulation (EU) 2017/746.

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(76)In order to facilitate a smooth, effective and harmonised implementation of this Regulation a
European Artificial Intelligence Board should be established. The Board should reflect thevarious interests of the AI eco-system and be composed of representatives of the Member
States. In order to ensure the involvement of relevant stakeholders, a standing subgroup of
the Board should be created. The Board should be responsible for a number of advisorytasks, including issuing opinions, recommendations, advice or contributing to guidance onmatters related to the implementation of this Regulation, including on enforcement matters,
technical specifications 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 artificial intelligence. In orderto give some flexibility to Member States in the designation of their representatives in the AI
Board, such representatives may be any persons belonging to public entities who shouldhave the relevant competences and powers to facilitate coordination at national level andcontribute to 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 andnotified bodies. The standing subgroup for market surveillance should act as the
Administrative Cooperation Group (ADCO) for this Regulation in the meaning of Article 30
of Regulation (EU) 2019/1020. In line with the role and tasks of the Commission pursuant to
Article 33 of Regulation (EU) 2019/1020, the Commission should support the activities ofthe standing subgroup for market surveillance by undertaking market evaluations or studies,notably with a view to identifying aspects of this Regulation requiring specific and urgent
coordination among market surveillance authorities. The Board may establish other standingor temporary sub-groups as appropriate for the purpose of examining specific issues. The
Board should also cooperate, as appropriate, with relevant EU bodies, experts groups andnetworks active in the context of relevant EU legislation, including in particular those active
under relevant EU regulation on data, digital products and services.

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(76a) The Commission should actively support the Member States and operators in theimplementation and enforcement of this Regulation. In this regard it should develop
guidelines on particular topics aiming at facilitating the application of this Regulation, while
paying particular attention to the needs of SMEs and start-us in sectors most likely to beaffected. In order to support adequate enforcement and the capacities of the Member States,
Union testing facilities on AI and a pool of relevant experts should be established and madeavailable to the Member States.
(77)

Member States hold a key role in the application and enforcement of this Regulation. In thisrespect, each Member State should designate one or more national competent authorities forthe 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
competent authorities within the meaning of this Regulation, in accordance with their
specific national organisational characteristics and needs.

(78)

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. This system is also key toensure 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 to report to therelevant authorities any serious incidents resulting from the use of their AI systems.

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

(79a) This Regulation is without prejudice to the competences, tasks, powers and independence of
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 specific safeguard
procedure should be set for ensuring adequate and timely enforcement against AI systems
presenting a risk to health, safety and fundamental rights. The procedure for such AI
systems presenting a risk should be applied to high-risk AI systems presenting a risk,
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 which havebeen made available in violation of the transparency requirements laid down in thisRegulation and present a risk.

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(80)Union legislation on financial services includes internal governance and risk management
rules and requirements which are applicable to regulated financial institutions in the courseof provision 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 legislation, the authorities
responsible for the supervision and enforcement of the financial services legislation should
be designated as competent authorities for the purpose of supervising the implementation ofthis 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 fulfill these market surveillance tasks. Those competentauthorities should have all powers under this Regulation and Regulation (EU) 2019/1020 on
market surveillance 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 legislation. 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 (SSM) established by Council
Regulation No 1024/2013, 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 the rules
applicable to credit institutions regulated under Directive 2013/36/EU of the European
Parliament and of the Council27, it is also appropriate to integrate some of the providers’procedural obligations in relation to risk management, post marketing monitoring anddocumentation 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 thequality management system of providers and the monitoring obligation placed on users ofhigh-risk AI systems to the extent 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/EU (Solvency II)

27

Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activityof 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).

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and the insurance intermediaries under Directive 2016/97/EU and other types of financial
institutions subject to requirements regarding internal governance, arrangements orprocesses established pursuant to the relevant Union financial services legislation to ensure
consistency and equal treatment in the financial sector.
(81)

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 trustworthy artificial
intelligence in the Union. Providers of non-high-risk AI systems should be encouraged tocreate codes of conduct intended to foster the voluntary application of the requirements
applicable to high-risk AI systems, adapted in light of the intended purpose of the systems
and the lower risk involved. Providers should also be encouraged to apply on a voluntarybasis additional requirements related, for example, to environmental sustainability,
accessibility to persons with disability, stakeholders’ participation in the design anddevelopment of AI systems, and diversity of the development teams. The Commission may
develop initiatives, including of a sectorial 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.

(82)

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 herein arenevertheless safe when placed on the market or put into service. To contribute to thisobjective, the Directive 2001/95/EC of the European Parliament and of the Council28 would
apply as a safety net.

(83)

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, in accordancewith Union or national law.

28

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general productsafety (OJ L 11, 15.1.2002, p. 4).

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(84)Member States should take all necessary measures to ensure that the provisions of thisRegulation are implemented, including by laying down effective, proportionate anddissuasive penalties for their infringement, and in respect of the ne bis in idem principle. For
certain specific infringements, Member States should take into account the margins andcriteria set out in this Regulation. The European Data Protection Supervisor should have thepower to impose fines on Union institutions, agencies and bodies falling within the scope of
this Regulation.

(85)

In order to ensure that the regulatory framework can be adapted where necessary, the power
to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission
to amend the Union harmonisation legislation listed in Annex II, the high-risk AI systems
listed in Annex III, the provisions regarding technical documentation listed in Annex IV, thecontent of the EU declaration of conformity in Annex V, the provisions regarding theconformity assessment procedures in Annex VI and VII and the provisions establishing thehigh-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. 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-Making29. 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 systematicallyhave access to meetings of Commission expert groups dealing with the preparation ofdelegated acts. Such consultations and advisory support should also be carried out in theframework of the activities of the AI Board and its subgroups.

29

OJ L 123, 12.5.2016, p. 1.

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(86)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 Parliament andof the Council30. It is of particular importance that, in accordance with the principles laid
down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, wheneverbroader expertise is needed in the early preparation of draft implementing acts, theCommission makes use of expert groups, consults targeted stakeholders or carries out public
consultations, as appropriate. Such consultations and advisory support should also be carriedout in the framework of the activities of the AI Board and its subgroups, including the
preparation of implementing acts in relation to Articles 4, 4b and 6.

(87)

Since the objective of this Regulation 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 Unionlevel, the Union may adopt measures in accordance with the principle of subsidiarity 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 to achieve that
objective.

(87a) 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, fromthat 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 as defined in this Regulation.

30

Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying
down the rules and general principles concerning mechanisms for control by the Member States of theCommission's exercise of implementing powers (OJ L 55, 28.2.2011, p.13).

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(88)This Regulation should apply from … [OP – please insert the date established in Art. 85].
However, the infrastructure related to the governance and the conformity assessment systemshould be operational before that date, therefore the provisions on notified bodies andgovernance structure should apply from … [OP – please insert the date – three months
following the entry into force of this Regulation]. 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 ofthis Regulation. Therefore the provisions on penalties should apply from [OP – please insert
the date – twelve months following the entry into force of this Regulation].

(89)

The European Data Protection Supervisor and the European Data Protection Board wereconsulted in accordance with Article 42(2) of Regulation (EU) 2018/1725 and delivered an
opinion on […]”.

HAVE ADOPTED THIS REGULATION:

TITLE I
GENERAL PROVISIONS

Article 1
Subject matter
This Regulation lays down:(a)harmonised rules for the placing on the market, the putting into service and the use of
artificial intelligence systems (‘AI systems’) in the Union;(a)prohibitions of certain artificial intelligence practices;(b)

specific requirements for high-risk AI systems and obligations for operators of such
systems;

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LIMITEEN(c)harmonised transparency rules for certain AI systems;(d)rules on market monitoring, market surveillance and governance;(e)measures in support of innovation.

Article 2
Scope
1.

This Regulation applies to:(a)providers placing on the market or putting into service AI systems in the Union,
irrespective of whether those providers are physically present or established within
the Union or in a third country;(b)users of AI systems who are physically present or established within the Union;(c)

providers and users of AI systems who are physically present or established in a third
country, where the output produced by the 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)

2.

authorised representatives of providers, which are established in the Union;

For AI systems classified as high-risk AI systems in accordance with Articles 6(1) and 6(2)related to products covered by Union harmonisation legislation listed in Annex II, section
B only Article 84 of this Regulation shall apply. Article 53 shall apply only insofar as therequirements for high-risk AI systems under this Regulation have been integrated underthat Union harmonisation legislation.

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3.

This Regulation shall not apply to AI systems if and insofar placed on the market, put into
service, or used with or without modification of such systems for the purpose of activities
which fall outside the scope of Union law, and in any event activities concerning military,defence or national security, regardless of the type of entity carrying out those activities.
In addition, this Regulation shall not apply to AI systems which are not placed on themarket or put into service in the Union, where the output is used in the Union for the
purpose of activities which fall outside the scope of Union law, and in any event activities
concerning military, defence or national security, regardless of the type of entity carryingout those activities.

4.

This Regulation shall not apply 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
agreements for law enforcement and judicial cooperation with the Union or with one ormore Member States.

5.

This Regulation shall not affect the application of the provisions on the liability ofintermediary service providers set out in Chapter II, Section 4 of Directive 2000/31/EC of
the European Parliament and of the Council31 [as to be replaced by the corresponding
provisions of the Digital Services Act].

6.

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

7.

This Regulation shall not apply to any research and development activity regarding AI
systems.

8.

This Regulation shall not apply to obligations of users who are natural persons using AI
systems in the course of a purely personal non-professional activity, except Article 52.

31

Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of
information society services, in particular electronic commerce, in the Internal Market ('Directive on electroniccommerce') (OJ L 178, 17.7.2000, p. 1).

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Article 3
Definitions
For the purpose of this Regulation, the following definitions apply:(1)‘artificial intelligence system’ (AI system) means a system that is designed to operate withelements of autonomy and that, based on machine and/or human-provided data and inputs,
infers how to achieve a given set of objectives using machine learning and/or logic- andknowledge based approaches, and produces system-generated outputs such as content(generative AI systems), predictions, recommendations or decisions, influencing theenvironments with which the AI system interacts;(1a)‘life cycle of an AI system’ means the duration of an AI system, from design throughretirement. Without prejudice to the powers of the market surveillance authorities, such
retirement may happen at any point in time during the post-market monitoring phase upon
the decision of the provider and implies that the system may not be used further. An AI
system lifecycle is also ended by a substantial modification to the AI system made by theprovider or any other natural or legal person, in which case the substantially modified AI
system shall be considered as a new AI system.

(1b)‘general purpose AI system’ means an AI system that - irrespective of how it is placed on
the market or put into service, including as open source software - is intended by theprovider to perform generally applicable functions such as image and speech recognition,
audio and video generation, pattern detection, question answering, translation and others; ageneral purpose AI system may be used in a plurality of contexts and be integrated in aplurality of other AI systems;(2)‘provider’ means a natural or legal person, public authority, agency or other body thatdevelops an AI system or that has an AI system developed and places that system on themarket or puts it into service under its own name or trademark, whether for payment or
free of charge;

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(3)[deleted];(3a)‘small and medium-sized enterprise’ (SMEs) means an enterprise as defined in the Annex
of Commission Recommendation 2003/361/EC concerning the definition of micro, small
and medium-sized enterprises;(4)‘user’ means any natural or legal person, including a public authority, agency or other
body, under whose authority the system is used;(5)‘authorised representative’ means any natural or legal person physically present or
established in the Union who has received and accepted a written mandate from a providerof an AI system to, respectively, perform and carry out on its behalf the obligations andprocedures established by this Regulation;(5a)‘product manufacturer’ means a manufacturer within the meaning of any of the Union
harmonisation legislation listed in Annex II;(6)‘importer’ means any natural or legal person physically present or established in the Union
that places on the market an AI system that bears the name or trademark of a natural or
legal person established outside the Union;(7)‘distributor’ means any natural or legal person in the supply chain, other than the provider
or the importer, that makes an AI system available on the Union market;(8)‘operator’ means the provider, the product manufacturer, the user, the authorised
representative, the importer or the distributor;(9)‘placing on the market’ means the first making available of an AI system on the Union
market;(10)‘making available on the market’ means any supply of an AI system for distribution or useon the Union market in the course of a commercial activity, whether in return for payment
or free of charge;

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LIMITEEN(11)‘putting into service’ means the supply of an AI system for first use directly to the user orfor 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;(14)‘safety component of a product or system’ means a component of a product or of a system
which fulfils a safety function for that product or 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 the user ofin particular an AI system’s intended purpose and proper use;

(16)

‘recall of an AI system’ means any measure aimed at achieving the return to the provider
or taking it out of service or disabling the use of an AI system made available to users;(17)‘withdrawal of an AI system’ means any measure aimed at preventing 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)‘conformity assessment’ means the process of verifying whether the requirements set out
in Title III, Chapter 2 of this Regulation relating to a high-risk AI system have been
fulfilled;

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LIMITEEN(20)‘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;(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 designated in accordance with thisRegulation and other relevant Union harmonisation legislation;(23)‘substantial modification’ means a change to the AI system following its placing on themarket or putting into service which affects the compliance of the AI system with therequirements set out in Title III, Chapter 2 of this Regulation, or a modification to theintended purpose for which the AI system has been assessed. For high-risk AI systems that
continue to learn after being placed on the market or put into service, changes to the highrisk AI system and its performance that have been pre-determined by the provider at the
moment of the initial conformity assessment and are part of the information contained in
the technical documentation referred to in point 2(f) of Annex IV, shall not constitute a
substantial modification.

(24)‘CE marking of conformity’ (CE marking) means a marking by which a provider indicatesthat an AI system is in conformity with the requirements set out in Title III, Chapter 2 or in
Article 4b of this Regulation and other applicable Union legal act harmonising theconditions for the marketing of products (‘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;

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LIMITEEN(27)‘harmonised standard’ means a European standard as defined in Article 2(1)(c) ofRegulation (EU) No 1025/2012;(28)‘common specification’ means a set of technical specifications, as defined in point 4 of
Article 2 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, among other things, inorder to prevent overfitting; whereas the validation dataset can be a separate dataset or partof the training dataset, either as a fixed or variable split;(31)‘testing data’ means data used for providing an independent evaluation of the trained andvalidated AI system in order to confirm the expected performance of that system before its
placing on the market or putting into service;(32)‘input data’ means data provided to or directly acquired by an AI system on the basis ofwhich the system produces an output;(33)‘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;(34)‘emotion recognition system’ means an AI system for the purpose of identifying or
inferring psychological states, emotions or intentions of natural persons on the basis of
their biometric data;(35)‘biometric categorisation system’ means an AI system for the purpose of assigning natural
persons to specific categories on the basis of their biometric data;

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LIMITEEN(36)‘remote biometric identification system’ means an AI system for the purpose of identifying
natural persons typically at a distance, without their active involvement, through thecomparison of a person’s biometric data with the biometric data contained in a reference
data repository;(37)‘‘real-time’ remote biometric identification system’ means a remote biometricidentification system whereby the capturing of biometric data, the comparison and theidentification all occur instantaneously or near instantaneously;(38)[deleted](39)‘publicly accessible space’ means any publicly or privately owned physical place
accessible to an undetermined number of natural persons regardless of whether certain
conditions or circumstances for access have been predetermined, and regardless of thepotential capacity restrictions;(40)‘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;(41)‘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 the safeguarding against and the prevention of
threats to public security;(42)[deleted]

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LIMITEEN(43)‘national competent authority’ means any of the following: the notifying authority and themarket surveillance authority. As regards AI systems put into service or used by EU
institutions, agencies, offices and bodies, the European Data Protection Supervisor shallfulfil the responsibilities that in the Member States are entrusted to the national competentauthority and, as relevant, any reference to national competent authorities or market
surveillance authorities in this Regulation shall be understood as referring to the European
Data Protection Supervisor;(44)‘serious incident’ means any 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 damage to a person’s health;(b)a serious and irreversible disruption of the management and operation of criticalinfrastructure;

(45)

(c)

breach of obligations under Union law intended to protect fundamental rights;(d)serious damage to property or the environment.

‘critical infrastructure’ means an asset, system or part thereof which is necessary for thedelivery of a service that is essential for the maintenance of vital societal functions or
economic activities within the meaning of Article 2(4) and (5) of Directive …../….. on theresilience of critical entities;(46)‘personal data’ means data as defined in point (1) of Article 4 of Regulation (EU)2016/679;(47)‘non-personal data’ means data other than personal data as defined in point (1) of Article 4
of Regulation (EU) 2016/679;

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LIMITEEN(48)‘testing in real world conditions’ means the temporary testing of an AI system for its
intended purpose in real world conditions outside of 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; testingin real world conditions shall not be considered as placing the AI system on the market or
putting it into service within the meaning of this Regulation, provided that all conditions
under Article 53 or Article 54a are fulfilled;(49)‘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;(50)‘subject’ for the purpose of real world testing means a natural person who participates intesting in real world conditions;(51)‘informed consent’ means a subject's free 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 the subject's decision toparticipate; in the case of minors and of incapacitated subjects, the informed consent shallbe given by their legally designated representative;(52)‘AI regulatory sandbox’ means a concrete framework set up by a national competentauthority which offers providers or prospective providers of AI systems the possibility todevelop, train, validate and test, where appropriate in real world conditions, an innovative
AI system, pursuant to a specific plan for a limited time under regulatory supervision.

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Article 4
Implementing acts
In order to ensure uniform conditions for the implementation of this Regulation as regards machinelearning approaches and logic- and knowledged based approaches referred to in Article 3(1), theCommission may adopt implementing acts to specify the technical elements of those approaches,taking into account market and technological developments. Those implementing acts shall be
adopted in accordance with the examination procedure referred to in Article 74(2).

TITLE IAGENERAL PURPOSE AI SYSTEMS

Article 4aCompliance of general purpose AI systems with this Regulation
1.

Without prejudice to Articles 5, 52, 53 and 69 of this Regulation, general purpose AI
systems shall only comply with the requirements and obligations set out in Article 4b.

2.

Such requirements and obligations shall apply irrespective of whether the general
purpose AI system is placed on the market or put into service as a pre-trained modeland whether further fine-tuning of the model is to be performed by the user of thegeneral purpose AI system.

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Article 4b
Requirements for general purpose AI systems and obligations for providers of such
systems
1.

General purpose AI systems which may be used as high risk AI systems or ascomponents of high risk AI systems in the meaning of Article 6, shall comply with therequirements established in Title III, Chapter 2 of this Regulation as from the date ofapplication of the implementing acts adopted by the Commission in accordance withthe examination procedure referred to in Article 74(2) no later than 18 months after theentry into force of this Regulation. Those implementing acts shall specify and adapt theapplication of the requirements established in Title III, Chapter 2 to general purpose AI
systems in the light of their characteristics, technical feasibility, specificities of the AI
value chain and of market and technological developments. When fulfilling thoserequirements, the generally acknowledged state of the art shall be taken into account.

2.

Providers of general purpose AI systems referred to in paragraph 1 shall comply, as
from the date of application of the implementing acts referred to in paragraph 1, withthe obligations set out in Articles 16aa, 16e, 16f, 16g, 16i, 16j, 25, 48 and 61.

3.

For the purpose of complying with the obligations set out in Article 16e, providers
shall follow the conformity assessment procedure based on internal control set out inAnnex VI, points 3 and 4.

4.

Providers of such systems shall also keep the technical documentation referred to in
Article 11 at the disposal of the national competent authorities for a period ending ten
years after the general purpose AI system is placed on the Union market or put into
service in the Union.

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5.

Providers of general purpose AI systems shall cooperate with and provide thenecessary information to other providers intending to put into service or place such
systems on the Union market as high-risk AI systems or as components of high-risk AI
systems, with a view to enabling the latter to comply with their obligations under thisRegulation. Such cooperation between providers shall preserve, as appropriate,
intellectual property rights, and confidential business information or trade secrets inaccordance with Article 70. In order to ensure uniform conditions for the
implementation of this Regulation as regards the information to be shared by theproviders of general purpose AI systems, the Commission may adopt implementing
acts in accordance with the examination procedure referred to in Article 74(2).

6.

In complying with the requirements and obligations referred to in paragraphs 1, 2 and3:- any reference to the intended purpose shall be understood as referring to possible useof the general purpose AI systems as high risk AI systems or as components of AI highrisk systems in the meaning of Article 6;- any reference to the requirements for high-risk AI systems in Chapter II, Title III shallbe understood as referring only to the requirements set out in the present Article.

Article 4c
Exceptions to Article 4b
1.

Article 4b shall not apply when the provider has explicitly excluded all high-risk usesin the instructions of use or information accompanying the general purpose AI system.

2.

Such exclusion shall be made in good faith and shall not be deemed justified if theprovider has sufficient reasons to consider that the system may be misused.

3.

When the provider detects or is informed about market misuse they shall take allnecessary and proportionate measures to prevent such further misuse, in particulartaking into account the scale of the misuse and the seriousness of the associated risks.

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TITLE II
PROHIBITED ARTIFICIAL INTELLIGENCE PRACTICESArticle 5
1.

The following artificial intelligence practices shall be prohibited:(a)the placing on the market, putting into service or use of an AI system that deploys
subliminal techniques beyond a person’s consciousness with the objective to or theeffect of materially distorting a person’s behaviour in a manner that causes or isreasonably likely to cause that person or another person physical or psychological
harm;

(b)

the placing on the market, putting into service or use of an AI system that exploits
any of the vulnerabilities of a specific group of persons due to their age, disability ora specific social or economic situation, with the objective to or the effect ofmaterially distorting the behaviour of a person pertaining to that group in a mannerthat causes or is reasonably likely to cause that person or another person physical or
psychological harm;(c)the placing on the market, putting into service or use of AI systems for the evaluation
or classification of natural persons over a certain period of time based on their social
behaviour or known or predicted personal or personality characteristics, with thesocial score leading to either or both of the following:(i)

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

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(ii)detrimental or unfavourable treatment of certain natural persons or groups
thereof that is unjustified or disproportionate to their social behaviour or its
gravity;(d)the use of ‘real-time’ remote biometric identification systems in publicly accessible
spaces by law enforcement authorities or on their behalf for the purpose of law
enforcement, unless and in as far as such use is strictly necessary for one of thefollowing objectives:(i)the targeted search for specific potential victims of crime;(ii)

the prevention of a specific and substantial threat to the critical infrastructure,
life, health or physical safety of natural persons or the prevention of terrorist
attacks;(iii) the localisation or identification of a natural person for the purposes ofconducting a criminal investigation, prosecution or executing a criminal
penalty for offences, referred to in Article 2(2) of Council Framework Decision
2002/584/JHA32 and punishable in the Member State concerned by a custodial
sentence or a detention order for a maximum period of at least three years, orother specific offences punishable in the Member State concerned by acustodial sentence or a detention order for a maximum period of at least five
years, as determined by the law of that Member State.
2.

The use of ‘real-time’ remote biometric identification systems in publicly accessible spaces
for the purpose of law enforcement for any of the objectives referred to in paragraph 1
point d) shall take into account the following elements:(a)the nature of the situation giving rise to the possible use, in particular the seriousness,probability and scale of the harm caused in the absence of the use of the system;

32

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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LIMITEEN(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.

In addition, the use of ‘real-time’ remote biometric identification systems in publicly
accessible spaces for the purpose of law enforcement for any of the objectives referred toin paragraph 1 point d) shall comply with necessary and proportionate safeguards andconditions in relation to the use, in particular as regards the temporal, geographic andpersonal limitations.
3.

As regards paragraphs 1, point (d) and 2, each use for the purpose of law enforcement of a‘real-time’ remote biometric identification system in publicly accessible spaces shall be
subject to a prior authorisation granted by a judicial authority or by an independentadministrative authority of the Member State in which the use is to take place, issued upona reasoned request and in accordance with the detailed rules of national law referred to inparagraph 4. However, in a duly justified situation of urgency, the use of the system may
be commenced without an authorisation provided that, such authorisation shall be
requested without undue delay during use of the AI system, and if such authorisation isrejected, its use shall be stopped with immediate effect.
The competent judicial or administrative authority shall only grant the authorisation where
it is satisfied, based on objective evidence or clear indications presented to it, that the useof the ‘real-time’ remote biometric identification system at issue is necessary for andproportionate to achieving one of the objectives specified in paragraph 1, point (d), as
identified in the request. In deciding on the request, the competent judicial oradministrative authority shall take into account the elements referred to in paragraph 2.

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LIMITEEN4.

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 purpose of law enforcement within the limits and under the conditions listed inparagraphs 1, point (d), 2 and 3. That Member State shall lay down in its national law thenecessary detailed rules for the request, issuance and exercise of, as well as supervisionand reporting relating to, the authorisations referred to in paragraph 3. Those rules shallalso specify in respect of which of the objectives listed in paragraph 1, point (d), includingwhich of the criminal offences referred to in point (iii) thereof, the competent authorities
may be authorised to use those systems for the purpose of law enforcement.

TITLE IIIHIGH-RISK AI SYSTEMSCHAPTER 1
CLASSIFICATION OF AI SYSTEMS AS HIGH-RISK

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

An AI system that is itself a product covered by the Union harmonisation legislation listed
in Annex II shall be considered as high risk if it is required to undergo a third-party
conformity assessment with a view to the placing on the market or putting into service ofthat product pursuant to the above mentioned legislation.

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2.

An AI system intended to be used as a safety component of a product covered by thelegislation referred to in paragraph 1 shall be considered as high risk if it is required toundergo a third-party conformity assessment with a view to the placing on the market or
putting into service of that product pursuant to above mentioned legislation. This provision
shall apply irrespective of whether the AI system is placed on the market or put into
service independently from the product.

3.

AI systems referred to in Annex III shall be considered high-risk unless the output of thesystem is purely accessory in respect of the relevant action or decision to be taken and is
not therefore likely to lead to a significant risk to the health, safety or fundamental rights.
In order to ensure uniform conditions for the implementation of this Regulation, theCommission shall, no later than one year after the entry into force of this Regulation, adopt
implementing acts to specify the circumstances where the output of AI systems referred toin Annex III would be purely accessory in respect of the relevant action or decision to betaken. Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 74, paragraph 2.

Article 7
Amendments to Annex III
1.

The Commission is empowered to adopt delegated acts in accordance with Article 73 toamend the list in Annex III by adding 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 points 1 to 8 ofAnnex III;(b)

the AI systems pose a risk of harm to the health and safety, or a risk of adverse
impact on fundamental rights, that is, in respect of its severity and probability ofoccurrence, equivalent to or greater than the risk of harm or of adverse impact posedby the high-risk AI systems already referred to in Annex III.

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2.

When assessing for the purposes of paragraph 1 whether an AI system poses a risk of harmto the health and safety or a risk of adverse impact on fundamental rights that is equivalent
to or greater than the risk of harm posed by the high-risk AI systems already referred to in
Annex III, 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 extent to which the use of an AI system has already caused harm to the health andsafety or adverse impact on the fundamental rights or has given rise to significant
concerns in relation to the materialisation of such harm or adverse impact, as
demonstrated by reports or documented allegations submitted to national competentauthorities;(d)the potential extent of such harm or such adverse impact, in particular in terms of its
intensity and its ability to affect a plurality of persons;(e)the extent to which potentially harmed or adversely impacted persons are dependent
on the outcome produced with an AI system, in particular because for practical or
legal reasons it is not reasonably possible to opt-out from that outcome;(f)the extent to which potentially harmed or adversely impacted persons are in avulnerable position in relation to the user of an AI system, in particular due to an
imbalance of power, knowledge, economic or social circumstances, or age;(g)

the extent to which the outcome produced with an AI system is not easily reversible,
whereby outcomes having an impact on the health or safety of persons shall not be
considered as easily reversible;

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LIMITEEN(h)the extent to which existing Union legislation 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)
(i)

effective measures to prevent or substantially minimise those risks;

the magnitude and likelihood of benefit of the AI use for individuals, groups, or
society at large.

3.

The Commission is empowered to adopt delegated acts in accordance with Article 73 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(s) concerned no longer pose 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.

CHAPTER 2
REQUIREMENTS FOR HIGH-RISK AI SYSTEMS

Article 8Compliance with the requirements
1.

High-risk AI systems shall comply with the requirements established in this Chapter,taking into account the generally acknowledged state of the art.

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The intended purpose of the high-risk AI system and the risk management system referred
to in Article 9 shall be taken into account when ensuring compliance with thoserequirements.

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 updating. It shall comprise the following steps:(a)identification and analysis of the known and foreseeable risks most likely to occur tohealth, safety and fundamental rights in view of the intended purpose of the high-risk
AI system;(b)[deleted];(c)evaluation of other possibly arising risks based on the analysis of data gathered fromthe post-market monitoring system referred to in Article 61;(d)adoption of suitable risk management measures in accordance with the provisions of
the following paragraphs.

The risks referred to in this paragraph 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.

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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 Chapter 2, with a view to minimising risks
more effectively while achieving an appropriate balance in implementing the measures tofulfil those requirements.

4.

The risk management measures referred to in paragraph 2, point (d) shall be such that any
residual risk associated with each hazard as well as the overall residual risk of the high-risk
AI systems is judged acceptable.
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 as
far as possible through adequate design and development of the high risk AI system;(b)where appropriate, implementation of adequate mitigation and control measures inrelation to risks that cannot be eliminated;(c)provision of adequate information pursuant to Article 13, in particular as regards therisks referred to in paragraph 2, point (b) of this Article, and, where appropriate,
training to users.

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,
training to be expected by the user and the environment in which the system is intended to
be used.
5.

High-risk AI systems shall be tested in order to ensure that high-risk AI systems perform ina manner that is consistent with their intended purpose and they are in compliance with therequirements set out in this Chapter.

6.

Testing procedures may include testing in real world conditions in accordance with Article
54a.

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The testing of the high-risk AI systems shall be performed, as appropriate, at any point intime throughout the development process, and, in any event, prior to the placing on themarket or the putting into service. Testing shall be made against preliminarily defined
metrics and probabilistic thresholds that are appropriate to the intended purpose of thehigh-risk AI system.

8.

The risk management system described in paragraphs 1 to 7 shall give specificconsideration to whether the high-risk AI system is likely to be accessed by or have an
impact on persons under the age of 18.

9.

For providers of high-risk AI systems that are subject to requirements regarding internalrisk management processes under relevant sectorial Union law, the aspects described inparagraphs 1 to 8 may be part of the risk management procedures established pursuant tothat law.

Article 10
Data and data governance1.

High-risk AI systems which make use of techniques involving the training of models withdata shall be developed on the basis of training, validation and testing data sets that meetthe quality criteria referred to in paragraphs 2 to 5.

2.

Training, validation and testing data sets shall be subject to appropriate data governanceand management practices. Those practices shall concern in particular,(a)the relevant design choices;(b)data collection processes;(c)relevant data preparation processing operations, such as annotation, labelling,cleaning, enrichment and aggregation;

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LIMITEEN(d)the formulation of relevant assumptions, notably with respect to the information thatthe data are supposed to measure and represent;(e)a prior 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 health and safety ofnatural persons or lead to discrimination prohibited by Union law;(g)

the identification of any possible data gaps or shortcomings, and how those gaps andshortcomings can be addressed.

3.

Training, validation and testing data sets shall be relevant, representative, and to the best
extent possible, free of errors and complete. They shall have the appropriate statisticalproperties, including, where applicable, as regards the persons or groups of persons on
which the high-risk AI system is intended to be used. These characteristics of the data sets
may be met at the level of individual data sets or a combination thereof.

4.

Training, validation and testing data sets shall take into account, to the extent required by
the intended purpose, the characteristics or elements that are particular to the specificgeographical, behavioural or functional setting within which the high-risk AI system isintended to be used.

5.

To the extent that it is strictly necessary for the purposes of ensuring bias monitoring,detection and correction in relation to the high-risk AI systems, the providers of such
systems may process special categories of personal data referred to in Article 9(1) ofRegulation (EU) 2016/679, Article 10 of Directive (EU) 2016/680 and Article 10(1) ofRegulation (EU) 2018/1725, subject to appropriate safeguards for the fundamental rights
and freedoms of natural persons, including technical limitations on the re-use and use ofstate-of-the-art security and privacy-preserving measures, such as pseudonymisation, or
encryption where anonymisation may significantly affect the purpose pursued.

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

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 to demonstrate that the highrisk AI system complies with the requirements set out in this Chapter and provide national
competent authorities and notified bodies with all the necessary information in a clear andcomprehensive form to assess the compliance of the AI system with those requirements. It
shall contain, at a minimum, the elements set out in Annex IV or, in the case of SMEs,
including start-ups, any equivalent documentation meeting the same objectives, unlessdeemed inappropriate by the competent authority.

2.

Where a high-risk AI system related to a product, to which the legal acts listed in Annex II,
section A apply, is placed on the market or put into service one single technicaldocumentation shall be drawn up containing all the information set out in Annex IV aswell as the information required under those legal acts.

3.

The Commission is empowered to adopt delegated acts in accordance with Article 73 toamend Annex IV where necessary to ensure that, in the light of technical progress, thetechnical documentation provides all the necessary information to assess the compliance ofthe system with the requirements set out in this Chapter.

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Article 12
Record-keeping
1.

High-risk AI systems shall technically allow for the automatic recording of events (‘logs’)
over the duration of the life cycle of the system.

2.

In order to ensure a level of traceability of the AI system’s functioning that is appropriate
to the intended purpose of the system, logging capabilities shall enable the recording of
events relevant for(i) identification of situations that may result in the AI system presenting a risk within themeaning of Article 65(1) or in a substantial modification;(ii) facilitation of the post-market monitoring referred to in Article 61; and(iii) monitoring of the operation of high-risk AI systems referred to in Article 29(4).

4.

For high-risk AI systems referred to in paragraph 1, point (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);(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).

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Article 13
Transparency and provision of information to users
1.

High-risk AI systems shall be designed and developed in such a way to ensure that theiroperation is sufficiently transparent with a view to achieving compliance with the relevant
obligations of the user and of the provider set out in Chapter 3 of this Title and enablingusers to understand and use the system appropriately.

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 users.

3.

The information referred to in paragraph 2 shall specify:(a)the identity and the contact details of the provider and, where applicable, of its
authorised representative;(b)

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

its intended purpose, inclusive of the specific geographical, behavioural orfunctional setting within which the high-risk AI system is intended to be used;(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, which may lead to risks to thehealth and safety or fundamental rights referred to in Aricle 9(2);14954/22
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(iv) when appropriate, its behaviour regarding specific persons or groups of persons
on which the system is intended to be used;(v)

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 AI system;(vi) when appropriate, description of the expected output of the system.
(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 AI systems by
the users;(e)the computational and hardware resources needed, the expected lifetime of the highrisk AI system and any necessary maintenance and care measures, including theirfrequency, to ensure the proper functioning of that AI system, including as regards
software updates;(f)a description of the mechanism included within the AI system that allows users toproperly collect, store and interpret the logs, where relevant.

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 the AI system is in use.

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Human oversight shall aim at preventing or minimising 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 particularwhen such risks persist notwithstanding the application of other requirements set out in this
Chapter.

3.

Human oversight shall be ensured through either one or all of the following types ofmeasures:(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
user.

4.

For the purpose of implementing paragraphs 1 to 3, the high-risk AI system shall be
provided to the user in such a way that natural persons to whom human oversight is
assigned are enabled, as appropriate and proportionate to the circumstances:(a)to understand the capacities and limitations of the high-risk AI system and be able toduly monitor its operation;(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’);(c)

to correctly interpret the high-risk AI system’s output, taking into account for
example the interpretation tools and methods available;(d)to decide, in any particular situation, not to use the high-risk AI system or otherwise
disregard, override or reverse the output of the high-risk AI system;(e)

to intervene on the operation of the high-risk AI system or interrupt the systemthrough a “stop” button or a similar procedure.

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For high-risk AI systems referred to in point 1(a) of Annex III, the measures referred to inparagraph 3 shall be such as to ensure that, in addition, no action or decision is taken by theuser on the basis of the identification resulting from the system unless this has been
separately verified and confirmed by at least two natural persons. The requirement for aseparate verification by at least two natural persons shall not apply to high risk AI systems
used for the purpose of law enforcement, migration, border control or asylum, in cases
where Union or national law considers the application of this requirement to bedisproportionate.

Article 15
Accuracy, robustness and cybersecurity
1.

High-risk AI systems shall be designed and developed in such a way that they achieve, inthe light of their intended purpose, an appropriate level of accuracy, robustness andcybersecurity, and perform consistently in those respects throughout their lifecycle.

2.

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

3.

High-risk AI systems shall be resilient as regards errors, faults or inconsistencies 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.
The robustness of high-risk AI systems may be achieved through technical redundancy
solutions, which may include backup or fail-safe plans.
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 to eliminate or reduce as far as possible the risk ofpossibly biased outputs influencing input for future operations (‘feedback loops’) are duly
addressed with appropriate mitigation measures.

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4.

High-risk AI systems shall be resilient as regards attempts by unauthorised third parties toalter their use or performance by exploiting the system vulnerabilities.
The technical solutions aimed at ensuring the cybersecurity of high-risk AI systems shallbe appropriate to the relevant circumstances and the risks.
The technical solutions to address AI specific vulnerabilities shall include, whereappropriate, measures to prevent and control for attacks trying to manipulate the training
dataset (‘data poisoning’), inputs designed to cause the model to make a mistake(‘adversarial examples’), or model flaws.

CHAPTER 3
OBLIGATIONS OF PROVIDERS AND USERS OF HIGH-RISK AI SYSTEMS AND
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
Chapter 2 of this Title;(aa)

indicate their name, registered trade name or registered trade mark, the address at which
they can be contacted on the high-risk AI system or, where that is not possible, on its
packaging or its accompanying documentation, as applicable;(b)have a quality management system in place which complies with Article 17;(c)keep the documentation referred to in Article 18;14954/22
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LIMITEEN(d)when under their control, keep the logs automatically generated by their high-risk AI
systems as referred to in Article 20;(e)ensure that the high-risk AI system undergoes the relevant conformity assessment
procedure as referred to in Article 43, prior to its placing on the market or putting into
service;(f)comply with the registration obligations referred to in Article 51(1);(g)

take the necessary corrective actions as referred to in Article 21, if the high-risk AI system
is not in conformity with the requirements set out in Chapter 2 of this Title;(h)inform the relevant national competent authority of the Member States in which they madethe AI system available or put it into service and, where applicable, the notified body of the
non-compliance and of any corrective actions taken;(i)to affix the CE marking to their high-risk AI systems to indicate the conformity with thisRegulation in accordance with Article 49;(j)upon request of a national competent authority, demonstrate the conformity of the highrisk AI system with the requirements set out in Chapter 2 of this Title.

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, the means to be used to ensure that thehigh-risk AI system complies with the requirements set out in Chapter 2 of this Title;(f)systems and procedures for data management, including data collection, 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 andfor the purposes of the placing on the market or 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 61;(i)procedures related to the reporting of a serious incident in accordance with Article
62;

(j)

the handling of communication with national competent authorities, competentauthorities, including sectoral ones, 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;

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LIMITEEN(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 aspects listed in this paragraph.
2.

The implementation of aspects referred to in paragraph 1 shall be proportionate to the sizeof the provider’s organisation.

2a.

For providers of high-risk AI systems that are subject to obligations regarding quality
management systems under relevant sectorial Union law, the aspects described inparagraph 1 may be part of the quality management systems pursuant to that law.

3.

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

Article 18
Documentation keeping
1.

The provider shall, for a period ending 10 years after the AI system has been placed on themarket or put into service, keep at the disposal of the national competent authorities:(a)the technical documentation referred to in Article 11;(b)

the documentation concerning the quality management system referred to in
Article 17;(c)the documentation concerning the changes approved by notified bodies whereapplicable;

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1a.

(d)

the decisions and other documents issued by the notified bodies where applicable;(e)the EU declaration of conformity referred to in Article 48.

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.

2.

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

Article 19
Conformity assessment
1.

Providers of high-risk AI systems shall ensure that their systems undergo the relevant
conformity assessment procedure in accordance with Article 43, prior to their placing on
the market or putting into service. Where the compliance of the AI systems with therequirements set out in Chapter 2 of this Title has been demonstrated following that
conformity assessment, the providers shall draw up an EU declaration of conformity inaccordance with Article 48 and affix the CE marking of conformity in accordance with
Article 49.

2.

[deleted]

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Article 20
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 by virtue of a contractual arrangement with the user or otherwise by law. They
shall keep them for a period of at least six months, unless provided otherwise in applicable
Union or national law, in particular in Union 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 legislation shallmaintain the logs automatically generated by their high-risk AI systems as part of the
documentation kept under the relevant financial service legislation.

Article 21
Corrective actions
Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI
system which they have placed on the market or put into service is not in conformity with thisRegulation shall immediately investigate, where applicable, the causes in collaboration with thereporting user and take the necessary corrective actions to bring that system into conformity, towithdraw it or to recall it, as appropriate. They shall inform the distributors of the high-risk AI
system in question and, where applicable, the authorised representative and importers accordingly.

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Article 22
Duty of information
Where the high-risk AI system presents a risk within the meaning of Article 65(1) and that risk is
known to the provider of the system, that provider shall immediately inform the national competentauthorities of the Member States in which it made the system available and, where applicable, thenotified body that issued a certificate for the high-risk AI system, in particular of the noncompliance and of any corrective actions taken.

Article 23
Cooperation with competent authorities
Providers of high-risk AI systems shall, upon request by a national competent authority, providethat authority with all the information and documentation necessary to demonstrate the conformityof the high-risk AI system with the requirements set out in Chapter 2 of this Title, in a language
which can be easily understood by the authority of the Member State concerned. Upon a reasoned
request from a national competent authority, providers shall also give that authority access to thelogs, referred to in Article 12(1), automatically generated by the high-risk AI system, to the extent
such logs are under their control by virtue of a contractual arrangement with the user or otherwise
by law.

Article 23a
Conditions for other persons to be subject to the obligations of a provider
1.

Any natural or legal person shall be considered a provider of a new high-risk AI system forthe 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 allocated otherwise;

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(b)[deleted](c)they make a substantial modification to a high-risk AI system already placed on themarket or put into service;(d)they modify the intended purpose of an AI system which is not high-risk and isalready placed on the market or put ito service, in a way which makes the modified
system a high-risk AI system;(e)they place on the market or put into service a general purpose AI system as a highrisk AI system or as a component of a high-risk AI system.

2.

Where the circumstances referred to in paragraph 1, point (a) or (c), occur, the provider that
initially placed the high-risk AI system on the market or put it into service shall no longer beconsidered a provider for the purposes of this Regulation.

3.

For high-risk AI systems that are safety components of products to which the legal acts listed
in Annex II, section A apply, the manufacturer of those products shall be considered theprovider of the high-risk AI system and shall be subject to the obligations under Article 16
under either of the following scenarios:(i)the high-risk AI system is placed on the market together with the product under thename or trademark of the product manufacturer;(ii)

the high-risk AI system is put into service under the the name or trademark of the
product manufacturer after the product has been placed on the market.

Article 24[deleted]

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Article 25
Authorised representatives
1.

Prior to making their systems available on the Union market providers established outside
the Union shall, by written mandate, appoint an authorised representative which isestablished in the Union.

2.

The authorised representative shall perform the tasks specified in the mandate received
from the provider. For the purpose of this Regulation, the mandate shall empower theauthorised representative to carry out only the following tasks:(-a) verify that the EU declaration of conformity and the technical documentation havebeen drawn up and that an appropriate conformity

assessment procedure has

been carried out by the provider;(a)keep at the disposal of the national competent authorities and national authorities
referred to in Article 63(7), for a period ending 10 years after the high-risk AI system
has been placed on the market or put into service, the contact details of the provider
by which the authorised representative has been appointed, a copy of the EU
declaration of conformity, the technical documentation and, if applicable, thecertificate issued by the notified body;(b)provide a national competent authority, upon a reasoned request, with all theinformation and documentation, including that kept according to point (b), necessary
to demonstrate the conformity of a high-risk AI system with the requirements set out
in Chapter 2 of this Title, including access to the logs, 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 by virtue of a contractual arrangement with the user orotherwise by law;(c)cooperate with national competent authorities, upon a reasoned request, on any
action the latter takes in relation to the high-risk AI system.

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information referred to in Annex VIII, Part II, 1 to 11, is correct.

The authorised representative shall terminate the mandate if it has sufficient reasons to consider thatthe provider acts contrary to its obligations under this Regulation. In such a case, it shall also
immediately inform the market surveillance authority of the Member State in which it isestablished, as well as, where applicable, the relevant notified body, about the termination of themandate and the reasons thereof.
The authorised representative shall be legally liable for defective AI systems on the same basis as,
and jointly and severally with, the provider in respect of its potential liability under Council
Directive 85/374/EEC.

Article 26
Obligations of importers
1.

Before placing a high-risk AI system on the market, importers of such system shall ensurethat such a 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 that AI system;(b)

the provider has drawn up the technical documentation in accordance with Annex
IV;

(c)

the system bears the required CE conformity marking and is accompanied by the EU
declaration of conformity and instructions of use;(d)the authorised representative referred to in Article 25 has been established by theprovider.

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Where an importer has sufficient reasons 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 that system on the market until that AI system has beenbrought into conformity. Where the high-risk AI system presents a risk within the meaningof Article 65(1), the importer shall inform the provider of the AI system, the authorised
representatives 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 or, where that is notpossible, on its packaging or its accompanying documentation, as applicable.

4.

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

4a.

Importers shall keep, for a period ending 10 years after the AI system has been placed on
the market or put into service, a copy of the certificate issued by the notified body, whereapplicable, of the instructions for use and of the EU declaration of conformity.

5.

Importers shall provide national competent authorities, upon a reasoned request, with allnecessary information and documentation, including that kept in accordance withparagraph 5, to demonstrate the conformity of a high-risk AI system with the requirements
set out in Chapter 2 of this Title in a language which can be easily understood by thatnational competent authority. To this purpose they shall also ensure that the technicaldocumentation can be made available to those authorities.

5a.

Importers shall cooperate with national competent authorities on any action thoseauthorities take in relation to an AI system, of which they are the importer.

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Article 27
Obligations of distributors
1.

Before making a high-risk AI system available on the market, distributors shall verify thatthe high-risk AI system bears the required CE conformity marking, that it is accompanied
by a copy of EU declaration of conformity and instruction of use, and that the provider andthe importer of the system, as applicable, have complied with their obligations set out
Article 16, point (b) and 26(3) respectively.

2.

Where a distributor considers or has reason to consider that a high-risk AI system is not in
conformity with the requirements set out in Chapter 2 of this Title, it shall not make thehigh-risk AI system available on the market until that system has been brought into
conformity with those requirements. Furthermore, where the system presents a risk within
the meaning of Article 65(1), the distributor shall inform the provider or the importer of thesystem, as applicable, to that effect.

3.

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

4.

A distributor that considers or has reason to consider that a high-risk AI system which it
has made available on the market is not in conformity with the requirements set out in
Chapter 2 of this Title shall take the corrective actions necessary to bring that system into
conformity with those requirements, to withdraw it or recall it or shall ensure that theprovider, 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 65(1),the distributor shall immediately inform the national competent authorities of the Member
States in which it has made the product available to that effect, 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 national competent authority, distributors of high-risk AI
systems shall provide that authority with all the information and documentation regarding
its activities as described in paragraph 1 to 4.

5a.

Distributors shall cooperate with national competent authorities on any action thoseauthorities take in relation to an AI system, of which they are the distributor.

Article 28[deleted]

Article 29
Obligations of users of high-risk AI systems
1.

Users of high-risk AI systems shall use such systems in accordance with the instructions ofuse accompanying the systems, pursuant to paragraphs 2 and 5 of this Article.

1a.

Users shall assign human oversight to natural persons who have the necessary competence,
training and authority.

2.

The obligations in paragraph 1 and 1a are without prejudice to other user obligations under
Union or national law and to the user’s discretion in organising its own resources andactivities for the purpose of implementing the human oversight measures indicated by theprovider.

3.

Without prejudice to paragraph 1, to the extent the user exercises control over the input
data, that user shall ensure that input data is relevant in view of the intended purpose of thehigh-risk AI system.

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4.

Users shall implement human oversight and monitor the operation of the high-risk AI
system on the basis of the instructions of use. When they have reasons to consider that theuse in accordance with the instructions of use may result in the AI system presenting a risk
within the meaning of Article 65(1) they shall inform the provider or distributor andsuspend the use of the system. They shall also inform the provider or distributor when they
have identified any serious incident and interrupt the use of the AI system. In case the user
is not able to reach the provider, Article 62 shall apply mutatis mutandis. This obligation
shall not cover sensitive operational data of users of AI systems which are law enforcement
authorities.
For users that are financial institutions subject to requirements regarding their internal
governance, arrangements or processes under Union financial services legislation, themonitoring obligation set out in the first subparagraph shall be deemed to be fulfilled bycomplying with the rules on internal governance arrangements, processes and mechanisms
pursuant to the relevant financial service legislation.

5.

Users of high-risk AI systems shall keep the logs, referred to in Article 12(1),automatically generated by that high-risk AI system, to the extent such logs are under theircontrol. They shall keep them for a period of at least six months, unless provided otherwise
in applicable Union or national law, in particular in Union law on the protection of
personal data.
Users that are financial institutions subject to requirements regarding their internal
governance, arrangements or processes under Union financial services legislation shallmaintain the logs as part of the documentation kept pursuant to the relevant Union
financial service legislation.

5a.

Users of high-risk AI systems that are public authorities, agencies or bodies, with the
exception of law enforcement, border control, immigration or asylum authorities, shallcomply with the registration obligations referred to in Article 51. When they find that thesystem that they envisage to use has not been registered in the EU database referred to in
Article 60 they shall not use that system and shall inform the provider or the distributor.

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6.

Users of high-risk AI systems shall use the information provided under Article 13 tocomply with their obligation to carry out a data protection impact assessment under Article
35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, whereapplicable.

6a.

Users shall cooperate with national competent authorities on any action those authorities
take in relation to an AI system, of which they are the user.

CHAPTER 4
NOTIFIYING AUTHORITIES AND NOTIFIED BODIESArticle 30
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.

2.

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

3.

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

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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 not offer or provide any activities that conformity assessment
bodies perform or any consultancy services on a commercial or competitive basis.

6.

Notifying authorities shall safeguard the confidentiality of the information they obtain in
accordance with Article 70.

7.

Notifying authorities shall have an adequate number of competent personnel at theirdisposal for the proper performance of their tasks.

8.

[deleted]

Article 31
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.

2.

The application for notification shall be accompanied by a description of the conformity
assessment activities, the conformity assessment module or modules and the AI systems
for which the conformity assessment body claims to be competent, as well as by anaccreditation certificate, where one exists, issued by a national accreditation body attestingthat the conformity assessment body fulfils the requirements laid down in Article 33. Any
valid document related to existing designations of the applicant notified body under any
other Union harmonisation legislation shall be added.

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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 33. 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 their designation procedure under this Regulation, as
appropriate. The notified body shall update the documentation referred to in paragraph 2
and paragraph 3 whenever relevant changes occur, in order to enable the authority
responsible for notified bodies to monitor and verify continuous compliance with all therequirements laid down in Article 33.

Article 32
Notification procedure1.

Notifying authorities may only notify conformity assessment bodies which have satisfied
the requirements laid down in Article 33.

2.

Notifying authorities shall notify those bodies to the Commission and the other Member
States using the electronic notification tool developed and managed by the Commission.

3.

The notification referred to in paragraph 2 shall include full details of the conformity
assessment activities, the conformity assessment module or modules and the AI systems
concerned and the relevant attestation of competence. Where a notification is not based onan accreditation certificate as referred to in Article 31 (2), the notifying authority shallprovide the Commission and the other Member States with documentary evidence whichattests to the conformity assessment body's competence and the arrangements in place toensure that that body will be monitored regularly and will continue to satisfy therequirements laid down in Article 33.

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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 31(2), or within two months of a notification by the
notifying authority where it includes documentary evidence referred to in Article 31(3).

5.

[deleted]

Article 33
Requirements relating to notified bodies
1.

A notified body shall be established under national law and have legal personality.

2.

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

3.

The organisational structure, allocation of responsibilities, reporting lines and operation of
notified bodies shall be such as to ensure that there is confidence in the performance by
and in the results of the conformity 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 it performs conformity assessment activities. Notified bodies shall also be
independent of any other operator having an economic interest in the high-risk AI systemthat is assessed, as well as of any competitors of the provider.

5.

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.

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6.

Notified bodies shall have documented procedures in place ensuring that their personnel,
committees, subsidiaries, subcontractors and any associated body or personnel of externalbodies respect the confidentiality of the information in accordance with Article 70 whichcomes into their possession during the performance of conformity assessment activities,
except when disclosure is required by law. The staff of notified bodies shall be bound toobserve professional secrecy with regard to all information obtained in carrying out theirtasks under this Regulation, except in relation to the notifying authorities of the Member
State in which their activities are carried out.

7.

Notified bodies shall have procedures for the performance of activities which take due
account of the size of an undertaking, the sector in which it operates, its structure, thedegree of complexity of the AI system in question.

8.

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

9.

Notified bodies shall be capable of carrying out all the tasks falling to them under thisRegulation with the highest degree of professional integrity and the requisite competencein the specific field, whether those tasks are carried out by notified bodies themselves or on
their behalf and under their responsibility.

10.

Notified bodies shall have sufficient internal competences to be able to effectively 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 artificial intelligence
technologies, data and data computing and to the requirements set out in Chapter 2 of thisTitle.

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11.

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.

12.

[deleted]

Article 33a
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 33 in so far as the applicable harmonised standards cover those requirements.

Article 34
Subsidiaries of and subcontracting by notified bodies
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 33 and shall inform the notifying
authority accordingly.

2.

Notified bodies shall take full responsibility for the tasks performed by subcontractors or
subsidiaries wherever these are established.

3.

Activities may be subcontracted or carried out by a subsidiary only with the agreement of
the provider.

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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 5 years from thetermination date of the subcontracting activity.

Article 34a

Operational obligations of notified bodies
1.

Notified bodies shall verify the conformity of high-risk AI system in accordance with theconformity assessment procedures referred to in Article 43.

2.

Notified bodies shall perform their activities while avoiding unnecessary burdens forproviders, and taking due account of the size of an undertaking, the sector in which it
operates, its structure and the degree of complexity of the high risk AI system in question.
In so doing, the notified body shall nevertheless respect the degree of rigour and the levelof protection required for the compliance of the high risk AI system with the requirementsof this Regulation.

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 30
to allow that authority to conduct its assessment, designation, notification, monitoring
activities and to facilitate the assessment outlined in this Chapter.

Article 35
Identification numbers and lists of notified bodies designated under this Regulation
1.

The Commission shall assign an identification number to notified bodies. It shall assign asingle number, even where a body is notified under several Union acts.

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The Commission shall make publicly available the list of the bodies notified under thisRegulation, including the identification numbers that have been assigned to them and theactivities for which they have been 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 32(2).

2.

The procedures described in Article 31 and 32 shall apply to extensions of the scope of thenotification. For changes to the notification other than extensions of its scope, theprocedures laid down in the following paragraphs shall apply.
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 one year before ceasing its activities. The certificates may remain valid
for a temporary 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 AI systems covered by those certificates. The new notified bodyshall complete a full assessment of the AI systems affected by the end of that period before
issuing new certificates for those systems. Where the notified body has ceased its activity,
the notifying authority shall withdraw the designation.

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3.

Where a notifying authority has sufficient reasons to consider that a notified body nolonger meets the requirements laid down in Article 33, or that it is failing to fulfil its
obligations, the notifying authority shall, provided that the the notified body had theopportunity to make its views known, restrict, suspend or withdraw notification as
appropriate, depending on the seriousness of the failure to meet those requirements or fulfil
those obligations. It shall immediately inform the Commission and the other Member
States accordingly.

4.

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

5.

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

6.

In the event of 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 notification;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 conformity of AI systems on the market;d)inform the Commission and the Member States about certificates of which it has
required their suspension or withdrawal;

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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 certificates
for which it has required suspension or withdrawal. That competent authority shalltake the appropriate measures, where necessary, to avoid a potential risk to health,safety or fundamental rights.

7.

With the exception of certificates unduly issued, and where a notification has beensuspended or restricted, the certificates shall remain valid in 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 and actions anticipated to remedy the suspension or restriction; orb)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 authority responsible for notified
bodies determines that the notified body does not have the capability to support
existing certificates issued, the provider shall provide to the national competentauthorities of the Member State in which the provider of the system covered by thecertificate has its registered place of business, within three months of the suspension
or restriction, a written confirmation that another qualified notified body is
temporarily assuming the functions of the notified body to monitor and remain
responsible for the certificates during the period of suspension or restriction.

8.

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 in the following
circumstances:

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a)where the national competent authority of the Member State in which the provider ofthe AI system covered by the certificate has its registered place of business has
confirmed that there is no risk to health, safety and fundamental rights associatedwith the systems in question; andb)another notified body has confirmed in writing that it will assume immediate
responsibilities for those systems and will have completed assessment of them withintwelve months of the withdrawal of the designation.

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 further periodsof three months, which altogether shall not exceed twelve months.
The national competent authority or the notified body assuming the functions of thenotified body affected by the change of notification 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 whether a notified body complies with the requirements laid down in Article 33.

2.

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

3.

The Commission shall ensure that all confidential information obtained in the course of its
investigations pursuant to this Article is treated confidentially in accordance with Article
70.

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4.

Where the Commission ascertains that a notified body does not meet or no longer meetsthe requirements laid down in Article 33, it shall inform the notifying authority of thereasons of such an ascertainment and request it to take the necessary corrective measures,
including the suspension, restriction or withdrawal of the designation if necessary. Where
the notifying authority fails to take the necessary corrective measures, the Commission
may, by means of implementing acts, suspend, restrict or withdraw the notification. That
implementing act shall be adopted in accordance with the examination procedure referred
to in Article 74(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.

The notifying authority shall ensure that the bodies notified by them participate in the workof that group, directly or by means of designated representatives.

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 in Article 33.

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STANDARDS, CONFORMITY ASSESSMENT, CERTIFICATES, REGISTRATION

Article 40
Harmonised standards
1.

High-risk AI systems or general purpose AI systems which are in conformity with harmonised
standards or parts thereof the references of which have been published in the Official Journalof the European Union shall be presumed to be in conformity with the requirements set out in
Chapter 2 of this Title or, as applicable, with requirements set out in Article 4a and Article 4b,
to the extent those standards cover those requirements.

2.

When issuing a standardisation request to European standardisation organisations inaccordance with Article 10 of Regulation 1025/2012, the Commission shall specify thatstandards are coherent, clear and drafted in such a way that they aim to fulfil in particular thefollowing objectives:a)ensure that AI systems placed on the market or put into service in the Union are safeand respect Union values and strengthen the Union's open strategic autonomy;b) promote investment and innovation in AI, including through increasing legal certainty, as
well as competitiveness and growth of the Union market;c)enhance multistakeholder governance, representative of all relevant European
stakeholders (e.g. industry, SMEs, civil society, researchers);d)contribute to strengthening global cooperation on standardisation in the field of AI thatis consistent with Union values and interests.

The Commission shall request the European standardisation organisations to provide
evidence of their best efforts to fulfil the above objectives.

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Article 41
Common specifications
1.

The Commission is empowered to adopt, after consulting the AI Board referred to in
Article 56, implementing acts in accordance with the examination procedure referred to in
Article 74(2) establishing common technical specifications for the requirements set out in
Chapter 2 of this Title, or, as applicable, with requirements set out in Article 4a and Article
4b, where the following conditions have been fulfilled:(a)no reference to harmonised standards covering the relevant essential safety or
fundamental right concerns is published in the Official Journal of the European Unionin accordance with Regulation (EU) No 1025/2012;(b)

the Commission has requested, pursuant to Article 10(1) of Regulation 1025/2012, one
or more European standardisation organisations to draft a harmonised standard for therequirements set out in Chapter 2 of this Title;(c)the request referred to in point (b) has not been accepted by any of the European
standardisation organisations or the harmonised standards addressing that request are
not delivered within the deadline set in accordance with article 10(1) of Regulation
1025/2012 or those standards do not comply with the request.

1a.

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 that theconditions in paragraph 1 are fulfilled.

2.

In the early preparation of the draft implementing act establishing the common
specification, the Commission shall fulfil the objectives referred to in Article 40(2) andgather the views of relevant bodies or expert groups established under relevant sectorial
Union law. Based on that consultation, the Commission shall prepare the draft
implementing act.

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3.

High-risk AI systems or general purpose AI systems which are in conformity with thecommon specifications referred to in paragraph 1 shall be presumed to be in conformity
with the requirements set out in Chapter 2 of this Title or, as applicable, with requirements
set out in Article 4a and Article 4b, to the extent those common specifications cover thoserequirements.

4.

When references of a harmonised standard are published in the Official Journal of theEuropean Union, implementing acts referred to in paragraph 1, which cover therequirements set out in Chapter 2 of this Title or requirements set out in Article 4a andArticle 4b, shall be repealed, as applicable.

5.

When a Member State considers that a common specification does not entirely satisfy therequirements set out in Chapter 2 of this Title or requirements set out in Article 4a andArticle 4b, as applicable, it shall inform the Commission thereof with a detailed
explanation and the Commission shall assess that information and, if appropriate, amend
the implementing act establishing the common specification in question.

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 or functional setting within which they are intended to be usedshall be presumed to be in compliance with the respective requirements set out in Article
10(4).

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2.

High-risk AI systems or general purpose AI systems that have been certified or for which astatement of conformity has been issued under a cybersecurity scheme pursuant toRegulation (EU) 2019/881 of the European Parliament and of the Council33 and thereferences of which have been published in the Official Journal of the European Union
shall be presumed to be in compliance with the cybersecurity requirements set out in
Article 15 of this Regulation in so far as the cybersecurity certificate or statement ofconformity or parts thereof cover those requirements.

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 Chapter 2 of thisTitle, the provider has applied harmonised standards referred to in Article 40, or, whereapplicable, common specifications referred to in Article 41, the provider shall opt for oneof the following procedures:(a)the conformity assessment procedure based on internal control referred to in Annex
VI; or(b)

the conformity assessment procedure based on assessment of the quality
management system and assessment of the technical documentation, with the
involvement of a notified body, referred to in Annex VII.

Where, in demonstrating the compliance of a high-risk AI system with the requirements set
out in Chapter 2 of this Title, the provider has not applied or has applied only in part
harmonised standards referred to in Article 40, or where such harmonised standards do notexist and common specifications referred to in Article 41 are not available, the provider
shall follow the conformity assessment procedure set out in Annex VII.

33

Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (theEuropean Union Agency for Cybersecurity) and on information and communications technology cybersecurity
certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 1).

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For the purpose of the conformity assessment procedure referred to in Annex VII, theprovider may choose any of the notified bodies. However, when the system is intended tobe put into service by law enforcement, immigration or asylum authorities as well as EU
institutions, bodies or agencies, the market surveillance authority referred to in Article
63(5) or (6), as applicable, shall act as a notified body.
2.

For high-risk AI systems referred to in points 2 to 8 of Annex III and for general purpose
AI systems referred in Title 1a, providers shall follow the conformity assessment
procedure based on internal control as referred to in Annex VI, which does not provide forthe involvement of a notified body.

3.

For high-risk AI systems, to which legal acts listed in Annex II, section A, apply, theprovider shall follow the relevant conformity assessment as required under those legal acts.
The requirements set out in Chapter 2 of this Title 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 purpose 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 Chapter 2 of this Title, provided that the compliance of those
notified bodies with requirements laid down in Article 33(4), (9) and (10) has beenassessed in the context of the notification procedure under those legal acts.
Where the legal acts listed in Annex II, section A, enable the manufacturer of the productto opt out from a third-party conformity assessment, provided that that manufacturer hasapplied all harmonised standards covering all the relevant requirements, that manufacturer
may make use of that option only if he has also applied harmonised standards or, whereapplicable, common specifications referred to in Article 41, covering the requirements set
out in Chapter 2 of this Title.

4.

[deleted]

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The Commission is empowered to adopt delegated acts in accordance with Article 73 forthe purpose of updating Annexes VI and Annex VII in light of technical progress.

6.

The Commission is empowered to adopt delegated acts to amend paragraphs 1 and 2 inorder to subject high-risk AI systems referred to in points 2 to 8 of Annex III to theconformity assessment procedure referred to in Annex VII or parts thereof. The
Commission shall adopt such delegated acts taking into account the effectiveness of theconformity assessment procedure based on internal control referred to in Annex VI inpreventing or minimizing the risks to health and safety and protection of fundamental
rights posed by such systems as well as the availability of adequate capacities andresources among notified bodies.

Article 44
Certificates
1.

Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in aa language which can be easily undestood by the relevant authorities in the Member Statein which the notified body is established.

2.

Certificates shall be valid for the period they indicate, which shall not exceed five years.
On application by the provider, the validity of a certificate may be extended for further
periods, each not exceeding five years, based on a re-assessment in accordance with theapplicable conformity assessment procedures. Any supplement to a certificate shall remain
valid as long as the certificate which it supplements is valid.

3.

Where a notified body finds that an AI system no longer meets the requirements set out in
Chapter 2 of this Title, it shall, taking account of the principle of proportionality, suspend
or withdraw the certificate issued or impose any restrictions on it, unless compliance withthose requirements 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.

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Article 45
Appeal against decisions of notified bodies
An appeal procedure against decisions of the notified bodies shall be available.

Article 46
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, quality management system approvals issued in accordance with therequirements 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;(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;

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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 AI systems with relevant information on issues
relating to negative and, on request, positive conformity assessment results.

4.

The obligations referred to in paragraphs 1 to 3 shall be complied with in accordance with
Article 70.

Article 47
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 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 and the protection of key industrial and infrastructural assets.
That authorisation shall be for a limited period of time while the necessary conformity
assessment procedures are being carried out, taking into account the exceptional reasonsjustifying the derogation. The completion of those procedures shall be undertaken without
undue delay.

1a.

In a duly justified situation of urgency for exceptional reasons of public security or in caseof specific, substantial and imminent threat to the life or physical safety of natural persons,law enforcement authorities or civil protection authorities may put a specific high-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, and if such
authorisation is rejected, its use shall be stopped with immediate effect and all the results
and outputs of this use shall be immediately discarded.

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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 of Chapter
2 of this Title. The market surveillance authority shall inform the Commission and theother Member States of any authorisation issued pursuant to paragraph 1. This obligation
shall not cover sensitive operational data in relation to the activities of law enforcement
authorities.

3.

[deleted]

4.

[deleted]

5.

[deleted]6.

For high-risk AI systems related to products covered by Union harmonisation legislationreferred to in Annex II Section A, only the conformity assessment derogation procedures
established in that legislation shall apply.

Article 48
EU declaration of conformity
1.

The provider shall draw up a written or electronically signed EU declaration of conformity
for each AI system and keep it at the disposal of the national competent authorities for 10
years after the AI system has been placed on the market or put into service. The EU
declaration of conformity shall identify the AI system for which it has been drawn up. A
copy of the EU declaration of conformity 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 in question meetsthe requirements set out in Chapter 2 of this Title. The EU declaration of conformity shallcontain the information set out in Annex V and shall be translated into a language that canbe easily understood by the national competent authorities of the Member State(s) in which
the high-risk AI system is 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 legislations applicable to the high-risk AI system. The
declaration shall contain all the information required for identification of 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 Chapter 2 of this Title. The provider shallkeep the EU declaration of conformity up-to-date as appropriate.

5.

The Commission shall be empowered to adopt delegated acts in accordance with Article 73
for the purpose of updating the content of the EU declaration of conformity set out inAnnex V in order to introduce elements that become necessary in light of technicalprogress.

Article 49
CE marking of conformity
1.

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

2.

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.

3.

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 shall also be indicated in any promotional material which
mentions that the high-risk AI system fulfils the requirements for CE marking.

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Article 50[deleted]

Article 51
Registration of relevant operators and of high-risk AI systems listed in Annex III
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 Annex III, points 1, 6 and 7 in
the areas of law enforcement, migration, asylum and border control management, and highrisk AI systems referred to in Annex III point 2, the provider and where applicable, theauthorised representative shall register themselves in the EU database referred to in Article
60. The provider or, where applicable the authorised representative, shall also register theirsystems in that database.

2.

Before using a high-risk AI system listed in Annex III, users of high-risk AI systems thatare public authorities, agencies or bodies, or entities acting on their behalf, shall registerthemselves in the EU database referred to in Article 60 and select the system that theyenvisage to use.
The obligations laid down in the previous subparagraph shall not apply to law
enforcement, border control, immigration or asylum authorities, agencies or bodies andauthorities, agencies or bodies using high-risk AI systems referred to Annex III point 2, as
well as to entities acting on their behalf.

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TITLE IV
TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND USERS OF
CERTAIN AI SYSTEMS

Article 52
Transparency obligations for providers and users of certain AI systems
1.

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

2.

Users of a biometric categorisation system shall inform of the operation of the system thenatural persons exposed thereto. This obligation shall not apply to AI systems used forbiometric categorisation, which are permitted by law to detect, prevent and investigate
criminal offences, subject to appropriate safeguards for the rights and freedoms of third
parties.

2a.

Users of an emotion recognition system shall inform of the operation of the system thenatural persons exposed thereto. This obligation shall not apply to AI systems used foremotion recognition which are permitted by law to detect, prevent and investigate criminal
offences, subject to appropriate safeguards for the rights and freedoms of third parties.

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3.

Users of an AI system that generates or manipulates image, audio or video content that
appreciably resembles existing persons, objects, places or other entities or events andwould falsely appear to a person to be authentic or truthful (‘deep fake’), shall disclose thatthe content has been artificially generated or manipulated.
However, the first subparagraph shall not apply where the use is authorised by law todetect, prevent, investigate and prosecute criminal offences or where the content is part ofan evidently creative, satirical, artistic or fictional work or programme subject toappropriate safeguards for the rights and freedoms of third parties.

3a.

The information referred to in paragraphs 1 to 3 shall be provided to natural persons in aclear and distinguishable manner at the latest at the time of the first interaction or exposure.

4.

Paragraphs 1, 2, 2a and 3 and 3a shall not affect the requirements and obligations set out inTitle III of this Regulation and shall be without prejudice to other transparency obligations
for users of AI systems laid down in Union or national law.

TITLE VMEASURES IN SUPPORT OF INNOVATION

Article 53
AI regulatory sandboxes-1a.

National competent authorities may establish AI regulatory sandboxes for thedevelopment, training, testing and validation of innovative AI systems under the directsupervision, guidance and support by the national competent authority, before thosesystems are placed on the market or put into service. Such regulatory sandboxes may
include testing in real world conditions supervised by the national competent authorities.

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-1b.

[deleted]-1c

Where appropriate, national competent authorities shall cooperate with other relevant
authorities and may allow for the involvement of other actors within the AI ecosystem.

-1d.

This Article shall not affect other regulatory sandboxes established under national or Union
law, including in cases where the products or services that are tested in them are linked tothe use of innovative AI systems. Member States shall ensure an appropriate level ofcooperation between the authorities supervising those other sandboxes and the national
competent authorities.

1.

[deleted]

1a.

[deleted]

1b.

The establishment of AI regulatory sandboxes under this Regulation shall aim to contributeto one or more of the following objectives:a) foster innovation and competitiveness and facilitate the development of an AI
ecosystem;b) facilitate and accelerate access to the Union market for AI systems, in particular whenprovided by small and medium enterprises (SMEs), including start-ups;c) improve legal certainty and contribute to the sharing of best practices throughcooperation with the authorities involved in the AI regulatory sandbox with a view toensuring future compliance with this Regulation and, where appropriate, with other
Union and Member States legislation;d) contribute to evidence-based regulatory learning.

2.

[deleted]

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2a.

Access to the AI regulatory sandboxes shall be open to any provider or prospective
provider of an AI system who fulfils the eligibility and selection criteria referred to inparagraph 6(a) and who has been selected by the national competent authorities following
the selection procedure referred to in paragraph 6(b). Providers or prospective providers
may also submit applications in partnership with users or any other relevant third parties.
Participation in the AI regulatory sandbox shall be limited to a period that is appropriate to
the complexity and scale of the project. This period may be extended by the national
competent authority.
Participation in the AI regulatory sandbox shall be based on a specific plan referred to inparagraph 6 of this Article that shall be agreed between the participant(s) and the national
competent authoritie(s), as applicable.

3.

The participation in the AI regulatory sandboxes shall not affect the supervisory andcorrective powers of the authorities supervising the sandbox. Those authorities shall
exercice their supervisory powers in a flexible manner within the limits of the relevant
legislation, using their discretionary powers when implementing legal provisions to a
specific AI sandbox project, with the objective of supporting innovation in AI in theUnion.
Provided that the participant(s) respect the sandbox plan and the terms and conditions fortheir participation as referred to in paragraph 6(c) and follow in good faith the guidance
given by the authorities, no administrative fines shall be imposed by the authorities forinfringement of applicable Union or Member State legislation relating to the AI systemsupervised in the sandbox, including the provisions of this Regulation.

4.

The participants remain liable under applicable Union and Member States liability
legislation for any damage caused in the course of their participation in an AI regulatory
sandbox.

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4a.

Upon request of the provider or prospective provider of the AI system, the national
competent authority shall provide, where applicable, a written proof of the activities
successfully carried out in the sandbox. The national competent authority shall also
provide an exit report detailing the activities carried out in the sandbox and the related
results and learning outcomes. Such written proof and exit report could be taken into
account by market surveillance authorities or notified bodies, as applicable, in the context
of conformity assessment procedures or market surveillance checks.
Subject to the confidentiality provisions in Article 70 and with the agreement of thesandbox participants, the European Commission and the AI 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 participant and the national competentauthority explicitly agree to this, the exit report can be made publicly available through thesingle information platform referred to in article 55(3)(b).

4b.

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

5.

National competent authorities shall make publicly available annual reports on theimplementation of the AI regulatory sandboxes, including good practices, lessons learnt
and recommendations on their setup and, where relevant, on the application of thisRegulation and other Union legislation supervised within the sandbox. Those annual
reports shall be submitted to the AI Board which shall make publicly available a summaryof all good practices, lessons learnt and recommendations. This obligation to make annual
reports publicly available shall not cover sensitive operational data in relation to theactivities of law enforcement, border control, immigration or asylum authorities. The
Commission and the AI Board shall, where appropriate, take the annual reports into
account when exercising their tasks under this Regulation.

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The Commission shall ensure that information about AI regulatory sandboxes, including
about those established under this Article, is available through the single information
platform referred to in Article 55(3)(b).

6.

The modalities and the conditions for the establishment and operation of the AI regulatory
sandboxes under this Regulation shall be adopted through implementing acts in accordancewith the examination procedure referred to in Article 74(2).
The modalities and conditions shall to the best extent possible support flexibility fornational competent authorities to establish and operate their AI regulatory sandboxes,
foster innovation and regulatory learning and shall particularly take into account the
special circumstances and capacities of participating SMEs, including start-ups.
Those implementing acts shall include common main principles on the following issues:a)eligibility and selection for participation in the AI regulatory sandbox;b)

procedure for the application, participation, monitoring, exiting from andtermination of the AI regulatory sandbox, including the sandbox plan and the exit
report;c)7.

the terms and conditions applicable to the participants.

When national competent authorities consider authorising testing in real world conditions
supervised within the framework of an AI regulatory sandbox established under this
Article, they shall specifically agree with the participants on the terms and conditions ofsuch testing and in particular on the appropriate safeguards with the view to protect
fundamental rights, health and safety. Where appropriate, they shall cooperate with othernational competent authorities with a view to ensure consistent practices across the Union.

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Article 54
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 for the purposes of developing, testing and training of innovative AI systems inthe sandbox under the following cumulative conditions:(a)the innovative AI systems shall be developed for safeguarding substantial public
interest by a public authority or another natural or legal person governed by publiclaw or by private law and in one or more of the following areas:(i)[deleted](ii)

public safety and health, including prevention, control and treatment of disease
and improvement of health care systems;(iii) protection and improvement of the quality of the environment, including green
transition, climate change mitigation and adaptation;(iv) energy sustainability, transport and mobility;(v)

efficiency and quality of public administration and public services;(vi) cybersecurity and resilience of critical infrastructure.
(b)

the data processed are necessary for complying with one or more of the requirements
referred to in Title III, Chapter 2 where those requirements cannot be effectively
fulfilled by processing anonymised, synthetic or other non-personal data;

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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 mechanism 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 theparticipants and only authorised persons have access to that data;(e)any personal data processed are not to be transmitted, transferred or otherwise
accessed by other parties that are not participants in the sandbox, unless suchdisclosure occurs in compliance with Regulation (EU) 2016/679 or, whereapplicable, Regulation 2018/725, and all participants have agreed to it;(f)any processing of personal data in the context of the sandbox shall not affect theapplication of the rights of the data subjects as provided for under Union law on theprotection of personal data, in particular in Article 22 of Regulation (EU) 2016/679
and Article 24 of Regulation (EU) 2018/1725;(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)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 in Annex IV;

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enforcement, border control, immigration or asylum authorities.

1a.

For the purpose of prevention, investigation, detection or prosecution of criminal offencesor the execution of criminal penalties, including the safeguarding against and theprevention of 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 Member State or Union law and subject to the same cumulative
conditions as referred to in paragraph 1.

2.

Paragraph 1 is without prejudice to Union or Member States laws laying down the basis forthe processing of personal data which is necessary for the purpose of developing, testing
and training of innovative AI systems or any other legal basis, in compliance with Union
law on the protection of personal data.

Article 54a
Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
1.

Testing of 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 the provisions of this Article and the real-world testing planreferred to in this Article.
The detailed elements of the real-world testing plan shall be specified in implementing acts
adopted by the Commission in accordance with the examination procedure referred to in
Article 74(2).

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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
putting into service of the AI system on their own or in partnership with one or more
prospective users.

3.

The testing of high-risk AI systems in real world conditions under this Article shall be
without prejudice to ethical review that may be required by national or Union 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(s) where thetesting in real world conditions is to be conducted;(b) the market surveillance authority in the Member State(s) where the testing in realworld conditions is to be conducted have not objected to the testing within 30 days
after its submission;(c) the provider or prospective provider with the exception of high-risk AI systems
referred to in Annex III, points 1, 6 and 7 in the areas of law enforcement, migration,asylum and border control management, and high risk AI systems referred to in Annex
III point 2, has registered the testing in real world conditions in the EU databasereferred to in Article 60(5a) with a Union-wide unique single identification number
and the information specified in Annex VIIIa;(d) the provider or prospective provider conducting the testing in real world conditions isestablished in the Union or it has appointed a legal representative for the purpose of
the testing in real world conditions who is established in the Union;

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(e) data collected and processed for the purpose of the testing in real world conditions
shall not be transferred to countries outside the Union, unless the transfer and theprocessing provides equivalent safeguards to those provided under Union law;(f) the testing in real world conditions does not last longer than necessary to achieve its
objectives and in any case not longer than 12 months;(g) persons belonging to vulnerable groups due to their age, physical or mental disability
are appropriately protected;(h) [deleted](i) where a provider or prospective provider organises the testing in real world conditions
in cooperation with one or more prospective users, the latter have been informed of all
aspects of the testing that are relevant to their decision to participate, and given therelevant instructions on how to use the AI system referred to in Article 13; theprovider or prospective provider and the user(s) shall conclude an agreement
specifying their roles and responsibilities with a view to ensuring compliance with theprovisions for testing in real world conditions under this Regulation and otherapplicable Union and Member States legislation;(j) the subjects of the testing in real world conditions have given informed consent inaccordance with Article 54b, or in the case of law enforcement, where the seeking of
informed consent would prevent the AI system from being tested, the testing itself andthe outcome of the testing in the real world conditions shall not have a negative effecton the subject;(k) the testing in real world conditions is effectively overseen by the provider orprospective provider and user(s) with persons who are suitably qualified in therelevant field and have the necessary capacity, training and authority to perform theirtasks;(l) the predictions, recommendations or decisions of the AI system can be effectively
reversed or disregarded.

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5.

Any subject of the testing in real world conditions, or his or her legally designatedrepresentative, as appropriate, may, without any resulting detriment and without having toprovide any justification, withdraw from the testing at any time by revoking his or her
informed consent. The withdrawal of the informed consent shall not affect the activities
already carried out and the use of data obtained based on the informed consent before its
withdrawal.

6.

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 62 of thisRegulation. The provider or prospective provider shall adopt immediate mitigation
measures or, failing that, suspend the testing in real world conditions until such mitigation
takes place or otherwise terminate it. The provider or prospective provider shall establish aprocedure for the prompt recall of the AI system upon such termination of the testing inreal world conditions.

7.

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

8.

The provider and prospective provider shall be liable under applicable Union and Member
States liability legislation for any damage caused in the course of their participation in thetesting in real world conditions.

Article 54b
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 54a, informed consent
shall be freely given by the subject of testing prior to his or her participation in such testing
and after having been duly informed with concise, clear, relevant, and understandable
information regarding:

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LIMITEEN(i)the nature and objectives of the testing in real world conditions and the possible
inconvenience that may be linked to his or her participation;(ii)

the conditions under which the testing in real world conditions is to be conducted,
including the expected duration of the subject's participation;(iii) the subject's rights and guarantees regarding participation, in particular his or her
right to 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;(iv) the modalities for requesting the reversal or the disregard of the predictions,recommendations or decisions of the AI system;(v)

the Union-wide unique single identification number of the testing in real world
conditions in accordance with Article 54a(4c) and the contact details of the provider
or its legal representative from whom further information can be obtained.

2.

The informed consent shall be dated and documented and a copy shall be given to thesubject or his or her legal representative.

Article 55
Support measures for operators, in particular SMEs, including start-ups
1.

Member States shall undertake the following actions:(a)provide SMEs, including start-ups, with priority access to the AI regulatory
sandboxes to the extent that they fulfil the eligibility and selection criteria;(b)organise specific awareness raising and training activities about the application ofthis Regulation tailored to the needs of the SMEs, including start-ups, and, as
appropriate, local public authorities;

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LIMITEEN(c)where appropriate, establish a dedicated channel for communication with SMEs,
including start-ups and, as appropriate, local public authorities to provide advice andrespond to queries about the implementation of this Regulation, including as regards
participation in AI regulatory sandboxes.

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 Commission shall undertake the following actions:(a)upon request of the AI Board, provide standardised templates for the areas coveredby this Regulation;(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 55a

Derogations for specific operators

1.

The obligations laid down in Article 17 of this Regulation shall not apply to microenterprises
as defined in Article 2(3) of the Annex to the Commission Recommendation 2003/361/EC
concerning the definition of micro, small and medium-sized enterprises, provided thoseenterprises do not have partner enterprises or linked enterprises as defined in Article 3 of thesame Annex.

2.

Paragraph 1 shall not be interpreted as exempting those operators from fulfilling any otherrequirements and obligations laid down in this Regulation, including those established in
Articles 9, 61 and 62.

3.

Requirements and obligations for general purpose AI systems laid down in Article 4b shallnot apply to micro, small and medium-sized enterprises, provided those enterprises do nothave partner enterprises or linked enterprises as defined in Article 3 of the the Annex to theCommission Recommendation 2003/361/EC concerning the definition of micro, small andmedium-sized enterprises.

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TITLE VI
GOVERNANCE
CHAPTER 1
EUROPEAN ARTIFICIAL INTELLIGENCE BOARD

Article 56
Establishment and structure of the European Artificial Intelligence Board
1.

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

2.

The Board shall be composed of one representative per Member State. The European Data
Protection Supervisor shall participate as an observer. The Commission shall also attend
the Board’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.

2a.

Each representative shall be designated by their Member State for a period of 3 years,
renewable once.

2aa.

Member States shall ensure that their representatives in the Board:(i)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 58;(ii)

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;

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(iii) 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.
3.

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,duration of mandate and specifications of the tasks of the Chair, the voting modalities, andthe organisation of the Board’s activities and its sub-groups.
The Board shall establish a standing subgroup serving as a platform for stakeholders toadvise the Board on all issues related to the implementation of this Regulation, including
on the preparation of implementing and delegated acts. To this purpose, organisations
representing the interests of the providers and users of AI systems, including SMEs andstart-ups, as well as civil society organisations, representatives of affected persons,researchers, standardisation organisations, notified bodies, laboratories and testing andexperimentation facilities shall be invited to participate to this sub-group. The Board shallestablish two standing sub-groups to provide a platform for cooperation and exchange
among market surveillance authorities and notifying authorities on issues related to market
surveillance and notified bodies respectively.
The Board may establish other standing or temporary sub-groups as appropriate for the
purpose of examining specific issues. Where appropriate, stakeholders referred to in theprevious subparagraph may be invited to such sub-groups or to specific meetings of those
subgroups in the capacity of observers.

3a.

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

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The Board shall be chaired by one of the representatives of the Member States. Upon
request of the Chair, the Commission shall convene the meetings and prepare the agenda inaccordance with the tasks of the Board pursuant to this Regulation and its rules ofprocedure. The Commission shall provide administrative and analytical support for theactivities of the Board pursuant to this Regulation.

Article 57[deleted]

Article 58
Tasks of the Board
The Board shall advice and assist the Commission and the Member States in order to facilitate theconsistent and effective application of this Regulation. For this purpose the Board may in particular:(a)collect and share technical and regulatory expertise and best practices among Member
States;(b)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 47, the functioning of regulatory sandboxes and testing in real world conditions
referred to in Article 53, 54 and 54a;(c)

upon 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 technical specifications or existing standards regarding the requirements set out inTitle III, Chapter 2,(ii)

on the use of harmonised standards or common specifications referred to in Articles
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(iii) on the preparation of guidance documents, including the guidelines concerning thesetting of administrative fines referred to in Article 71;(d)advise the Commission on the potential need for amendment of Annex III in accordance with
Articles 4 and 7, taking into account relevant available evidence and the latest develoments intechnology;(e)advise the Commission during the preparation of delegated or implementing act pursuant tothis Regulation;f)cooperate, as appropriate, with relevant EU bodies, experts groups and networks in particularin the fields of product safety, cybersecurity, competition, digital and media services,financial services, cryptocurrencies, consumer protection, data and fundamental rights
protection;g)contribute and provide relevant advice to the Commission in the development of the guidancereferred to in Article 58a or request the development of such guidance;(h)to assist the work of market surveillance authorities and, in cooperation and subject toagreement of the concerned market surveillance authorities, promote and support cross-bordermarket surveillance investigations, including with respect to the emergence of risks ofsystemic nature that may stem from AI systems;(i)contribute to the assessment of training needs for staff of Member States involved in
implementing this Regulation;(j)advise the Commission in relation to international matters on artificial intelligence.

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GUIDELINES FROM THE COMMISSION

Article 58a
Guidelines from the Commission on the implementation of this Regulation
1.

Upon the request of the Member States or the Board, or on its own initiative, the Commission
shall issue guidelines on the practical implementation of this Regulation, and in particular on(i)the application of the requirements referred to in Articles 8 - 15;(ii)

the prohibited practices referred to in Article 5;(iii) the practical implementation of the provisions related to substantial modification;(iv) the practical implementation of uniform conditions referred to in Article 6, paragraph 3,
including examples in relation to high risk AI systems referred to in Annex III;(v)

the practical implementation of transparency obligations laid down in Article 52;(vi) the relationship of this Regulation with other relevant Union legislation, including as
regards consistency in their enforcement.
When issuing such guidelines, the Commission shall pay particular attention to the needs of SMEs
including start-ups, local public authorities and sectors most likely to be affected by this Regulation.

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NATIONAL COMPETENT AUTHORITIESArticle 59
Designation of national competent authorities
1.

[deleted]2.

Each Member State shall establish or designate at least one notifying authority and at least
one market surveillance authority for the purpose of this Regulation as national competentauthorities. These national competent authorities shall be organised so as to safeguard thepriniciples of objectivity and impartiality of their activities and tasks. Provided that thoseprinicples are respected, such activities and tasks may be performed by one or several
designated authorities, in accordance with the organisational needs of the Member State.

3.

Member States shall inform the Commission of their designation or designations.

4.

Member States shall ensure that national competent authorities are provided with adequate
financial resources, technical equipment and well qualified human resources to effectively
fulfil their tasks under this Regulation.

5.

By [one year after entry into force of this Regulation] and afterwards six months before
the deadline referred to in Article 84(2) Member States shall inform the Commission on
the status of the financial resources, technical equipment and human resources of thenational competent authorities with an assessment of their adequacy. The Commission
shall transmit that information to the Board for discussion and possible recommendations.

6.

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

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7.

National competent authorities may provide advice on the implementation of thisRegulation, including tailored to SME providers, including start-ups. Whenever national
competent authorities intend to provide guidance and advice with regard to an AI system inareas covered by other Union legislation, the competent national authorities under that
Union legislation shall be consulted, as appropriate. Member States may also establish one
central contact point for communication with operators.

8.

When Union institutions, agencies and bodies fall within the scope of this Regulation, theEuropean Data Protection Supervisor shall act as the competent authority for theirsupervision.
TITLE VII

EU DATABASE FOR HIGH-RISK AI SYSTEMS LISTED IN ANNEX III

Article 60
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 a EU
database containing information referred to in paragraph 2 concerning relevant operatorsand high-risk AI systems listed in Annex III which are registered in accordance with
Articles 51 and 54a. When setting the fuctional specifications of such database, theCommission shall consult the AI Board.

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The data listed in Annex VIII, Part I, shall be entered into the EU database by theproviders, authorised representatives and relevant users, as applicable, upon theirregistration. The data listed in Annex VIII, Part II, 1 to 11, shall be entered into the EU
database by the providers, or where applicable by the authorised representative, in
accordance with Article 51. The data referred in Annex VIII, Part II, 12 shall be
automatically generated by the database based on the information provided by relevant
users pursuant to Article 51(2). The data listed in Annex VIIIa shall be entered into the
database by the prospective providers or providers in accordance with Article 54a.

3.

[deleted]

4.

The EU database shall contain no personal data, except for the information listed in Annex
VIII, and shall be without prejudice to Article 70.

5.

The Commission shall be the controller of the EU database. It shall make available toproviders, prospective providers and users adequate technical and administrative support.

5a.

Information contained in the EU database registered in accordance with Article 51 shall beaccessible to the public. The information registered in accordance with Article 54a shall beaccessible only to market surveillance authorites and the Commission, unless theprospective provider or provider has given consent for making this information also
accessible the public.

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TITLE VIII
POST-MARKET MONITORING, INFORMATION SHARING, MARKETSURVEILLANCE
CHAPTER 1
POST-MARKET MONITORING

Article 61
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 risks of the high-risk AI system.

2.

In order to allow the provider to evaluate the compliance of AI systems with therequirements set out in Title III, Chapter 2 throughout their life cycle, the post-market
monitoring system shall collect, document and analyse relevant data, which may beprovided by users or which may be collected through other sources on the performance ofhigh-risk AI systems. This obligation shall not cover sensitive operational data of users ofAI systems which are law enforcement authorities.

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.

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4.

For high-risk AI systems covered by the legal acts referred to in Annex II, Section A,
where a post-market monitoring system and plan is already established under thatlegislation, the post-market monitoring documentation as prepared under that legislation
shall be deemed sufficient, provided that the template referred to paragraph 3 is used.
The first subparagraph shall also apply high-risk AI systems referred to in point 5 ofAnnex III placed on the market or put into service by financial institutions that are subject
to requirements regarding their internal governance, arrangements or processes under
Union financial services legislation.

CHAPTER 2
SHARING OF INFORMATION ON SERIOUS INCIDENTS

Article 62
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.
Such notification 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 providers becomes aware of the serious
incident.

2.

Upon receiving a notification related to a serious incident referred to in Article 3(44)(c),the relevant market surveillance authority shall inform the national public authorities orbodies referred to in Article 64(3). The Commission shall develop dedicated guidance tofacilitate compliance with the obligations set out in paragraph 1. That guidance shall be
issued 12 months after the entry into force of this Regulation, at the latest.

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For high-risk AI systems referred to in point 5 of Annex III which are placed on the market
or put into service by providers that are financial institutions that are subject torequirements regarding their internal governance, arrangements or processes under Union
financial services legislation, the notification of serious incidents shall be limited to thosereferred to in Article 3(44)(c).

4.

For high-risk AI systems which are safety components of devices, or are themselvesdevices, covered by Regulation (EU) 2017/745 and Regulation (EU) 2017/746 thenotification of serious incidents shall be limited to those referred to in Article 3(44)(c) andbe made to the national competent authority chosen for this purpose by the Member States
where that incident occurred.

CHAPTER 3
ENFORCEMENT

Article 63
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.
However, for the purpose 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 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.

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2.

As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020,
the market surveillance authorities shall report to the Commission about the outcomes of
relevant market surveillance activities under this Regulation.

3.

For high-risk AI systems, related to products to which legal acts listed in Annex II, section
A apply, the market surveillance authority for the purposes of this Regulation shall be theauthority responsible for market surveillance activities designated under those legal acts or,in justified circumstances and provided that coordination is ensured, another relevant
authority identified by the Member State.
The procedures referred to in Articles 65, 66, 67 and 68 of this Regulation shall not apply
to AI systems related to products, to which legal acts listed in Annex II, section A apply,
when such legal acts already provide for procedures having the same objective. In such acase, these sectoral procedures shall apply instead.

4.

For high-risk AI systems placed on the market, put into service or used by financial
institutions regulated by Union legislation on financial services, the market surveillanceauthority for the purposes of this Regulation shall be the relevant national authority
responsible for the financial supervision of those institutions under that legislation in so far
as the placement on the market, putting into service or the use of the AI system is in directconnection with the provision of those financial services.
By way of a derogation from the previous subparagraph, in justified circumstances andprovided that coordination is ensured, another relevant authority may be identified by theMember State as 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(SSM) established by Council Regulation No 1204/2013, should report, without delay, tothe European Central Bank any information identified in the course of their market
surveillance activities that may be of potential interest for the European Central Bank’s
prudential supervisory tasks as specified in that Regulation.

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For high-risk AI systems listed in point 1(a) in so far as the systems are used for law
enforcement purposes, points 6, 7 and 8 of Annex III, Member States shall designate as
market surveillance authorities for the purposes of this Regulation either the national
authorities supervising the activities of the law enforcement, border control, immigration,asylum or judicial authorities, or the competent data protection supervisory authorities
under Directive (EU) 2016/680, or Regulation 2016/679. 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.

6.

Where Union institutions, agencies and bodies fall within the scope of this Regulation, theEuropean Data Protection Supervisor shall act as their market surveillance authority.

7.

Member States shall facilitate the 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 II or other
Union legislation that might be relevant for the high-risk AI systems referred to in Annex
III.

8.

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

9.

Market surveillance authorities shall be granted access to the source code of the high-risk
AI system upon a reasoned request and only when the following cumulative conditions are
fulfilled:

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provided by the provider have been exhausted or proved insufficient.
10.

Any information and documentation obtained by market surveillance authorities shall betreated in compliance with the confidentiality obligations set out in Article 70.

11.

Complaints to the relevant market surveillance authority can be submitted by any naturalor legal person having grounds to consider that there has been an infringement of theprovisions of this Regulation.
In accordance with Article 11(3)(e) and (7)(a) of Regulation (EU) 2019/1020, complaints
shall be taken into account for the purpose of conducting the market surveillance activities
and be handled in line with the dedicated procedures established therefore by the market
surveillance authorities.

Article 63a
Supervision of testing in real world conditions by market surveillance authorities
1.

Market surveillance authorities shall have the competence and powers to ensure that testingin real 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 54, the market surveillance authorities shallverify the compliance with the provisions of Article 54a as part of their supervisory role
for the AI regulatory sandbox. Those authorities may, as appropriate, allow the testing inreal world conditions to be conducted by the provider or prospective provider in derogation
to the conditions set out in Article 54a(4) (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 consideringthat the conditions set out in Articles 54a and 54b are not met, it may take any of thefollowing decisions on its territory, as appropriate:(a) suspend or terminate the testing in real world conditions;(b) require the provider or prospective provider and user(s) to modify any aspect of thetesting 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 54a(4)(b), the decisionor the objection shall indicate the grounds thereof and the modalities and conditions for theprovider or prospective provider to challenge the decision or objection.

5.

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

Article 64
Powers of authorities protecting fundamental rights
1.

[deleted]

2.

[deleted]

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3.

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 whenaccess to that documentation is necessary for the fulfilment of the competences under theirmandate within the limits of their jurisdiction. The relevant public authority or body shallinform the market surveillance authority of the Member State concerned of any such
request.

4.

By 3 months after the entering into force of this Regulation, each Member State shallidentify the public authorities or bodies referred to in paragraph 3 and make the list
publicly available. Member States shall notify the list to the Commission and all otherMember States and keep the list up to date.

5.

Where the documentation referred to in paragraph 3 is insufficient to ascertain whether abreach of obligations under Union law intended to protect fundamental rights has occurred,
the public authority or body referred to paragraph 3 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 reasonable time following
the request.

6.

Any information and documentation obtained by the national public authorities or bodies
referred to in paragraph 3 pursuant to the provisions of this Article shall be treated incompliance with the confidentiality obligations set out in Article 70.

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Article 65
Procedure for dealing with AI systems presenting a risk at national level1.

AI systems presenting a risk shall be understood as a product presenting a risk defined in
Article 3, point 19 of Regulation (EU) 2019/1020 insofar as risks to the health or safety or
to fundamental rights of persons are concerned.

2.

Where the market surveillance authority of a Member State has sufficient reasons to
consider that an AI system presents a risk as referred to in paragraph 1, they shall carry out
an evaluation of the AI system concerned in respect of its compliance with all therequirements and obligations laid down in this Regulation. When risks to fundamental
rights are identified, the market surveillance authority shall also inform the relevant
national public authorities or bodies referred to in Article 64(3). The relevant operators
shall cooperate as necessary with the market surveillance authorities and the other national
public authorities or bodies referred to in Article 64(3).
Where, in the course of that evaluation, the market surveillance authority finds that the AI
system does not comply with the requirements and obligations laid down in thisRegulation, 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 fromthe market, or to recall it, within a period it may prescribe.
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.

3.

Where the market surveillance authority considers that non-compliance is not restricted toits 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 theoperator to take.

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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 market throughout the Union.

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, to withdraw the product from that market or to recall it.
That authority shall notify the Commission and the other Member States, without undue
delay, 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, the nature of the non-compliance alleged and the risk involved, thenature and duration of the national measures taken and the arguments put forward by therelevant operator. In particular, the market surveillance authorities shall indicate whether
the non-compliance is due to one or more of the following:(-a) non-compliance with the prohibition of the artificial intelligence practices referred toin Article 5;(a)a failure of a high-risk AI system to meet requirements set out in Title III, Chapter 2;(b)shortcomings in the harmonised standards or common specifications referred to in
Articles 40 and 41 conferring a presumption of conformity.

(c)

non-compliance with provisions set out in Article 52;(d)non-compliance of general purpose AI systems with the requirements and obligations
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The market surveillance authorities of the Member States other than the market
surveillance authority of the Member 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 at their disposal relating to the non-compliance of the AI
system concerned, and, in the event of disagreement with the notified national measure, of
their objections.

8.

Where, within three months of receipt of the notification referred to in paragraph 5, noobjection has been raised by either a Member State or the Commission in respect of aprovisional measure taken by a Member State, that measure shall be deemed justified. Thisis without prejudice to the procedural rights of the concerned operator in accordance with
Article 18 of Regulation (EU) 2019/1020. The period referred to in the first sentence of
this paragraph shall be reduced to 30 days in the case of non-compliance with theprohibition of the artificial intelligence practices referred to in Article 5.

9.

The market surveillance authorities of all Member States shall then ensure that appropriate
restrictive measures are taken in respect of the AI system concerned, such as withdrawal of
the product from their market, without undue delay.

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Article 66
Union safeguard procedure
1.

Where, within three months of receipt of the notification referred to in Article 65(5), or 30days in the case of non-compliance with the prohibition of the artificial intelligencepractices referred to in Article 5, objections are raised by a Member State against ameasure taken by another Member State, or where the Commission considers the measure
to be contrary to Union law, the Commission shall without undue delay enter into
consultation with the relevant Member State’s market surveillance authority and operator
or operators and shall evaluate the national measure. On the basis of the results of that
evaluation, the Commission shall decide whether the national measure is justified or notwithin 9 months, or 60 days in the case of non-compliance with the prohibition of theartificial intelligence practices referred to in Article 5, starting from the notificationreferred to in Article 65(5). It shall and notify such decision to the Member State
concerned. The Commission shall also inform all other Member States of such decision.

2.

If the measure taken by the relevant Member State’s market surveillance authority is
considered justified by the Commission, the market surveillance authorities of all Member
States shall ensure that appropriate restrictive measures are taken in respect of the AI
system concerned, such as withdrawal of the AI system from their market without undue
delay, and shall inform the Commission accordingly. If the national measure is consideredunjustified by the Commission, the market surveillance authority of the Member State
concerned shall withdraw the measure and inform the Commission accordingly.

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.

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Article 67
Compliant high-risk or general purpose AI systems which present a risk
1.

Where, having performed an evaluation under Article 65, the market surveillance authorityof a Member State finds that although a high-risk or general purpose AI system is incompliance with this Regulation, it presents a risk to the health or safety of persons or to
fundamental rights, it shall require the relevant operator to take all appropriate measures toensure that the AI system concerned, when placed on the market or put into service, nolonger presents that risk, to withdraw the AI system from the market or to recall it without
undue delay, within a period it may prescribe.

2.

The provider or other relevant operators shall ensure that corrective action is taken in
respect of all the AI systems concerned that they have made available on the market
throughout the Union within the timeline prescribed by the market surveillance authority of
the Member State referred to in paragraph 1.

3.

The Member State shall immediately inform the Commission and the other Member States.
That information shall include all available details, in particular the data necessary for theidentification of the AI system concerned, the origin and the supply chain of the AI system,
the nature of the risk involved and the nature and duration of the national measures taken.

4.

The Commission shall without undue delay enter into consultation with the Member Statesconcerned and the relevant operator and shall evaluate the national measures taken. On thebasis of the results of that evaluation, the Commission shall decide whether the measure isjustified or not and, where necessary, propose appropriate measures.

5.

The Commission shall address its decision to the Member States concerned, and inform allother Member States.

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Article 68
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 conformity marking has been affixed in violation of Article 49;(b)

the conformity marking has not been affixed;(c)the EU declaration of conformity has not been drawn up;(d)the EU declaration of conformity has not been drawn up correctly;(e)the identification number of the notified body, which is involved in the conformity
assessment procedure, where applicable, has not been affixed;

2.

Where the non-compliance referred to in paragraph 1 persists, the Member State concerned
shall take all appropriate measures to restrict or prohibit the high-risk AI system being
made available on the market or ensure that it is recalled or withdrawn from the market.

Article 68a
Union testing facilities in the area of artificial intelligence
1.

The Commission shall designate one or more Union testing facilities pursuant to Article 21
of Regulation (EU) 1020/2019 in the area of artificial intelligence.

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2.

Without prejudice to the activities of Union testing facilities referred to in Article 21(6) ofRegulation (EU) 1020/2019, Union testing facilities referred to in paragraph 1 shall also
provide independent technical or scientific advice at the request of the Board or market
surveillance authorities.

Article 68b
Central pool of independent experts
1.

Upon request of the AI Board, the Commission shall, by means of an implementing act,
make provisions on the creation, maintenance and financing of a central pool of
independent experts to support the enforcement activities under this Regulation.

2.

Experts shall be selected by the Commission and included in the central pool on the basis
of up-to-date scientific or technical expertise in the field of artificial intelligence, having
due regard to the technical areas covered by the requirements and obligations in thisRegulation and the activities of market surveillance authorities pursuant to Article 11 ofRegulation (EU) 1020/2019. The Commission shall determine the number of experts in thepool in accordance with the required needs.

3.

Experts may have the following tasks:(a) provide advice to and support the work of market surveillance authorities, at theirrequest;(b) support cross-border market surveillance investigations as referred to in Article 58(h),without prejudice of the powers of market surveillance authorities;(c) advise and support the Commission when carrying out its duties in the context of thesafeguard clause pursuant to Article 66.

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The experts shall perform their tasks with impartiality, objectivity and ensure theconfidentiality of information and data obtained in carrying out their tasks and activities.
Each expert shall draw up a declaration of interests, which shall be made publicly
available. The Commission shall establish systems and procedures to actively manage andprevent potential conflicts of interest.

5.

The Member States may be required to pay fees for the advice and support by the experts.
The structure and the level of fees as well as the scale and structure of recoverable costs
shall be adopted by the Commission by means of the implementing act referred to inparagraph 1, taking into account the objectives of the adequate implementation of thisRegulation, cost-effectiveness and the necessity to ensure an effective access to experts by
all Member States.

6.

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 testing
facilities pursuant to Article 68a and experts pursuant to this Article is efficiently organised
and provides the best possible added value.

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TITLE IXCODES OF CONDUCTArticle 69
Codes of conduct for voluntary application of specific requirements
1.

The Commission, and the Member States shall facilitate the drawing up of codes ofconduct intended to encourage the voluntary application to AI systems other than high-risk
AI systems of one or more of the requirements set out in Title III, Chapter 2 of thisRegulation to the best extent possible, taking into account the available, technical solutions
allowing for the application of such requirements.

2.

The Commission and the Member States shall facilitate the drawing up of codes of conduct
intended to encourage the voluntary application to all AI systems of specific requirements
related, for example, to environmental sustainability, including as regards energy-efficient
programming, accessibility for persons with a disability, stakeholders participation in thedesign and development of the AI systems and diversity of development teams on the basisof clear objectives and key performance indicators to measure the achievement of thoseobjectives. The Commission and the Member States shall also facilitate, where appropriate,
the drawing of codes of conduct applicable on a voluntary basis with regard to users'
obligations in relation to AI systems.

3.

Codes of conduct applicable on a voluntary basis may be drawn up by individual providersof AI systems or by organisations representing them or by both, including with the
involvement of users and any interested stakeholders and their representative
organisations, or, where appropriate, by users with regard to their obligations. Codes ofconduct may cover one or more AI systems taking into account the similarity of theintended purpose of the relevant systems.

4.

The Commission and the Member States shall take into account the specific interests andneeds of SME providers, including start-ups, when encouraging and facilitating thedrawing up of codes of conduct referred to in this Article.

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TITLE X
CONFIDENTIALITY AND PENALTIESArticle 70
Confidentiality
1.

National competent authorities, notified bodies, the Commission, the Board, and any othernatural or legal person involved in the application of this Regulation shall, in accordancewith Union or national law, put appropriate technical and organisational measures in place
to ensure the confidentiality of information and data obtained in carrying out their tasks
and activities in such a manner as to protect, in particular:(a) intellectual property rights, and confidential business information or trade secrets of anatural or legal person, including source code, except the cases referred to in Article 5 ofDirective 2016/943 on the protection of undisclosed know-how and business information(trade secrets) against their unlawful acquisition, use and disclosure apply.
(b) the effective implementation of this Regulation, in particular for the purpose of
inspections, investigations or audits;(c) public and national security interests;(d) integrity of criminal or administrative proceedings;(e) the integrity of information classified in accordance with Union or national law.

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2.

Without prejudice to paragraph 1, information exchanged on a confidential basis between
the national competent authorities and between national competent authorities and theCommission shall not be disclosed without the prior consultation of the originating
national competent authority and the user when high-risk AI systems referred to in points
1, 6 and 7 of Annex III are used by law enforcement, border control, immigration or
asylum authorities, when such disclosure would jeopardise public and national security
interests. This obligation to exchange information shall not cover sensitive operational
data in relation to the activities of law enforcement, border control, immigration or asylum
authorities.
When the law enforcement, immigration or asylum authorities are providers of high-risk
AI systems referred to in points 1, 6 and 7 of Annex III, the technical documentationreferred to in Annex IV shall remain within the premises of those authorities. Thoseauthorities shall ensure that the market surveillance authorities referred to in Article 63(5)and (6), as applicable, can, upon request, immediately access the documentation or obtain acopy thereof. Only staff of the market surveillance authority holding the appropriate levelof security clearance shall be allowed to access that documentation or any copy thereof.

3.

Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member
States and their relevant authorities, as well as notified bodies, with regard to the exchange
of information and the dissemination of warnings, including in the context of cross-bordercooperation, nor the obligations of the parties concerned to provide information undercriminal law of the Member States.

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Article 71
Penalties
1.

In compliance with the terms and conditions laid down in this Regulation, Member Statesshall lay down the rules on penalties, including administrative fines, applicable toinfringements of this Regulation and shall take all measures necessary to ensure that they
are properly and effectively implemented. The penalties provided for shall be effective,
proportionate, and dissuasive. They shall take into particular account the size and interestsof SME providers, including start-ups, and their economic viability. They shall also take
into account whether the use of the AI system is in the context of personal nonprofessional activity.

2.

The Member States shall without delay notify the Commission of those rules and of thosemeasures and of any subsequent amendment affecting them.

3.

Non-compliance with any of the prohibitions of the artificial intelligence practices referred
to in Article 5 shall be subject to administrative fines of up to 30 000 000 EUR or, if theoffender is company, up to 6 % of its total worldwide annual turnover for the preceding
financial year, whichever is higher. In case of SMEs, including start-ups, these fines shallbe up to 3% of their worldwide annual turnover for the preceding financial year.

4.

Infringements of the following provisions related to operators or notified bodies, shall be
subject to administrative fines of up to 20 000 000 EUR or, if the offender is a company,
up to 4 % of its total worldwide annual turnover for the preceding financial year,
whichever is higher:-a)obligations of providers pursuant to Articles 4b and 4c;a)obligations of providers pursuant to Article 16;b)obligations for certain other persons pursuant to Article 23a;

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e)obligations of distributors pursuant to Article 27;

f)obligations of users pursuant to Article 29, paragraphs 1 to 6a;g)requirements and obligations of notified bodies pursuant to Article 33, 34(1), 34(3),34(4), 34a;h)transparency obligations for providers and users pursuant to Article 52.

In case of SMEs, including start-ups, these fines shall be up to 2% of their worldwide
annual turnover for the preceding financial year.
5.

The supply of incorrect, incomplete or misleading information to notified bodies andnational competent authorities in reply to a request shall be subject to administrative finesof up to 10 000 000 EUR or, if the offender is a company, up to 2 % of its total worldwide
annual turnover for the preceding financial year, whichever is higher. In case of SMEs,
including start-ups, these fines shall be up to 1% of their worldwide annual turnover forthe preceding financial year.

6.

When deciding on the amount of the administrative fine in each individual case, allrelevant circumstances of the specific situation 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;(aa) the intentional or negligent character of the infringement;(ab) any action taken by the operator in order to remedy the infringement and mitigate thepossible adverse effects of the infringement;

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LIMITEEN(b)whether administrative fines have been already applied by other market surveillanceauthorities in other Member States to the same operator for the same infringement;(ba) whether administrative fines have been already 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 Act;(c)the size, the annual turnover and market share of the operator committing theinfringement;(d)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.

7.

Each Member State shall lay down rules on whether and to what extent administrativefines may be imposed on public authorities and bodies established in that Member State.

8.

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 orother bodies as applicable in those Member States. The application of such rules in thoseMember States shall have an equivalent effect.

9.

The exercise by the market surveillance authority of its powers under this Article shall be
subject to appropriate procedural safeguards in accordance with Union and Member State
law, including effective judicial remedy and due process.

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Article 72
Administrative fines on Union institutions, agencies and bodies
1.

The European Data Protection Supervisor may impose administrative fines on Union
institutions, agencies and bodies falling within the scope of this Regulation. When deciding
whether to impose an administrative fine and deciding on the amount of the administrative
fine in each individual case, all relevant circumstances of the specific situation shall betaken into account and due regard shall be given to the following:(a)the nature, gravity and duration of the infringement and of its consequences;(b)the cooperation with the European Data Protection Supervisor in order to remedy the
infringement and mitigate the possible adverse effects of the infringement, including
compliance with any of the measures previously ordered by the European Data
Protection Supervisor against the Union institution or agency or body concerned withregard to the same subject matter;(c)2.

any similar previous infringements by the Union institution, agency or body;Non-compliance with any of the prohibitions of the artificial intelligence practices referred
to in Article 5 shall be subject to administrative fines of up to 500 000 EUR.

3.

Non-compliance of the AI system with any requirements or obligations under thisRegulation, other than those laid down in Articles 5 and 10, shall be subject toadministrative fines of up to 250 000 EUR.

4.

Before taking decisions pursuant to this Article, the European Data Protection Supervisor
shall give the Union institution, agency or body which is the subject of the proceedings
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 circumstances on which the parties
concerned have been able to comment. Complainants, if any, shall be associated closelywith the proceedings.

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The rights of defense 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 be the income of the generalbudget of the Union.

TITLE XI
DELEGATION OF POWER AND COMMITTEE PROCEDURE

Article 73
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 delegation of power referred to in Article 7(1), Article 7(3), Article 11(3), Article
43(5) and (6) and Article 48(5) shall be conferred on the Commission for a period of five
years from [entering into force of the Regulation].
The Commission shall draw up a report in respect of the delegation of power not later thannine months before the end of the 5 year period. The delegation of power shall be tacitly
extended for periods of an identical duration, unless the European Parliament or theCouncil opposes such extension not later than three months before the end of each period.

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The delegation of power referred to in Article 7(1), Article 7(3), Article 11(3), Article
43(5) and (6) and Article 48(5) may be revoked at any time by the European Parliament orby the Council. A decision of revocation shall put an end to the delegation of power
specified in that decision. It shall take effect the day following that of its publication in the
Official Journal of the European Union or at a later date specified therein. It shall notaffect the validity of any delegated acts already in force.

4.

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to theEuropean Parliament and to the Council.

5.

Any delegated act adopted pursuant to Article 7(1), Article 7(3), Article 11(3), Article
43(5) and (6) and Article 48(5) shall enter into force only if no objection has been
expressed by either the European Parliament or the Council within a period of threemonths 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 theCommission that they will not object. That period shall be extended by three months at theinitiative of the European Parliament or of the Council.

Article 74
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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TITLE XIIFINAL PROVISIONS

Article 75
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 in the meaning ofRegulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of theCouncil*, the requirements set out in Chapter 2, Title III of that Regulation shall be taken into
account.”__________* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”14954/22
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Article 76
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 in the meaning of Regulation (EU) YYY/XX [on Artificial
Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III,
Chapter 2 of that Regulation shall be taken into account.
__________* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”

Article 77
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 in the meaning of Regulation (EU) YYY/XX on [Artificial
Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III,
Chapter 2 of that Regulation shall be taken into account.
__________* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”14954/22
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Article 78
Amendment to Directive 2014/90/EU
In Article 8 of Directive 2014/90/EU, the following paragraph is added:“4. For Artificial Intelligence systems which are safety components in the meaning of Regulation(EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council*, whencarrying out 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 therequirements set out in Title III, Chapter 2 of that Regulation.
__________* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.

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Article 79
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 in themeaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament andof the Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into
account.
__________* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.

Article 80
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 in the meaning of Regulation (EU) YYY/XX [on Artificial
Intelligence] of the European Parliament and of the Council *, the requirements set out in Title III,
Chapter 2 of that Regulation shall be taken into account.
__________* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.

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Article 81
Amendment 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 to paragraph 1
concerning Artificial Intelligence systems which are safety components in the meaning ofRegulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of theCouncil*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into
account.
__________* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”
(2) In Article 19, the following paragraph is added:“4. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligencesystems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial
Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into
account.”(3) In Article 43, the following paragraph is added:“4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligencesystems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial
Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into
account.”

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(4) In Article 47, the following paragraph is added:“3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligencesystems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial
Intelligence], the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into
account.”(5) In Article 57, the following paragraph is added:“When adopting those implementing acts concerning Artificial Intelligence systems which aresafety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence], therequirements set out in Title III, Chapter 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 Intelligencesystems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial
Intelligence] , the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into
account.”.

Article 82
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 intelligencesystems which are safety components in the meaning of Regulation (EU) YYY/XX [on Artificial
Intelligence] of the European Parliament and of the Council*, the requirements set out in Title III,
Chapter 2 of that Regulation shall be taken into account.
__________* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.

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Article 83
AI systems already placed on the market or put into service
1.

This Regulation shall not apply to the AI systems which are components of the large-scale
IT systems established by the legal acts listed in Annex IX that have been placed on themarket or put into service before [12 months after the date of application of thisRegulation referred to in Article 85(2)], unless the replacement or amendment of thoselegal acts leads to a significant change in the design or intended purpose of the AI systemor AI systems concerned.
The requirements laid down in this Regulation shall be taken into account, whereapplicable, in the evaluation of each large-scale IT systems established by the legal acts
listed in Annex IX to be undertaken as provided for in those respective acts.

2.

This Regulation shall apply to the high-risk AI systems, other than the ones referred to inparagraph 1, that have been placed on the market or put into service before [date ofapplication of this Regulation referred to in Article 85(2)], only if, from that date, thosesystems are subject to significant changes in their design or intended purpose.

Article 84
Evaluation and review
1.

[deleted]

1b.

The Commission shall assess the need for amendment of the list in Annex III every 24
months following the entry into force of this Regulation and until the end of the period of
the delegation of power. The findings of that assessment shall be presented to the European
Parliament and the Council.

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2.

By [three years after the date of application of this Regulation referred to in Article 85(2)]and every four years thereafter, the Commission shall submit a report on the evaluation andreview of this Regulation to the European Parliament and to the Council. The reports shallbe made public.

3.

The reports referred to in paragraph 2 shall devote specific attention to the following:(a)the status of the financial resources, technical equipment and human resources of thenational competent authorities in order to effectively perform the tasks assigned tothem under this Regulation;(b)

the state of penalties, and notably administrative fines as referred to in Article 71(1),applied by Member States to infringements of the provisions of this Regulation.

4.

Within [three years after the date of application of this Regulation referred to in Article
85(2)] and every four years thereafter, where appropriate, the Commission shall evaluate
the impact and effectiveness of voluntary codes of conduct to foster the application of therequirements set out in Title III, Chapter 2 for AI systems other than high-risk AI systems
and possibly other additional requirements for AI systems, including as regards
environmental sustainability.

5.

For the purpose of paragraphs 1a to 4 the Board, the Member States and national
competent authorities shall provide the Commission with information on its request.

6.

In carrying out the evaluations and reviews referred to in paragraphs 1a to 4 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.

7.

The Commission shall, if necessary, submit appropriate proposals to amend thisRegulation, in particular taking into account developments in technology and in the light ofthe state of progress in the information society.

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Article 85
Entry into force and application
1.

This Regulation shall enter into force on the twentieth day following that of its publicationin the Official Journal of the European Union.

2.

This Regulation shall apply from [36 months following the entering into force of theRegulation].

3.

By way of derogation from paragraph 2:(a)Title III, Chapter 4 and Title VI shall apply from [twelve months following theentry into force of this Regulation];(b)

Article 71 shall apply from [twelve months following the entry into force of thisRegulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,

For the European Parliament

For the Council

The President

The President

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ANNEX I[deleted]

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ANNEX II
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 Council of 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);

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);

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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 and93/42/EEC (OJ L 117, 5.5.2017, p. 1;

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).

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1.

Regulation (EC) No 300/2008 of the European Parliament and of the Council of 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).

2.

Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15
January 2013 on the approval and market surveillance of two- or three-wheel vehicles andquadricycles (OJ L 60, 2.3.2013, p. 52);

3.

Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5
February 2013 on the approval and market surveillance of agricultural and forestry
vehicles (OJ L 60, 2.3.2013, p. 1);

4.

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);

5.

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).

6.

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);

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7.

Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27
November 2019 on type-approval requirements for motor vehicles and their trailers, andsystems, 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);

8.

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 points (a) and (b) of Article 2(1) thereof,
where it concerns unmanned aircraft and their engines, propellers, parts and equipment tocontrol them remotely, are concerned.

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ANNEX III
HIGH-RISK AI SYSTEMS REFERRED TO IN ARTICLE 6(3)In each of the areas listed under points 1-8, the AI systems specifically mentioned under each letterare considered to be high-risk AI systems pursuant to Article 6(3):1.

Biometrics:(a)2.

Remote biometric identification systems.

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

3.

Education and vocational training:(a)AI systems intended to be used to determine access, admission or to assign natural
persons to educational and vocational training institutions or programmes at alllevels;(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 or programmes at all levels.

4.

Employment, workers management and access to self-employment:(a)AI systems intended to be used for recruitment or selection of natural persons,notably to place targeted job advertisements, to analyse and filter job applications,and to evaluate candidates;

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(b)AI intended to be used to make decisions on promotion and termination of workrelated contractual relationships, to allocate tasks based on individual behavior or
personal traits or characteristics and to monitor and evaluate performance andbehavior 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, as well as to grant, reduce, revoke, or reclaim such benefits andservices;(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 put into service by
providers that are micro and small-sized enterprises as defined in the Annex ofCommission Recommendation 2003/361/EC for their own use;(c)

AI systems intended to be used to dispatch, or to establish priority in the dispatchingof emergency first response services, including by firefighters and medical aid;(d)

AI systems intended to be used for risk assessment and pricing in relation to natural
persons in the case of life and health insurance with the exception of AI systems put
into service by providers that are micro and small-sized enterprises as defined in the
Annex of Commission Recommendation 2003/361/EC for their own use.

6.

Law enforcement:(a)AI systems intended to be used by law enforcement authorities or on their behalf toassess the risk of a natural person for offending or reoffending or the risk for anatural person to become a potential victim of criminal offences;

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(b)AI systems intended to be used by law enforcement authorities or on their behalf aspolygraphs and similar tools or to detect the emotional state of a natural person;(c)[deleted](d)

AI systems intended to be used by law enforcement authorities or on their behalf toevaluate the reliability of evidence in the course of investigation or prosecution of
criminal offences;(e)

AI systems intended to be used by law enforcement authorities or on their behalf topredict the occurrence or reoccurrence of an actual or potential criminal offence
based on profiling of natural persons as referred to in Article 3(4) of Directive (EU)2016/680 or to assess personality traits and characteristics or past criminal behaviourof natural persons or groups;(f)

AI systems intended to be used by law enforcement authorities or on their behalf to
profile natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 in
the course of detection, investigation or prosecution of criminal offences.

(g)7.

[deleted]

Migration, asylum and border control management:(a)AI systems intended to be used by competent public authorities or on their behalf aspolygraphs and similar tools or to detect the emotional state of a natural person;(b)

AI systems intended to be used by competent public authorities or on their behalf toassess 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 has entered into the territory of a
Member State;

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AI systems intended to be used by competent public authorities or on their behalf to
examine applications for asylum, visa and residence permits and associatedcomplaints with regard to the eligibility of the natural persons applying for a status.

8.

Administration of justice and democratic processes:(a)AI systems intended to be used by a judicial authority or on their behalf to interpretfacts or the law and to apply the law to a concrete set of facts.

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ANNEX IVTECHNICAL 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 person/s developing the system the date and the version of
the system;(b)

how the AI system interacts or can be used to interact with hardware or software thatis not part of the AI system itself, where applicable;(c)the versions of relevant software or firmware and any requirement related to version
update;(d)the description of all forms in which the AI system is placed on the market or put
into service (e.g. software package embedded into hardware, downloadable, APIetc.);(e)the description of 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, marking and internal layout of those products;(g)2.

instructions of use for the user and, where applicable installation instructions;

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 these have been used, integrated or modified by the provider;

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LIMITEEN(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, also with regard to persons or groups of persons on which the system isintended to be used; the main classification choices; what the system is designed to
optimise for and the relevance of the different parameters; the description of the
expected output of the system; the decisions about any possible trade-off maderegarding the technical solutions adopted to comply with the requirements set out inTitle III, Chapter 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;(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 users, in accordance with Articles
13(3)(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 Title III, Chapter 2;14954/22
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LIMITEEN(g)the validation and testing procedures used, including information about the validationand testing data used and their main characteristics; metrics used to measureaccuracy, robustness, cybersecurity and compliance with other relevant requirements
set out in Title III, Chapter 2 as well as potentially discriminatory impacts; test logs
and all test reports dated and signed by the responsible persons, including withregard to pre-determined changes as referred to under point (f).

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 users; specifications on input data, as appropriate;

4.

A detailed description of the risk management system in accordance with Article 9;5.

A description of relevant changes made by the provider to the system through its lifecycle;

6.

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 Title III, Chapter 2, including a list of other relevant standards andtechnical specifications applied;7.

A copy of the EU declaration of conformity;

8.

A detailed description of the system in place to evaluate the AI system performance in the
post-market phase in accordance with Article 61, including the post-market monitoringplan referred to in Article 61(3).

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ANNEX V
EU DECLARATION OF CONFORMITYThe EU declaration of conformity referred to in Article 48, shall contain all of the following
information:
1.

AI system name and type and any additional unambiguous reference allowing
identification and traceability of the AI system;

2.

Name and address of the provider or, where applicable, their authorised representative;

3.

A statement that the EU declaration of conformity is issued under the sole responsibility ofthe provider;4.

A statement that the AI system in question is in conformity with this Regulation and, if
applicable, with any other relevant Union legislation that provides for the issuing of an EU
declaration of conformity;

5.

References to any relevant harmonised standards used or any other common specificationin relation to which conformity is declared;

6.

Where applicable, the name and identification number of the notified body, a descriptionof the conformity assessment procedure performed and identification of the certificate
issued;7.

Place and date of issue of the declaration, name and function of the person who signed it aswell as an indication for, and on behalf of whom, that person signed, signature.

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ANNEX VI
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 to 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 Title III, Chapter 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 61 is consistent with the technicaldocumentation.

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ANNEX VII
CONFORMITY BASED ON ASSESSMENT OF QUALITY MANAGEMENT SYSTEM
AND ASSESSMENT OF TECHNICAL DOCUMENTATION
1.

Introduction
Conformity based on assessment of quality management system and assessment of thetechnical 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 theauthorised representative, their name and address as well;(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;(d)the documentation concerning the quality management system which shall cover all
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LIMITEEN(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.
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.

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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 their tasks, the notified body shall be granted fullaccess to the training, validation, and testing datasets used, including, where appropriate
and subject to security safeguards, through application programming interfaces (API) or
other relevant technical means and tools enabling remote access.

4.4.

In examining the technical documentation, the notified body may require that the provider
supplies further evidence or carries out further tests so as to enable a proper assessment ofconformity of the AI system with the requirements set out in Title III, Chapter 2.
Whenever the notified body is not satisfied with the tests carried out by the provider, thenotified body shall directly carry out adequate tests, as appropriate.

4.5.

Notified bodies shall be granted access to the source code of the AI system upon areasoned request and only when the following cumulative conditions are fulfilled:a) Access to source code is necessary to assess the conformity of the high-risk AI systemwith the requirements set out in Title III, Chapter 2, andb) testing/auditing procedures and verifications based on the data and documentation
provided by the provider have been exhausted or proved insufficient.

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The decision shall be notified to the provider or its authorised representative. The
notification shall contain the conclusions of the assessment of the technical documentationand the reasoned assessment decision.
Where the AI system is in conformity with the requirements set out in Title III, Chapter 2,
an EU technical documentation assessment certificate shall be issued by the notified body.
The certificate shall indicate the name and address of the provider, the conclusions of theexamination, the conditions (if any) for its validity and the data necessary for theidentification 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.
Where the AI system is not in conformity with the requirements set out in Title III, Chapter
2, the notified body shall refuse to issue an EU technical documentation assessment
certificate and shall inform the applicant accordingly, giving detailed reasons for its
refusal.
Where the AI system does not meet the requirement relating to the data used to train it, retraining 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 EU technical documentation assessment certificate shall contain specificconsiderations on the quality data used to train the AI system, notably on the reasons for
non-compliance.

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Any change to the AI system that could affect the compliance of the AI system with therequirements or its intended purpose shall be approved by the notified body which issued
the EU technical documentation assessment certificate. The provider shall inform such
notified body of its intention to introduce any of the above-mentioned changes or if it
becomes otherwise 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 EU 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 EU technical documentation assessment certificate.

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 fulfils 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 an EU technical documentation assessment certificate was issued.

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ANNEX VIII
INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF OPERATORSAND HIGH-RISK AI SYSTEMS IN ACCORDANCE WITH ARTICLE 51
Providers, authorised representatives and users that are public authorities, agencies or bodies shallsubmit the information referred to in Part I. Providers or, when applicable, authorised
representatives shall ensure that the information on their high-risk AI systems referred to in Part II,
1 to 11 is complete, correct and kept up-to-date. Information laid down in II.12 shall be
automatically generated by the database.
Part I. Information related to operators (upon operators’registration)-1.

Type of operator (provider, authorised representative or user);

1.

Name, address and contact details of the provider;

2.

Where submission of information is carried out by another person on behalf of theoperator, the name, address and contact details of that person;

Part II. Information related to the high-risk AI system
1.

Name, address and contact details of the provider

2.

Name, address and contact details of the authorised representative, where applicable;

3.

AI system trade name and any additional unambiguous reference allowing identificationand traceability of the AI system;

4.

Description of the intended purpose of the AI system;

5.

Status of the AI system (on the market, or in service; no longer placed on the market/inservice, recalled);

6.

Type, number and expiry date of the certificate issued by the notified body and the name oridentification number of that notified body, when applicable;

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7.

A scanned copy of the certificate referred to in point 6, when applicable;

8.

Member States in which the AI system is or has been placed on the market, put into service
or made available in the Union;

9.

A copy of the EU declaration of conformity referred to in Article 48;

10.

Electronic instructions for use;

11.

URL for additional information (optional).

12.

Name, address and contact details of users

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ANNEX VIIIa

INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF HIGH-RISK AI
SYSTEMS LISTED IN ANNEX III IN RELATION TO TESTING IN REAL WORLD CONDITIONSIN ACCORDANCE WITH ARTICLE 54a

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 54a:

1. Union-wide unique single identification number of the testing in real world conditions;
2. Name and contact details of the provider or prospective provider and users involved in the testingin real world conditions;
3. A brief description of the AI system, its intended purpose and other information necessary for theidentification 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 IXUNION LEGISLATION ON LARGE-SCALE IT SYSTEMS IN THE AREA OF FREEDOM,SECURITY AND JUSTICE
1.

Schengen Information System(a)

Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28
November 2018 on the use of the Schengen Information System for the return ofillegally staying third-country nationals (OJ L 312, 7.12.2018, p. 1).

(b)Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28
November 2018 on the establishment, operation and use of the Schengen Information
System (SIS) in the field of border checks, and amending the Convention
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 Council of 28
November 2018 on the establishment, operation and use of the Schengen Information
System (SIS) in the field of police cooperation and judicial cooperation in criminal
matters, amending and repealing Council Decision 2007/533/JHA, and repealing
Regulation (EC) No 1986/2006 of the European Parliament and of the Council andCommission Decision 2010/261/EU (OJ L 312, 7.12.2018, p. 56).

2.

Visa Information System(a)

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF
THE COUNCIL amending Regulation (EC) No 767/2008, Regulation (EC) No
810/2009, Regulation (EU) 2017/2226, Regulation (EU) 2016/399, Regulation
XX/2018 [Interoperability Regulation], and Decision 2004/512/EC and repealing
Council Decision 2008/633/JHA - COM(2018) 302 final. To be updated once theRegulation is adopted (April/May 2021) by the co-legislators.

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EN

3.

Eurodac(a)Amended proposal for a REGULATION OF THE EUROPEAN PARLIAMENTAND OF THE COUNCIL on the establishment of 'Eurodac' for the comparison of
biometric data for the effective application of Regulation (EU) XXX/XXX[Regulation on Asylum and Migration Management] and of Regulation (EU)XXX/XXX [Resettlement Regulation], for identifying an illegally staying thirdcountry national or stateless person and on requests for the comparison with Eurodac
data by Member States' law enforcement authorities and Europol for law
enforcement purposes and amending Regulations (EU) 2018/1240 and (EU)2019/818 – COM(2020) 614 final.

4.

Entry/Exit System(a)

Regulation (EU) 2017/2226 of the European Parliament and of the Council of 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 bordersof the Member States and determining the conditions for access to the EES for law
enforcement purposes, and amending the Convention implementing the Schengen
Agreement and Regulations (EC) No 767/2008 and (EU) No 1077/2011 (OJ L 327,
9.12.2017, p. 20).

5.

European Travel Information and Authorisation System(a)

Regulation (EU) 2018/1240 of the European Parliament and of the Council of 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 Council of 12
September 2018 amending Regulation (EU) 2016/794 for the purpose of establishinga European Travel Information and Authorisation System (ETIAS) (OJ L 236,
19.9.2018, p. 72).

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6.

European Criminal Records Information System on third-country nationals and statelesspersons(a)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).

7.

Interoperability(a)Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May
2019 on establishing a framework for interoperability between EU information
systems in the field of borders and visa (OJ L 135, 22.5.2019, p. 27).

(b)Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May
2019 on establishing a framework for interoperability between EU information
systems in the field of police and judicial cooperation, asylum and migration (OJ L
135, 22.5.2019, p. 85).

______________

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