Notat vedr. aftale om forordning om kunstig intelligens

Udenrigsministeriet
Asiatisk Plads 2
DK-1448 København K
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Telefax +45 32 54 05 33
E-mail: um@um.dk
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Medlemmerne af Folketingets Europaudvalg
Bilag Sagsnummer Kontor
2 24/00679 EKN 9. februar 2024
NOTAT
Aftale om forordning om kunstig intelligens
Til underretning for Folketingets Europaudvalg vedlægges Digitalise-
rings- og Ligestillingsministeriets orienterende notat vedrørende aftale
om forordning om kunstig intelligens.
Lars Løkke Rasmussen
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Council of the
European Union
Brussels, 26 January 2024
(OR. en)
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TELECOM 22
JAI 98
COPEN 18
CYBER 14
DATAPROTECT 32
EJUSTICE 3
COSI 6
IXIM 15
ENFOPOL 21
RELEX 77
MI 65
COMPET 68
CODEC 133
Interinstitutional File:
2021/0106(COD)
NOTE
From: Presidency
To: Permanent Representatives Committee
No. Cion doc.: 8115/21
Subject: Proposal for a Regulation of the European Parliament and of the Council
laying down harmonised rules on artificial intelligence (Artificial Intelligence
Act) and amending certain Union legislative acts
- Analysis of the final compromise text with a view to agreement
I. INTRODUCTION
1. The Commission adopted the proposal for a Regulation laying down harmonised rules on
artificial intelligence (Artificial Intelligence Act, hereinafter: the AI Act) on 21 April 2021.
2. The Council unanimously adopted its General Approach on the proposal on 6 December
2022, while the European Parliament (hereinafter: the EP) confirmed its position in a plenary
vote on 14 June 2023.
3. On 14 June 2023, 18 July 2023, 2-3 October 2023 and 24 October 2023 the first four political
trilogues were held, during which some of the less controversial parts of the proposal were
agreed and compromise was also found on the provisions concerning measures in support of
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innovation, as well as and on the mechanism for classification of AI systems as high-risk.
Moreover, during those initial trilogues the co-legislators explored potential landing zones
with regard to the remaining issues, in particular the regulation of general purpose AI models
and systems, governance, as well the prohibitions and law enforcement package.
4. On 29 November 2023 and 1 December 2023, the Committee of Permanent Representatives
granted the Presidency a revised mandate to continue the negotiations on all the outstanding
elements of the proposal. The fifth and final trilogue was held between 6 and 8 December
2023. During this extended round of negotiations the Council and the EP came to an
agreement on all political issues and successfully closed the interinstitutional negotiations.
Following this political agreement, the co-legislators proceeded to carry out further technical
work in January 2024 in order to align the text of the recitals with the text of the articles as
agreed during the final trilogue.
5. In the Annex to this document delegations will find the text of the proposal for a Regulation
laying down harmonised rules on artificial intelligence (the AI Act), updated according to the
provisional political agreement reached at the fifth trilogue between 6 and 8 December 2023.
II. MAIN ELEMENTS OF THE COMPROMISE
1. Subject matter and scope
As regards the subject matter, the compromise text of Article 1(1) includes a high-level
statement that one of the purposes of the AI Act is to ensure a high level of protection of
health, safety and fundamental rights enshrined in the Charter, which includes democracy,
rule of law and environmental protection. However, all subsequent references in the text to
the risks addressed by the Regulation only include risks to health, safety and fundamental
rights, in line with the Council’s mandate.
Concerning the scope, the compromise text makes it clear that national security is excluded.
The wording concerning this exclusion in Article 2(3) has been fine tuned to align it more
closely with the respective language used in recently agreed legal acts, such as the Cyber
Resilience Act and the Data Act, while the text of the corresponding Recital 12a has
remained the same as in the Council’s mandate.
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2. Definition of an AI system
The definition of an AI system in Article 3(1) has been modified to align it more closely
with the work of international organisations working on artificial intelligence, notably the
OECD. Moreover, the corresponding Recital 6 details further the key characteristics of the
definition and clarifies that the definition is not intended to cover simpler traditional
software systems or programming approaches, which are based on the rules defined solely
by natural persons to automatically execute operations. Additionally, the Commission has
been tasked to develop guidelines on the application of the definition of an AI system.
3. Prohibited AI practices
Regarding the list of prohibited AI practices in Article 5, the compromise text includes the
changes as previously accepted by the Committee of Permanent Representatives in the
Council’s revised mandate. This means that the list includes the prohibition of real-time
biometric identification by law enforcement authorities in publicly accessible spaces, but
with some notable and clearly defined exceptions, as listed in Article 5(1)(d), which are
now subject to a range of safeguards, including monitoring and oversight measures and
limited reporting obligations at EU level. Additional accepted prohibitions include
untargeted scraping of facial images for the purpose of a creating or expanding facial
recognition databases, emotion recognition but only at the workplace and in educational
institutions (and with exceptions for safety and medical reasons), a very limited prohibition
of biometric categorization based on certain specific beliefs or characteristics, as well as a
limited and targeted ban on individual predictive policing. The wording on the predictive
policing ban has been slightly modified and it now covers systems which assess or predict
the risk of a natural person to commit a criminal offence, based solely on the profiling of a
natural person or on assessing their personality traits and characteristics. However, this
prohibition will not apply to AI systems used to support the human assessment of the
involvement of a person in a criminal activity.
Finally, it is important to point out that as part of the compromise other biometric
categorisation systems and emotion recognition systems, as well as post-remote biometric
identification systems, which have not been included in the list of prohibitions in Article 5,
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have been added to Annex III (List of high-risk AI systems), with some further limitations
of their scope.
4. Post-remote biometric identification
In addition to being included in the list of high-risk AI systems in Annex III, the use of
post-remote biometric identification by law enforcement authorities has been made subject
to some additional safeguards in Article 29. These safeguards include some limited
transparency measures and the requirement for law enforcement authorities to request an
authorisation for the use of post-remote biometric identification, which could be given by a
judicial authority or an administrative authority whose decision is binding and subject to a
judicial review. This can be done prior or ex post, within 48 hours. Furthermore, the
compromise text clarifies that post-remote biometric identification should not be used for
law enforcement purposes in an untargeted way without any link to a criminal offence, a
criminal proceeding, a genuine and present or genuine and foreseeable threat of a criminal
offence or the search for a specific missing person.
5. Exceptions for law enforcement authorities
The compromise agreement preserves all the exceptions for law enforcement authorities that
were added in the Council’s revised mandate, including derogation from conformity
assessment and the possibility to start real world testing of high-risk AI systems without
prior authorisation. Nevertheless, in order to secure these concessions, the Council had to
agree that market surveillance authorities for high-risk AI systems in the field of law
enforcement would be either the data protection authorities or any other authorities
designated pursuant to conditions laid down in Articles 1 to 44 of the Law Enforcement
Directive.
6. Fundamental rights impact assessment
In line with the Council’s revised mandate, in Article 29a the compromise text includes a
light version of the obligation for some deployers to conduct a fundamental rights impact
assessment. The obligation is relatively easy to comply with, and it concerns only deployers
that are bodies governed by public law, private actors providing public services, and
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deployers that are banking and insurance service providers using AI systems listed as high-
risk in Annex III, point 5, (b) and (ca). The fundamental rights impact assessment will
need to be carried out only for aspects not covered by other legal obligations, such as Data
Protection Impact Assessment under the GDPR and will be procedurally aligned with
existing processes in order to eliminate any overlap and additional burden. Moreover,
compliance with this obligation will be facilitated by the AI Office, which has been tasked
with the development of a template for a questionnaire which deployers will be able to use
to meet the relevant requirements.
7. Testing high-risk AI systems in real world conditions outside AI regulatory sandboxes
As part of the compromise, the text of the AI Act includes provisions on testing high-risk AI
systems in real world conditions outside AI regulatory sandboxes, in Articles 54a and 54b.
The Council’s revised mandate has been preserved in this respect, which means that testing
high-risk AI systems in real world conditions outside AI regulatory sandboxes will be
possible, but it will be subject to a range of safeguards, which include, inter alia, the
requirement for approval from the market surveillance authority, the right for affected
persons to request to delete their data after testing in real world conditions, the right for
market surveillance authorities to request information related to testing in real world
conditions from providers, including the power to conduct inspections, limited duration of
such testing, as well as some additional safeguards designed specifically for testing in real
world conditions in the areas of law enforcement, migration, asylum and border control
management.
8. General purpose AI models
The compromise agreement includes new provisions concerning general purpose AI models
(GPAI models) in Articles 52a – 52e. These new rules introduce horizontal obligations for
all GPAI models, which will include keeping up-to-date and making available, upon request,
technical documentation to the AI Office and national competent authorities. They also
include providing certain information and documentation to downstream providers for the
purpose of compliance with the AI Act. There are some additional requirements for models
with systemic risks, which would include performing model evaluation, making risk
assessments and taking risk mitigation measures, ensuring an adequate level of
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cybersecurity protection, and reporting serious incidents to the AI Office and national
competent authorities. Compliance with these requirements can be achieved through codes
of practice, which will be developed by the industry, with the participation of the Member
States (through the AI Board), and facilitated by the AI Office. The drawing up of the codes
of practice should be an open process to which all interested stakeholders will be invited,
both companies as well as civil society and academia. The AI Office will also evaluate these
codes of practice and can formally approve them, or, in case they are inadequate to cover the
obligations, provide common rules for the implementation of the obligations through an
implementing act. The compromise agreement also provides that standards will be a
possibility for compliance in the future.
Classification of GPAI models as presenting systemic risks will initially depend on the
capability, either based on a quantitative threshold of the cumulative amount of compute
used for its training measured in floating point operations (FLOPs), or on an individual
designation decision of the Commission that takes into account criteria listed in Annex IXc
(e.g. the number of parameters, quality and size of the dataset, input and output modalities
or the reach measures in business users).The initial FLOPs threshold for this has been set as
10^25, so higher than what the EP initially wanted but lower than in the Council’s mandate,
which was 10^26. However, in this context it is important to note that the Commission will
be obliged to adapt the threshold in the light of evolving technological developments, such
as algorithmic improvements or increased hardware efficiency, in order to keep up with the
state of the art, reflecting the capabilities recorded in the most advanced general purpose AI
models.
Regarding copyright, the compromise agreement states that providers of GPAI models will
need to put in place a policy to respect Union copyright law, as well as make publicly
available a sufficiently detailed summary about the content used for training of the general-
purpose AI model, based on a template provided by the AI Office. Recital 60k explains that
this summary should not be technically detailed but comprehensive at a general level, while
taking into due account the need to protect trade secrets and confidential business
information.
Finally, with regard to GPAI systems, the compromise agreement defines them as AI
systems based on GPAI models that can serve a variety of purposes. Article 28 includes
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rules to align them to the risk-based approach of the AI Act. Providers of such systems will
be obliged to provide all the information and elements to downstream providers of high-risk
AI systems so that they can comply with the respective requirements, including for the
purpose of conformity assessment. Article 63a further clarifies the conditions in which
national market surveillance authorities should collaborate with the AI Office to ensure the
compliance of GPAI systems that can be used directly by deployers for at least one purpose
classified as high-risk, when they consider the GPAI systems are not compliant.
9. Governance and enforcement
Linked to the agreements on GPAI models, as summarized in point 8 above, the
compromise text also includes the new rules on governance in Title VI. While for AI
systems the market surveillance system on the national level will apply, these new rules for
GPAI models provide for a new more centralised system of oversight and enforcement. For
this purpose, the AI Office will be established as a new governance structure with a number
of specific tasks in respect of GPAI models, and with a strong link with the scientific
community to support its work.
The newly proposed governance structure also includes an enhanced role for the AI Board.
Its list of tasks has been extended to give the Member States a stronger coordination role,
including with regard to AI regulatory sandboxes, consultations with stakeholders and
awareness raising activities. The AI Board will also provide opinions to the Commission on
the qualified alerts concerning general purpose AI models. The provisions on the
composition and functioning of the AI Board have been maintained as in the Council’s
General Approach.
The final text also introduces two new advisory bodies. A scientific panel of independent
experts will provide technical advice and input to the AI Office and market surveillance
authorities. The scientific panel also has a key role in the enforcement of rules for GPAI
models, as it will be able to launch qualified alerts of possible risks to the AI Office.
Building on the General Approach, Member States will have the possibility to call upon
experts of the scientific panels to support their market surveillance activities. An advisory
forum will provide stakeholder input to the Commission (including the AI Office) and to the
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AI Board. It will comprise a balanced selection of stakeholders, including industry, start-
ups, SMEs, civil society and academia.
Finally, on the issue of appointing more than one competent authority covered by Article
59(2), the compromise text maintains the Council’s position, which gives the Member States
the flexibility to appoint at least one notifying authority and at least one market surveillance
authority as national competent authorities. In addition, Member States shall designate one
market surveillance authority to act as a single point of contact.
10. Derogation from conformity assessment
In line with the Council’s mandate, the compromise text preserves the derogation from
conformity assessment in Article 47(1), and also the related exemption (urgency procedure)
for law enforcement authorities in Article 47(1a), without the need for judicial
authorisation. However, to secure this concession, it has been necessary to re-introduce in
the text the wording regarding the control of the authorisation process by the Commission,
as provided in points 3, 4 and 5 of Article 47, which were previously deleted in the
Council’s General Approach.
11. AI systems already placed on the market or put into service
Concerning AI systems already placed on the market or put into service, in the case of
public authorities which are providers or deployers of high-risk AI systems the compromise
agreement in Article 83(2) is to offer them 4 years from the entry into application to make
their systems compliant. This change does not depart significantly from the Council’s
position, as it is highly unlikely that within this 4-year period such systems would not go
through a substantial modification, which was supposed to trigger the requirement to
comply in the Council’s General Approach. Moreover, in Article 83(3) it has been agreed
that every GPAI model that is placed on the market before the entry into application of the
provisions related to GPAI models (12 months after entry into force) will have 2 years after
the date if entry into application of these provisions (3 years in total) to be brought in
compliance (irrespective of whether there is a substantial modification or not).
12. Implementing acts and delegated acts
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With regard to delegated and implementing acts, the compromise text preserves the choices
as in the Council’s revised mandate, with the exception of two cases of implementing acts
where it was clarified that legally only delegated acts are possible, namely to update the
thresholds of FLOPs in Article 52a and to update the methodology for the classification of
high-impact models in Article 52b.
13. Penalties
The amounts of penalties for the infringements of the various aspects of the AI Act have
been fine tuned in Article 71. Notably, for non-compliance with the provisions concerning
prohibited AI practices outlined in Article 5, the penalty has been set at 35 million EUR or
7% of annual turnover, slightly above the limit set in the Council’s revised mandate, which
was 35 million EUR or 6.5% of annual turnover. On the other hand, the amounts of
penalties agreed for the remaining cases are slightly lower than in the Council’s position.
Finally, Article 72a sets out the fines for providers of general purpose AI models, in case of
infringements of the obligations or non-compliance with the enforcement measures, e.g.
requests for information. The maximum amount of fines has been aligned to those for
providers of high-risk AI systems. It is important to highlight that there will be an additional
grace period for providers of general purpose AI models, because no fines can be imposed
during the first year after entry into application of the rules.
14. Entry into application
On the entry of application as specified in Article 85, the compromise agreement provides
for 24 months with regard to most parts of the Regulation, with slightly shorter deadlines for
some elements, namely 6 months for prohibitions and 12 months for provisions concerning
notifying authorities and notified bodies, governance, general purpose AI models,
confidentiality and penalties, and a slightly longer deadline of 36 months for high-risk AI
systems covered by Annex II.
III. CONCLUSION
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1. The Presidency invites the Committee of the Permanent Representatives to:
a. endorse the annexed compromise text as agreed with the European Parliament during
the final trilogue, and
b. mandate the Presidency to inform the European Parliament that, should the European
Parliament adopt its position at first reading, in accordance with Article 294
paragraph 3 of the Treaty, in the form set out in the compromise package contained
in the Annex to this document (subject to revision by the lawyer linguists of both
institutions), the Council would, in accordance with Article 294, paragraph 4 of the
Treaty, approve the European Parliament’s position and the act shall be adopted in
the wording which corresponds to the European Parliament’s position.
_______________________
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ANNEX
2021/0106 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE
(ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION
LEGISLATIVE ACTS
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 European Central Bank2,
Having regard to the joint opinion of the European Data Protection Board and the European Data
Protection Supervisor,
Having regard to the opinion of the Committee of the Regions3,
Acting in accordance with the ordinary legislative procedure,
Whereas:
(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, placing on the
1
OJ C […], […], p. […].
2
Reference to ECB opinion.
3
OJ C […], […], p. […].
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market, putting into service and the use of artificial intelligence systems in the Union in
conformity with Union values, to promote the uptake of human centric and trustworthy
artificial intelligence while ensuring a high level of protection of health, safety,
fundamental rights enshrined in the Charter, including democracy and rule of law and
environmental protection, against harmful effects of artificial intelligence systems in the
Union and to support innovation. This regulation ensures the free movement of AI-based
goods and services cross-border, thus preventing Member States from imposing
restrictions on the development, marketing and use of Artificial Intelligence systems (AI
systems), unless explicitly authorised by this Regulation.
(1a) This Regulation should be applied in conformity with the values of the Union enshrined in
the Charter facilitating the protection of individuals, companies, democracy and rule of law
and the environment while boosting innovation and employment and making the Union a
leader in the uptake of trustworthy AI.
(2) AI systems can be easily deployed in multiple sectors of the economy 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
trustworthy and safe and is developed and used in compliance with fundamental rights
obligations. Differing national rules may lead to fragmentation of the internal market and
decrease legal certainty for operators that develop, import or use AI systems. A consistent
and high level of protection throughout the Union should therefore be ensured in order to
achieve trustworthy AI, while divergences hampering the free circulation, innovation,
deployment and uptake 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 remote biometric identification for the
purpose of law enforcement, for the use of AI systems for risk assessments of natural
persons for the purpose of law enforcement and for the use of AI systems of biometric
categorization for the purpose of law enforcement, it is appropriate to base this Regulation,
in as far as those specific rules are concerned, on Article 16 of the TFEU. In light of those
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specific rules and the recourse to Article 16 TFEU, it is appropriate to consult the
European Data Protection Board.
(3) Artificial intelligence is a fast evolving family of technologies that contributes to a wide
array of economic, environmental and societal benefits across the entire spectrum of
industries and social activities. By improving prediction, optimising operations and
resource allocation, and personalising digital solutions available for individuals and
organisations, the use of artificial intelligence can provide key competitive advantages to
companies and support socially and environmentally beneficial outcomes, for example in
healthcare, farming, food safety, education and training, media, sports, culture,
infrastructure management, energy, transport and logistics, public services, security,
justice, resource and energy efficiency, environmental monitoring, the conservation and
restoration of biodiversity and ecosystems and climate change mitigation and adaptation.
(4) At the same time, depending on the circumstances regarding its specific application, use,
and level of technological development, artificial intelligence may generate risks and cause
harm to public interests and fundamental rights that are protected by Union law. Such harm
might be material or immaterial, including physical, psychological, societal or economic
harm.
(4a) Given the major impact that artificial intelligence can have on society and the need to build
trust, it is vital for artificial intelligence and its regulatory framework to be developed
according to Union values enshrined in Article 2 TEU, the fundamental rights and
freedoms enshrined in the Treaties, the Charter. As a pre-requisite, artificial intelligence
should be a human-centric technology. It should serve as a tool for people, with the
ultimate aim of increasing human well-being.
(4aa) In order to ensure a consistent and high level of protection of public interests as regards
health, safety and fundamental rights, common rules for all high-risk AI systems should be
established. Those rules should be consistent with the Charter of fundamental rights of the
European Union (the Charter) and should be non-discriminatory and in line with the
Union’s international trade commitments. They should also take into account the European
Declaration on Digital Rights and Principles for the Digital Decade (2023/C 23/01) and the
Ethics Guidelines for Trustworthy Artificial Intelligence (AI) of the High-Level Expert
Group on Artificial Intelligence.
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(5) A Union legal framework laying down harmonised rules on artificial intelligence is
therefore needed to foster the development, use and uptake of artificial intelligence in the
internal 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, including democracy,
rule of law and environmental protection as recognised and protected by Union law. To
achieve that objective, rules regulating the placing on the market, putting into service and
use of certain AI systems should be laid down, thus ensuring the smooth functioning of the
internal market and allowing those systems to benefit from the principle of free movement
of goods and services. These rules should be clear and robust in protecting fundamental
rights, supportive of new innovative solutions, enabling to a European ecosystem of public
and private actors creating AI systems in line with Union values and unlocking the
potential of the digital transformation across all regions of the Union. By laying down
those rules as well as measures in support of innovation with a particular focus on SMEs
including startups, this Regulation supports the objective of promoting the European
human-centric approach to AI and being a global leader in the development of secure,
trustworthy and ethical artificial intelligence as stated by the European Council4, and it
ensures the protection of ethical principles, as specifically requested by the the European
Parliament5.
(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, and
protection of workers, and product safety, to which this Regulation is complementary. As a
consequence all rights and remedies provided for 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. Furthermore, in the context of employment and protection of workers, this
Regulation should therefore not affect Union law on social policy and national labour law,
in compliance with Union law, concerning employment and working conditions, including
4
European Council, Special meeting of the European Council (1 and 2 October 2020) – Conclusions, EUCO
13/20, 2020, p. 6.
5
European Parliament resolution of 20 October 2020 with recommendations to the Commission on a framework
of ethical aspects of artificial intelligence, robotics and related technologies, 2020/2012(INL).
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health and safety at work and the relationship between employers and workers. This
Regulation should also not affect the exercise of fundamental rights as recognised in the
Member States and at Union level, including the right or freedom to strike or to take other
action covered by the specific industrial relations systems in Member States as well as, the
right to negotiate, to conclude and enforce collective agreements or to take collective
action in accordance with national law. [This Regulation should not affect the provisions
aiming to improve working conditions in platform work set out in Directive ... [COD
2021/414/EC]] On top of that, this Regulation 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 effect of limiting the use of certain AI systems where such
laws fall outside the scope of this Regulation or pursue other legitimate public interest
objectives than those pursued by this Regulation. 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 legitimate public interest objectives, should not
be affected by this Regulation.
(5aa) The fundamental right to the protection of personal data is safeguarded in particular by
Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive 2016/680. Directive
2002/58/EC additionally protects private life and the confidentiality of communications,
including by way of providing conditions for any personal and non-personal data storing in
and access from terminal equipment. Those Union legal acts provide the basis for
sustainable and responsible data processing, including where datasets include a mix of
personal and non-personal data. This Regulation does not seek to affect the application of
existing Union law governing the processing of personal data, including the tasks and
powers of the independent supervisory authorities competent to monitor compliance with
those instruments. It also does not affect the obligations of providers and deployers of AI
systems in their role as data controllers or processors stemming from national or 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
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profiling. Harmonised rules for the placing on the market, the putting into service and the
use of AI systems established under this Regulation should facilitate the effective
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.
(5ab) This Regulation should be without prejudice to the provisions regarding the liability of
intermediary service providers set out in Directive 2000/31/EC of the European Parliament
and of the Council [as amended by the Digital Services Act].
(6) The notion of AI system in this Regulation should be clearly defined and closely aligned
with the work of international organisations working on artificial intelligence to ensure
legal certainty, facilitate international convergence and wide acceptance, while providing
the flexibility to accommodate the rapid technological developments in this field.
Moreover, it should be based on key characteristics of artificial intelligence systems, that
distinguish it from simpler traditional software systems or programming approaches and
should not cover systems that are based on the rules defined solely by natural persons to
automatically execute operations. A key characteristic of AI systems is their capability to
infer. This inference refers to the process of obtaining the outputs, such as predictions,
content, recommendations, or decisions, which can influence physical and virtual
environments and to a capability of AI systems to derive models and/or algorithms from
inputs/data. The techniques that enable inference while building an AI system include
machine learning approaches that learn from data how to achieve certain objectives; and
logic- and knowledge-based approaches that infer from encoded knowledge or symbolic
representation of the task to be solved. The capacity of an AI system to infer goes beyond
basic data processing, enable learning, reasoning or modelling. The term “machine-based”
refers to the fact that AI systems run on machines. The reference to explicit or implicit
objectives underscores that AI systems can operate according to explicit defined objectives
or to implicit objectives. The objectives of the AI system may be different from the
intended purpose of the AI system in a specific context. For the purposes of this
Regulation, environments should be understood as the contexts in which the AI systems
operate, whereas outputs generated by the AI system, reflect different functions performed
by AI systems and include predictions, content, recommendations or decisions. AI
systems are designed to operate with varying levels of autonomy, meaning that they have
some degree of independence of actions from human involvement and of capabilities to
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operate without human intervention. The adaptiveness that an AI system could exhibit after
deployment, refers to self-learning capabilities, allowing the system to change while in use.
AI systems can be used on a stand-alone basis or as a component of a product, irrespective
of whether the system is physically integrated into the product (embedded) or serve the
functionality of the product without being integrated therein (non-embedded).
(6a) The notion of ‘deployer’ 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
under its authority, except where the AI system is used in the course of a personal non-
professional activity. Depending on the type of AI system, the use of the system may affect
persons other than the deployer.
(7) The notion of biometric data used in this Regulation should be interpreted in light of the
notion of biometric data as defined in Article 4(14) of Regulation (EU) 2016/679 of the
European Parliament and of the Council 6, Article 3(18) of Regulation (EU) 2018/1725 of
the European Parliament and of the Council 7 and Article 3(13) of Directive (EU)
2016/680 of the European Parliament and of the Council 8.Biometric data can allow for the
authentication, identification or categorisation of natural persons and for the recognition of
emotions of natural persons.
(7a) The notion of biometric identification as used in this Regulation should be defined as the
automated recognition of physical, physiological and behavioural human features such as
the face, eye movement, body shape, voice, prosody, gait, posture, heart rate, blood
pressure, odour, keystrokes characteristics, for the purpose of establishing an individual’s
identity by comparing biometric data of that individual to stored biometric data of
individuals in a reference database, irrespective of whether the individual has given its
consent or not. This excludes AI systems intended to be used for biometric verification,
which includes authentication, whose sole purpose is to confirm that a specific natural
6
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection
of natural persons with regard to the processing of personal data and on the free movement of such data, and
repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
7
Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the
protection of natural persons with regard to the processing of personal data by the Union institutions, bodies,
offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and
Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39)
8
Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of
natural persons with regard to the processing of personal data by competent authorities for the purposes of the
prevention, 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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person is the person he or she claims to be and to confirm the identity of a natural person
for the sole purpose of having access to a service, unlocking a device or having security
access to premises.
(7b) The notion of biometric categorisation as used in this Regulation should be defined as
assigning natural persons to specific categories on the basis of their biometric data. Such
specific categories can relate to aspects such as sex, age, hair colour, eye colour, tattoos,
behavioural or personality traits, language, religion, membership of a national minority,
sexual or political orientation. This does not include biometric categorization systems that
are a purely ancillary feature intrinsically linked to another commercial service meaning
that the feature cannot, for objective technical reasons, be used without the principal
service and the integration of that feature or functionality is not a means to circumvent the
applicability of the rules of this Regulation. For example, filters categorizing facial or body
features used on online marketplaces could constitute such an ancillary feature as they can
only be used in relation to the principal service which consists in selling a product by
allowing the consumer to preview the display of the product on him or herself and help the
consumer to make a purchase decision. Filters used on online social network services
which categorise facial or body features to allow users to add or modify pictures or videos
could also be considered as ancillary feature as such filter cannot be used without the
principal service of the social network services consisting in the sharing of content online.
(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
without their active involvement, typically at a distance, through the comparison of a
person’s biometric data with the biometric data contained in a reference database,
irrespectively of the particular technology, processes or types of biometric data used. Such
remote biometric identification systems are typically used to perceive multiple persons or
their behaviour simultaneously in order to facilitate significantly the identification of
natural persons without their active involvement. This excludes AI systems intended to be
used for biometric verification, which includes authentication, whose sole purpose is to
confirm that a specific natural person is the person he or she claims to be and to confirm
the identity of a natural person for the sole purpose of having access to a service, unlocking
a device or having security access to premises. This exclusion is justified by the fact that
such systems are likely to have a minor impact on fundamental rights of natural persons
compared to the remote biometric identification systems which may be used for the
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processing of the biometric data of a large number of persons without their active
involvement. In the case of ‘real-time’ systems, the capturing of the biometric data, the
comparison and the identification occur all instantaneously, near-instantaneously or in any
event without a significant delay. In this regard, there should be no scope for
circumventing the rules of this Regulation on the ‘real-time’ use of the AI systems in
question 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 with
similar functionality. In the case of ‘post’ systems, in contrast, the biometric data have
already been captured and the comparison and identification occur only after a significant
delay. This involves material, such as pictures or video footage generated by closed circuit
television cameras or private devices, which has been generated before the use of the
system in respect of the natural persons concerned.
(8a) The notion of emotion recognition system for the purpose of this regulation should be
defined as an AI system for the purpose of identifying or inferring emotions or intentions
of natural persons on the basis of their biometric data. This refers to emotions or intentions
such as happiness, sadness, anger, surprise, disgust, embarrassment, excitement, shame,
contempt, satisfaction and amusement. It does not include physical states, such as pain or
fatigue. It does not refer for example to systems used in detecting the state of fatigue of
professional pilots or drivers for the purpose of preventing accidents. It does also not
include the mere detection of readily apparent expressions, gestures or movements, unless
they are used for identifying or inferring emotions. These expressions can be basic facial
expressions such as a frown or a smile, or gestures such as the movement of hands, arms or
head, or characteristics of a person’s voice, for example a raised voice or whispering.
(9) For the purposes of this Regulation the notion of publicly accessible space should be
understood as referring to any physical place that is accessible to an undetermined number
of natural persons, and irrespective of whether the place in question is privately or publicly
owned and irrespective 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
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restrictions, access is subject 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 if access 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 and workplaces that are intended to be accessed only by
relevant employees and service providers are places that are not publicly accessible.
Publicly accessible spaces should not include prisons or border control. Some other areas
may be composed of both not publicly accessible and publicly accessible areas, such as the
hallway of a private residential building 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 public should however be determined on a case-by-case basis,
having regard to the specificities of the individual situation at hand.
(9b) In order to obtain the greatest benefits from AI systems while protecting fundamental
rights, health and safety and to enable democratic control, AI literacy should equip
providers, deployers and affected persons with the necessary notions to make informed
decisions regarding AI systems. These notions may vary with regard to the relevant context
and can include understanding the correct application of technical elements during the AI
system’s development phase, the measures to be applied during its use, the suitable ways in
which to interpret the AI system’s output, and, in the case of affected persons, the
knowledge necessary to understand how decisions taken with the assistance of AI will
impact them. In the context of the application this Regulation, AI literacy should provide
all relevant actors in the AI value chain with the insights required to ensure the appropriate
compliance and its correct enforcement. Furthermore, the wide implementation of AI
literacy measures and the introduction of appropriate follow-up actions could contribute to
improving working conditions and ultimately sustain the consolidation, and innovation
path of trustworthy AI in the Union. The European Artificial Intelligence Board should
support the Commission, to promote AI literacy tools, public awareness and understanding
of the benefits, risks, safeguards, rights and obligations in relation to the use of AI systems.
In cooperation with the relevant stakeholders, the Commission and the Member States
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should facilitate the drawing up of voluntary codes of conduct to advance AI literacy
among persons dealing with the development, operation and use of AI.
(10) In order to ensure a level playing field and an effective protection of rights and freedoms of
individuals across the Union, the rules established by this Regulation should apply to
providers of AI systems in a non-discriminatory manner, irrespective of whether they are
established within the Union or in a third country, and to deployers of AI systems
established within the Union.
(11) In light of their digital nature, certain AI systems should fall within the scope of this
Regulation even when they are neither placed on the market, nor put into service, nor used
in 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 those
circumstances, 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 the circumvention of this Regulation and to ensure an effective protection of
natural persons located in the Union, this Regulation should also apply to providers and
deployers of AI systems that are established in a third country, to the extent the output
produced by those systems is intended to be used in the Union. 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 and international organisations when acting in
the framework of cooperation or international agreements concluded at national or
European level for law enforcement and judicial cooperation with the Union or with its
Member States, under the condition that this third country or international organisations
provide adequate safeguards with respect to the protection of fundamental rights and
freedoms of individuals. Where relevant, this may also cover activities of entities entrusted
by the third countries to carry out specific tasks in support of such law enforcement and
judicial cooperation. Such framework for cooperation or agreements have been established
bilaterally between Member States and third countries or between the European Union,
Europol and other EU agencies and third countries and international organisations. The
authorities competent for supervision of the law enforcement and judicial authorities under
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the AI Act should assess whether these frameworks for cooperation or international
agreements include adequate safeguards with respect to the protection of fundamental
rights and freedoms of individuals. Recipient Member States authorities and Union
institutions, offices and bodies making use of such outputs in the Union remain
accountable to ensure their use complies with Union law. When those international
agreements are revised or new ones are concluded in the future, the contracting parties
should undertake the utmost effort to align those agreements with the requirements of this
Regulation.
(12) This Regulation should also apply to Union institutions, offices, bodies and agencies when
acting as a provider or deployer of an AI system.
(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,
those should 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 specificities 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
regulation of AI systems in the context of the use of lethal force and other AI systems in
the context of military and defence activities. As regards national security purposes, the
exclusion is justified 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 needs of 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 for military, 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 this Regulation. 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 the market 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.), fall within the scope of this Regulation and providers of those systems
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should ensure compliance with 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.
(12c) This Regulation should support innovation, respect freedom of science, and should not
undermine research and development activity. It is therefore necessary to exclude from its
scope AI systems and models specifically developed and put into service for the sole
purpose of scientific research and development. Moreover, it is necessary to ensure that the
Regulation does not otherwise affect scientific research and development activity on AI
systems or models prior to being placed on the market or put into service. As regards
product oriented research, testing and development activity regarding AI systems or
models, the provisions of this Regulation should also not apply prior to these systems and
models being put into service or placed on the market. 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 and
development activity and to the application of provisions on regulatory sandboxes and
testing in real world conditions. Furthermore, without prejudice to the foregoing regarding
AI systems specifically developed and put into service for the sole purpose of scientific
research and development, any other AI system that may be used for the conduct of any
research and development activity should remain subject to the provisions of this
Regulation. Under all circumstances, any research and development activity should be
carried out in accordance with recognised ethical and professional standards for scientific
research and should be conducted according to applicable Union law.
(14) In order to introduce a proportionate and effective set of binding rules for AI systems, a
clearly defined risk-based approach should be followed. That approach should tailor the
type and content of such rules to the intensity and scope of the risks that AI systems can
generate. It is therefore necessary to prohibit certain unacceptable artificial intelligence
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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.
(14a) While the risk-based approach is the basis for a proportionate and effective set of binding
rules, it is important to recall the 2019 Ethics Guidelines for Trustworthy AI developed by
the independent High-Level Expert Group on AI (HLEG) appointed by the Commission.
In those Guidelines the HLEG developed seven non-binding ethical principles for AI
which should help ensure that AI is trustworthy and ethically sound. The seven principles
include: human agency and oversight; technical robustness and safety; privacy and data
governance; transparency; diversity, non-discrimination and fairness; societal and
environmental well-being and accountability. Without prejudice to the legally binding
requirements of this Regulation and any other applicable Union law, these Guidelines
contribute to the design of a coherent, trustworthy and human-centric Artificial
Intelligence, in line with the Charter and with the values on which the Union is founded.
According to the Guidelines of HLEG, human agency and oversight means that AI systems
are developed and used as a tool that serves people, respects human dignity and personal
autonomy, and that is functioning in a way that can be appropriately controlled and
overseen by humans. Technical robustness and safety means that AI systems are developed
and used in a way that allows robustness in case of problems and resilience against
attempts to alter the use or performance of the AI system so as to allow unlawful use by
third parties, and minimise unintended harm. Privacy and data governance means that AI
systems are developed and used in compliance with existing privacy and data protection
rules, while processing data that meets high standards in terms of quality and integrity.
Transparency means that AI systems are developed and used in a way that allows
appropriate traceability and explainability, while making humans aware that they
communicate or interact with an AI system, as well as duly informing deployers of the
capabilities and limitations of that AI system and affected persons about their rights.
Diversity, non-discrimination and fairness means that AI systems are developed and used
in a way that includes diverse actors and promotes equal access, gender equality and
cultural diversity, while avoiding discriminatory impacts and unfair biases that are
prohibited by Union or national law. Social and environmental well-being means that AI
systems are developed and used in a sustainable and environmentally friendly manner as
well as in a way to benefit all human beings, while monitoring and assessing the long-term
impacts on the individual, society and democracy. The application of these principles
should be translated, when possible, in the design and use of AI models. They should in
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any case serve as a basis for the drafting of codes of conduct under this Regulation. All
stakeholders, including industry, academia, civil society and standardisation organisations,
are encouraged to take into account as appropriate the ethical principles for the
development of voluntary best practices and standards.
(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 abusive 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.
(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 and impairs their autonomy, decision-making and free choices. The placing on the
market, putting into service or use of certain AI systems with the objective to or the effect
of materially distorting human behaviour, whereby significant harms, in particular having
sufficiently important adverse impacts on physical, psychological health or financial
interests are likely to occur, are particularly dangerous and should therefore be forbidden.
Such AI systems deploy subliminal components such as audio, image, video stimuli that
persons cannot perceive as those stimuli are beyond human perception or other
manipulative or deceptive 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
they are still deceived or not able to control or resist. This could be for example, facilitated
by machine-brain interfaces or virtual reality as they allow for a higher degree of control of
what stimuli are presented to persons, insofar as they may be materially distorting their
behaviour in a significantly harmful manner. In addition, AI systems may also otherwise
exploit vulnerabilities of a person or 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 used with the objective to or the effect of materially distorting
the behaviour of a person and in a manner that causes or is reasonably likely to cause
significant harm to that or another person or groups of persons, including harms that may
be accumulated over time and should therefore be prohibited. The intention to distort the
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behaviour may not be presumed if the distortion results from factors external to the AI
system which are outside of the control of the provider or the deployer, meaning factors
that may not be reasonably foreseen and mitigated by the provider or the deployer of the
AI system. In any case, it is not necessary for the provider or the deployer to have the
intention to cause significant harm, as long as such harm results from the manipulative or
exploitative AI-enabled practices. The prohibitions for such AI practices are
complementary to the provisions contained in Directive 2005/29/EC, notably 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
or otherwise. The prohibitions of manipulative and exploitative practices in this
Regulation should not affect lawful practices in the context of medical treatment such as
psychological treatment of a mental disease or physical rehabilitation, when those practices
are carried out in accordance with the applicable legislation and medical standards, for
example explicit consent of the individuals or their legal representatives. In addition,
common and legitimate commercial practices, for example in the field of advertising, that
are in compliance with the applicable law should not in themselves be regarded as
constituting harmful manipulative AI practices.
(16a) Biometric categorisation systems that are based on individuals’ biometric data, such as an
individual person’s face or fingerprint, to deduce or infer an individuals’ political opinions,
trade union membership, religious or philosophical beliefs, race, sex life or sexual
orientation should be prohibited. This prohibition does not cover the lawful labelling,
filtering or categorisation of biometric datasets acquired in line with Union or national law
according to biometric data, such as the sorting of images according to hair colour or eye
colour, which can for example be used in the area of law enforcement.
(17) AI systems providing social scoring of natural persons by public or 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 or groups thereof based on multiple data points related
to their social behaviour in multiple contexts or known, inferred or predicted personal or
personality characteristics over certain periods of time. The social score obtained from
such AI systems may lead to the detrimental or unfavourable treatment of natural persons
or whole groups thereof in social contexts, which are unrelated to the context in which the
data was originally generated or collected or to a detrimental treatment that is
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disproportionate or unjustified to the gravity of their social behaviour. AI systems entailing
such unacceptable scoring practices leading to such detrimental or unfavourable outcomes
should be therefore prohibited. This prohibition should not affect lawful evaluation
practices of natural persons done for a specific purpose in compliance with national and
Union law.
(18) The use of AI systems for ‘real-time’ remote biometric identification of natural persons in
publicly accessible spaces for the purpose of law enforcement is particularly intrusive to
the rights and freedoms of the concerned persons, to the extent that it may affect the
private life of a large part of the population, evoke a feeling of constant surveillance and
indirectly dissuade the exercise of the freedom of assembly and other fundamental rights.
Technical inaccuracies of AI systems intended for the remote biometric identification of
natural persons can lead to biased results and entail discriminatory effects. This is
particularly relevant when it comes to age, ethnicity, race, sex or disabilities. In addition,
the immediacy of the impact and the limited opportunities for further checks or corrections
in relation to the use of such systems operating in ‘real-time’ carry heightened risks for the
rights and freedoms of the persons that are concerned by law enforcement activities.
(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 the risks. Those situations involve the search for certain victims of crime
including missing people; certain threats to the life or physical safety of natural persons or
of a terrorist attack; and the localisation or identification of perpetrators or suspects of the
criminal offences referred to in Annex IIa 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 four years and as they are defined 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, the list of criminal
offences as referred in Annex IIa is based on the 32 criminal offences listed in the Council
Framework Decision 2002/584/JHA9, taking into account that some are in practice likely
to be more relevant than others, in that the recourse to ‘real-time’ remote biometric
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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identification will foreseeably be necessary and proportionate to highly varying degrees for
the practical pursuit of the localisation or identification of a perpetrator or suspect of the
different criminal offences listed and having regard to the likely differences in the
seriousness, probability and scale of the harm or possible negative consequences.
An imminent threat to life or physical safety of natural persons could also result from a
serious disruption of critical infrastructure, as defined in Article 2, point (a) of Directive
2008/114/EC, where the disruption or destruction of such critical infrastructure would
result in an imminent threat to life or physical safety of a person, including through serious
harm to the provision of basic supplies to the population or to the exercise of the core
function of the State.
In addition, this Regulation should preserve the ability for law enforcement, border control,
immigration or asylum authorities to carry out identity checks in the presence of the person
that is concerned in accordance with 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.
(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 nature of the situation giving rise to the request and the consequences of the use for the
rights and freedoms of all persons concerned and the safeguards and conditions provided
for with the use. In addition, the use of ‘real-time’ remote biometric identification systems
in publicly accessible spaces for the purpose of law enforcement should only be deployed
to confirm the specifically target individual’s identity and should be limited to what is
strictly necessary concerning the period of time as well as geographic and personal scope,
having regard in particular to the evidence or indications regarding the threats, the victims
or perpetrator. The use of the ‘real-time’ remote biometric identification system in publicly
accessible spaces should only be authorised if the law enforcement authority has completed
a fundamental rights impact assessment and, unless provided otherwise in this Regulation,
has registered the system in the database as set out in this Regulation. The reference
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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 specific
authorisation by a judicial authority or by an independent administrative authority whose
decision is binding of a Member State. Such authorisation should in principle be obtained
prior to the use of the system with a view to identify a person or persons. Exceptions to this
rule should be allowed in duly justified situations of urgency, that is, situations where the
need to use the systems in question 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 and conditions, 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 request such
authorisation whilst providing the reasons for not having been able to request it earlier,
without undue delay and, at the latest within 24 hours. If such authorisation is rejected, the
use of real-time biometric identification systems linked to that authorisation should be
stopped with immediate effect and all the data related to such use should be discarded and
deleted. Such data includes input data directly acquired by an AI system in the course of
the use of such system as well as the results and outputs of the use linked to that
authorisation. It should not include input legally acquired in accordance with another
national or Union law. In any case, no decision producing an adverse legal effect on a
person may be taken solely based on the output of the remote biometric identification
system.
(21a) In order to carry out their tasks in accordance with the requirements set out in this
Regulation as well as in national rules, the relevant market surveillance authority and the
national data protection authority should be notified of each use of the ‘real-time biometric
identification system’. National market surveillance authorities and the national data
protection authorities that have been notified should submit to the Commission an annual
report on the use of ‘real-time biometric identification systems’.
(22) Furthermore, it is appropriate to provide, within the exhaustive framework set by this
Regulation that such use in the territory of a Member State in accordance with this
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Regulation 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 of
national 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 the objectives capable of justifying authorised use identified in this Regulation.
These national rules should be notified to the Commission at the latest 30 days following
their adoption.
(23) The use of AI systems for ‘real-time’ remote biometric identification of natural persons in
publicly accessible spaces for the purpose of law enforcement necessarily involves the
processing 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 in
respect 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,
outside that framework, for the competent authorities, where they act for purpose of law
enforcement, to use such systems and process such data in connection thereto on the
grounds listed in Article 10 of Directive (EU) 2016/680. In this context, this Regulation is
not intended 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
by competent 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
than law enforcement should therefore not be subject to the requirement of an authorisation
under this Regulation and the applicable detailed rules of national law that may give effect
to it.
(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’ remote
biometric 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
than law enforcement, Article 9(1) of Regulation (EU) 2016/679 and Article 10(1) of
Regulation (EU) 2018/1725 prohibit the processing of biometric data subject to limited
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exceptions as provided in those articles. In application of Article 9(1) of Regulation (EU)
2016/679, the use of remote biometric identification for purposes other than law
enforcement has already been subject to prohibition decisions by national data protection
authorities.
(25) In accordance with Article 6a of Protocol No 21 on the position of the United Kingdom
and Ireland in respect of the area of freedom, security and justice, as annexed to the TEU
and to the TFEU, Ireland is not bound by the rules laid down in Article 5(1), point (d), (2),
(3), (3a), (4) and (5), Article 5(1)(ba) to the extent it applies to the use of biometric
categorisation systems for activities in the field of police cooperation and judicial
cooperation in criminal matters, Article 5(1)(da) to the extent it applies to the use of AI
systems covered by that provision and Article 29(6a) of this Regulation adopted on the
basis of Article 16 of the TFEU which relate to the processing of personal data by the
Member States when carrying out activities falling within the scope of Chapter 4 or
Chapter 5 of Title V of Part Three of the TFEU, where Ireland is not bound by the rules
governing the forms of judicial cooperation 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,
annexed to the TEU and TFEU, Denmark is not bound by rules laid down in Article 5(1),
point (d), (2), (3), (3a), (4) and (5), Article 5(1)(ba) to the extent it applies to the use of
biometric categorisation systems for activities in the field of police cooperation and
judicial cooperation in criminal matters, Article 5(1)(da) to the extent it applies to the use
of AI systems covered by that provision and Article 29(6a) 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 of Part Three of the TFEU.
(26a) In line with the presumption of innocence, natural persons in the EU should always be
judged on their actual behaviour. Natural persons should never be judged on AI-predicted
behaviour based solely on their profiling, personality traits or characteristics, such as
nationality, place of birth, place of residence, number of children, debt, their type of car,
without a reasonable suspicion of that person being involved in a criminal activity based on
objective verifiable facts and without human assessment thereof. Therefore, risk
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assessments of natural persons in order to assess the risk of them offending or for
predicting the occurrence of an actual or potential criminal offence solely based on the
profiling of a natural person or on assessing their personality traits and characteristics
should be prohibited. In any case, this prohibition does not refer to nor touch upon risk
analytics that are not based on the profiling of individuals or on the personality traits and
characteristics of individuals, such as AI systems using risk analytics to assess the risk of
financial fraud by undertakings based on suspicious transactions or risk analytic tools to
predict the likelihood of localisation of narcotics or illicit goods by customs authorities, for
example based on known trafficking routes.
(26b) The placing on the market, putting into service for this specific purpose, or use of AI
systems that create or expand facial recognition databases through the untargeted scraping
of facial images from the internet or CCTV footage should be prohibited, as this practice
adds to the feeling of mass surveillance and can lead to gross violations of fundamental
rights, including the right to privacy.
(26c) There are serious concerns about the scientific basis of AI systems aiming to identify or
infer emotions, particularly as expression of emotions vary considerably across cultures
and situations, and even within a single individual. Among the key shortcomings of such
systems are the limited reliability, the lack of specificity and the limited generalizability.
Therefore, AI systems identifying or inferring emotions or intentions of natural persons on
the basis of their biometric data may lead to discriminatory outcomes and can be intrusive
to the rights and freedoms of the concerned persons. Considering the imbalance of power
in the context of work or education, combined with the intrusive nature of these systems,
such systems could lead to detrimental or unfavourable treatment of certain natural persons
or whole groups thereof. Therefore, the placing on the market, putting into service, or use
of AI systems intended to be used to detect the emotional state of individuals in situations
related to the workplace and education should be prohibited. This prohibition should not
cover AI systems placed on the market strictly for medical or safety reasons, such as
systems intended for therapeutical use.
(26d) Practices that are prohibited by Union legislation, including data protection law, non-
discrimination law, consumer protection law, and competition law, should not be affected
by this Regulation.
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(27) High-risk AI systems should only be placed on the Union market, put into service or used
if they comply with certain mandatory requirements. Those requirements should ensure
that high-risk AI systems available in the Union or whose output is otherwise used in the
Union do not pose unacceptable risks to important Union public interests as recognised and
protected by Union law. Following the New Legislative Framework approach, as clarified
in Commission notice the ‘Blue Guide’ on the implementation of EU product rules 2022
(C/2022/3637) the general rule is that several pieces of the EU legislation, such as
Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In Vitro
Diagnostic Devices or Directive 2006/42/EC on Machinery, may have to be taken into
consideration for one product, since the making available or putting into service can only
take place when the product complies with all applicable Union harmonisation legislation.
To ensure consistency and avoid unnecessary administrative burden or costs, providers of a
product that contains one or more high-risk artificial intelligence system, to which the
requirements of this Regulation as well as requirements of the Union harmonisation
legislation listed in Annex II, Section A apply, should have a flexibility on operational
decisions on how to ensure compliance of a product that contains one or more artificial
intelligence systems with all applicable requirements of the Union harmonised legislation
in a best way. AI systems identified as high-risk should be limited to those that have a
significant harmful impact on the health, safety and fundamental rights of persons in the
Union and such limitation minimises any potential restriction to international trade, if any.
(28) AI systems could have an adverse impact to health and safety of persons, in particular
when such systems operate as safety components of products. Consistently with the
objectives of Union harmonisation legislation to facilitate the free movement of products in
the internal market and to ensure that only safe and otherwise compliant products find their
way into the market, 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 in complex environments. Similarly, in the health sector where the
stakes for life and health are particularly high, increasingly sophisticated diagnostics
systems and systems supporting human decisions should be reliable and accurate.
(28a) The extent of the adverse impact caused by the AI system on the fundamental rights
protected by the Charter is of particular relevance when classifying an AI system as high-
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risk. Those rights include the right to human dignity, respect for private and family life,
protection of personal data, freedom of expression and information, freedom of assembly
and of association, and non-discrimination, right to education consumer protection,
workers’ rights, rights of persons with disabilities, gender equality, intellectual property
rights, right to an effective remedy and to a fair trial, right of defence and the presumption
of innocence, right to good administration. In addition to those rights, it is important to
highlight that children have specific 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 the children’s vulnerabilities and provision of such protection and
care as necessary for their well-being. The fundamental right to a high level of
environmental protection enshrined in the Charter and implemented in Union policies
should also be considered when assessing the severity of the harm that an AI system can
cause, including in relation to the health and safety of persons.
(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
300/2008 of the European Parliament and of the Council10, Regulation (EU) No 167/2013
of the European 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,
10
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).
11
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).
12
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 and quadricycles (OJ L 60, 2.3.2013, p. 52).
13
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).
14
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).
15
Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and
market surveillance of motor vehicles and their trailers, and of systems, components and separate technical
units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and
repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).
16
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)
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and Regulation (EU) 2019/2144 of the European Parliament and of the Council17, it is
appropriate to amend those acts to ensure that the Commission takes into account, on the
basis of the technical and regulatory specificities of each sector, and without interfering
with existing governance, conformity assessment and enforcement mechanisms and
authorities established therein, the mandatory requirements for high-risk AI systems laid
down in this Regulation when adopting any relevant future delegated or implementing acts
on the basis of those acts.
(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 listed in
Annex II, it is appropriate 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 potentially explosive 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 not
necessarily 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 the
relevant Union harmonisation legislation that applies to the product. This is notably the
case for Regulation (EU) 2017/745 of the European Parliament and of the Council18 and
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).
17
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, and systems, components and separate technical
units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and
vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and
repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament
and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010,
(EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU)
No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No
351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1).
18
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 and
repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
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Regulation (EU) 2017/746 of the European Parliament and of the Council19, where a third-
party conformity assessment is provided for medium-risk and high-risk products.
(32) As regards stand-alone AI systems, meaning 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 light of their intended purpose, they pose a high risk of
harm to the health and safety or the fundamental rights of persons, taking into account both
the severity of the possible harm and its probability of occurrence and they are used in a
number of specifically pre-defined areas specified in 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 that the Commission should be empowered
to adopt, via delegated acts, to take into account the rapid pace of technological
development, as well as the potential changes in the use of AI systems.
(32a) It is also important to clarify that there may be specific cases in which AI systems referred
to pre-defined areas specified in this Regulation do not lead to a significant risk of harm to
the legal interests protected under those areas, because they do not materially influence the
decision-making or do not harm those interests substantially. For the purpose of this
Regulation an AI system not materially influencing the outcome of decision-making
should be understood as an AI system that does not impact the substance, and thereby the
outcome, of decision-making, whether human or automated. This could be the case if one
or more of the following conditions are fulfilled. The first criterion should be that the AI
system is intended to perform a narrow procedural task, such as an AI system that
transforms unstructured data into structured data, an AI system that classifies incoming
documents into categories or an AI system that is used to detect duplicates among a large
number of applications. These tasks are of such narrow and limited nature that they pose
only limited risks which are not increased through the use in a context listed in Annex III.
The second criterion should be that the task performed by the AI system is intended to
improve the result of a previously completed human activity that may be relevant for the
purpose of the use case listed in Annex III. Considering these characteristics, the AI system
only provides an additional layer to a human activity with consequently lowered risk. For
example, this criterion would apply to AI systems that are intended to improve the
language used in previously drafted documents, for instance in relation to professional
19
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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tone, academic style of language or by aligning text to a certain brand messaging. The third
criterion should be that the AI system is intended to detect decision-making patterns or
deviations from prior decision-making patterns. The risk would be lowered because the use
of the AI system follows a previously completed human assessment which it is not meant
to replace or influence, without proper human review. Such AI systems include for
instance those that, given a certain grading pattern of a teacher, can be used to check ex
post whether the teacher may have deviated from the grading pattern so as to flag potential
inconsistencies or anomalies. The fourth criterion should be that the AI system is intended
to perform a task that is only preparatory to an assessment relevant for the purpose of the
use case listed in Annex III, thus making the possible impact of the output of the system
very low in terms of representing a risk for the assessment to follow. For example, this
criterion covers smart solutions for file handling, which include various functions from
indexing, searching, text and speech processing or linking data to other data sources, or AI
systems used for translation of initial documents. In any case, AI systems referred to in
Annex III should be considered to pose significant risks of harm to the health, safety or
fundamental rights of natural persons if the AI system implies profiling within the meaning
of Article 4(4) of Regulation (EU) 2016/679 and Article 3(4) of Directive (EU) 2016/680
and Article 3(5) of Regulation 2018/1725. To ensure traceability and transparency, a
provider who considers that an AI system referred to in Annex III is not high-risk on the
basis of the aforementioned criteria should draw up documentation of the assessment
before that system is placed on the market or put into service and should provide this
documentation to national competent authorities upon request. Such provider should be
obliged to register the system in the EU database established under this Regulation. With a
view to provide further guidance for the practical implementation of the criteria under
which AI systems referred to in Annex III are exceptionally not high-risk, the Commission
should, after consulting the AI Board, provide guidelines specifying this practical
implementation completed by a comprehensive list of practical examples of high risk and
non-high risk use cases of AI systems.
(33a) As biometric data constitutes a special category of sensitive personal data, it is appropriate
to classify as high-risk several critical use-cases of biometric systems, insofar as their use
is permitted under relevant Union and national law. Technical inaccuracies of AI systems
intended for the remote biometric identification of natural persons can lead to biased
results and entail discriminatory effects. This is particularly relevant when it comes to age,
ethnicity, race, sex or disabilities. Therefore, remote biometric identification systems
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should be classified as high-risk in view of the risks that they pose. This excludes AI
systems intended to be used for biometric verification, which includes authentication,
whose sole purpose is to confirm that a specific natural person is the person he or she
claims to be and to confirm the identity of a natural person for the sole purpose of having
access to a service, unlocking a device or having secure access to premises.
In addition, AI systems intended to be used for biometric categorisation according to
sensitive attributes or characteristics protected under Article 9(1) of Regulation (EU)
2016/679 based on biometric data, in so far as these are not prohibited under this
Regulation, and emotion recognition systems that are not prohibited under this Regulation,
should be classified as high-risk. Biometric systems which are intended to be used solely
for the purpose of enabling cybersecurity and personal data protection measures should not
be considered as high-risk systems.
(34) As regards the management and operation of critical infrastructure, it is appropriate to
classify as high-risk the AI systems intended to be used as safety components in the
management and operation of critical digital infrastructure as listed in 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 and
health of persons at large scale and lead to appreciable disruptions in the ordinary conduct
of social and economic activities. Safety components of critical infrastructure, including
critical digital infrastructure, are systems used to directly protect the physical integrity of
critical infrastructure or health and safety of persons and property but which are not
necessary 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 for cybersecurity purposes should not qualify as safety components. Examples
of safety components of such critical infrastructure may include systems for monitoring
water pressure or fire alarm controlling systems in cloud computing centres.
(35) Deployment of AI systems in education is important to promote high-quality digital
education and training and to allow all learners and teachers to acquire and share the
necessary digital skills and competences, including media literacy, and critical thinking, to
take an active part in the economy, society, and in democratic processes. However, AI
systems used in education or vocational training, notably for determining access or
admission, for assigning persons to educational and vocational training institutions or
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programmes at all levels, for evaluating learning outcomes of persons, for assessing the
appropriate level of education for an individual and materially influencing the level of
education and training that individuals will receive or be able to access or for monitoring
and detecting prohibited behaviour of students during tests should be classified as high-risk
AI systems, since they may determine the educational and professional course of a
person’s life and therefore affect their ability to secure their livelihood. When improperly
designed and used, such systems can be particularly intrusive and may violate the right to
education and training as well as the right not to be discriminated against and perpetuate
historical patterns of discrimination, for example against women, certain age groups,
persons with disabilities, or persons of certain racial or ethnic origins or sexual orientation.
(36) AI systems used in employment, workers management and access to self-employment,
notably for the recruitment and selection of persons, for making decisions affecting terms
of the work related relationship promotion and termination of work-related contractual
relationships for allocating tasks based on individual behaviour, personal traits or
characteristics and for monitoring or evaluation of persons in work-related contractual
relationships, should also be classified as high-risk, since those systems may appreciably
impact future career prospects, livelihoods of these persons and workers’ rights. Relevant
work-related contractual relationships should meaningfully involve employees and persons
providing services through platforms as referred to in the Commission Work Programme
2021. Throughout the recruitment process and in the evaluation, promotion, or retention of
persons in work-related contractual relationships, such systems may perpetuate historical
patterns of discrimination, for example against women, certain age groups, persons with
disabilities, or persons of certain racial or ethnic origins or sexual orientation. AI systems
used to monitor the performance and behaviour of these persons may also undermine their
fundamental rights to data protection and privacy.
(37) Another area in which the use of AI systems deserves special consideration is the access to
and enjoyment of certain essential private and public services and benefits necessary for
people to fully participate in society or to improve one’s standard of living. In particular,
natural persons applying for or receiving essential public assistance benefits and services
from public authorities namely healthcare services, social security benefits, social services
providing protection in cases such as maternity, illness, industrial accidents, dependency or
old age and loss of employment and social and housing assistance, are typically dependent
on those benefits and services and in a vulnerable position in relation to the responsible
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authorities. If AI systems are used for determining whether such benefits and services
should be granted, denied, reduced, revoked or reclaimed by authorities, including whether
beneficiaries are legitimately entitled to such benefits or services, those systems may have
a significant impact on persons’ livelihood and may infringe their fundamental rights, such
as the right to social protection, non-discrimination, human dignity or an effective remedy
and should therefore be classified as high-risk. Nonetheless, this Regulation should not
hamper the development and use of innovative approaches in the public administration,
which would stand to benefit from a wider use of compliant and safe AI systems, provided
that those systems do not entail a high risk to legal and natural persons. In addition, AI
systems used to evaluate the credit score or creditworthiness of natural persons should be
classified as high-risk AI systems, since they determine those persons’ access to financial
resources or essential services such as housing, electricity, and telecommunication
services. AI systems used for this purpose may lead to discrimination of persons or groups
and perpetuate historical patterns of discrimination, for example based on racial or ethnic
origins, gender, disabilities, age, sexual orientation, or create new forms of discriminatory
impacts. However, AI systems provided for by Union law for the purpose of detecting
fraud in the offering of financial services and for prudential purposes to calculate credit
institutions’ and insurances undertakings’ capital requirements should not be considered as
high-risk under this Regulation. Moreover, AI systems intended to be used for risk
assessment and pricing in relation to natural persons for health and life insurance can also
have a significant impact on persons’ livelihood and if not duly designed, developed and
used, can infringe their fundamental rights and can lead to serious consequences for
people’s life and health, including financial exclusion and discrimination. Finally, AI
systems used to evaluate and classify emergency calls by natural persons or to dispatch or
establish priority in the dispatching of emergency first response services, including by
police, firefighters and medical aid, as well as of emergency healthcare patient triage
systems, should also be classified as high-risk since they make decisions in very critical
situations for the life and health of persons and their property.
(38) Given their role and responsibility, actions by law enforcement authorities involving
certain uses of AI systems are characterised by a significant degree of power imbalance
and may lead to surveillance, arrest or deprivation of a natural person’s liberty as well as
other adverse impacts on fundamental rights guaranteed in the Charter. In particular, if the
AI system is not trained with high quality data, does not meet adequate requirements in
terms of its performance, its accuracy or robustness, or is not properly designed and tested
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before being put on the market or otherwise put into service, it may single out people in a
discriminatory or otherwise incorrect or unjust manner. Furthermore, the exercise of
important procedural fundamental rights, such as the right to an effective remedy and to a
fair trial as well as the right of defence and the presumption of innocence, could be
hampered, in particular, where such AI systems are not sufficiently transparent,
explainable and documented. It is therefore appropriate to classify as high-risk, insofar as
their use is permitted under relevant Union and national law, a number of AI systems
intended to be used in the law enforcement context where accuracy, reliability and
transparency is particularly important to avoid adverse impacts, retain public trust and
ensure accountability and effective redress. In view of the nature of the activities in
question and the risks relating thereto, those high-risk AI systems should include in
particular AI systems intended to be used by or on behalf of law enforcement authorities or
by Union agencies, offices or bodies in support of law enforcement authorities for
assessing the risk of a natural person to become a victim of criminal offences, as
polygraphs and similar tools , for the evaluation of the reliability of evidence in in the
course of investigation or prosecution of criminal offences, and, insofar not prohibited
under this regulation, for assessing the risk of a natural person of offending or reoffending
not solely based on profiling of natural persons nor based on assessing personality traits
and characteristics or past criminal behaviour of natural persons or groups, for profiling in
the course of detection, investigation or prosecution of criminal offences, . AI systems
specifically intended to be used for administrative proceedings by tax and customs
authorities as well as by financial intelligence units carrying out administrative tasks
analysing information pursuant to Union anti-money laundering legislation should not be
classified as high-risk AI systems used by law enforcement authorities for the purposes of
prevention, detection, investigation and prosecution of criminal offences. The use of AI
tools by law enforcement and authorities should not become a factor of inequality, or
exclusion. The impact of the use of AI tools on the defence rights of suspects should not be
ignored, notably the difficulty in obtaining meaningful information on the functioning of
these systems and the consequent difficulty in challenging their results in court, in
particular by individuals under investigation.
(39) AI systems used in migration, asylum and border control management affect people who
are often in particularly vulnerable position and who are dependent on the outcome of the
actions of the competent public authorities. The accuracy, non-discriminatory nature and
transparency of the AI systems used in those contexts are therefore particularly important
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to guarantee 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, insofar as their use is permitted under relevant Union and national law AI
systems intended to be used by or on behalf of competent public authorities or by Union
agencies, offices or bodies charged with tasks in the fields of migration, asylum and border
control management as polygraphs and similar tools, for assessing certain risks posed by
natural persons entering the territory of a Member State or applying for visa or asylum, for
assisting competent public authorities for the examination, including related assessment of
the reliability of evidence, of applications for asylum, visa and residence permits and
associated complaints with regard to the objective to establish the eligibility of the natural
persons applying for a status, for the purpose of detecting, recognising or identifying
natural persons in the context of migration, asylum and border control management with
the exception of travel documents. AI systems in the area of migration, asylum and border
control management covered by this Regulation should comply with the relevant
procedural requirements set by the Directive 2013/32/EU of the European Parliament and
of the Council20, the Regulation (EC) No 810/2009 of the European Parliament and of the
Council21 and other relevant legislation. The use of AI systems in migration, asylum and
border control management should in no circumstances be used by Member States or
Union institutions, agencies or bodies as a means to circumvent their international
obligations under the Convention of 28 July 1951 relating to the Status of Refugees as
amended by the Protocol of 31 January 1967, nor should they be used to in any way
infringe on the principle of non-refoulement, or deny safe and effective legal avenues into
the territory of the Union, including the right to international protection.
(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 and
to a fair trial. In particular, to address the risks of potential biases, errors and opacity, it is
appropriate to qualify as high-risk AI systems intended to be used by a judicial authority or
on its behalf to assist judicial authorities in researching and interpreting facts and the law
and in applying the law to a concrete set of facts. AI systems intended to be used by
20
Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures
for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60).
21
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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alternative dispute resolution bodies for those purposes should also be considered high-risk
when the outcomes of the alternative dispute resolution proceedings produce legal effects
for the parties. The use of artificial intelligence tools can support the decision-making
power of judges or judicial independence, but should not replace it, as the final decision-
making must remain a human-driven activity and decision. Such qualification should not
extend, however, to AI systems intended for purely ancillary administrative activities that
do not affect the actual administration of justice in individual cases, such as anonymisation
or pseudonymisation of judicial decisions, documents or data, communication between
personnel, administrative tasks.
(40a) Without prejudice to the rules provided for in [Regulation xxx on the transparency and
targeting of political advertising], and in order to address the risks of undue external
interference to the right to vote enshrined in Article 39 of the Charter, and of adverse
effects on democracy, and the rule of law, AI systems intended to be used to influence the
outcome of an election or referendum or the voting behaviour of natural persons in the
exercise of their vote in elections or referenda should be classified as high-risk AI systems
with the exception of AI systems whose output natural persons are not directly exposed to,
such as tools used to organise, optimise and structure political campaigns from an
administrative and logistical point of view.
(41) The fact that an AI system is classified as a high-risk AI system under this Regulation
should not be interpreted as indicating that the use of the system is lawful under other acts
of Union law or under national law compatible with Union law, such as on the protection
of personal data, on the use of polygraphs and similar tools or other systems to detect the
emotional state of natural persons. Any such use should continue to occur solely in
accordance with the applicable requirements resulting from the Charter and from the
applicable acts of secondary Union law and national law. This Regulation should not be
understood as providing for the legal ground for processing of personal data, including
special categories of personal data, where relevant, unless it is specifically provided for
otherwise in this Regulation.
(42) To mitigate the risks from high-risk AI systems placed on the market or put into service
and to ensure a high level of trustworthiness, certain mandatory requirements should apply
to high-risk AI systems, taking into account the intended purpose and the context of use of
the AI system and according to the risk management system to be established by the
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provider. The measures adopted by the providers to comply with the mandatory
requirements of this Regulation should take into account the generally acknowledge state
of the art on artificial intelligence, be proportionate and effective to meet the objectives of
this Regulation. Following the New Legislative Framework approach, as clarified in
Commission notice the ‘Blue Guide’ on the implementation of EU product rules 2022
(C/2022/3637), the general rule is that several pieces of the EU legislation may have to be
taken into consideration for one product, since the making available or putting into service
can only take place when the product complies with all applicable Union harmonisation
legislation. Hazards of AI systems covered by the requirements of this Regulation concern
different aspects than the existing Union harmonisation acts and therefore the requirements
of this Regulation would complement the existing body of the Union harmonisation acts.
For example, machinery or medical devices products incorporating an AI system might
present risks not addressed by the essential health and safety requirements set out in the
relevant Union harmonised legislation, as this sectoral legislation does not deal with risks
specific to AI systems. This calls for a simultaneous and complementary application of the
various legislative acts. To ensure consistency and avoid unnecessary administrative
burden or costs, providers of a product that contains one or more high-risk artificial
intelligence system, to which the requirements of this Regulation as well as requirements
of the Union harmonisation legislation listed in Annex II, Section A apply, should have a
flexibility on operational decisions on how to ensure compliance of a product that contains
one or more artificial intelligence systems with all applicable requirements of the Union
harmonised legislation in a best way. This flexibility could mean, for example a decision
by the provider to integrate a part of the necessary testing and reporting processes,
information and documentation required under this Regulation into already existing
documentation and procedures required under the existing Union harmonisation legislation
listed in Annex II, Section A. This however should not in any way undermine the
obligation of the provider to comply with all the applicable requirements.
(42a) The risk management system should consist of a continuous, iterative process that is
planned and run throughout the entire lifecycle of a high-risk AI system. This process
should be aimed at identifying and mitigating the relevant risks of artificial intelligence
systems on health, safety and fundamental rights. The risk management system should be
regularly reviewed and updated to ensure its continuing effectiveness, as well as
justification and documentation of any significant decisions and actions taken subject to
this Regulation. This process should ensure that the provider identifies risks or adverse
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impacts and implements mitigation measures for the known and reasonably foreseeable
risks of artificial intelligence systems to the health, safety and fundamental rights in light
of its intended purpose and reasonably foreseeable misuse, including the possible risks
arising from the interaction between the AI system and the environment within which it
operates. The risk management system should adopt the most appropriate risk management
measures in the light of the state of the art in AI. When identifying the most appropriate
risk management measures, the provider should document and explain the choices made
and, when relevant, involve experts and external stakeholders. In identifying reasonably
foreseeable misuse of high-risk AI systems the provider should cover uses of the AI
systems which, while not directly covered by the intended purpose and provided for in the
instruction for use may nevertheless be reasonably expected to result from readily
predictable human behaviour in the context of the specific characteristics and use of the
particular AI system. Any known or foreseeable circumstances, related to the use of the
high-risk AI system in accordance with its intended purpose or under conditions of
reasonably foreseeable misuse, which may lead to risks to the health and safety or
fundamental rights should be included in the instructions for use provided by the provider.
This is to ensure that the deployer is aware and takes them into account when using the
high-risk AI system. Identifying and implementing risk mitigation measures for
foreseeable misuse under this Regulation should not require specific additional training
measures for the high-risk AI system by the provider to address them. The providers
however are encouraged to consider such additional training measures to mitigate
reasonable foreseeable misuses as necessary and appropriate.
(43) Requirements should apply to high-risk AI systems as regards risk management, the
quality and relevance of data sets used, technical documentation and record-keeping,
transparency and the provision of information to deployers, human oversight, and
robustness, accuracy and cybersecurity. Those requirements are necessary to effectively
mitigate the risks for health, safety and fundamental rights, and no other less trade
restrictive measures are reasonably available, thus avoiding unjustified restrictions to trade.
(44) High quality data and access to high quality data plays a vital role in providing structure
and in ensuring the performance of many AI systems, especially when techniques
involving the training of models are used, with a view to ensure that the high-risk AI
system performs as intended and safely and it does not become a source of discrimination
prohibited by Union law. High quality datasets for training, validation and testing require
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the implementation of appropriate data governance and management practices. Datasets for
training, validation and testing, including the labels, should be relevant, sufficiently
representative, and to the best extent possible free of errors and complete in view of the
intended purpose of the system. In order to facilitate compliance with EU data protection
law, such as Regulation (EU) 2016/679, data governance and management practices
should include, in the case of personal data, transparency about the original purpose of the
data collection, The datasets should also have the appropriate statistical properties,
including as regards the persons or groups of persons in relation to whom the high-risk AI
system is intended to be used, with specific attention to the mitigation of possible biases in
the datasets, that are likely to affect the health and safety of persons, negatively impact
fundamental rights or lead to discrimination prohibited under Union law, especially where
data outputs influence inputs for future operations (‘feedback loops’) . Biases can for
example be inherent in underlying datasets, especially when historical data is being used,
or generated when the systems are implemented in real world settings. Results provided by
AI systems could be influenced by such inherent biases that are inclined to gradually
increase and thereby perpetuate and amplify existing discrimination, in particular for
persons belonging to certain vulnerable groups including racial or ethnic groups. The
requirement for the datasets to be to the best extent possible complete and free of errors
should not affect the use of privacy-preserving techniques in the context of the
development and testing of AI systems. In particular, datasets should take into account, to
the extent required by their intended purpose, the features, characteristics or elements that
are particular to the specific geographical, contextual, behavioural or functional setting
which the AI system is intended to be used. The requirements related to data governance
can be complied with by having recourse to third parties that offer certified compliance
services including verification of data governance, data set integrity, and data training,
validation and testing practices, as far as compliance with the data requirements of this
Regulation are ensured.
(45) For the development and assessment 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 their respective 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
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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 of AI systems.
(45a) The right to privacy and to protection of personal data must be guaranteed throughout the
entire lifecycle of the AI system. In this regard, the principles of data minimisation and
data protection by design and by default, as set out in Union data protection law, are
applicable when personal data are processed. Measures taken by providers to ensure
compliance with those principles may include not only anonymisation and encryption, but
also the use of technology that permits algorithms to be brought to the data and allows
training of AI systems without the transmission between parties or copying of the raw or
structured data themselves, without prejudice to the requirements on data governance
provided for in this Regulation.
(44c) In order to protect the right of others from the discrimination that might result from the
bias in AI systems, the providers should, exceptionally, to the extent that it is strictly
necessary for the purposes of ensuring bias detection and correction in relation to the high-
risk AI systems, subject to appropriate safeguards for the fundamental rights and freedoms
of natural persons and following the application of all applicable conditions laid down
under this Regulation in addition to the conditions laid down in Regulation (EU) 2016/679,
Directive (EU) 2016/680 and Regulation (EU) 2018/1725,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.
(46) Having comprehensible information on how high-risk AI systems have been developed
and how they perform throughout their lifetime is essential to enable traceability of those
systems, verify compliance with the requirements under this Regulation, as well as
monitoring of their operations and post market monitoring. This requires keeping records
and the availability of a technical documentation, containing information which is
necessary to assess the compliance of the AI system with the relevant requirements and
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facilitate post market monitoring. Such information should include the general
characteristics, capabilities and limitations of the system, algorithms, data, training, testing
and validation processes used as well as documentation on the relevant risk management
system and drawn in a clear and comprehensive form. The technical documentation should
be kept up to date, appropriately throughout the lifetime of the AI system. Furthermore,
high risk AI systems should technically allow for automatic recording of events (logs) over
the duration of the lifetime of the system.
(47) To address concerns related to opacity and complexity of certain AI systems and help
deployers to fulfil their obligations under this Regulation, transparency should be required
for high-risk AI systems before they are placed on the market or put it into service. High-
risk AI systems should be designed in a manner to enable deployers to understand how the
AI system works, evaluate its functionality, and comprehend its strengths and limitations.
High-risk AI systems should be accompanied by appropriate information in the form of
instructions of use. Such information should include the characteristics, capabilities and
limitations of performance of the AI system. These would cover information on possible
known and foreseeable circumstances related to the use of the high-risk AI system,
including deployer action that may influence system behaviour and performance, under
which the AI system can lead to risks to health, safety, and fundamental rights, on the
changes that have been pre-determined and assessed for conformity by the provider and on
the relevant human oversight measures, including the measures to facilitate the
interpretation of the outputs of the AI system by the deployers. Transparency, including the
accompanying instructions for use, should assist deployers in the use of the system and
support informed decision making by them. Among others, deployers should be in a better
position to make the correct choice of the system they intend to use in the light of the
obligations applicable to them, be educated about the intended and precluded uses, and use
the AI system correctly and as appropriate. In order to enhance legibility and accessibility
of the information included in the instructions of use, where appropriate, illustrative
examples, for instance on the limitations and on the intended and precluded uses of the AI
system, should be included. Providers should ensure that all documentation, including the
instructions for use, contains meaningful, comprehensive, accessible and understandable
information, taking into account the needs and foreseeable knowledge of the target
deployers. Instructions for use should be made available in a language which can be easily
understood by target deployers, as determined by the Member State concerned.
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(48) High-risk AI systems should be designed and developed in such a way that natural persons
can oversee their functioning, ensure that they are used as intended and that their impacts
are addressed over the system’s lifecycle. 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 the system is subject to in-built operational constraints that cannot be
overridden by the system itself and is responsive to the human operator, and that the
natural persons to whom human oversight has been assigned have the necessary
competence, training and authority to carry out that role. It is also essential, as appropriate,
to ensure that high-risk AI systems include mechanisms to guide and inform a natural
person to whom human oversight has been assigned to make informed decisions if, when
and how to intervene in order to avoid negative consequences or risks, or stop the system if
it does not perform as intended. Considering the significant consequences for persons in
case of incorrect matches by certain biometric identification systems, it is appropriate to
provide for an enhanced human oversight requirement for those systems so that no action
or decision may be taken by the deployer on the basis of the identification resulting from
the system unless this has been separately verified and confirmed by at least 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 sufficient that the separate verifications by the different persons are
automatically recorded in the logs generated by the system. Given the specificities of the
areas of law enforcement, migration, border control and asylum, this requirement should
not apply in cases where Union or national law considers the application of this
requirement to be disproportionate.
(49) High-risk AI systems should perform consistently throughout their lifecycle and meet an
appropriate level of accuracy, robustness and cybersecurity, in the light of their intended
purpose and in accordance with the generally acknowledged state of the art. The
Commission and relevant organisations and stakeholders are encouraged to take due
consideration of mitigation of risks and negative impacts of the AI system. The expected
level of performance metrics should be declared in the accompanying instructions of use.
Providers are urged to communicate this information to deployers in a clear and easily
understandable way, free of misunderstandings or misleading statements. The EU
legislation on legal metrology, including on Measuring Instruments Directive (MID) and
Non-automatic weighing instruments (NAWI) Directive, aims to ensure the accuracy of
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measurements and to help the transparency and fairness of commercial transactions. In this
context, in cooperation with relevant stakeholders and organisation, such as metrology and
benchmarking authorities, the Commission should encourage, as appropriate, the
development of benchmarks and measurement methodologies for AI systems. In doing so,
the Commission should take note and collaborate with international partners working on
metrology and relevant measurement indicators relating to Artificial Intelligence.
(50) The technical robustness is a key requirement for high-risk AI systems. They should be
resilient in relation to harmful or otherwise undesirable behaviour that may result from
limitations within the systems or the environment in which the systems operate (e.g. errors,
faults, inconsistencies, unexpected situations). Therefore, technical and organisational
measures should be taken to ensure robustness of high-risk AI systems, for example by
designing and developing appropriate technical solutions to prevent or minimize harmful
or otherwise undesirable behaviour. Those technical solution may include for instance
mechanisms enabling the system 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 by
malicious 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) or
trained models (e.g. adversarial attacks or membership inference), or exploit vulnerabilities
in the AI system’s digital assets or the underlying ICT infrastructure. To ensure a level of
cybersecurity appropriate to the risks, suitable measures, such as security controls, should
therefore be taken by the providers of high-risk AI systems, also taking into account as
appropriate the underlying ICT infrastructure.
(51a) Without prejudice to the requirements related to robustness and accuracy set out in this
Regulation, high-risk AI systems which fall within the scope of the Regulation 2022/0272,
in accordance with Article 8 of the Regulation 2022/0272 may demonstrate compliance
with the cybersecurity requirement of this Regulation by fulfilling the essential
cybersecurity requirements set out in Article 10 and Annex I of the Regulation
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2022/0272.When high-risk AI systems fulfil the essential requirements of Regulation
2022/0272, they should be deemed compliant with the cybersecurity requirements set out
in this Regulation in so far as the achievement of those requirements is demonstrated in the
EU declaration of conformity or parts thereof issued under Regulation 2022/0272. For this
purpose, the assessment of the cybersecurity risks, associated to a product with digital
elements classified as high-risk AI system according to this Regulation, carried out under
Regulation 2022/0272, should consider risks to the cyber resilience of an AI system as
regards attempts by unauthorised third parties to alter its use, behaviour or performance,
including AI specific vulnerabilities such as data poisoning or adversarial attacks, as well
as, as relevant, risks to fundamental rights as required by this Regulation. The conformity
assessment procedure provided by this Regulation should apply in relation to the essential
cybersecurity requirements of a product with digital elements covered by Regulation
2022/0272 and classified as a high-risk AI system under this Regulation. However, this
rule should not result in reducing the necessary level of assurance for critical products with
digital elements covered by Regulation 2022/0272. Therefore, by way of derogation from
this rule, high-risk AI systems that fall within the scope of this Regulation and are also
qualified as important and critical products with digital elements pursuant to Regulation
2022/0272 and to which the conformity assessment procedure based on internal control
referred to in Annex VI of this Regulation applies, are subject to the conformity
assessment provisions of Regulation 2022/0272 insofar as the essential cybersecurity
requirements of Regulation 2022/0272 are concerned. In this case, for all the other aspects
covered by this Regulation the respective provisions on conformity assessment based on
internal control set out in Annex VI of this Regulation should apply. Building on the
knowledge and expertise of ENISA on the cybersecurity policy and tasks assigned to
ENISA under the Regulation 2019/1020 the European Commission should cooperate with
ENISA on issues related to cybersecurity of AI systems.
(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
22
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the
requirements for accreditation and market surveillance relating to the marketing of products and repealing
Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
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768/2008/EC of the European Parliament and of the Council23 on a common framework
for the marketing of products and Regulation (EU) 2019/1020 of the European Parliament
and of the Council24 on market surveillance and compliance of products (‘New Legislative
Framework for the marketing of products’).
(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.
(53a) As signatories to the United Nations Convention on the Rights of Persons with Disabilities
(UNCRPD), the Union and the Member States are legally obliged to protect persons with
disabilities from discrimination and promote their equality, to ensure that persons with
disabilities have access, on an equal basis with others, to information and communications
technologies and systems, and to ensure respect for privacy for persons with disabilities.
Given the growing importance and use of AI systems, the application of universal design
principles to all new technologies and services should ensure full and equal access for
everyone potentially affected by or using AI technologies, including persons with
disabilities, in a way that takes full account of their inherent dignity and diversity. It is
therefore essential that Providers ensure full compliance with accessibility requirements,
including Directive (EU) 2016/2102 and Directive (EU) 2019/882. Providers should ensure
compliance with these requirements by design. Therefore, the necessary measures should
be integrated as much as possible into the design of the high-risk AI system.
(54) The provider should establish a sound quality management system, ensure the
accomplishment of the required conformity assessment procedure, draw up the relevant
documentation and establish a robust post-market monitoring system. Providers of high-
risk AI systems that are subject to obligations regarding quality management systems
under relevant sectorial Union law should have the possibility to include the elements of
the quality management system provided for in this Regulation as part of the existing
quality management system provided for in that other sectorial Union legislation. The
23
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).
24
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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complementarity between this Regulation and existing sectorial Union law should also be
taken into account in future standardization activities or guidance adopted by the
Commission. Public authorities which put into service high-risk AI systems for their own
use may adopt and implement the rules for the quality management system as part of the
quality management system adopted at a national or regional level, as appropriate, taking
into account the specificities of the sector and the competences and organisation of the
public authority in question.
(56) To enable enforcement of this Regulation and create a level-playing field for operators, and
taking into account the different forms of making available of digital products, it is
important to ensure that, under all circumstances, a person established in the Union can
provide authorities with all the necessary information on the compliance of an AI system.
Therefore, prior to making their AI systems available in the Union, providers established
outside the Union shall, by written mandate, appoint an authorised representative
established in the Union. This authorised representative plays a pivotal 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 who are not established in the Union and in serving as their
contact person established in the Union.
(56a) In the light of the nature and complexity of the value chain for AI systems and in line with
New Legislative Framework principles, it is essential to ensure legal certainty and facilitate
the compliance with this Regulation. Therefore, it is necessary to clarify the role and the
specific obligations of relevant operators along the value chain, such as importers and
distributors who may contribute to the development of AI systems. In certain situations
those operators could act in more than one role at the same time and should therefore fulfil
cumulatively all relevant obligations associated with those roles. For example, an operator
could act as a distributor and an importer at the same time.
(57) To ensure legal certainty, it is necessary to clarify that, under certain specific conditions,
any distributor, importer, deployer or other third-party should be considered a provider of a
high-risk AI system and therefore assume all the relevant obligations. This would be the
case if that party puts its name or trademark on a high-risk AI system already placed on the
market or put into service, without prejudice to contractual arrangements stipulating that
the obligations are allocated otherwise, or if that party make a substantial modification to a
high-risk AI system that has already been placed on the market or has already been put into
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service and in a way that it remains a high-risk AI system in accordance with Article 6, or
if it modifies the intended purpose of an AI system, including a general purpose AI system,
which has not been classified as high-risk and has already been placed on the market or
put into service, in a way that the AI system becomes a high-risk AI system in accordance
with Article 6. These provisions should apply without prejudice to more 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 applicable requirements,
should continue to apply to high-risk AI systems that are medical devices within the
meaning of that Regulation.
(57a) General purpose AI systems may be used as high-risk 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, the providers of
such systems should, irrespective of whether they may be used as high-risk AI systems as
such by other providers or as components of high-risk AI systems and unless provided
otherwise under this Regulation, closely cooperate with the providers of the respective
high-risk AI systems to enable their compliance with the relevant obligations under this
Regulation and with the competent authorities established under this Regulation.
(57b) Where, under the conditions laid down in this Regulation, the provider that initially placed
the AI system on the market or put it into service should no longer be considered the
provider for the purposes of this Regulation, and when that provider has not expressly
excluded the change of the AI system into a high-risk AI system, the former provider
should nonetheless closely cooperate and make available the necessary information and
provide the reasonably expected technical access and other assistance that are required for
the fulfilment of the obligations set out in this Regulation, in particular regarding the
compliance with the conformity assessment of high-risk AI systems.
(57c) In addition, where a high-risk AI system that is a safety component of a product which is
covered by a relevant 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
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obligations of the provider established in this Regulation and notably ensure that the AI
system embedded in the final product complies with the requirements of this Regulation.
(57d) Within the AI value chain multiple parties often supply AI systems, tools and services but
also components or processes that are incorporated by the provider into the AI system with
various objectives, including the model training, model retraining, model testing and
evaluation, integration into software, or other aspects of model development. These parties
have an important role in the value chain towards the provider of the high-risk AI system
into which their AI systems, tools, services, components or processes are integrated, and
should provide by written agreement this provider with the necessary information,
capabilities, technical access and other assistance based on the generally acknowledged
state of the art, in order to enable the provider to fully comply with the obligations set out
in this Regulation, without compromising their own intellectual property rights or trade
secrets.
(57e) Third parties making accessible to the public tools, services, processes, or AI components
other than general-purpose AI models, shall not be mandated to comply with requirements
targeting the responsibilities along the AI value chain, in particular towards the provider
that has used or integrated them, when those tools, services, processes, or AI components
are made accessible under a free and open licence. Developers of free and open-source
tools, services, processes, or AI components other than general-purpose AI models should
be encouraged to implement widely adopted documentation practices, such as model cards
and data sheets, as a way to accelerate information sharing along the AI value chain,
allowing the promotion of trustworthy AI systems in the Union.
(57f) The Commission could develop and recommend voluntary model contractual terms
between providers of high-risk AI systems and third parties that supply tools, services,
components or processes that are used or integrated in high-risk AI systems, to facilitate
the cooperation along the value chain. When developing voluntary model contractual
terms, the Commission should also take into account possible contractual requirements
applicable in specific sectors or business cases.
(58) Given the nature of AI systems and the risks to safety and fundamental rights possibly
associated with their use, including as regards the need to ensure proper monitoring of the
performance of an AI system in a real-life setting, it is appropriate to set specific
responsibilities for deployers. Deployers should in particular take appropriate technical and
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organisational measures to ensure they use high-risk AI systems in accordance with the
instructions of use and certain other obligations should be provided for with regard to
monitoring of the functioning of the AI systems and with regard to record-keeping, as
appropriate. Furthermore, deployers should ensure that the persons assigned to implement
the instructions for use and human oversight as set out in this Regulation have the
necessary competence, in particular an adequate level of AI literacy, training and authority
to properly fulfil those tasks. These obligations should be without prejudice to other
deployer obligations in relation to high-risk AI systems under Union or national law.
(58b) This Regulation is without prejudice to obligations for employers to inform or to inform
and consult workers or their representatives under Union or national law and practice,
including directive 2002/14/EC on a general framework for informing and consulting
employees, on decisions to put into service or use AI systems. It remains necessary to
ensure information of workers and their representatives on the planned deployment of
high-risk AI systems at the workplace in cases where the conditions for those information
or information and consultation obligations in other legal instruments are not fulfilled.
Moreover, such information right is ancillary and necessary to the objective of protecting
fundamental rights that underlies this Regulation. Therefore, an information requirement to
that effect should be laid down in this regulation, without affecting any existing rights of
workers.
(58b) Whilst risks related to AI systems can result from the way such systems are designed, risks
can as well stem from how such AI systems are used. Deployers of high-risk AI system
therefore play a critical role in ensuring that fundamental rights are protected,
complementing the obligations of the provider when developing the AI system. Deployers
are best placed to understand how the high-risk AI system will be used concretely and can
therefore identify potential significant risks that were not foreseen in the development
phase, due to a more precise knowledge of the context of use, the people or groups of
people likely to be affected, including vulnerable groups. Deployers of high-risk AI
systems referred to in Annex III also play a critical role in informing natural persons and
should, when they make decisions or assist in making decisions related to natural persons,
where applicable, inform the natural persons that they are subject to the use of the high risk
AI system. This information should include the intended purpose and the type of decisions
it makes. The deployer should also inform the natural person about its right to an
explanation provided under this Regulation. With regard to high-risk AI systems used for
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law enforcement purposes, this obligation should be implemented in accordance with
Article 13 of Directive 2016/680.
(58d) Any processing of biometric data involved in the use of AI systems for biometric
identification for the purpose of law enforcement needs to comply with Article 10 of
Directive (EU) 2016/680, that allows such processing only where strictly necessary,
subject to appropriate safeguards for the rights and freedoms of the data subject, and where
authorised by Union or Member State law. Such use, when authorized, also needs to
respect the principles laid down in Article 4 paragraph 1 of Directive (EU) 2016/680
including lawfulness, fairness and transparency, purpose limitation, accuracy and storage
limitation.
(58e) Without prejudice to applicable Union law, notably the GDPR and Directive (EU)
2016/680 (the Law Enforcement Directive), considering the intrusive nature of post remote
biometric identification systems, the use of post remote biometric identification systems
shall be subject to safeguards. Post biometric identification systems should always be used
in a way that is proportionate, legitimate and strictly necessary, and thus targeted, in terms
of the individuals to be identified, the location, temporal scope and based on a closed
dataset of legally acquired video footage. In any case, post remote biometric identification
systems should not be used in the framework of law enforcement to lead to indiscriminate
surveillance. The conditions for post remote biometric identification should in any case not
provide a basis to circumvent the conditions of the prohibition and strict exceptions for real
time remote biometric identification.
(58g) In order to efficiently ensure that fundamental rights are protected, deployers of high-risk
AI systems that are bodies governed by public law, or private operators providing public
services and operators deploying certain high-risk AI system referred to in Annex III, such
as banking or insurance entities, should carry out a fundamental rights impact assessment
prior to putting it into use. Services important for individuals that are of public nature may
also be provided by private entities. Private operators providing such services of public
nature are linked to tasks in the public interest such as in the area of education, healthcare,
social services, housing, administration of justice. The aim of the fundamental rights
impact assessment is for the deployer to identify the specific risks to the rights of
individuals or groups of individuals likely to be affected, identify measures to be taken in
case of the materialisation of these risks. The impact assessment should apply to the first
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use of the high-risk AI system, and should be updated when the deployer considers that
any of the relevant factors have changed. The impact assessment should identify the
deployer’s relevant processes in which the high-risk AI system will be used in line with its
intended purpose, and should include a description of the period of time and frequency in
which the system is intended to be used as well as of specific categories of natural persons
and groups who are likely to be affected in the specific context of use. The assessment
should also include the identification of specific risks of harm likely to impact the
fundamental rights of these persons or groups. While performing this assessment, the
deployer should take into account information relevant to a proper assessment of impact,
including but not limited to the information given by the provider of the high-risk AI
system in the instructions for use. In light of the risks identified, deployers should
determine measures to be taken in case of the materialization of these risks, including for
example governance arrangements in that specific context of use, such as arrangements for
human oversight according to the instructions of use or, complaint handling and redress
procedures, as they could be instrumental in mitigating risks to fundamental rights in
concrete use-cases. After performing this impact assessment, the deployer should notify
the relevant market surveillance authority. Where appropriate, to collect relevant
information necessary to perform the impact assessment, deployers of high-risk AI system,
in particular when AI systems are used in the public sector, could involve relevant
stakeholders, including the representatives of groups of persons likely to be affected by the
AI system, independent experts, and civil society organisations in conducting such impact
assessments and designing measures to be taken in the case of materialization of the risks.
The AI Office should develop a template for a questionnaire in order to facilitate
compliance and reduce the administrative burden for deployers.
(60a) The notion of general purpose AI models should be clearly defined and set apart from the
notion of AI systems to enable legal certainty. The definition should be based on the key
functional characteristics of a general-purpose AI model, in particular the generality and
the capability to competently perform a wide range of distinct tasks. These models are
typically trained on large amounts of data, through various methods, such as self-
supervised, unsupervised or reinforcement learning. General purpose AI models may be
placed on the market in various ways, including through libraries, application
programming interfaces (APIs), as direct download, or as physical copy. These models
may be further modified or fine-tuned into new models. Although AI models are essential
components of AI systems, they do not constitute AI systems on their own. AI models
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require the addition of further components, such as for example a user interface, to become
AI systems. AI models are typically integrated into and form part of AI systems. This
Regulation provides specific rules for general purpose AI models and for general purpose
AI models that pose systemic risks, which should apply also when these models are
integrated or form part of an AI system. It should be understood that the obligations for the
providers of general purpose AI models should apply once the general purpose AI models
are placed on the market. When the provider of a general purpose AI model integrates an
own model into its own AI system that is made available on the market or put into service,
that model should be considered as being placed on the market and, therefore, the
obligations in this Regulation for models should continue to apply in addition to those for
AI systems. The obligations foreseen for models should in any case not apply when an own
model is used for purely internal processes that are not essential for providing a product or
a service to third parties and the rights of natural persons are not affected. Considering
their potential significantly negative effects, the general-purpose AI models with systemic
risk should always be subject to the relevant obligations under this Regulation. The
definition should not cover AI models used before their placing on the market for the sole
purpose of research, development and prototyping activities. This is without prejudice to
the obligation to comply with this Regulation when, following such activities, a model is
placed on the market.
(60b) Whereas the generality of a model could, among other criteria, also be determined by a
number of parameters, models with at least a billion of parameters and trained with a large
amount of data using self-supervision at scale should be considered as displaying
significant generality and competently performing a wide range of distinctive tasks.
(60c) Large generative AI models are a typical example for a general-purpose AI model, given
that they allow for flexible generation of content (such as in the form of text, audio, images
or video) that can readily accommodate a wide range of distinctive tasks.
(60d) When a general-purpose AI model is integrated into or forms part of an AI system, this
system should be considered a general-purpose AI system when, due to this integration,
this system has the capability to serve a variety of purposes. A general-purpose AI system
can be used directly, or it may be integrated into other AI systems.
(60e) Providers of general purpose AI models have a particular role and responsibility in the AI
value chain, as the models they provide may form the basis for a range of downstream
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systems, often provided by downstream providers that necessitate a good understanding of
the models and their capabilities, both to enable the integration of such models into their
products, and to fulfil their obligations under this or other regulations. Therefore,
proportionate transparency measures should be foreseen, including the drawing up and
keeping up to date of documentation, and the provision of information on the general
purpose AI model for its usage by the downstream providers. Technical documentation
should be prepared and kept up to date by the general purpose AI model provider for the
purpose of making it available, upon request, to the AI Office and the national competent
authorities. The minimal set of elements contained in such documentations should be
outlined, respectively, in Annex (IXb) and Annex (IXa). The Commission should be
enabled to amend the Annexes by delegated acts in the light of the evolving technological
developments.
(60i) Software and data, including models, released under a free and open-source licence that
allows them to be openly shared and where users can freely access, use, modify and
redistribute them or modified versions thereof, can contribute to research and innovation in
the market and can provide significant growth opportunities for the Union economy.
General purpose AI models released under free and open-source licences should be
considered to ensure high levels of transparency and openness if their parameters,
including the weights, the information on the model architecture, and the information on
model usage are made publicly available. The licence should be considered free and open-
source also when it allows users to run, copy, distribute, study, change and improve
software and data, including models under the condition that the original provider of the
model is credited, the identical or comparable terms of distribution are respected.
(60i+1) Free and open-source AI components covers the software and data, including models and
general purpose AI models, tools, services or processes of an AI system. Free and open-
source AI components can be provided through different channels, including their
development on open repositories. For the purpose of this Regulation, AI components that
are provided against a price or otherwise monetised, including through the provision of
technical support or other services, including through a software platform, related to the AI
component, or the use of personal data for reasons other than exclusively for improving the
security, compatibility or interoperability of the software, with the exception of
transactions between micro enterprises, should not benefit from the exceptions provided to
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free and open source AI components. The fact of making AI components available through
open repositories should not, in itself, constitute a monetisation.
(60f) The providers of general purpose AI models that are released under a free and open source
license, and whose parameters, including the weights, the information on the model
architecture, and the information on model usage, are made publicly available should be
subject to exceptions as regards the transparency-related requirements imposed on general
purpose AI models, unless they can be considered to present a systemic risk, in which case
the circumstance that the model is transparent and accompanied by an open source license
should not be considered a sufficient reason to exclude compliance with the obligations
under this Regulation. In any case, given that the release of general purpose AI models
under free and open source licence does not necessarily reveal substantial information on
the dataset used for the training or fine-tuning of the model and on how thereby the respect
of copyright law was ensured, the exception provided for general purpose AI models from
compliance with the transparency-related requirements should not concern the obligation
to produce a summary about the content used for model training and the obligation to put
in place a policy to respect Union copyright law in particular to identify and respect the
reservations of rights expressed pursuant to Article 4(3) of Directive (EU) 2019/790.
(60i) General purpose models, in particular large generative models, capable of generating text,
images, and other content, present unique innovation opportunities but also challenges to
artists, authors, and other creators and the way their creative content is created, distributed,
used and consumed. The development and training of such models require access to vast
amounts of text, images, videos, and other data. Text and data mining techniques may be
used extensively in this context for the retrieval and analysis of such content, which may
be protected by copyright and related rights. Any use of copyright protected content
requires the authorization of the rightholder concerned unless relevant copyright
exceptions and limitations apply. Directive (EU) 2019/790 introduced exceptions and
limitations allowing reproductions and extractions of works or other subject matter, for the
purposes of text and data mining, under certain conditions. Under these rules, rightholders
may choose to reserve their rights over their works or other subject matter to prevent text
and data mining, unless this is done for the purposes of scientific research. Where the
rights to opt out has been expressly reserved in an appropriate manner, providers of
general-purpose AI models need to obtain an authorisation from rightholders if they want
to carry out text and data mining over such works.
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(60j) Providers that place general purpose AI models on the EU market should ensure
compliance with the relevant obligations in this Regulation. For this purpose, providers of
general purpose AI models should put in place a policy to respect Union law on copyright
and related rights, in particular to identify and respect the reservations of rights expressed
by rightholders pursuant to Article 4(3) of Directive (EU) 2019/790. Any provider placing
a general purpose AI model on the EU market should comply with this obligation,
regardless of the jurisdiction in which the copyright-relevant acts underpinning the training
of these general purpose AI models take place. This is necessary to ensure a level playing
field among providers of general purpose AI models where no provider should be able to
gain a competitive advantage in the EU market by applying lower copyright standards than
those provided in the Union.
(60k) In order to increase transparency on the data that is used in the pre-training and training of
general purpose AI models, including text and data protected by copyright law, it is
adequate that providers of such models draw up and make publicly available a sufficiently
detailed summary of the content used for training the general purpose model. While taking
into due account the need to protect trade secrets and confidential business information,
this summary should be generally comprehensive in its scope instead of technically
detailed to facilitate parties with legitimate interests, including copyright holders, to
exercise and enforce their rights under Union law, for example by listing the main data
collections or sets that went into training the model, such as large private or public
databases or data archives, and by providing a narrative explanation about other data
sources used. It is appropriate for the AI Office to provide a template for the summary,
which should be simple, effective, and allow the provider to provide the required summary
in narrative form.
(60ka) With regard to the obligations imposed on providers of general purpose AI models to put
in place a policy to respect Union copyright law and make publicly available a summary of
the content used for the training, the AI Office should monitor whether the provider has
fulfilled those obligations without verifying or proceeding to a work-by-work assessment
of the training data in terms of copyright compliance. This Regulation does not affect the
enforcement of copyright rules as provided for under Union law.
(60g) Compliance with the obligations foreseen for the providers of general purpose AI models
should be commensurate and proportionate to the type of model provider, excluding the
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need for compliance for persons who develop or use models for non-professional or
scientific research purposes, who should nevertheless be encouraged to voluntarily comply
with these requirements. Without prejudice to Union Copyright law, compliance with these
obligations should take due account of the size of the provider and allow simplified ways
of compliance for SMEs including start-ups, that should not represent an excessive cost
and not discourage the use of such models. In case of a modification or fine-tuning of a
model, the obligations for providers should be limited to that modification or fine-tuning,
for example by complementing the already existing technical documentation with
information on the modifications, including new training data sources, as a means to
comply with the value chain obligations provided in this Regulation.
(60m) General purpose AI models could pose systemic risks which include, but are not limited to,
any actual or reasonably foreseeable negative effects in relation to major accidents,
disruptions of critical sectors and serious consequences to public health and safety; any
actual or reasonably foreseeable negative effects on democratic processes, public and
economic security; the dissemination of illegal, false, or discriminatory content. Systemic
risks should be understood to increase with model capabilities and model reach, can arise
along the entire lifecycle of the model, and are influenced by conditions of misuse, model
reliability, model fairness and model security, the degree of autonomy of the model, its
access to tools, novel or combined modalities, release and distribution strategies, the
potential to remove guardrails and other factors. In particular, international approaches
have so far identified the need to devote attention to risks from potential intentional misuse
or unintended issues of control relating to alignment with human intent; chemical,
biological, radiological, and nuclear risks, such as the ways in which barriers to entry can
be lowered, including for weapons development, design acquisition, or use; offensive
cyber capabilities, such as the ways in vulnerability discovery, exploitation, or operational
use can be enabled; the effects of interaction and tool use, including for example the
capacity to control physical systems and interfere with critical infrastructure; risks from
models of making copies of themselves or “self-replicating” or training other models; the
ways in which models can give rise to harmful bias and discrimination with risks to
individuals, communities or societies; the facilitation of disinformation or harming privacy
with threats to democratic values and human rights; risk that a particular event could lead
to a chain reaction with considerable negative effects that could affect up to an entire city,
an entire domain activity or an entire community.
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(60n) It is appropriate to establish a methodology for the classification of general purpose AI
models as general purpose AI model with systemic risks. Since systemic risks result from
particularly high capabilities, a general-purpose AI models should be considered to present
systemic risks if it has high-impact capabilities, evaluated on the basis of appropriate
technical tools and methodologies, or significant impact on the internal market due to its
reach. High-impact capabilities in general purpose AI models means capabilities that
match or exceed the capabilities recorded in the most advanced general-purpose AI
models. The full range of capabilities in a model could be better understood after its release
on the market or when users interact with the model. According to the state of the art at the
time of entry into force of this Regulation, the cumulative amount of compute used for the
training of the general purpose AI model measured in floating point operations (FLOPs) is
one of the relevant approximations for model capabilities. The amount of compute used for
training cumulates the compute used across the activities and methods that are intended to
enhance the capabilities of the model prior to deployment, such as pre-training, synthetic
data generation and fine-tuning. Therefore, an initial threshold of FLOPs should be set,
which, if met by a general-purpose AI model, leads to a presumption that the model is a
general-purpose AI model with systemic risks. This threshold should be adjusted over time
to reflect technological and industrial changes, such as algorithmic improvements or
increased hardware efficiency, and should be supplemented with benchmarks and
indicators for model capability. To inform this, the AI Office should engage with the
scientific community, industry, civil society and other experts. Thresholds, as well as tools
and benchmarks for the assessment of high-impact capabilities, should be strong predictors
of generality, its capabilities and associated systemic risk of general-purpose AI models,
and could take into taking into account the way the model will be placed on the market or
the number of users it may affect. To complement this system, there should be a possibility
for the Commission to take individual decisions designating a general-purpose AI model as
a general-purpose AI model with systemic risk if it is found that such model has
capabilities or impact equivalent to those captured by the set threshold. This decision
should be taken on the basis of an overall assessment of the criteria set out in Annex YY,
such as quality or size of the training data set, number of business and end users, its input
and output modalities, its degree of autonomy and scalability, or the tools it has access to.
Upon a reasoned request of a provider whose model has been designated as a general-
purpose AI model with systemic risk, the Commission should take the request into account
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and may decide to reassess whether the general-purpose AI model can still be considered
to present systemic risks.
(60o) It is also necessary to clarify a procedure for the classification of a general purpose AI
model with systemic risks. A general purpose AI model that meets the applicable threshold
for high-impact capabilities should be presumed to be a general purpose AI models with
systemic risk. The provider should notify the AI Office at the latest two weeks after the
requirements are met or it becomes known that a general purpose AI model will meet the
requirements that lead to the presumption. This is especially relevant in relation to the
FLOP threshold because training of general purpose AI models takes considerable
planning which includes the upfront allocation of compute resources and, therefore,
providers of general purpose AI models are able to know if their model would meet the
threshold before the training is completed. In the context of this notification, the provider
should be able to demonstrate that because of its specific characteristics, a general purpose
AI model exceptionally does not present systemic risks, and that it thus should not be
classified as a general purpose AI model with systemic risks. This information is valuable
for the AI Office to anticipate the placing on the market of general purpose AI models with
systemic risks and the providers can start to engage with the AI Office early on. This is
especially important with regard to general-purpose AI models that are planned to be
released as open-source, given that, after open-source model release, necessary measures to
ensure compliance with the obligations under this Regulation may be more difficult to
implement.
(60p) If the Commission becomes aware of the fact that a general purpose AI model meets the
requirements to classify as a general purpose model with systemic risk, which previously
had either not been known or of which the relevant provider has failed to notify the
Commission, the Commission should be empowered to designate it so. A system of
qualified alerts should ensure that the AI Office is made aware by the scientific panel of
general-purpose AI models that should possibly be classified as general purpose AI models
with systemic risk, in addition to the monitoring activities of the AI Office.
(60q) The providers of general-purpose AI models presenting systemic risks should be subject, in
addition to the obligations provided for providers of general purpose AI models, to
obligations aimed at identifying and mitigating those risks and ensuring an adequate level
of cybersecurity protection, regardless of whether it is provided as a standalone model or
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embedded in an AI system or a product. To achieve these objectives, the Regulation should
require providers to perform the necessary model evaluations, in particular prior to its first
placing on the market, including conducting and documenting adversarial testing of
models, also, as appropriate, through internal or independent external testing. In addition,
providers of general-purpose AI models with systemic risks should continuously assess
and mitigate systemic risks, including for example by putting in place risk management
policies, such as accountability and governance processes, implementing post-market
monitoring, taking appropriate measures along the entire model’s lifecycle and cooperating
with relevant actors across the AI value chain.
(60r) Providers of general purpose AI models with systemic risks should assess and mitigate
possible systemic risks. If, despite efforts to identify and prevent risks related to a general
purpose AI model that may present systemic risks, the development or use of the model
causes a serious incident, the general purpose AI model provider should without undue
delay keep track of the incident and report any relevant information and possible corrective
measures to the Commission and national competent authorities. Furthermore, providers
should ensure an adequate level of cybersecurity protection for the model and its physical
infrastructure, if appropriate, along the entire model lifecycle. Cybersecurity protection
related to systemic risks associated with malicious use of or attacks should duly consider
accidental model leakage, unsanctioned releases, circumvention of safety measures, and
defence against cyberattacks, unauthorised access or model theft. This protection could be
facilitated by securing model weights, algorithms, servers, and datasets, such as through
operational security measures for information security, specific cybersecurity policies,
adequate technical and established solutions, and cyber and physical access controls,
appropriate to the relevant circumstances and the risks involved.
(60s) The AI Office should encourage and facilitate the drawing up, review and adaptation of
Codes of Practice, taking into account international approaches. All providers of general-
purpose AI models could be invited to participate. To ensure that the Codes of Practice
reflect the state of the art and duly take into account a diverse set of perspectives, the AI
Office should collaborate with relevant national competent authorities, and could, where
appropriate, consult with civil society organisations and other relevant stakeholders and
experts, including the Scientific Panel, for the drawing up of the Codes. Codes of Practice
should cover obligations for providers of general-purpose AI models and of general-
purpose models presenting systemic risks. In addition, as regards systemic risks, Codes of
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Practice should help to establish a risk taxonomy of the type and nature of the systemic
risks at Union level, including their sources. Codes of practice should also be focused on
specific risk assessment and mitigation measures.
(60t) The Codes of Practice should represent a central tool for the proper compliance with the
obligations foreseen under this Regulation for providers of general-purpose AI models.
Providers should be able to rely on Codes of Practice to demonstrate compliance with the
obligations. By means of implementing acts, the Commission may decide to approve a
code of practice and give it a general validity within the Union, or, alternatively, to provide
common rules for the implementation of the relevant obligations, if, by the time the
Regulation becomes applicable, a Code of Practice cannot be finalised or is not deemed
adequate by the AI Office. Once a harmonised standard is published and assessed as
suitable to cover the relevant obligations by the AI Office, the compliance with a European
harmonised standard should grant providers the presumption of conformity. Providers of
general purpose AI models should furthermore be able to demonstrate compliance using
alternative adequate means, if codes of practice or harmonized standards are not available,
or they choose not to rely on those.
(60u) This Regulation regulates AI systems and models by imposing certain requirements and
obligations for relevant market actors that are placing them on the market, putting into
service or use in the Union, thereby complementing obligations for providers of
intermediary services that embed such systems or models into their services regulated by
Regulation (EU) 2022/2065. To the extent that such systems or models are embedded into
designated very large online platforms or very large online search engines, they are subject
to the risk management framework provided for in Regulation (EU) 2022/2065.
Consequently, the corresponding obligations of the AI Act should be presumed to be
fulfilled, unless significant systemic risks not covered by Regulation (EU) 2022/2065
emerge and are identified in such models. Within this framework, providers of very large
online platforms and very large search engines are obliged to assess potential systemic
risks stemming from the design, functioning and use of their services, including how the
design of algorithmic systems used in the service may contribute to such risks, as well as
systemic risks stemming from potential misuses. Those providers are also obliged to take
appropriate mitigating measures in observance of fundamental rights.
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(60aa) Considering the quick pace of innovation and the technological evolution of digital
services in scope of different instruments of Union law in particular having in mind the
usage and the perception of their recipients, the AI systems subject to this Regulation may
be provided as intermediary services or parts thereof within the meaning of Regulation
(EU) 2022/2065, which should be interpreted in a technology-neutral manner. For
example, AI systems may be used to provide online search engines, in particular, to the
extent that an AI system such as an online chatbot performs searches of, in principle, all
websites, then incorporates the results into its existing knowledge and uses the updated
knowledge to generate a single output that combines different sources of information.
(60v) Furthermore, obligations placed on providers and deployers of certain AI systems in this
Regulation to enable the detection and disclosure that the outputs of those systems are
artificially generated or manipulated are particularly relevant to facilitate the effective
implementation of Regulation (EU) 2022/2065. This applies in particular as regards the
obligations of providers of very large online platforms or very large online search engines
to identify and mitigate systemic risks that may arise from the dissemination of content that
has been artificially generated or manipulated, in particular risk of the actual or foreseeable
negative effects on democratic processes, civic discourse and electoral processes, including
through disinformation.
(61) Standardisation should play a key role to provide technical solutions to providers to ensure
compliance with this Regulation, in line with the state of the art, to promote innovation as
well as competitiveness and growth in the single market. Compliance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of
the Council25, which are normally expected to reflect the state of the art, should be a means
for providers to demonstrate conformity with the requirements of this Regulation. A
balanced representation of interests involving all relevant stakeholders in the development
of standards, in particular SME’s, consumer organisations and environmental and social
stakeholders in accordance with Article 5 and 6 of Regulation 1025/2012 should therefore
be encouraged. In order to facilitate compliance, the standardisation requests should be
issued by the Commission without undue delay. When preparing the standardisation
request, the Commission should consult the AI advisory Forum and the Board in order to
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 the
European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No
1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
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collect relevant expertise. However, in the absence of relevant references to harmonised
standards, the Commission should be able to establish, via implementing acts, and after
consultation of the AI Advisory forum, common specifications for certain requirements
under this Regulation. The common specification should be an exceptional fall back
solution to facilitate the provider’s obligation to comply with the requirements of this
Regulation, when the standardisation request has not been accepted by any of the European
standardisation organisations, or when the relevant harmonized standards insufficiently
address fundamental rights concerns, or when the harmonised standards do not comply
with the request, or when there are delays in the adoption of an appropriate harmonised
standard. If such delay in the adoption of a harmonised standard is due to the technical
complexity of the standard in question, this should be considered by the Commission
before contemplating the establishment of common specifications. When developing
common specifications, the Commission is encouraged to cooperate with international
partners and international standardisation bodies.
(61a) It is appropriate that, without prejudice to the use of harmonised standards and common
specifications, providers of high-risk AI system that has been trained and tested on data
reflecting the specific geographical, behavioural, contextual or functional setting within
which the AI system is intended to be used, should be presumed to be in compliance with
the respective measure provided for under the requirement on data governance set out in
this Regulation. Without prejudice to the requirements related to robustness and accuracy
set out in this Regulation, in line with Article 54(3) of Regulation (EU) 2019/881 of the
European Parliament and of the Council, high-risk AI systems that have been certified or
for which a statement of conformity has been issued under a cybersecurity scheme
pursuant to that Regulation and the references of which have been published in the Official
Journal of the European Union should be presumed to be in compliance with the
cybersecurity requirement of this Regulation in so far as the cybersecurity certificate or
statement of conformity or parts thereof cover the cybersecurity requirement of this
Regulation This remains without prejudice to the voluntary 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, the
compliance of those AI systems with the requirements of this Regulation should be
assessed as 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.
(64) Given the complexity of high-risk AI systems and the risks that are associated to them, it is
important to develop an adequate system of conformity assessment procedure for high risk
AI systems involving notified bodies, so called third party conformity assessment.
However, given the current experience of professional pre-market certifiers in the field of
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
rule by the provider under its own responsibility, with the only exception of AI systems
intended to be used for biometrics.
(65) In order to carry out third-party conformity assessments when so required, notified bodies
should be notified under this Regulation by the national competent authorities, provided
they are compliant with a set of requirements, notably on independence, competence,
absence of conflicts of interests and suitable cybersecurity requirements. Notification of
those bodies should be sent by national competent authorities to the Commission and 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.
(65a) In line with Union commitments under the World Trade Organization Agreement on
Technical Barriers to Trade, it is adequate to facilitate the mutual recognition of
conformity assessment results produced by competent conformity assessment bodies,
independent of the territory in which they are established, provided that those conformity
assessment bodies established under the law of a third country meet the applicable
requirements of the Regulation and the Union has concluded an agreement to that extent.
In this context, the Commission should actively explore possible international instruments
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for that purpose and in particular pursue the conclusion of mutual recognition agreements
with third countries.
(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 the
system changes, that AI system should be considered a new AI system which should
undergo a new conformity assessment. However, changes occurring to the algorithm and
the performance 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
constitute a substantial modification, provided that those changes have been pre-
determined by the provider and assessed at the moment of the conformity assessment.
(67) High-risk AI systems should bear the CE marking to indicate their conformity with this
Regulation so that they can move freely within the internal market. For high-risk AI
systems embedded in a product, a physical CE marking should be affixed, and may be
complemented by a digital CE marking. For high-risk AI systems only provided digitally, a
digital CE marking should be used. Member States should not create unjustified obstacles
to the placing on the market or putting into service of high-risk 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, the protection of the environment and climate change 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, environmental protection and the
protection of key industrial and infrastructural assets, market surveillance authorities could
authorise the placing on the market or putting into service of AI systems which have not
undergone a conformity assessment. In a duly justified situations as provided under this
regulations, law enforcement authorities or civil protection authorities may put a specific
high-risk AI system into service without the authorisation of the market surveillance
authority, provided that such authorisation is requested during or after the use without
undue delay.
(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 of
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high-risk AI systems other than those related to products falling within the scope of
relevant existing Union harmonisation legislation, as well as providers who consider that
an AI system referred to in annex III is by derogation not high-risk, should be required to
register themselves and information about their 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, deployers of high-risk AI systems that are public authorities, agencies or bodies,
shall register themselves in such database and select the system that they envisage to use..
Other deployers should be entitled to do so voluntarily. This section of the database should
be publicly accessible, free of charge, the information should be easily navigable,
understandable and machine-readable. The database should also be user-friendly, for
example by providing search functionalities, including through keywords, allowing the
general public to find relevant information included in Annex VIII and on the areas of risk
under Annex III to which the high-risk AI systems correspond. Any substantial
modification of high-risk AI systems should also be registered in the EU database. For
high risk AI systems in the area of law enforcement, migration, asylum and border control
management, the registration obligations should be fulfilled in a secure non-public section
of the database. Access to the secure non-public section should be strictly limited to the
Commission as well as to market surveillance authorities with regard to their national
section of that database. High risk AI systems in the area of critical infrastructure should
only be registered at national level. The Commission should be the controller of the EU
database, in accordance with Regulation (EU) 2018/1725 of the European Parliament and
of the Council26. In order to ensure the full functionality 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. The Commission
should take into account cybersecurity and hazard-related risks when carrying out its tasks
as data controller on the EU database. In order to maximise the availability and use of the
database by the public, the database, including the information made available through it,
should comply with requirements under the Directive 2019/882.
(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
26
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection
of natural persons with regard to the processing of personal data and on the free movement of such data, and
repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
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subject to specific transparency obligations without prejudice to the requirements and
obligations for high-risk AI systems and subject to targeted exceptions to take into account
the special need of law enforcement. In particular, natural persons should be notified that
they are interacting 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 the circumstances and the context of use. When implementing such obligation, the
characteristics 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 those
groups as well. Moreover, natural persons should be notified when they are exposed to
systems 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, tattoos, personal traits, ethnic
origin, personal preferences and interests. Such information and notifications should be
provided in accessible formats for persons with disabilities.
(70a) A variety of AI systems can generate large quantities of synthetic content that becomes
increasingly hard for humans to distinguish from human-generated and authentic content.
The wide availability and increasing capabilities of those systems have a significant impact
on the integrity and trust in the information ecosystem, raising new risks of misinformation
and manipulation at scale, fraud, impersonation and consumer deception. In the light of
those impacts, the fast technological pace and the need for new methods and techniques to
trace origin of information, it is appropriate to require providers of those systems to embed
technical solutions that enable marking in a machine readable format and detection that the
output has been generated or manipulated by an AI system and not a human. Such
techniques and methods should be sufficiently reliable, interoperable, effective and robust
as far as this is technically feasible, taking into account available techniques or a
combination of such techniques, such as watermarks, metadata identifications,
cryptographic methods for proving provenance and authenticity of content, logging
methods, fingerprints or other techniques, as may be appropriate. When implementing this
obligation, providers should also take into account the specificities and the limitations of
the different types of content and the relevant technological and market developments in
the field, as reflected in the generally acknowledged state-of-the-art. Such techniques and
methods can be implemented at the level of the system or at the level of the model,
including general-purpose AI models generating content, thereby facilitating fulfilment of
this obligation by the downstream provider of the AI system. To remain proportionate, it is
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appropriate to envisage that this marking obligation should not cover AI systems
performing primarily an assistive function for standard editing or AI systems not
substantially altering the input data provided by the deployer or the semantics thereof.
(70b) Further to the technical solutions employed by the providers of the system, deployers , 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 (‘deep fakes’), should also clearly and distinguishably 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 this transparency
obligation should not be interpreted as indicating 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 Fundamental 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 and freedoms of third parties. In those cases, the
transparency obligation for deep fakes set out in this Regulation is limited to disclosure of
the existence of such generated or manipulated content in an appropriate manner that does
not hamper the display or enjoyment of the work, including its normal exploitation and
use, while maintaining the utility and quality of the work. In addition, it is also appropriate
to envisage a similar disclosure obligation in relation to AI-generated or manipulated text
to the extent it is published with the purpose of informing the public on matters of public
interest unless the AI-generated content has undergone a process of human review or
editorial control and a natural or legal person holds editorial responsibility for the
publication of the content.
(70c) To ensure consistent implementation, it is appropriate to empower the Commission to
adopt implementing acts on the application of the provisions on the labelling and detection
of artificially generated or manipulated content. Without prejudice to the mandatory nature
and full applicability of these obligations, the Commission may also encourage and
facilitate the drawing up of codes of practice at Union level to facilitate the effective
implementation of the obligations regarding the detection and labelling of artificially
generated or manipulated content, including to support practical arrangements for making,
as appropriate, the detection mechanisms accessible and facilitating cooperation with other
actors in the value chain, disseminating content or checking its authenticity and
provenance to enable the public to effectively distinguish AI-generated content.
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(70d) The obligations placed on providers and deployers of certain AI systems in this Regulation
to enable the detection and disclosure that the outputs of those systems are artificially
generated or manipulated are particularly relevant to facilitate the effective implementation
of Regulation (EU) 2022/2065. This applies in particular as regards the obligations of
providers of very large online platforms or very large online search engines to identify and
mitigate systemic risks that may arise from the dissemination of content that has been
artificially generated or manipulated, in particular risk of the actual or foreseeable negative
effects on democratic processes, civic discourse and electoral processes, including through
disinformation. The requirement to label content generated by AI systems under this
Regulation is without prejudice to the obligation in Article 16(6) of Regulation 2022/2065
for providers of hosting services to process notices on illegal content received pursuant to
Article 16(1) and should not influence the assessment and the decision on the illegality of
the specific content. That assessment should be performed solely with reference to the
rules governing the legality of the content.
(70e) The compliance with the transparency obligations for the AI systems coved by this
Regulation should not be interpreted as indicating that the use of the system or its output is
lawful under this Regulation or other Union and Member State law and should be without
prejudice to other transparency obligations for deployers of AI systems laid down in Union
or national law.
(71) Artificial intelligence is a rapidly developing family of technologies that requires
regulatory oversight and a safe and controlled space for experimentation, while ensuring
responsible innovation and integration of appropriate safeguards and risk mitigation
measures. To ensure a legal framework that promotes innovation, is future-proof and
resilient to disruption, Member States should ensure that their national competent
authorities establish at least one artificial intelligence regulatory sandbox at national level
to facilitate the development and testing of innovative AI systems under strict regulatory
oversight before these systems are placed on the market or otherwise put into service.
Member States could also fulfil this obligation through participating in already existing
regulatory sandboxes or establishing jointly a sandbox with one or several Member States’
competent authorities, insofar as this participation provides equivalent level of national
coverage for the participating Member States. Regulatory sandboxes could be established
in physical, digital or hybrid form and may accommodate physical as well as digital
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products. Establishing authorities should also ensure that the regulatory sandboxes have the
adequate resources for their functioning, including financial and human resources.
(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 and
pre-marketing phase with a view to ensuring compliance of the innovative AI systems with
this Regulation and other relevant Union and Member States legislation, to enhance legal
certainty for innovators and the competent authorities’ oversight and understanding of the
opportunities, emerging risks and the impacts of AI use, to facilitate regulatory learning for
authorities and companies, including with a view to future adaptions of the legal
framework, to support cooperation and the sharing of best practices with the authorities
involved in the AI regulatory sandbox, and to accelerate access to markets, including by
removing barriers for small and medium enterprises (SMEs), including start-ups.
Regulatory sandboxes should be widely available throughout the Union, and particular
attention should be given to their accessibility for 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 the
Union and contribute to evidence-based regulatory learning. The supervision of the AI
systems in the AI regulatory sandbox should therefore cover their development, training,
testing and validation before the systems are placed on the market or put into service, as
well as the notion and occurrence of substantial modification that may require a new
conformity assessment procedure. Any significant risks identified during the development
and testing of such AI systems should result in adequate mitigation and, failing that, in the
suspension of the development and testing process 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 of other actors within the AI ecosystem such as national or
European standardisation organisations, notified bodies, testing and experimentation
facilities, research and experimentation labs, European Digital innovation hubs and
relevant stakeholder and civil society organisations. To ensure uniform implementation
across the Union and economies of scale, it is appropriate 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 other sandboxes aiming at ensuring compliance with legislation
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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.
(72a) This Regulation should provide the legal basis for the providers and prospective providers
in the AI regulatory sandbox to use personal data collected for other purposes for
developing certain AI systems in the public interest within the AI regulatory sandbox, only
under specified conditions, in line with Article 6(4) and 9(2)(g) of Regulation (EU)
2016/679, and Article 5, 6 and 10 of Regulation (EU) 2018/1725, and without prejudice to
Articles 4(2) and 10 of Directive (EU) 2016/680. All other obligations of 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, this Regulation 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. Providers and prospective providers 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 adequately mitigate any identified - significant risks to safety, health, and
fundamental rights that may arise during the development, testing and experimentation in
the sandbox.
(72b) 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 and
taking into account the possible consequences of such testing on individuals, it should be
ensured that appropriate and sufficient guarantees and conditions are introduced by the
Regulation 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
in such testing under this Regulation is distinct from and without prejudice to consent of
data subjects for the processing of their personal data under the relevant data protection
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law. It is also important to minimise the risks and enable oversight by competent
authorities and therefore require prospective providers to have a real-world testing plan
submitted to competent market surveillance authority, register the testing in dedicated
sections in the EU-wide database subject to some limited exceptions, set limitations on the
period for which the testing can be done and require additional safeguards for persons
belonging to certain vulnerable groups as well as a written agreement defining the roles
and responsibilities of prospective providers and deployers and effective oversight by
competent personnel involved in the real world testing. Furthermore, it is appropriate to
envisage additional safeguards to ensure that the predictions, recommendations or
decisions of the AI system can be effectively reversed and disregarded and that personal
data is protected and is deleted when the subjects have withdrawn their consent to
participate in the testing without prejudice to their rights as data subjects under the EU data
protection law. As regards transfer of data, it is also appropriate to envisage that data
collected and processed for the purpose of the testing in real world conditions should only
be transferred to third countries outside the Union provided appropriate and applicable
safeguards under Union law are implemented, notably in accordance with bases for
transfer of personal data under Union law on data protection, while for non-personal data
appropriate safeguards are put in place in accordance with Union law, such as the Data
Governance Act and the Data Act.
(72c) To ensure that Artificial Intelligence leads to socially and environmentally beneficial
outcomes, Member States are encouraged to support and promote research and
development of AI solutions in support of socially and environmentally beneficial
outcomes, such as AI-based solutions to increase accessibility for persons with disabilities,
tackle socio-economic inequalities, or meet environmental targets, by allocating sufficient
resources, including public and Union funding, and, where appropriate and provided that
the eligibility and selection criteria are fulfilled, considering in particular projects which
pursue such objectives. Such projects should be based on the principle of interdisciplinary
cooperation between AI developers, experts on inequality and non- discrimination,
accessibility, consumer, environmental, and digital rights, as well as academics.
(73) In order to promote and protect innovation, it is important that the interests of SMEs,
including start-ups, that are providers or deployers of AI systems are taken into particular
account. To this objective, Member States should develop initiatives, which are targeted at
those operators, including on, awareness raising and information communication. Member
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States shall provide SME’s, including start-ups, having a registered office or a branch in
the Union, with priority access to the AI regulatory sandboxes provided that they fulfil the
eligibility conditions and selection criteria and without precluding other providers and
prospective providers to access the sandboxes provided the same conditions and criteria are
fulfilled. Member States shall utilise existing channels and where appropriate, establish
new dedicated channels for communication with SMEs, start-ups, deployers other
innovators and, as appropriate, local public authorities, to support SMEs throughout their
development path by providing guidance and responding to queries about the
implementation of this Regulation. Where appropriate, these channels shall work together
to create synergies and ensure homogeneity in their guidance to SMEs including start-ups
and deployers. Additionally, Member States should facilitate the participation of SMEs and
other relevant stakeholders in the standardisation development processes. Moreover, the
specific interests and needs of SMEs including start-up providers should be taken into
account when Notified Bodies set conformity assessment fees. The Commission should
regularly assess the certification and compliance costs for SMEs including start-ups,
through transparent consultations deployers and should work with Member States to lower
such costs. For example, 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 for communication with operators is one which is broadly understood by the largest
possible number of cross-border deployers. In order to address the specific needs of SMEs
including start-ups, the Commission should provide standardised templates for the areas
covered by this Regulation upon request of the AI Board. Additionally, the Commission
should complement Member States’ efforts by providing a single information platform
with easy-to-use information with regards to this Regulation for all providers and
deployers, by organising appropriate communication campaigns to raise awareness about
the obligations arising from this Regulation, and by evaluating and promoting the
convergence of best practices in public procurement procedures in relation to AI systems.
Medium-sized enterprises which recently changed from the small to medium-size category
within the meaning of the Annex to Recommendation 2003/361/EC (Article 16) should
have access to these support measures, as these new medium-sized enterprises may
sometimes lack the legal resources and training necessary to ensure proper understanding
and compliance with provisions.
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(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 Union level should,
as appropriate, contribute to the achievement of the objectives of this Regulation.
(74) In particular, in order to minimise the risks to implementation resulting from lack of
knowledge and expertise in the market as well as to facilitate compliance of providers,
notably SMEs, including start-ups, and notified bodies with their obligations under this
Regulation, the AI-on demand platform, the European Digital Innovation Hubs and the
Testing and Experimentation Facilities established by the Commission and the Member
States at national or EU level should contribute to the implementation of this Regulation.
Within their respective mission and fields of competence, they may provide in particular
technical and 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 allow microenterprises to fulfil
one of the most costly obligations, namely to establish a quality management system, in a
simplified manner which would reduce the administrative burden and the costs for those
enterprises without affecting the level of protection and the need for compliance with the
requirements for high-risk AI systems. The Commission should develop guidelines to
specify the elements of the quality management system to be fulfilled in this simplified
manner by microenterprises.
(75) It is appropriate that the Commission facilitates, to the extent possible, access to Testing
and Experimentation Facilities to bodies, groups or laboratories established or accredited
pursuant to any relevant Union harmonisation legislation and which fulfil tasks in the
context of conformity assessment of products or devices covered by that Union
harmonisation legislation. This is notably the case for expert panels, expert laboratories
and reference laboratories in the field of medical devices pursuant to Regulation (EU)
2017/745 and Regulation (EU) 2017/746.
(75a) This Regulation should establish a governance framework that both allows to coordinate
and support the application of this Regulation at national level, as well as build capabilities
at Union level and integrate stakeholders in the field of artificial intelligence. The effective
implementation and enforcement of this Regulation require a governance framework that
allows to coordinate and build up central expertise at Union level. The Commission has
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established the AI Office by Commission decision of […], which has as its mission to
develop Union expertise and capabilities in the field of artificial intelligence and to
contribute to the implementation of Union legislation on artificial intelligence. Member
States should facilitate the tasks of the AI Office with a view to support the development of
Union expertise and capabilities at Union level and to strengthen the functioning of the
digital single market. Furthermore, a European Artificial Intelligence Board composed of
representatives of the Member States, a scientific panel to integrate the scientific
community and an advisory forum to contribute stakeholder input to the implementation of
this Regulation, both at national and Union level, should be established. The development
of Union expertise and capabilities should also include making use of existing resources
and expertise, notably through synergies with structures built up in the context of the
Union level enforcement of other legislation and synergies with related initiatives at Union
level, such as the EuroHPC Joint Undertaking and the AI Testing and Experimentation
Facilities under the Digital Europe Programme.
(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
the various interests of the AI eco-system and be composed of representatives of the
Member States. The Board should be responsible for a number of advisory tasks, including
issuing opinions, recommendations, advice or contributing to guidance on matters related
to the implementation of this Regulation, including on enforcement matters, technical
specifications or existing standards regarding the requirements established in this
Regulation and providing advice to the Commission and the Member States and their
national competent authorities on specific questions related to artificial intelligence. In
order to 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
should have the relevant competences and powers to facilitate coordination at national
level and contribute 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 surveillance authorities and notifying authorities on issues related respectively to
market surveillance and notified 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 of the standing subgroup for market surveillance by undertaking
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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 standing or temporary sub-groups as appropriate for the purpose
of examining specific issues. The Board should also cooperate, as appropriate, with
relevant EU bodies, expert groups and networks active in the context of relevant EU
legislation, including in particular those active under relevant EU regulation on data,
digital products and services.
(76x) With a view to ensure the involvement of stakeholders in the implementation and
application of this Regulation, an advisory forum should be established to advise and
provide technical expertise to the Board and the Commission. To ensure a varied and
balanced stakeholder representation between commercial and non-commercial interest and,
within the category of commercial interests, with regards to SMEs and other undertakings,
the advisory forum should comprise inter alia industry, start-ups, SMEs, academia, civil
society, including social partners, as well as the Fundamental Rights Agency, European
Union Agency for Cybersecurity, the European Committee for Standardization (CEN), the
European Committee for Electrotechnical Standardization (CENELEC) and the European
Telecommunications Standards Institute (ETSI).
(76y) To support the implementation and enforcement of this Regulation, in particular the
monitoring activities of the AI Office as regards general-purpose AI models, a scientific
panel of independent experts should be established. The independent experts constituting
the scientific panel should be selected on the basis of up-to-date scientific or technical
expertise in the field of artificial intelligence and should perform their tasks with
impartiality, objectivity and ensure the confidentiality of information and data obtained in
carrying out their tasks and activities. To allow reinforcing national capacities necessary
for the effective enforcement of this Regulation, Member States should be able to request
support from the pool of experts constituting the scientific panel for their enforcement
activities.
(76a) In order to support adequate enforcement as regards AI systems and reinforce the
capacities of the Member States, EU AI testing support structures should be established
and made available to the Member States.
(77) Member States hold a key role in the application and enforcement of this Regulation. In
this respect, each Member State should designate at least one notifying authority and at
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least one market surveillance authority as national competent authorities for the purpose of
supervising the application and implementation of this Regulation. Member States may
decide to appoint any kind of public entity to perform the tasks of the national competent
authorities within the meaning of this Regulation, in accordance with their specific national
organisational characteristics and needs. In order to increase organisation efficiency on the
side of Member States and to set a single point of contact vis-à-vis the public and other
counterparts at Member State and Union levels, each Member State should designate a
market surveillance authority to act as single point of contact.
(77a) The national competent authorities should exercise their powers independently, impartially
and without bias, so as to safeguard the principles of objectivity of their activities and tasks
and to ensure the application and implementation of this Regulation. The members of these
authorities should refrain from any action incompatible with their duties and should be
subject to confidentiality rules under this Regulation.
(78) In order to ensure that providers of high-risk AI systems can take into account the
experience on the use of high-risk AI systems for improving their systems and the design
and development process or can take any possible corrective action in a timely manner, all
providers should have a post-market monitoring system in place. Where relevant, post-
market monitoring should include an analysis of the interaction with other AI systems
including other devices and software. Post-market monitoring should not cover sensitive
operational data of deployers which are law enforcement authorities. This system is also
key to ensure that the possible risks emerging from AI systems which continue to ‘learn’
after being placed on the market or put into service can be more efficiently and timely
addressed. In this context, providers should also be required to have a system in place to
report to the relevant authorities any serious incidents resulting from the use of their AI
systems, meaning incident or malfunctioning leading to death or serious damage to health,
serious and irreversible disruption of the management and operation of critical
infrastructure, breaches of obligations under Union law intended to protect fundamental
rights or serious damage to property or the environment.
(79) In order to ensure an appropriate and effective enforcement of the requirements and
obligations 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
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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 specific requirements and obligations under this Regulation, market surveillance
authorities may take measures in relation to all AI systems when they present a risk in
accordance with this Regulation. Due to the specific nature of Union institutions, agencies
and bodies falling within the scope of this Regulation, it 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 carry out 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 in
violation of the prohibited practices laid down in this Regulation and AI systems which
have been made available in violation of the transparency requirements laid down in this
Regulation and present a risk.
(80) Union legislation on financial services includes internal governance and risk management
rules and requirements which are applicable to regulated financial institutions in the course
of provision of those services, including when they make use of AI systems. In order to
ensure coherent application and enforcement of the obligations under this Regulation and
relevant rules and requirements of the Union financial services legislation, the competent
authorities for the supervision and enforcement of the financial services legislation, notably
competent authorities as defined in Directive 2009/138/EC, Directive (EU) 2016/97,
Directive 2013/36/EU Regulation (EU) No 575/2013, Directive 2008/48/EC and Directive
2014/17/EU of the European Parliament and of the Council, should be designated, within
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their respective competences, as competent authorities for the purpose of supervising the
implementation of this Regulation, including for market surveillance activities, as regards
AI systems provided or used by regulated and supervised financial institutions unless
Member States decide to designate another authority to fulfil these market surveillance
tasks. Those competent authorities 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 the supervision of credit institutions regulated under
Directive 2013/36/EU, which are participating 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 of potential 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 and documentation into the existing obligations
and procedures under Directive 2013/36/EU. In order to avoid overlaps, limited
derogations should also be envisaged in relation to the quality management system of
providers and the monitoring obligation placed on deployers of high-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) and the insurance intermediaries
under Directive 2016/97/EU and other types of financial institutions subject to
requirements regarding internal governance, arrangements or processes established
pursuant to the relevant Union financial services legislation to ensure consistency and
equal treatment in the financial sector.
27
Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity
of credit institutions and the prudential supervision of credit institutions and investment firms, amending
Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).
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(80-x) Each market surveillance authority for high-risk AI systems listed in point 1 of Annex III
insofar as these systems are used for law enforcement purposes and for purposes listed in
points 6, 7 and 8 of Annex III should have effective investigative and corrective powers,
including at least the power to obtain access to all personal data that are being processed
and to all information necessary for the performance of its tasks. The market surveillance
authorities should be able to exercise their powers by acting with complete independence.
Any limitations of their access to sensitive operational data under this Regulation should
be without prejudice to the powers conferred to them by Directive 2016/680. No exclusion
on disclosing data to national data protection authorities under this Regulation should
affect the current or future powers of those authorities beyond the scope of this Regulation.
(80x) The market surveillance authorities of the Member States and the Commission should be
able to propose joint activities, including joint investigations, to be conducted by market
surveillance authorities or market surveillance authorities jointly with the Commission,
that have the aim of promoting compliance, identifying non-compliance, raising awareness
and providing guidance in relation to this Regulation with respect to specific categories of
high-risk AI systems that are found to present a serious risk across several Member States.
Joint activities to promote compliance should be carried out in accordance with Article 9 of
the 2019/1020. The AI Office should provide coordination support for joint investigations.
(80y) It is necessary to clarify the responsibilities and competences on national and Union level
as regards AI systems that are built on general-purpose AI models. To avoid overlapping
competences, where an AI system is based on a general-purpose AI model and the model
and system are provided by the same provider, the supervision should take place at Union
level through the AI Office, which should have the powers of a market surveillance
authority within the meaning of Regulation (EU) 2019/1020 for this purpose. In all other
cases, national market surveillance authorities remain responsible for the supervision of AI
systems. However, for general-purpose AI systems that can be used directly by deployers
for at least one purpose that is classified as high-risk, market surveillance authorities
should cooperate with the AI Office to carry out evaluations of compliance and inform the
Board and other market surveillance authorities accordingly. Furthermore, market
surveillance authorities should be able to request assistance from the AI Office where the
market surveillance authority is unable to conclude an investigation on a high-risk AI
system because of its inability to access certain information related to the general-purpose
AI model on which the high-risk AI system is built. In such cases, the procedure regarding
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mutual assistance in cross-border cases in Chapter VI of Regulation (EU) 2019/1020
should apply by analogy.
(80z) To make best use of the centralised Union expertise and synergies at Union level, the
powers of supervision and enforcement of the obligations on providers of general-purpose
AI models should be a competence of the Commission. The Commission should entrust the
implementation of these tasks to the AI Office, without prejudice to the powers of
organisation of the Commission and the division of competences between member States
and the Union based on the Treaties. The AI Office should be able to carry out all
necessary actions to monitor the effective implementation of this Regulation as regards
general-purpose AI models. It should be able to investigate possible infringements of the
rules on providers of general-purpose AI models both on its own initiative, following the
results of its monitoring activities, or upon request from market surveillance authorities in
line with the conditions set out in this Regulation. To support effective monitoring of the
AI Office, it should provide for the possibility that downstream providers lodge complaints
about possible infringements of the rules on providers of general purpose AI models.
(80z+1) With a view to complement the governance systems for general-purpose AI models, the
scientific panel should support the monitoring activities of the AI Office and may, in
certain cases, provide qualified alerts to the AI Office which trigger follow-ups such as
investigations. This should be the case where the scientific panel has reason to suspect that
a general-purpose AI model poses a concrete and identifiable risk at Union level.
Furthermore, this should be the case where the scientific panel has reason to suspect that a
general-purpose AI model meets the criteria that would lead to a classification as general-
purpose AI model with systemic risk. To equip the scientific panel with the information
necessary for the performance of these tasks, there should be a mechanism whereby the
scientific panel can request the Commission to require documentation or information from
a provider.
(80z+2) The AI Office should be able to take the necessary actions to monitor the effective
implementation of and compliance with the obligations for providers of general purpose AI
models laid down in this Regulation. The AI Office should be able to investigate possible
infringements in accordance with the powers provided for in this Regulation, including by
requesting documentation and information, by conducting evaluations, as well as by
requesting measures from providers of general purpose AI models. In the conduct of
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evaluations, in order to make use of independent expertise, the AI Office should be able to
involve independent experts to carry out the evaluations on its behalf. Compliance with the
obligations should be enforceable, inter alia, through requests to take appropriate measures,
including risk mitigation measures in case of identified systemic risks as well as restricting
the making available on the market, withdrawing or recalling the model. As a safeguard in
case needed beyond the procedural rights provided for in this Regulation, providers of
general-purpose AI models should have the procedural rights provided for in Article 18 of
Regulation (EU) 2019/1020, which should apply by analogy, without prejudice to more
specific procedural rights provided for by this Regulation.
(81) The development of AI systems other than high-risk AI systems in accordance with the
requirements of this Regulation may lead to a larger uptake of ethical and trustworthy
artificial intelligence in the Union. Providers of non-high-risk AI systems should be
encouraged to create codes of conduct, including related governance mechanisms, intended
to foster the voluntary application of some or all of the mandatory requirements applicable
to high-risk AI systems, adapted in light of the intended purpose of the systems and the
lower risk involved and taking into account the available technical solutions and industry
best practices such as model and data cards. Providers and, as appropriate, deployers of all
AI systems, high-risk or not, and models should also be encouraged to apply on a
voluntary basis additional requirements related, for example, to the elements of the
European ethic guidelines for trustworthy AI, environmental sustainability, AI literacy
measures, inclusive and diverse design and development of AI systems, including attention
to vulnerable persons and accessibility to persons with disability, stakeholders’
participation with the involvement as appropriate, of relevant stakeholders such as business
and civil society organisations, academia and research organisations, trade unions and
consumer protection organisation in the design and development of AI systems, and
diversity of the development teams, including gender balance. To ensure that the voluntary
codes of conduct are effective, they should be based on clear objectives and key
performance indicators to measure the achievement of those objectives. They should be
also developed in an inclusive way, as appropriate, with the involvement of relevant
stakeholders such as business and civil society organisations, academia and research
organisations, trade unions and consumer protection organisation. The Commission may
develop initiatives, including of a sectorial nature, to facilitate the lowering of technical
barriers hindering cross-border exchange of data for AI development, including on data
access infrastructure, semantic and technical interoperability of different types of data.
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(82) It is important that AI systems related to products that are not high-risk in accordance with
this Regulation and thus are not required to comply with the requirements set out for high-
risk AI systems are nevertheless safe when placed on the market or put into service. To
contribute to this objective, Regulation (EU) 2023/988 of the European Parliament and of
the Council28 would apply as a safety net.
(83) In order to ensure trustful and constructive cooperation of competent authorities on Union
and 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
accordance with Union or national law. They should carry out their tasks and activities in
such a manner as to protect, in particular, intellectual property rights, confidential business
information and trade secrets, the effective implementation of this Regulation, public and
national security interests, the integrity of criminal or administrative proceedings, and the
integrity of classified information.
(84) Compliance with this Regulation should be enforceable by means of the imposition of
penalties and other enforcement measures. Member States should take all necessary
measures to ensure that the provisions of this Regulation are implemented, including by
laying down effective, proportionate and dissuasive penalties for their infringement, and in
respect of the ne bis in idem principle. In order to strengthen and harmonise administrative
penalties for infringement of this Regulation, the upper limits for setting the administrative
fines for certain specific infringements should be laid down. When assessing the amount of
the fines, Member States should, in each individual case, take into account all relevant
circumstances of the specific situation, with due regard in particular to the nature, gravity
and duration of the infringement and of its consequences and to the provider’s size, in
particular if the provider is an SME including a start-up. The European Data Protection
Supervisor should have the power to impose fines on Union institutions, agencies and
bodies falling within the scope of this Regulation.
(84a) Compliance with the obligations on providers of general-purpose AI models imposed
under this Regulation should be enforceable among others by means of fines. To that end,
appropriate levels of fines should also be laid down for infringement of those obligations,
28
Regulation (EU) 2023/988 of the European Parliament and of the Council of of 10 May 2023 on general
product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and
Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of
the European Parliament and of the Council and Council Directive 87/357/EEC (Text with EEA relevance) (OJ
L 135, 23.5.2023, p. 1–51).
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including the failure to comply with measures requested by the Commission in accordance
with this Regulation, subject to appropriate limitation periods in accordance with the
principle of proportionality. All decisions taken by the Commission under this Regulation
are subject to review by the Court of Justice of the European Union in accordance with the
TFEU.
(84aa) Union and national law already provides effective remedies to natural and legal persons
whose rights and freedoms are adversely affected by the use of AI systems. Without
prejudice to those remedies, any natural or legal person having grounds to consider that
there has been an infringement of the provisions of this Regulation should be entitled to
lodge a complaint to the relevant market surveillance authority or the AI Office where
applicable.
(84b) Affected persons should have the right to request an explanation when a decision is taken
by the deployer with the output from certain high-risk systems as provided for in this
Regulation as the main basis and which produces legal effects or similarly significantly
affects him or her in a way that they consider to adversely impact their health, safety or
fundamental rights. This explanation should be a clear and meaningful and should provide
a basis for affected persons to exercise their rights. This should not apply to the use of AI
systems for which exceptions or restrictions follow from Union or national law and should
apply only to the extent this right is not already provided for under Union legislation.
(84c) Persons acting as ‘whistle-blowers’ on the breaches of this Regulation should be afforded
the protection guaranteed by Union legislation on the protection of persons who report
breaches of law. Therefore, Directive (EU) 2019/1937 should apply to the reporting of
breaches of this Regulation and the protection of persons reporting such breaches.
(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, the content of the EU declaration of conformity in Annex V, the provisions
regarding the conformity assessment procedures in Annex VI and VII, the provisions
establishing the high-risk AI systems to which the conformity assessment procedure based
on assessment of the quality management system and assessment of the technical
documentation should apply, the threshold as well as to supplement benchmarks and
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indicators in the rules for classification of general-purpose AI models with systemic risk,
the criteria for the designation of general-purpose AI models with systemic risk in Annex
IXc, the technical documentation for providers of general-purpose AI models in Annex
VIIIb and the transparency information for providers of general-purpose AI models in
Annex VIIIc. 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-Making1
. In particular, to
ensure equal participation in the preparation of delegated acts, the European Parliament
and the Council receive all documents at the same time as Member States’ experts, and
their experts systematically have access to meetings of Commission expert groups dealing
with the preparation of delegated acts.
(85a) Given the rapid technological developments and the required technical expertise in the
effective application of this Regulation, the Commission should evaluate and review this
Regulation by three years after the date of entry into application and every four years
thereafter and report to the European Parliament and the Council. In addition, taking into
account the implications for the scope of this Regulation, the Commission should carry out
an assessment of the need to amend the list in Annex III and the list of prohibited practices
once a year. Moreover, by two years after entry into application and every four years
thereafter, the Commission should evaluate and report to the European Parliament and to
the Council on the need to amend the high-risk areas in Annex III, the AI systems within
the scope of the transparency obligations in Title IV, the effectiveness of the supervision
and governance system and the progress on the development of standardisation
deliverables on energy efficient development of general-purpose AI models, including the
need for further measures or actions. Finally, within two years after the entry into
application and every three years thereafter, the Commission should evaluate the impact
and effectiveness of voluntary codes of conducts to foster the application of the
requirements set out in Title III, Chapter 2, for systems other than high-risk AI systems and
possibly other additional requirements for such AI systems.
(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
and of the Council1
.
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(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
Union level, 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 and
avoid 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 placed
on the market or put into service before the general date of application thereof, only if,
from that date, those systems are subject to significant changes in their design or intended
purpose. It is appropriate to clarify that, in this respect, the concept of significant change
should be understood as equivalent in substance to the notion of substantial modification,
which is used with regard only to high-risk AI systems as defined in this Regulation. By
way of exception and in light of public accountability, operators of AI systems which are
components of the large-scale IT systems established by the legal acts listed in Annex IX
and operators of high-risk AI systems that are intended to be used by public authorities
should take the necessary steps to comply with the requirements of this Regulation by end
of 2030 and by four years after the entry into application respectively.
(87b) Providers of high-risk AI systems are encouraged to start to comply, on voluntary basis,
with the relevant obligations foreseen under this Regulation already during the transitional
period.
(88) This Regulation should apply from … [OP – please insert the date established in Art. 85].
However, taking into account the unacceptable risk associated with the use of AI in certain
ways, the prohibitions should apply already from … [OP – please insert the date – 6
months after entry into force of this Regulation]. While the full effect of these prohibitions
follows with the establishment of the governance and enforcement of this Regulation,
anticipating the application of the prohibitions is important to take account of unacceptable
risk and has effect on other procedures, such as in civil law. Moreover, the infrastructure
related to the governance and the conformity assessment system should be operational
before [OP – please insert the date established in Art. 85], therefore the provisions on
notified bodies and governance structure should apply from … [OP – please insert the date
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– twelve months following the entry into force of this Regulation]. Given the rapid pace of
technological advancements and adoption of general-purpose AI models, obligations for
providers of general purpose AI models should apply within 12 months from the date of
entry into force. Codes of Practice should be ready at the latest 3 months before the entry
into application of the relevant provisions, to enable providers to demonstrate compliance
in time. The AI Office should ensure that classification rules and procedures are up to date
in light of technological developments. In addition, Member States should lay down and
notify to the Commission the rules on penalties, including administrative fines, and ensure
that they are properly and effectively implemented by the date of application of this
Regulation. Therefore, the provisions on penalties should apply from [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 were
consulted in accordance with Article 42(2) of Regulation (EU) 2018/1725 and delivered an
opinion on 18 June 2021.
TITLE I
GENERAL PROVISIONS
Article 1
Subject matter
1. The purpose of this Regulation is to improve the functioning of the internal market and
promoting the uptake of human centric and trustworthy artificial intelligence, while
ensuring a high level of protection of health, safety, fundamental rights enshrined in the
Charter, including democracy, rule of law and environmental protection against harmful
effects of artificial intelligence systems in the Union and supporting innovation.
2. This Regulation lays down:
(a) harmonised rules for the placing on the market, the putting into service and the use of
artificial intelligence systems (‘AI systems’) in the Union;
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(b) prohibitions of certain artificial intelligence practices;
(c) specific requirements for high-risk AI systems and obligations for operators of such
systems;
(d) harmonised transparency rules for certain AI systems;
(da) harmonised rules for the placing on the market of general-purpose AI models;
(e) rules on market monitoring, market surveillance governance and enforcement;
(ea) measures to support innovation, with a particular focus on SMEs, including start-ups.
Article 2
Scope
1. This Regulation applies to:
(a) providers placing on the market or putting into service AI systems or placing on the
market general-purpose AI models in the Union, irrespective of whether those
providers are established or who are located within the Union or in a third country;
(b) deployers of AI systems that have their place of establishment or who are located
within the Union;
(c) providers and deployers of AI systems that have their place of establishment or who
are located in a third country, where the output produced by the system is used in the
Union;
(ca) importers and distributors of AI systems;
(cb) product manufacturers placing on the market or putting into service an AI system
together with their product and under their own name or trademark;
(cc) authorised representatives of providers, which are not established in the Union.
(cc) affected persons that are located in the Union.
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2. For AI systems classified as high-risk AI systems in accordance with 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 the
requirements for high-risk AI systems under this Regulation have been integrated under
that Union harmonisation legislation.
3. This Regulation shall not apply to areas outside the scope of EU law and in any event shall
not affect the competences of the Member States concerning national security, regardless
of the type of entity entrusted by the Member States to carry out the tasks in relation to
those competences.
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 exclusively for military,
defence or national security purposes, regardless of the type of entity carrying out those
activities.
This Regulation shall not apply to AI systems which are not placed on the market or put
into service in the Union, where the output is used in the Union exclusively for military,
defence or national security purposes, regardless of the type of entity carrying out those
activities.
4. This Regulation shall not apply to public authorities in a third country nor to international
organisations falling within the scope of this Regulation pursuant to paragraph 1, where
those authorities or organisations use AI systems in the framework of international
cooperation or agreements for law enforcement and judicial cooperation with the Union or
with one or more Member States, under the condition that this third country or
international organisations provide adequate safeguards with respect to the protection of
fundamental rights and freedoms of individuals.
5. This Regulation shall not affect the application of the provisions on the liability of
intermediary service providers set out in Chapter II, Section 4 of Directive 2000/31/EC of
the European Parliament and of the Council29 [as to be replaced by the corresponding
provisions of the Digital Services Act].
29
Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of
information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic
commerce') (OJ L 178, 17.7.2000, p. 1).
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5a. This Regulation shall not apply to AI systems and models, including their output,
specifically developed and put into service for the sole purpose of scientific research and
development.
5a. Union law on the protection of personal data, privacy and the confidentiality of
communications applies to personal data processed in connection with the rights and
obligations laid down in this Regulation. This Regulation shall not affect Regulations (EU)
2016/679 and (EU) 2018/1725 and Directives 2002/58/EC and (EU) 2016/680, without
prejudice to arrangements provided for in Article 10(5) and Article 54 of this Regulation.
5b. This Regulation shall not apply to any research, testing and development activity regarding
AI systems or models prior to being placed on the market or put into service; those
activities shall be conducted respecting applicable Union law. The testing in real world
conditions shall not be covered by this exemption.
5b. This Regulation is without prejudice to the rules laid down by other Union legal acts
related to consumer protection and product safety.
5c. This Regulation shall not apply to obligations of deployers who are natural persons using
AI systems in the course of a purely personal non-professional activity.
5e. This Regulation shall not preclude Member States or the Union from maintaining or
introducing laws, regulations or administrative provisions which are more favourable to
workers in terms of protecting their rights in respect of the use of AI systems by
employers, or to encourage or allow the application of collective agreements which are
more favourable to workers.
5g. The obligations laid down in this Regulation shall not apply to AI systems released under
free and open source licences unless they are placed on the market or put into service as
high-risk AI systems or an AI system that falls under Title II and IV.
Article 3
Definitions
For the purpose of this Regulation, the following definitions apply:
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(1) ‘AI system‘ is a machine-based system designed to operate with varying levels of
autonomy and that may exhibit adaptiveness after deployment and that, for explicit
or implicit objectives, infers, from the input it receives, how to generate outputs such
as predictions, content, recommendations, or decisions that can influence physical or
virtual environments;
(1a) ‘risk’ means the combination of the probability of an occurrence of harm and the
severity of that harm;
(2) ‘provider’ means a natural or legal person, public authority, agency or other body
that develops an AI system or a general purpose AI model or that has an AI system
or a general purpose AI model developed and places them on the market or puts the
system into service under its own name or trademark, whether for payment or free of
charge;
(4) ‘deployer means any natural or legal person, public authority, agency or other body
using an AI system under its authority except where the AI system is used in the
course of a personal non-professional activity;
(5) ‘authorised representative’ means any natural or legal person located or established
in the Union who has received and accepted a written mandate from a provider of an
AI system or a general-purpose AI model to, respectively, perform and carry out on
its behalf the obligations and procedures established by this Regulation;
(6) ‘importer’ means any natural or legal person located 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 deployer, the authorised
representative, the importer or the distributor;
(9) ‘placing on the market’ means the first making available of an AI system or a general
purpose AI model on the Union market;
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(10) ‘making available on the market’ means any supply of an AI system or a general
purpose AI model for distribution or use on the Union market in the course of a
commercial activity, whether in return for payment or free of charge;
(11) ‘putting into service’ means the supply of an AI system for first use directly to the
deployer or for own use in the Union for its intended purpose;
(12) ‘intended purpose’ means the use for which an AI system is intended by the provider,
including the specific context and conditions of use, as specified in the information
supplied by the provider in the instructions for use, promotional or sales materials
and statements, as well as in the technical documentation;
(13) ‘reasonably foreseeable misuse’ means the use of an AI system in a way that is not in
accordance with its intended purpose, but which may result from reasonably
foreseeable human behaviour or interaction with other systems, including other AI
systems;
(14) ‘safety component 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 of in 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 deployers;
(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) ‘notifying authority’ means the national authority responsible for setting up and
carrying out the necessary procedures for the assessment, designation and
notification of conformity assessment bodies and for their monitoring;
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(20) ‘conformity assessment’ means the process of demonstrating whether the
requirements set out in Title III, Chapter 2 of this Regulation relating to a high-risk
AI system have been fulfilled;
(21) ‘conformity assessment body’ means a body that performs third-party conformity
assessment activities, including testing, certification and inspection;
(22) ‘notified body’ means a conformity assessment body notified in accordance with this
Regulation and other relevant Union harmonisation legislation;
(23) ‘substantial modification’ means a change to the AI system after its placing on the
market or putting into service which is not foreseen or planned in the initial
conformity assessment by the provider and as a result of which the compliance of the
AI system with the requirements set out in Title III, Chapter 2 of this Regulation is
affected or results in a modification to the intended purpose for which the AI system
has been assessed;
(24) ‘CE marking of conformity’ (CE marking) means a marking by which a provider
indicates that an AI system is in conformity with the requirements set out in Title III,
Chapter 2 of this Regulation and other applicable Union legislation harmonising the
conditions 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 and taking the measures pursuant to Regulation (EU) 2019/1020;
(27) ‘harmonised standard’ means a European standard as defined in Article 2(1)(c) of
Regulation (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;
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(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 and for tuning its non-learnable parameters and its learning process, among
other things, in order to prevent underfitting or overfitting; whereas the validation
dataset is a separate dataset or part of the training dataset, either as a fixed or variable
split;
(31) ‘testing data’ means data used for providing an independent evaluation of the 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
of which 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;
(33a) ‘biometric identification’ means the automated recognition of physical,
physiological, behavioural, and psychological human features for the purpose of
establishing an individual’s identity by comparing biometric data of that individual to
stored biometric data of individuals in a database;
(33c) ‘biometric verification’ means the automated verification of the identity of natural
persons by comparing biometric data of an individual to previously provided
biometric data (one-to-one verification, including authentication);
(33d) ‘special categories of personal data’ means the categories of personal data referred to
in Article 9(1) of Regulation (EU) 2016/679, Article 10 of Directive (EU) 2016/680
and Article 10(1) of Regulation (EU) 2018/1725;
(33e) ‘sensitive operational data’ means operational data related to activities of prevention,
detection, investigation and prosecution of criminal offences, the disclosure of which
can jeopardise the integrity of criminal proceedings;
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(34) ‘emotion recognition system’ means an AI system for the purpose of identifying or
inferring emotions or intentions of natural persons on the basis of their biometric
data;
(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 unless
ancillary to another commercial service and strictly necessary for objective technical
reasons;
(36) ‘remote biometric identification system’ means an AI system for the purpose of
identifying natural persons, without their active involvement, typically at a distance
through the comparison of a person’s biometric data with the biometric data
contained in a reference database;
(37) ‘‘real-time’ remote biometric identification system’ means a remote biometric
identification system whereby the capturing of biometric data, the comparison and
the identification all occur without a significant delay. This comprises not only
instant identification, but also limited short delays in order to avoid circumvention;
(38) ‘‘post’ remote biometric identification system’ means a remote biometric
identification system other than a ‘real-time’ remote biometric identification system;
(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 for access may apply, and regardless of the potential capacity
restrictions;
(40) ‘law enforcement authority’ means:
(a) any public authority competent 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; or
(b) any other body or entity entrusted by Member State law to exercise public
authority and public powers for the purposes of the prevention, investigation,
detection or prosecution of criminal offences or the execution of criminal
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penalties, including the safeguarding against and the prevention of threats to
public security;
(41) ‘law enforcement’ means activities carried out by law enforcement authorities or on
their behalf 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) ‘Artificial Intelligence Office’ means the Commission’s function of contributing to
the implementation, monitoring and supervision of AI systems, general purpose AI
models and AI governance. References in this Regulation to the Artificial
Intelligence office shall be understood as references to the Commission;
(43) ‘national competent authority’ means any of the following: the notifying authority
and the market surveillance authority. As regards AI systems put into service or used
by EU institutions, agencies, offices and bodies, 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
critical infrastructure;
(ba) breach of obligations under Union law intended to protect fundamental rights;
(bb) serious damage to property or the environment.
(44a) 'personal data' means personal data as defined in Article 4, point (1) of Regulation
(EU) 2016/679;
(44c) ‘non-personal data’ means data other than personal data as defined in point (1) of
Article 4 of Regulation (EU) 2016/679;
(be) ‘profiling’ means any form of automated processing of personal data as defined in
point (4) of Article 4 of Regulation (EU) 2016/679; or in the case of law enforcement
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authorities – in point 4 of Article 3 of Directive (EU) 2016/680 or, in the case of
Union institutions, bodies, offices or agencies, in point 5 Article 3 of Regulation
(EU) 2018/1725;
(bf) ‘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;
(44 eb)‘sandbox plan’ means a document agreed between the participating provider and the
competent authority describing the objectives, conditions, timeframe, methodology
and requirements for the activities carried out within the sandbox;
(bg) 'AI regulatory sandbox’ means a concrete and controlled framework set up by a
competent authority which offers providers or prospective providers of AI systems
the possibility to develop, train, validate and test, where appropriate in real world
conditions, an innovative AI system, pursuant to a sandbox plan for a limited time
under regulatory supervision;
(bh) ‘AI literacy’ refers to skills, knowledge and understanding that allows providers,
users and affected persons, taking into account their respective rights and obligations
in the context of this Regulation, to make an informed deployment of AI systems, as
well as to gain awareness about the opportunities and risks of AI and possible harm it
can cause;
(bi) ‘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 and verifying the conformity of the AI system with the requirements of this
Regulation; testing in 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;
(bj) ‘subject’ for the purpose of real world testing means a natural person who
participates in testing in real world conditions;
(bk) ‘informed consent’ means a subject's freely given, specific, unambiguous and
voluntary expression of his or her willingness to participate in a particular testing in
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real world conditions, after having been informed of all aspects of the testing that are
relevant to the subject's decision to participate;
(bl) "deep fake" means AI generated or manipulated image, audio or video content that
resembles existing persons, objects, places or other entities or events and would
falsely appear to a person to be authentic or truthful;
(44e) ‘widespread infringement’ means any act or omission contrary to Union law that
protects the interest of individuals:
(a) which has harmed or is likely to harm the collective interests of individuals
residing in at least two Member States other than the Member State, in which:
(i) the act or omission originated or took place;
(ii) the provider concerned, or, where applicable, its authorised
representative is established; or
(iii) the deployer is established, when the infringement is committed by the
deployer;
(b) which protects the interests of individuals, that have caused, cause or are likely
to cause harm to the collective interests of individuals and that have common
features, including the same unlawful practice, the same interest being
infringed and that are occurring concurrently, committed by the same operator,
in at least three Member States;
(44h) ‘critical infrastructure’ means an asset, a facility, equipment, a network or a system,
or a part of thereof, which is necessary for the provision of an essential service
within the meaning of Article 2(4) of Directive (EU) 2022/2557;
(44b) ‘general purpose AI model’ means an AI model, including when trained with a large
amount of data using self-supervision at scale, that displays significant generality and
is capable to competently perform a wide range of distinct tasks regardless of the
way the model is placed on the market and that can be integrated into a variety of
downstream systems or applications. This does not cover AI models that are used
before release on the market for research, development and prototyping activities;
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(44c) ‘high-impact capabilities’ in general purpose AI models means capabilities that
match or exceed the capabilities recorded in the most advanced general purpose AI
models;
(44d) ‘systemic risk at Union level’ means a risk that is specific to the high-impact
capabilities of general-purpose AI models, having a significant impact on the internal
market due to its reach, and with actual or reasonably foreseeable negative effects on
public health, safety, public security, fundamental rights, or the society as a whole,
that can be propagated at scale across the value chain;
(44e) ‘general purpose AI system’ means an AI system which is based on a general
purpose AI model, that has the capability to serve a variety of purposes, both for
direct use as well as for integration in other AI systems;
(44f) ’floating-point operation’ means any mathematical operation or assignment
involving floating-point numbers, which are a subset of the real numbers typically
represented on computers by an integer of fixed precision scaled by an integer
exponent of a fixed base;
(44g) ‘downstream provider’ means a provider of an AI system, including a general-
purpose AI system, which integrates an AI model, regardless of whether the model is
provided by themselves and vertically integrated or provided by another entity based
on contractual relations.
Article 4b
AI literacy
Providers and deployers of AI systems shall take measures to ensure, to their best extent, a
sufficient level of AI literacy of their staff and other persons dealing with the operation and
use of AI systems on their behalf, taking into account their technical knowledge,
experience, education and training and the context the AI systems are to be used in, and
considering the persons or groups of persons on which the AI systems are to be used.
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TITLE II
PROHIBITED ARTIFICIAL INTELLIGENCE PRACTICES
Article 5
Prohibited Artificial Intelligence Practices
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 or purposefully manipulative
or deceptive techniques, with the objective to or the effect of materially distorting a
person’s or a group of persons’ behaviour by appreciably impairing the person’s
ability to make an informed decision, thereby causing the person to take a decision
that that person would not have otherwise taken in a manner that causes or is likely
to cause that person, another person or group of persons significant harm;
(b) the placing on the market, putting into service or use of an AI system that exploits
any of the vulnerabilities of a person or a specific group of persons due to their age,
disability or a specific social or economic situation, with the objective to or the effect
of materially distorting the behaviour of that person or a person pertaining to that
group in a manner that causes or is reasonably likely to cause that person or another
person significant harm;
(ba) the placing on the market or putting into service for this specific purpose, or use of
biometric categorisation systems that categorise individually natural persons based
on their biometric data to deduce or infer their race, political opinions, trade union
membership, religious or philosophical beliefs, sex life or sexual orientation.
This prohibition does not cover any labelling or filtering of lawfully acquired
biometric datasets, such as images, based on biometric data or categorizing of
biometric data in the area of law enforcement;
(c) the placing on the market, putting into service or use of AI systems for the evaluation
or classification of natural persons or groups thereof over a certain period of time
based on their social behaviour or known, inferred or predicted personal or
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personality characteristics, with the social score leading to either or both of the
following:
(i) detrimental or unfavourable treatment of certain natural persons or whole
groups thereof in social contexts that are unrelated to the contexts in which the
data was originally generated or collected;
(ii) detrimental or unfavourable treatment of certain natural persons or groups
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 for the purpose of law enforcement unless and in as far as such use is strictly
necessary for one of the following objectives:
(i) the targeted search for specific victims of abduction, trafficking in human
beings and sexual exploitation of human beings as well as search for missing
persons;
(ii) the prevention of a specific, substantial and imminent threat to the life or
physical safety of natural persons or a genuine and present or genuine and
foreseeable threat of a terrorist attack;
(iii) the localisation or identification of a person suspected of having committed a
criminal offence, for the purposes of conducting a criminal investigation,
prosecution or executing a criminal penalty for offences, referred to in Annex
IIa and punishable in the Member State concerned by a custodial sentence or a
detention order for a maximum period of at least four years. This paragraph is
without prejudice to the provisions in Article 9 of the GDPR for the processing
of biometric data for purposes other than law enforcement.
(da) the placing on the market, putting into service for this specific purpose, or use of an
AI system for making risk assessments of natural persons in order to assess or predict
the risk of a natural person to commit a criminal offence, based solely on the
profiling of a natural person or on assessing their personality traits and
characteristics. This prohibition shall not apply to AI systems used to support the
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human assessment of the involvement of a person in a criminal activity, which is
already based on objective and verifiable facts directly linked to a criminal activity;
(db) the placing on the market, putting into service for this specific purpose, or use of AI
systems that create or expand facial recognition databases through the untargeted
scraping of facial images from the internet or CCTV footage;
(dc) the placing on the market, putting into service for this specific purpose, or use of AI
systems to infer emotions of a natural person in the areas of workplace and education
institutions except in cases where the use of the AI system is intended to be put in
place or into the market for medical or safety reasons.
1a. This Article shall not affect the prohibitions that apply where an artificial intelligence
practice infringes other Union law.
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 only be deployed for the purposes under paragraph 1, point (d) to confirm
the specifically targeted individual’s identity and it 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;
(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 to in
paragraph 1 point (d) shall comply with necessary and proportionate safeguards and
conditions in relation to the use in accordance with national legislations authorizing the use
thereof, in particular as regards the temporal, geographic and personal limitations. The use of
the ‘real-time’ remote biometric identification system in publicly accessible spaces shall only
be authorised if the law enforcement authority has completed a fundamental rights impact
assessment as provided for in Article 29a and has registered the system in the database
according to Article 51. However, in duly justified cases of urgency, the use of the system
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may be commenced without the registration, provided that the registration is completed
without undue delay.
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 an independent
administrative authority whose decision is binding of the Member State in which the use is
to take place, issued upon a reasoned request and in accordance with the detailed rules of
national law referred to in paragraph 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, at the latest within 24 hours. If such
authorisation is rejected, its use shall be stopped with immediate effect and all the data, as
well as the results and outputs of this use shall be immediately discarded and deleted.
The competent judicial authority or an independent administrative authority whose
decision is binding shall only grant the authorisation where it is satisfied, based on
objective evidence or clear indications presented to it, that the use of the ‘real-time’ remote
biometric identification system at issue is necessary for and proportionate to achieving one
of the objectives specified in paragraph 1, point (d), as identified in the request and, in
particular, remains limited to what is strictly necessary concerning the period of time as
well as geographic and personal scope. In deciding on the request, the competent judicial
authority or an independent administrative authority whose decision is binding shall take
into account the elements referred to in paragraph 2. It shall be ensured that no decision
that produces an adverse legal effect on a person may be taken by the judicial authority or
an independent administrative authority whose decision is binding solely based on the
output of the remote biometric identification system.
3a. Without prejudice to paragraph 3, each use of a ‘real-time’ remote biometric identification
system in publicly accessible spaces for law enforcement purposes shall be notified to the
relevant market surveillance authority and the national data protection authority in
accordance with the national rules referred to in paragraph 4. The notification shall as a
minimum contain the information specified under paragraph 5 and shall not include
sensitive operational data.
4. A Member State may decide to provide for the possibility to fully or partially authorise the
use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for
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the purpose of law enforcement within the limits and under the conditions listed in
paragraphs 1, point (d), 2 and 3. Member States concerned shall lay down in their national
law the necessary detailed rules for the request, issuance and exercise of, as well as
supervision and reporting relating to, the authorisations referred to in paragraph 3. Those
rules shall also specify in respect of which of the objectives listed in paragraph 1, point (d),
including which 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.
Member States shall notify those rules to the Commission at the latest 30 days following
the adoption thereof. Member States may introduce, in accordance with Union law, more
restrictive laws on the use of remote biometric identification systems.
5. National market surveillance authorities and the national data protection authorities of
Member States that have been notified of the use of ‘real-time’ remote biometric
identification systems in publicly accessible spaces for law enforcement purposes pursuant
to paragraph 3a shall submit to the Commission annual reports on such use. For that
purpose, the Commission shall provide Member States and national market surveillance
and data protection authorities with a template, including information on the number of the
decisions taken by competent judicial authorities or an independent administrative
authority whose decision is binding upon requests for authorisations in accordance with
paragraph 3 and their result.
6. The Commission shall publish annual reports on the use of ‘real-time’ remote biometric
identification systems in publicly accessible spaces for law enforcement purposes based on
aggregated data in Member States based on the annual reports referred to in paragraph 5,
which shall not include sensitive operational data of the related law enforcement activities.
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TITLE III
HIGH-RISK AI SYSTEMS
Chapter 1
CLASSIFICATION OF AI SYSTEMS AS HIGH-RISK
Article 6
Classification rules for high-risk AI systems
1. Irrespective of whether an AI system is placed on the market or put into service
independently from the products referred to in points (a) and (b), that AI system shall be
considered high-risk where both of the following conditions are fulfilled:
(a) the AI system is intended to be used as a safety component of a product, or the AI
system is itself a product, covered by the Union harmonisation legislation listed in
Annex II;
(b) the product whose safety component pursuant to point (a) is the AI system, or the AI
system itself as a product, is required to undergo a third-party conformity
assessment, with a view to the placing on the market or putting into service of that
product pursuant to the Union harmonisation legislation listed in Annex II.
2. In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in
Annex III shall also be considered high-risk.
2a. By derogation from paragraph 2 AI systems shall not be considered as high risk if they do
not pose a significant risk of harm, to the health, safety or fundamental rights of natural
persons, including by not materially influencing the outcome of decision making. This
shall be the case if one or more of the following criteria are fulfilled:
(a) the AI system is intended to perform a narrow procedural task;
(b) the AI system is intended to improve the result of a previously completed human
activity;
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(c) the AI system is intended to detect decision-making patterns or deviations from prior
decision-making patterns and is not meant to replace or influence the previously
completed human assessment, without proper human review; or
(d) the AI system is intended to perform a preparatory task to an assessment relevant for
the purpose of the use cases listed in Annex III.
Notwithstanding first subparagraph of this paragraph, an AI system shall always be
considered high-risk if the AI system performs profiling of natural persons.
2b. A provider who considers that an AI system referred to in Annex III is not high-risk shall
document its assessment before that system is placed on the market or put into service.
Such provider shall be subject to the registration obligation set out in Article 51(1a). Upon
request of national competent authorities, the provider shall provide the documentation of
the assessment.
2c. The Commission shall, after consulting the AI Board, and no later than 18 months after the
entry into force of this Regulation, provide guidelines specifying the practical
implementation of this article completed by a comprehensive list of practical examples of
high risk and non-high risk use cases on AI systems in accordance with the conditions set
out in Article 82a.
2d. The Commission is empowered to adopt delegated acts in accordance with Article 73 to
amend the criteria laid down in points (a) to (d) of the first subparagraph of paragraph 2a.
The Commission may adopt delegated acts adding new criteria to those laid down in points
(a) to (d) of the first subparagraph of paragraph 2a, or modifying them, only where there is
concrete and reliable evidence of the existence of AI systems that fall under the scope of
Annex III but that do not pose a significant risk of harm to the health, safety and
fundamental rights.
The Commission shall adopt delegated acts deleting any of the criteria laid down in the
first subparagraph of paragraph 2a where there is concrete and reliable evidence that this is
necessary for the purpose of maintaining the level of protection of health, safety and
fundamental rights in the Union.
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Any amendment to the criteria laid down in points (a) to (d) set out in the first
subparagraph of paragraph 2a shall not decrease the overall level of protection of health,
safety and fundamental rights in the Union.
When adopting the delegated acts, the Commission shall ensure consistency with the
delegated acts adopted pursuant to Article 7(1) and shall take account of market and
technological developments.
Article 7
Amendments to Annex III
1. The Commission is empowered to adopt delegated acts in accordance with Article 73 to
amend Annex III by adding or modifying use cases of high-risk AI systems where both of
the following conditions are fulfilled:
(a) the AI systems are intended to be used in any of the areas listed in points 1 to 8 of
Annex III;
(b) the AI systems pose a risk of harm to health and safety, or an adverse impact on
fundamental rights, and that risk is equivalent to or greater than the risk of harm or of
adverse impact posed by the high-risk AI systems already referred to in Annex III.
2. When assessing for the purposes of paragraph 1 whether an AI system poses a risk of harm
to 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;
(ba) the nature and amount of the data processed and used by the AI system, in particular
whether special categories of personal data are processed;
(bb) the extent to which the AI system acts autonomously and the possibility for a human
to override a decision or recommendations that may lead to potential harm;
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(c) the extent to which the use of an AI system has already caused harm to health and
safety, has had an adverse impact on fundamental rights or has given rise to
significant concerns in relation to the likelihood of such harm or adverse impact, as
demonstrated for example by reports or documented allegations submitted to national
competent authorities or by other reports, as appropriate;
(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 or to disproportionately affect
a particular group 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 there is an imbalance of power, or the potentially harmed or
adversely impacted persons are in a vulnerable position in relation to the user of an
AI system, in particular due to status, authority, knowledge, economic or social
circumstances, or age;
(g) the extent to which the outcome produced involving an AI system is easily corrigible
or reversible, taking into account the technical solutions available to correct or
reverse, whereby outcomes having and adverse impact on health, safety, fundamental
rights, shall not be considered as easily corrigible or reversible;
(gb) the magnitude and likelihood of benefit of the deployment of the AI system for
individuals, groups, or society at large, including possible improvements in product
safety;
(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) effective measures to prevent or substantially minimise those risks.
2a. The Commission is empowered to adopt delegated acts in accordance with Article 73 to
amend the list in Annex III by removing high-risk AI systems where both of the following
conditions are fulfilled:
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(a) the high-risk AI system(s) concerned no longer pose any significant risks to
fundamental rights, health or safety, taking into account the criteria listed in
paragraph 2;
(b) the deletion does not decrease the overall level of protection of health, safety and
fundamental rights under Union law.
Chapter 2
REQUIREMENTS FOR HIGH-RISK AI SYSTEMS
Article 8
Compliance with the requirements
1. High-risk AI systems shall comply with the requirements established in this Chapter,
taking into account its intended purpose as well as the generally acknowledged state of the
art on AI and AI related technologies. The risk management system referred to in Article 9
shall be taken into account when ensuring compliance with those requirements.
2a. Where a product contains an artificial intelligence system, to which the requirements of
this Regulation as well as requirements of the Union harmonisation legislation listed in
Annex II, Section A apply, providers shall be responsible for ensuring that their product is
fully compliant with all applicable requirements required under the Union harmonisation
legislation. In ensuring the compliance of high-risk AI systems referred in paragraph 1
with the requirements set out in Chapter 2 of this Title, and in order to ensure consistency,
avoid duplications and minimise additional burdens, providers shall have a choice to
integrate, as appropriate, the necessary testing and reporting processes, information and
documentation they provide with regard to their product into already existing
documentation and procedures required under the Union harmonisation legislation listed in
Annex II, Section A.
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Article 9
Risk management system
1. A risk management system shall be established, implemented, documented and maintained
in 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 regular
systematic review and updating. It shall comprise the following steps:
(a) identification and analysis of the known and the reasonably foreseeable risks that the
high-risk AI system can pose to the health, safety or fundamental rights when the
high-risk AI system is used in accordance with its intended purpose;
(b) estimation and evaluation of the risks that may emerge when the high-risk AI system
is used in accordance with its intended purpose and under conditions of reasonably
foreseeable misuse;
(c) evaluation of other possibly arising risks based on the analysis of data gathered from
the post-market monitoring system referred to in Article 61;
(d) adoption of appropriate and targeted risk management measures designed to address
the risks identified pursuant to point a of this paragraph in accordance with the
provisions of the following paragraphs.
2a. 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.
3. 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 to
fulfil those requirements.
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4. The risk management measures referred to in paragraph 2, point (d) shall be such that
relevant residual risk associated with each hazard as well as the overall residual risk of the
high-risk AI systems is judged to be acceptable.
In identifying the most appropriate risk management measures, the following shall be
ensured:
(a) elimination or reduction of identified risks and evaluated pursuant to paragraph 2 as
far as technically feasible through adequate design and development of the high-risk
AI system;
(b) where appropriate, implementation of adequate mitigation and control measures
addressing risks that cannot be eliminated;
(c) provision of the required information pursuant to Article 13, referred to in paragraph
2, point (b) of this Article, and, where appropriate, training to deployers.
With a view to eliminating or reducing risks related to the use of the high-risk AI system,
due consideration shall be given to the technical knowledge, experience, education,
training to be expected by the deployer and the presumable context in which the system is
intended to be used.
5. High-risk AI systems shall be tested for the purposes of identifying the most appropriate
and targeted risk management measures. Testing shall ensure that high-risk AI systems
perform consistently for their intended purpose and they are in compliance with the
requirements set out in this Chapter.
6. Testing procedures may include testing in real world conditions in accordance with Article
54a.
7. The testing of the high-risk AI systems shall be performed, as appropriate, at any point in
time throughout the development process, and, in any event, prior to the placing on the
market or the putting into service. Testing shall be made against prior defined metrics and
probabilistic thresholds that are appropriate to the intended purpose of the high-risk AI
system.
8. When implementing the risk management system described in paragraphs 1 to 6, providers
shall give consideration to whether in view of its intended purpose the high-risk AI system
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is likely to adversely impact persons under the age of 18 and, as appropriate, other
vulnerable groups of people.
9. For providers of high-risk AI systems that are subject to requirements regarding internal
risk management processes under relevant sectorial Union law, the aspects described in
paragraphs 1 to 8 may be part of or combined with the risk management procedures
established pursuant to that law.
Article 10
Data and data governance
1. High-risk AI systems which make use of techniques involving the training of models with
data shall be developed on the basis of training, validation and testing data sets that meet
the quality criteria referred to in paragraphs 2 to 5 whenever such datasets are used.
2. Training, validation and testing data sets shall be subject to appropriate data governance
and management practices appropriate for the intended purpose of the AI system. Those
practices shall concern in particular:
(a) the relevant design choices;
(aa) data collection processes and origin of data, and in the case of personal data, the
original purpose of data collection;
(c) relevant data preparation processing operations, such as annotation, labelling,
cleaning, updating, enrichment and aggregation;
(d) the formulation of assumptions, notably with respect to the information that the data
are supposed to measure and represent;
(e) an assessment of the availability, quantity and suitability of the data sets that are
needed;
(f) examination in view of possible biases that are likely to affect the health and safety
of persons, negatively impact fundamental rights or lead to discrimination prohibited
under Union law, especially where data outputs influence inputs for future
operations;
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(fa) appropriate measures to detect, prevent and mitigate possible biases identified
according to point (f);
(g) the identification of relevant data gaps or shortcomings that prevent compliance with
this Regulation, and how those gaps and shortcomings can be addressed.
3. Training, validation and testing datasets shall be relevant, sufficiently representative, and
to the best extent possible, free of errors and complete in view of the intended purpose.
They shall have the appropriate statistical properties, including, where applicable, as
regards the persons or groups of persons in relation to whom the high-risk AI system 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. Datasets shall take into account, to the extent required by the intended purpose, the
characteristics or elements that are particular to the specific geographical, contextual,
behavioural or functional setting within which the high-risk AI system is intended to be
used.
5. To the extent that it is strictly necessary for the purposes of ensuring bias detection and
correction in relation to the high-risk AI systems in accordance with the second paragraph,
point f and fa, the providers of such systems may exceptionally process special categories
of personal data referred to in Article 9(1) of Regulation (EU) 2016/679, Article 10 of
Directive (EU) 2016/680 and Article 10(1) of Regulation (EU) 2018/1725, subject to
appropriate safeguards for the fundamental rights and freedoms of natural persons. In
addition to provisions set out in the Regulation (EU) 2016/679, Directive (EU) 2016/680
and Regulation (EU) 2018/1725, all the following conditions shall apply in order for such
processing to occur:
(a) the bias detection and correction cannot be effectively fulfilled by processing other
data, including synthetic or anonymised data;
(b) the special categories of personal data processed for the purpose of this paragraph are
subject to technical limitations on the re-use of the personal data and state of the art
security and privacy-preserving measures, including pseudonymisation;
(c) the special categories of personal data processed for the purpose of this paragraph are
subject to measures to ensure that the personal data processed are secured, protected,
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subject to suitable safeguards, including strict controls and documentation of the
access, to avoid misuse and ensure only authorised persons have access to those
personal data with appropriate confidentiality obligations;
(d) the special categories of personal data processed for the purpose of this paragraph are
not to be transmitted, transferred or otherwise accessed by other parties;
(e) the special categories of personal data processed for the purpose of this paragraph are
deleted once the bias has been corrected or the personal data has reached the end of
its retention period, whatever comes first;
(f) the records of processing activities pursuant to Regulation (EU) 2016/679, Directive
(EU) 2016/680 and Regulation (EU) 2018/1725 includes justification why the
processing of special categories of personal data was strictly necessary to detect and
correct biases and this objective could not be achieved by processing other data.
6. For the development of high-risk AI systems not using techniques involving the training of
models, 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 high-
risk AI system complies with the requirements set out in this Chapter and provide national
competent authorities and notified bodies with the necessary information in a clear and
comprehensive form to assess the compliance of the AI system with those requirements. It
shall contain, at a minimum, the elements set out in Annex IV. SMEs, including start-ups,
may provide the elements of the technical documentation specified in Annex IV in a
simplified manner. For this purpose, the Commission shall establish a simplified technical
documentation form targeted at the needs of small and micro enterprises. Where an SME,
including start-ups, opts to provide the information required in Annex IV in a simplified
manner, it shall use the form referred to in this paragraph. Notified bodies shall accept the
form for the purpose of conformity assessment.
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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 technical
documentation shall be drawn up containing all the information set out in paragraph 1 as
well as the information required under those legal acts.
3. The Commission is empowered to adopt delegated acts in accordance with Article 73 to
amend Annex IV where necessary to ensure that, in the light of technical progress, the
technical documentation provides all the necessary information to assess the compliance of
the system with the requirements set out in this Chapter.
Article 12
Record-keeping
1. High-risk AI systems shall technically allow for the automatic recording of events (‘logs’)
over the duration of the lifetime 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 the
meaning 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;
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(d) the identification of the natural persons involved in the verification of the results, as
referred to in Article 14 (5).
Article 13
Transparency and provision of information to deployers
1. High-risk AI systems shall be designed and developed in such a way to ensure that their
operation is sufficiently transparent to enable deployers to interpret the system’s output and
use it appropriately. An appropriate type and degree of transparency shall be ensured with
a view to achieving compliance with the relevant obligations of the provider and deployer
set out in Chapter 3 of this Title.
2. High-risk AI systems shall be accompanied by instructions for use in an appropriate digital
format or otherwise that include concise, complete, correct and clear information that is
relevant, accessible and comprehensible to users.
3. The instructions for use shall contain at least the following information:
(a) the identity and the contact details of the provider and, where applicable, of its
authorised representative;
(b) the characteristics, capabilities and limitations of performance of the high-risk AI
system, including:
(i) its intended purpose;
(ii) the level of accuracy, including its metrics, robustness and cybersecurity
referred to in Article 15 against which the high-risk AI system has been tested
and validated and which can be expected, and any known and foreseeable
circumstances that may have an impact on that expected level of accuracy,
robustness and cybersecurity;
(iii) any known or foreseeable circumstance, related to the use of the high-risk AI
system in accordance with its intended purpose or under conditions of
reasonably foreseeable misuse, which may lead to risks to the health and safety
or fundamental rights referred to in Article 9(2);
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(iiia) where applicable, the technical capabilities and characteristics of the AI system
to provide information that is relevant to explain its output;
(iv) when appropriate, its performance 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;
(va) where applicable, information to enable deployers to interpret the system’s
output and use it appropriately.
(c) the changes to the high-risk AI system and its performance which have been pre-
determined 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 technical
measures put in place to facilitate the interpretation of the outputs of AI systems by
the deployers;
(e) the computational and hardware resources needed, the expected lifetime of the high-
risk AI system and any necessary maintenance and care measures, including their
frequency, to ensure the proper functioning of that AI system, including as regards
software updates;
(ea) where relevant, a description of the mechanisms included within the AI system that
allows users to properly collect, store and interpret the logs in accordance with
Article 12.
Article 14
Human oversight
1. High-risk AI systems shall be designed and developed in such a way, including with
appropriate 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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2. 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 particular
when such risks persist notwithstanding the application of other requirements set out in this
Chapter.
3. The oversight measures shall be commensurate to the risks, level of autonomy and context
of use of the AI system and shall be ensured through either one or all of the following
types of measures:
(a) measures identified and built, when technically feasible, into the high-risk AI system
by 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 the
market 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 properly understand the relevant capacities and limitations of the high-risk AI
system and be able to duly monitor its operation, also in view of detecting and
addressing anomalies, dysfunctions and unexpected performance;
(b) to remain aware of the possible tendency of automatically relying or over-relying on
the output produced by a high-risk AI system (‘automation bias’), in particular for
high-risk AI systems used to provide information or recommendations for decisions
to be taken by natural persons;
(c) to correctly interpret the high-risk AI system’s output, taking into account 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;
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(e) to intervene on the operation of the high-risk AI system or interrupt, the system
through a "stop" button or a similar procedure that allows the system to come to a
halt in a safe state.
5. For high-risk AI systems referred to in point 1(a) of Annex III, the measures referred to in
paragraph 3 shall be such as to ensure that, in addition, no action or decision is taken by the
deployer on the basis of the identification resulting from the system unless this has been
separately verified and confirmed by at least two natural persons with the necessary
competence, training and authority.
The requirement for a separate verification by at least two natural persons shall not apply
to high risk AI systems used for the purpose of law enforcement, migration, border control
or asylum, in cases where Union or national law considers the application of this
requirement to be disproportionate.
Article 15
Accuracy, robustness and cybersecurity
1. High-risk AI systems shall be designed and developed in such a way that they achieve an
appropriate level of accuracy, robustness, and cybersecurity, and perform consistently in
those respects throughout their lifecycle.
1a. To address the technical aspects of how to measure the appropriate levels of accuracy and
robustness set out in paragraph 1 of this Article and any other relevant performance
metrics, the Commission shall, in cooperation with relevant stakeholder and organisations
such as metrology and benchmarking authorities, encourage as appropriate, the
development of benchmarks and measurement methodologies.
2. The levels of accuracy and the relevant accuracy metrics of high-risk AI systems shall be
declared in the accompanying instructions of use.
3. High-risk AI systems shall be as resilient as possible regarding 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.
Technical and organisational measures shall be taken towards this regard.
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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 of
possibly biased outputs influencing input for future operations (‘feedback loops’) are duly
addressed with appropriate mitigation measures.
4. High-risk AI systems shall be resilient as regards to attempts by unauthorised third parties
to alter their use, outputs or performance by exploiting the system vulnerabilities.
The technical solutions aimed at ensuring the cybersecurity of high-risk AI systems shall
be appropriate to the relevant circumstances and the risks.
The technical solutions to address AI specific vulnerabilities shall include, where
appropriate, measures to prevent, detect, respond to, resolve and control for attacks trying
to manipulate the training dataset (‘data poisoning’), or pre-trained components used in
training (‘model poisoning’), inputs designed to cause the model to make a mistake
(‘adversarial examples’ or ‘model evasion’), confidentiality attacks or model flaws.
Chapter 3
OBLIGATIONS OF PROVIDERS AND DEPLOYERS 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;
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(b) have a quality management system in place which complies with Article 17;
(c) keep the documentation referred to in Article 18;
(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;
(ea) draw up an EU declaration of conformity in accordance with Article 48;
(eb) affix the CE marking to the high-risk AI system to indicate conformity with this
Regulation, in accordance with Article 49;
(f) comply with the registration obligations referred to in Article 51(1);
(g) take the necessary corrective actions and provide information as required in Article
21;
(j) upon a reasoned request of a national competent authority, demonstrate the
conformity of the high-risk AI system with the requirements set out in Chapter 2 of
this Title;
(ja) ensure that the high-risk AI system complies with accessibility requirements, in
accordance with Directive 2019/882 on accessibility requirements for products and
services and Directive 2016/2102 on the accessibility of the websites and mobile
applications of public sector bodies.
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 systematic
and orderly manner in the form of written policies, procedures and instructions, and shall
include at least the following aspects:
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(a) a strategy for regulatory compliance, including compliance with conformity
assessment procedures and procedures for the management of modifications to the
high-risk AI system;
(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 have
to be carried out;
(e) technical specifications, including standards, to be applied and, where the relevant
harmonised standards are not applied in full, or do not cover all of the relevant
requirements set out in Chapter II of this Title, the means to be used to ensure that
the high-risk AI system complies with those requirements;
(f) systems and procedures for data management, including data acquisition, 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 and for 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, other relevant
authorities, including those providing or supporting the access to data, notified
bodies, other operators, customers or other interested parties;
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(k) systems and procedures for record keeping of all relevant documentation and
information;
(l) resource management, including security of supply related measures;
(m) an accountability framework setting out the responsibilities of the management and
other 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 size
of the provider’s organisation. Providers shall in any event respect the degree of rigour and
the level of protection required to ensure compliance of their AI systems with this
Regulation.
2a. For providers of high-risk AI systems that are subject to obligations regarding quality
management systems or their equivalent function under relevant sectorial Union law, the
aspects described in paragraph 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, the
obligation 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 on
internal 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 the
market 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;
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(c) the documentation concerning the changes approved by notified bodies where
applicable;
(d) the decisions and other documents issued by the notified bodies where applicable;
(e) the EU declaration of conformity referred to in Article 48.
1a. Each Member State shall determine conditions under which the documentation referred to
in 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 shall
maintain the technical documentation as part of the documentation kept under the relevant
Union financial services legislation.
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. Without prejudice to applicable Union or national law, the logs shall be kept
for a period appropriate to the intended purpose of the high-risk AI system, of at least 6
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 shall
maintain the logs automatically generated by their high-risk AI systems as part of the
documentation kept under the relevant financial service legislation.
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Article 21
Corrective actions and duty of information
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 this Regulation shall immediately take the necessary corrective actions to
bring that system into conformity, to withdraw it, to disable it, or to recall it, as
appropriate. They shall inform the distributors of the high-risk AI system in question and,
where applicable, the deployers, the authorised representative and importers accordingly.
Where the high-risk AI system presents a risk within the meaning of Article 65(1) and the
provider becomes aware of that risk, they shall immediately investigate the causes, in
collaboration with the reporting deployer, where applicable, and inform the market
surveillance authorities of the Member States in which they made the high-risk AI system
available and, where applicable, the notified body that issued a certificate for the high-risk
AI system in accordance with Article 44, in particular, of the nature of the non-compliance
and of any relevant corrective action taken.
Article 23
Cooperation with competent authorities
1. Providers of high-risk AI systems shall, upon a reasoned request by a competent authority,
provide that authority all the information and documentation necessary to demonstrate the
conformity of 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 in an official Union
language determined by the Member State concerned.
1a. Upon a reasoned request by a national competent authority providers shall also give the
requesting national competent authority, as applicable, 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 their control.
1b. Any information obtained by a national competent authority pursuant to the provisions of
this Article shall be treated in compliance with the confidentiality obligations set out in
Article 70.
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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 is
established in the Union.
1b. The provider shall enable its authorised representative to perform its tasks under this
Regulation.
2. The authorised representative shall perform the tasks specified in the mandate received
from the provider. It shall provide a copy of the mandate to the market surveillance
authorities upon request, in one of the official languages of the institution of the Union
determined by the national competent authority. For the purpose of this Regulation, the
mandate shall empower the authorised representative to carry out the following tasks:
(-a) verify that the EU declaration of conformity and the technical documentation have
been 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, the
certificate issued by the notified body;
(b) provide a national competent authority, upon a reasoned request, with all the
information and documentation, including that kept according to point (a), 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, as referred to in Article 12(1),
automatically generated by the high-risk AI system to the extent such logs are under
the control of the provider;
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(c) cooperate with competent authorities, upon a reasoned request, on any action the
latter takes in relation to the high-risk AI system, in particular to reduce and mitigate
the risks posed by the high-risk AI system;
(ca) where applicable, comply with the registration obligations referred in Article 51(1),
or, if the registration is carried out by the provider itself, ensure that the information
referred to in [point 3] of Annex VIII is correct.
The mandate shall empower the authorised representative to be addressed, in addition to or
instead of the provider, by the competent authorities, on all issues related to ensuring
compliance with this Regulation.
2b. The authorised representative shall terminate the mandate if it considers or has reason to
consider that the 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 is established, as well as, where applicable, the relevant notified body,
about the termination of the mandate and the reasons thereof.
Article 26
Obligations of importers
1. Before placing a high-risk AI system on the market, importers of such system shall ensure
that 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 Article 11
and Annex IV;
(c) the system bears the required CE conformity marking and is accompanied by the EU
declaration of conformity and instructions of use;
(ca) the provider has appointed an authorised representative in accordance with Article
25(1).
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2. Where an importer has sufficient reason to consider that a high-risk AI system is not in
conformity with this Regulation, or is falsified, or accompanied by falsified
documentation, it shall not place that system on the market until that AI system has been
brought into conformity. Where the high-risk AI system presents a risk within the meaning
of 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 trademark, and the
address at which they can be contacted on the high-risk AI system and on its packaging or
its accompanying documentation, where applicable.
4. Importers shall ensure that, while a high-risk AI system is under their responsibility, where
applicable, storage or transport conditions do not jeopardise its compliance with the
requirements 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, where
applicable, of the instructions for use and of the EU declaration of conformity.
5. Importers shall provide national competent authorities, upon a reasoned request, with all
the necessary information and documentation including that kept in accordance with
paragraph 4a 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 them. To
this purpose they shall also ensure that the technical documentation can be made available
to those authorities.
5a. Importers shall cooperate with national competent authorities on any action those
authorities take, in particular to reduce and mitigate the risks posed by the high-risk AI
system.
Article 27
Obligations of distributors
1. Before making a high-risk AI system available on the market, distributors shall verify that
the 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 and
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the importer of the system, as applicable, have complied with their obligations set out in
Article 16, point (aa) and (b) and 26(3) respectively.
2. Where a distributor considers or has reason to consider, on the basis of the information in
its possession, 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 the high-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 the system, 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 the
system with the requirements set out in Chapter 2 of this Title.
4. A distributor that considers or has reason to consider, on the basis of the information in its
possession, 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 the provider, the importer or any relevant
operator, as appropriate, takes those corrective actions. Where the high-risk AI system
presents a risk within the meaning of Article 65(1), the distributor shall immediately
inform the provider or importer of the system and 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.
5. Upon a reasoned request from a national competent authority, distributors of the high-risk
AI system shall provide that authority with all the information and documentation
regarding its activities as described in paragraph 1 to 4 necessary to demonstrate the
conformity of a high-risk system with the requirements set out in Chapter 2 of this Title.
5a. Distributors shall cooperate with national competent authorities on any action those
authorities take in relation to an AI system, of which they are the distributor, in particular
to reduce or mitigate the risk posed by the high-risk AI system.
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Article 28
Responsibilities along the AI value chain
1. Any distributor, importer, deployer or other third-party shall be considered a provider of a
high-risk AI system for the purposes of this Regulation and shall be subject to the
obligations of the provider under Article 16, in any of the following circumstances:
(a) they put their name or trademark on a high-risk AI system already placed on the
market or put into service, without prejudice to contractual arrangements stipulating
that the obligations are allocated otherwise;
(b) they make a substantial modification to a high-risk AI system that has already been
placed on the market or has already been put into service and in a way that it remains
a high-risk AI system in accordance with Article 6;
(ba) they modify the intended purpose of an AI system, including a general purpose AI
system, which has not been classified as high-risk and has already been placed on the
market or put into service in such manner that the AI system becomes a high risk AI
system in accordance with Article 6.
2. Where the circumstances referred to in paragraph 1, point (a) to (ba) occur, the provider
that initially placed the AI system on the market or put it into service shall no longer be
considered a provider of that specific AI system for the purposes of this Regulation. This
former provider shall closely cooperate and shall make available the necessary information
and provide the reasonably expected technical access and other assistance that are required
for the fulfilment of the obligations set out in this Regulation, in particular regarding the
compliance with the conformity assessment of high-risk AI systems. This paragraph shall
not apply in the cases where the former provider has expressly excluded the change of its
system into a high-risk system and therefore the obligation to hand over the
documentation.
2a. 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
the provider of the high-risk AI system and shall be subject to the obligations under Article
16 under either of the following scenarios:
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(i) the high-risk AI system is placed on the market together with the product under the
name or trademark of the product manufacturer;
(ii) the high-risk AI system is put into service under the name or trademark of the product
manufacturer after the product has been placed on the market.
2b. The provider of a high risk AI system and the third party that supplies an AI system, tools,
services, components, or processes that are used or integrated in a high-risk AI system
shall, by written agreement, specify the necessary information, capabilities, technical
access and other assistance based on the generally acknowledged state of the art, in order
to enable the provider of the high risk AI system to fully comply with the obligations set
out in this Regulation. This obligation shall not apply to third parties making accessible to
the public tools, services, processes, or AI components other than general-purpose AI
models under a free and open licence.
The AI Office may develop and recommend voluntary model contractual terms between
providers of high-risk AI systems and third parties that supply tools, services, components
or processes that are used or integrated in high-risk AI systems. When developing
voluntary model contractual terms, the AI Office shall take into account possible
contractual requirements applicable in specific sectors or business cases. The model
contractual terms shall be published and be available free of charge in an easily usable
electronic format.
2b. Paragraphs 2 and 2a are without prejudice to the need to respect and protect intellectual
property rights and confidential business information or trade secrets in accordance with
Union and national law.
Article 29
Obligations of deployers of high-risk AI systems
1. Deployers of high-risk AI systems shall take appropriate technical and organisational
measures to ensure they use such systems in accordance with the instructions of use
accompanying the systems, pursuant to paragraphs 2 and 5 of this Article.
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1a. To the extent deployers exercise control over the high-risk AI system, they shall ensure
that the natural persons assigned to ensure human oversight of the high-risk AI systems
have the necessary competence, training and authority as well as the necessary support.
2. The obligations in paragraph 1 and 1a, are without prejudice to other deployer obligations
under Union or national law and to the deployer’s discretion in organising its own
resources and activities for the purpose of implementing the human oversight measures
indicated by the provider.
3. Without prejudice to paragraph 1 and 1a, to the extent the deployer exercises control over
the input data, that deployer shall ensure that input data is relevant and sufficiently
representative in view of the intended purpose of the high-risk AI system.
4. Deployers shall monitor the operation of the high-risk AI system on the basis of the
instructions of use and when relevant, inform providers in accordance with Article 61.
When they have reasons to consider that the use 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, without undue delay, inform the provider or distributor and relevant market
surveillance authority and suspend the use of the system. They shall also immediately
inform first the provider, and then the importer or distributor and relevant market
surveillance authorities when they have identified any serious incident. If the deployer is
not able to reach the provider, Article 62 shall apply mutatis mutandis. This obligation
shall not cover sensitive operational data of deployers of AI systems which are law
enforcement authorities.
For deployers that are financial institutions subject to requirements regarding their internal
governance, arrangements or processes under Union financial services legislation, the
monitoring obligation set out in the first subparagraph shall be deemed to be fulfilled by
complying with the rules on internal governance arrangements, processes and mechanisms
pursuant to the relevant financial service legislation.
5. Deployers of high-risk AI systems shall keep the logs automatically generated by that
high-risk AI system to the extent such logs are under their control for a period appropriate
to the intended purpose of the high-risk AI system, of at least six months, unless provided
otherwise in applicable Union or national law, in particular in Union law on the protection
of personal data.
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Deployers that are financial institutions subject to requirements regarding their internal
governance, arrangements or processes under Union financial services legislation shall
maintain the logs as part of the documentation kept pursuant to the relevant Union
financial service legislation.
(a) Prior to putting into service or use a high-risk AI system at the workplace, deployers
who are employers shall inform workers representatives and the affected workers
that they will be subject to the system. This information shall be provided, where
applicable, in accordance with the rules and procedures laid down in Union and
national law and practice on information of workers and their representatives.
(b) Deployers of high-risk AI systems that are public authorities or Union institutions,
bodies, offices and agencies shall comply with the registration obligations referred to
in Article 51. When they find that the system 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.
6. Where applicable, deployers of high-risk AI systems shall use the information provided
under Article 13 to comply 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.
6a. Without prejudice to Directive (EU) 2016/680, in the framework of an investigation for the
targeted search of a person convicted or suspected of having committed a criminal offence,
the deployer of an AI system for post-remote biometric identification shall request an
authorisation, prior, or without undue delay and no later than 48 hours, by a judicial
authority or an administrative authority whose decision is binding and subject to judicial
review, for the use of the system, except when the system is used for the initial
identification of a potential suspect based on objective and verifiable facts directly linked
to the offence. Each use shall be limited to what is strictly necessary for the investigation
of a specific criminal offence.
If the requested authorisation provided for in the first subparagraph of this paragraph is
rejected, the use of the post remote biometric identification system linked to that
authorisation shall be stopped with immediate effect and the personal data linked to the use
of the system for which the authorisation was requested shall be deleted.
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In any case, such AI system for post remote biometric identification shall not be used for
law enforcement purposes in an untargeted way, without any link to a criminal offence, a
criminal proceeding, a genuine and present or genuine and foreseeable threat of a criminal
offence or the search for a specific missing person.
It shall be ensured that no decision that produces an adverse legal effect on a person may
be taken by the law enforcement authorities solely based on the output of these post remote
biometric identification systems.
This paragraph is without prejudice to the provisions of Article 10 of the Directive (EU)
2016/680 and Article 9 of the GDPR for the processing of biometric data.
Regardless of the purpose or deployer, each use of these systems shall be documented in
the relevant police file and shall be made available to the relevant market surveillance
authority and the national data protection authority upon request, excluding the disclosure
of sensitive operational data related to law enforcement. This subparagraph shall be
without prejudice to the powers conferred by the Directive 2016/680 to supervisory
authorities.
Deployers shall, in addition, submit annual reports to the relevant market surveillance and
national data protection authorities on the uses of post-remote biometric identification
systems, excluding the disclosure of sensitive operational data related to law enforcement.
The reports can be aggregated to cover several deployments in one operation.
Member States may introduce, in accordance with Union law, more restrictive laws on the
use of post remote biometric identification systems.
6b. Without prejudice to Article 52, deployers of high-risk AI systems referred to in Annex III
that make decisions or assist in making decisions related to natural persons shall inform the
natural persons that they are subject to the use of the high-risk AI system. For high risk AI
systems used for law enforcement purposes Article 13 of Directive 2016/680 shall apply.
6c. Deployers shall cooperate with the relevant national competent authorities on any action
those authorities take in relation with the high-risk system in order to implement this
Regulation.
Article 29a
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Fundamental rights impact assessment for high-risk AI systems
1. Prior to deploying a high-risk AI system as defined in Article 6(2), with the exception of
AI systems intended to be used in the area listed in point 2 of Annex III, deployers that are
bodies governed by public law or private operators providing public services and operators
deploying high-risk systems referred to in Annex III, point 5, (b) and (ca) shall perform an
assessment of the impact on fundamental rights that the use of the system may produce. For
that purpose, deployers shall perform an assessment consisting of:
(a) a description of the deployer’s processes in which the high-risk AI system will be
used in line with its intended purpose;
(b) a description of the period of time and frequency in which each high-risk AI system
is intended to be used;
(c) the categories of natural persons and groups likely to be affected by its use in the
specific context;
(d) the specific risks of harm likely to impact the categories of persons or group of
persons identified pursuant point (c), taking into account the information given by
the provider pursuant to Article 13;
(e) a description of the implementation of human oversight measures, according to the
instructions of use;
(f) the measures to be taken in case of the materialization of these risks, including their
arrangements for internal governance and complaint mechanisms.
2. The obligation laid down in paragraph 1 applies to the first use of the high-risk AI system.
The deployer may, in similar cases, rely on previously conducted fundamental rights impact
assessments or existing impact assessments carried out by provider. If, during the use of the
high-risk AI system, the deployer considers that any of the factors listed in paragraph 1
change are or no longer up to date, the deployer will take the necessary steps to update the
information.
3. Once the impact assessment has been performed, the deployer shall notify the market
surveillance authority of the results of the assessment, submitting the filled template referred
to in paragraph 5 as a part of the notification. In the case referred to in Article 47(1),
deployers may be exempted from these obligations.
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4. If any of the obligations laid down in this article are already met through the data protection
impact assessment conducted pursuant to Article 35 of Regulation (EU) 2016/679 or Article
27 of Directive (EU) 2016/680, the fundamental rights impact assessment referred to in
paragraph 1 shall be conducted in conjunction with that data protection impact assessment.
5. The AI Office shall develop a template for a questionnaire, including through an automated
tool, to facilitate deployers to implement the obligations of this Article in a simplified
manner.
Chapter 4
NOTIFIYING AUTHORITIES AND NOTIFIED BODIES
Article 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, designation
and notification of conformity assessment bodies and for their monitoring. These
procedures shall be developed in cooperation between the notifying authorities of all
Member States.
2. Member States may decide that the assessment and monitoring referred to in paragraph 1
shall be carried out by a national accreditation body within the meaning of and in
accordance with Regulation (EC) No 765/2008.
3. Notifying authorities shall be established, organised and operated in such a way that no
conflict of interest arises with conformity assessment bodies and the objectivity and
impartiality of their activities are safeguarded.
4. Notifying authorities shall be organised in such a way that decisions relating to the
notification of conformity assessment bodies are taken by competent persons different
from those who carried out the assessment of those bodies.
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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 their
disposal for the proper performance of their tasks. Competent personnel shall have the
necessary expertise, where applicable, for their function, in fields such as information
technologies, artificial intelligence and law, including the supervision of fundamental
rights.
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 types of AI
systems for which the conformity assessment body claims to be competent, as well as by
an accreditation certificate, where one exists, issued by a national accreditation body
attesting that 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.
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 with
the 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
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responsible for notified bodies to monitor and verify continuous compliance with all the
requirements laid down in Article 33.
Article 32
Notification procedure
1. Notifying authorities may only notify conformity assessment bodies which have satisfied
the requirements laid down in Article 33.
2. Notifying authorities shall notify the Commission and the other Member States using the
electronic notification tool developed and managed by the Commission of each conformity
assessment body referred to in paragraph 1.
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 types of AI
systems concerned and the relevant attestation of competence. Where a notification is not
based on an accreditation certificate as referred to in Article 31 (2), the notifying authority
shall provide the Commission and the other Member States with documentary evidence
which attests to the conformity assessment body's competence and the arrangements in
place to ensure that that body will be monitored regularly and will continue to satisfy the
requirements laid down in Article 33.
4. The conformity assessment body concerned may perform the activities of a notified body
only where no objections are raised by the Commission or the other Member States within
two weeks of a notification by a notifying authority where it includes an accreditation
certificate referred to in Article 31(2), or within two months of a notification by the
notifying authority where it includes documentary evidence referred to in Article 31(3).
4a. Where objections are raised, the Commission shall without delay enter into consultation
with the relevant Member States and the conformity assessment body. In view thereof, the
Commission shall decide whether the authorisation is justified or not. The Commission
shall address its decision to the Member State concerned and the relevant conformity
assessment body.
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Article 33
Requirements relating to notified bodies
1. A notified body shall be established under national law of a Member State and have legal
personality.
2. Notified bodies shall satisfy the organisational, quality management, resources and process
requirements that are necessary to fulfil their tasks, as well as suitable cybersecurity
requirements.
3. The organisational structure, allocation of responsibilities, reporting lines and operation of
notified bodies shall 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 to
which it performs conformity assessment activities. Notified bodies shall also be
independent of any other operator having an economic interest in the high-risk AI system
that is assessed, as well as of any competitors of the provider. This shall not preclude the
use of assessed AI systems that are necessary for the operations of the conformity
assessment body or the use of such systems for personal purposes.
4a. A conformity assessment body, its top-level management and the personnel responsible for
carrying out the conformity assessment tasks shall not be directly involved in the design,
development, marketing or use of high-risk AI systems, or represent the parties engaged in
those activities. They shall not engage in any activity that may conflict with their
independence of judgement or integrity in relation to conformity assessment activities for
which they are notified. This shall in particular apply to consultancy services.
5. Notified bodies shall be organised and operated so as to safeguard the independence,
objectivity and impartiality of their activities. Notified bodies shall document and
implement a structure and procedures to safeguard impartiality and to promote and apply
the principles of impartiality throughout their organisation, personnel and assessment
activities.
6. Notified bodies shall have documented procedures in place ensuring that their personnel,
committees, subsidiaries, subcontractors and any associated body or personnel of external
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bodies respect the confidentiality of the information in accordance with Article 70 which
comes 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 to
observe professional secrecy with regard to all information obtained in carrying out their
tasks 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, the
degree 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 are
established 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 this
Regulation with the highest degree of professional integrity and the requisite competence
in 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 have
permanent availability of sufficient administrative, technical, legal and scientific personnel
who possess experience and knowledge relating to the relevant types of artificial
intelligence systems, data and data computing and to the requirements set out in Chapter 2
of this Title.
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.
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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 the relevant 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 the
subsidiary 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. Notified bodies shall make a list of their subsidiaries publicly available.
4. The relevant documents concerning the assessment of the qualifications of the
subcontractor 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 the
termination 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 the
conformity assessment procedures referred to in Article 43.
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2. Notified bodies shall perform their activities while avoiding unnecessary burdens for
providers, 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 level
of protection required for the compliance of the high risk AI system with the requirements
of this Regulation. Particular attention shall be paid to minimising administrative burdens
and compliance costs for micro and small enterprises as defined in Commission
Recommendation 2003/361/EC.
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 a
single number, even where a body is notified under several Union acts.
2. The Commission shall make publicly available the list of the bodies notified under this
Regulation, including the identification numbers that have been assigned to them and the
activities 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 tool
referred to in Article 32(2).
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-1a. The procedures described in Article 31 and 32 shall apply to extensions of the scope of the
notification. For changes to the notification other than extensions of its scope, the
procedures laid down in the following paragraphs shall apply.
Where a notified body decides to cease its conformity assessment activities it shall inform
the notifying authority and the providers concerned as soon as possible and in the case of a
planned 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 body
shall 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.
1. Where a notifying authority has sufficient reasons to consider that a notified body no
longer meets the requirements laid down in Article 33, or that it is failing to fulfil its
obligations, the notifying authority shall without delay investigate the matter with the
utmost diligence. In that context, it shall inform the notified body concerned about the
objections raised and give it the possibility to make its views known. If the notifying
authority comes to the conclusion that the notified body no longer meets the requirements
laid down in Article 33 or that it is failing to fulfil its obligations, it shall 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.
2a. Where its designation has been suspended, restricted, or fully or partially withdrawn, the
notified body shall inform the manufacturers concerned at the latest within 10 days.
2b. 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 to
market surveillance authorities at their request.
2c. 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;
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(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 to
ensure 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;
(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 shall
take the appropriate measures, where necessary, to avoid a potential risk to health,
safety or fundamental rights.
2d. With the exception of certificates unduly issued, and where a notification has been
suspended 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 to
certificates affected by the suspension or restriction, and the notifying authority has
outlined a timeline and actions anticipated to remedy the suspension or restriction; or
(b) the notifying authority has confirmed that no certificates relevant to the suspension
will be issued, amended or re-issued during the course of the suspension or
restriction, and states whether the notified body has the capability of continuing to
monitor and remain responsible for existing certificates issued for the period of the
suspension 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 competent
authorities of the Member State in which the provider of the system covered by the
certificate 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.
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2e. 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:
(a) where the national competent authority of the Member State in which the provider of
the 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 associated
with the systems in question; and
(b) another notified body has confirmed in writing that it will assume immediate
responsibilities for those systems and will have completed assessment of them within
twelve months of the withdrawal of the designation.
In the circumstances referred to in the first subparagraph, the national competent authority
of 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 periods
of three months, which altogether shall not exceed twelve months.
2f. The national competent authority or the notified body assuming the functions of the
notified body affected by the change of notification shall immediately inform the
Commission, the other Member States and the other notified bodies thereof.
Article 37
Challenge to the competence of notified bodies
1. The Commission shall, where necessary, investigate all cases where there are reasons to
doubt the competence of a notified body or the continued fulfilment by a notified body of
the requirements laid down in Article 33 and their applicable responsibilities.
2. The Notifying authority shall provide the Commission, on request, with all relevant
information relating to the notification or the maintenance of the competence of the
notified body concerned.
3. The Commission shall ensure that all sensitive information obtained in the course of its
investigations pursuant to this Article is treated confidentially in accordance with Article
70.
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4. Where the Commission ascertains that a notified body does not meet or no longer meets
the requirements for its notification, it shall inform the notifying Member State accordingly
and request it to take the necessary corrective measures, including suspension or
withdrawal of the notification if necessary. Where the Member State fails to take the
necessary corrective measures, the Commission may, by means of implementing acts,
suspend, restrict or withdraw the designation. 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 form
of a sectoral group of notified bodies.
2. The notifying authority shall ensure that the bodies notified by them participate in the work
of that group, directly or by means of designated representatives.
2a. The Commission shall provide for the exchange of knowledge and best practices between
the Member States' notifying authorities.
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 or
they ensure an equivalent level of compliance.
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Chapter 5
STANDARDS, CONFORMITY ASSESSMENT, CERTIFICATES,
REGISTRATION
Article 40
Harmonised standards and standardisation deliverables
1. High-risk AI systems or general purpose AI models which are in conformity with
harmonised standards or parts thereof the references of which have been published in the
Official Journal of the European Union in accordance with Regulation (EU) 1025/2012
shall be presumed to be in conformity with the requirements set out in Chapter 2 of this
Title or, as applicable, with the requirements set out in [Chapter on GPAI], to the extent
those standards cover those requirements.
2. The Commission shall issue standardisation requests covering all requirements of Title II
Chapter III and as applicable [GPAI Chapter] of this Regulation, in accordance with
Article 10 of Regulation EU (No)1025/2012 without undue delay. The standardisation
request shall also ask for deliverables on reporting and documentation processes to
improve AI systems resource performance, such as reduction of energy and other resources
consumption of the high-risk AI system during its lifecycle, and on energy efficient
development of general-purpose AI models. When preparing standardisation request, the
Commission shall consult the Board and relevant stakeholders, including the Advisory
Forum.
When issuing a standardisation request to European standardisation organisations, the
Commission shall specify that standards have to be consistent, including with the existing
and future standards developed in the various sectors for products covered by the existing
Union safety legislation listed in Annex II, clear and aimed at ensuring that AI systems or
models placed on the market or put into service in the Union meet the relevant
requirements laid down in this Regulation.
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The Commission shall request the European standardisation organisations to provide
evidence of their best efforts to fulfil the above objectives in accordance with Article 24 of
Regulation EU 1025/2012.
1c The actors involved in the standardisation process shall seek to promote investment and
innovation in AI, including through increasing legal certainty, as well as competitiveness
and growth of the Union market, and contribute to strengthening global cooperation on
standardisation and taking into account existing international standards in the field of AI
that are consistent with Union values, fundamental rights and interests, and enhance multi-
stakeholder governance ensuring a balanced representation of interests and effective
participation of all relevant stakeholders in accordance with Articles 5, 6, and 7 of
Regulation (EU) No 1025/2012
Article 41
Common specifications
1. The Commission is empowered to adopt, after consulting the Advisory Forum referred to
in Article 58a, implementing acts in accordance with the examination procedure referred to
in Article 74(2) establishing common specifications for the requirements set out in Chapter
2 of this Title or, as applicable, with requirements set out in Article [GPAI Chapter], for AI
systems within the scope of this Regulation, where the following conditions have been
fulfilled:
(a) 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 the requirements set out in Chapter 2 of this Title; and
(i) the request has not been accepted by any of the European standardisation
organisations; or
(ii) the harmonised standards addressing that request are not delivered within the
deadline set in accordance with article 10(1) of Regulation 1025/2012; or
(iii) the relevant harmonised standards insufficiently address fundamental rights
concerns; or
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(iv) the harmonised standards do not comply with the request; and
(b) no reference to harmonised standards covering the requirements referred to in
Chapter II of this Title has been published in the Official Journal of the European
Union, in accordance with Regulation (EU) No 1025/2012, and no such reference is
expected to be published within a reasonable period.
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 the
conditions in paragraph 1 are fulfilled.
3. High-risk AI systems which are in conformity with the common specifications referred to
in paragraph 1, or parts thereof, shall be presumed to be in conformity with the
requirements set out in Chapter 2 of this Title, to the extent those common specifications
cover those requirements.
3a. Where a harmonised standard is adopted by a European standardisation organisation and
proposed to the Commission for the publication of its reference in the Official Journal of
the European Union, the Commission shall assess the harmonised standard in accordance
with Regulation (EU) No 1025/2012. When reference of a harmonised standard is
published in the Official Journal of the European Union, the Commission shall repeal acts
referred to in paragraph 1 and 1b, or parts thereof which cover the same requirements set
out in Chapter 2 of this Title.
4. Where providers of high-risk AI systems do not comply with the common specifications
referred to in paragraph 1, they shall duly justify that they have adopted technical solutions
that meet the requirements referred to in Chapter II to a level at least equivalent thereto.
4b. When a Member State considers that a common specification does not entirely satisfy the
requirements set out in Chapter 2 of this Title, 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.
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Article 42
Presumption of conformity with certain requirements
1. High-risk AI systems that have been trained and tested on data reflecting the specific
geographical, behavioural, contextual or functional setting within which they are intended
to be used shall be presumed to be in compliance with the respective requirements set out
in Article 10(4).
2. High-risk AI systems that have been certified or for which a statement of conformity has
been issued under a cybersecurity scheme pursuant to Regulation (EU) 2019/881 of the
European Parliament and of the Council1
and the references 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 of conformity or parts thereof cover those
requirements.
Article 43
Conformity assessment
1. For high-risk AI systems listed in point 1 of Annex III, 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 applied harmonised standards referred to in Article 40, or, where
applicable, common specifications referred to in Article 41, the provider shall opt for one
of 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.
In demonstrating the compliance of a high-risk AI system with the requirements set out in
Chapter 2 of this Title, the provider shall follow the conformity assessment procedure set
out in Annex VII in the following cases:
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(a) where harmonised standards referred to in Article 40, do not exist and common
specifications referred to in Article 41 are not available;
(aa) the provider has not applied or has applied only in part the harmonised standard;
(b) where the common specifications referred to in point (a) exist but the provider has
not applied them;
(c) where one or more of the harmonised standards referred to in point (a) has been
published with a restriction and only on the part of the standard that was restricted.
For the purpose of the conformity assessment procedure referred to in Annex VII, the
provider may choose any of the notified bodies. However, when the system is intended to
be 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 providers shall follow the
conformity assessment procedure based on internal control as referred to in Annex VI,
which does not provide for the involvement of a notified body.
3. For high-risk AI systems, to which legal acts listed in Annex II, section A, apply, the
provider 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 those
legal acts shall be entitled to control the conformity of the high-risk AI systems with the
requirements 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 been
assessed 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 product
to opt out from a third-party conformity assessment, provided that that manufacturer has
applied all harmonised standards covering all the relevant requirements, that manufacturer
may make use of that option only if he has also applied harmonised standards or, where
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applicable, common specifications referred to in Article 41, covering the requirements set
out in Chapter 2 of this Title.
4. High-risk AI systems that have already been subject to a conformity assessment procedure
shall undergo a new conformity assessment procedure whenever they are substantially
modified, regardless of whether the modified system is intended to be further distributed or
continues to be used by the current deployer.
For high-risk AI systems that continue to learn after being placed on the market or put into
service, changes to the high-risk AI system and its performance that have been pre-
determined by the provider at the moment of the initial conformity assessment and 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.
5. The Commission is empowered to adopt delegated acts in accordance with Article 73 for
the 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 in
order to subject high-risk AI systems referred to in points 2 to 8 of Annex III to the
conformity assessment procedure referred to in Annex VII or parts thereof. The
Commission shall adopt such delegated acts taking into account the effectiveness of the
conformity assessment procedure based on internal control referred to in Annex VI in
preventing or minimizing the risks to health and safety and protection of fundamental
rights posed by such systems as well as the availability of adequate capacities and
resources among notified bodies.
Article 44
Certificates
1. Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in a
language which can be easily understood by the relevant authorities in the Member State in
which the notified body is established.
2. Certificates shall be valid for the period they indicate, which shall not exceed five years for
AI systems covered by Annex II and four years for AI systems covered by Annex III. On
application by the provider, the validity of a certificate may be extended for further
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periods, each not exceeding five years for AI systems covered by Annex II and four years
for AI systems covered by Annex III, based on a re-assessment in accordance with the
applicable 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 with
those requirements is ensured by appropriate corrective action taken by the provider of the
system within an appropriate deadline set by the notified body. The notified body shall
give reasons for its decision.
An appeal procedure against decisions of the notified bodies, including on issued
conformity certificates, 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 those
certificates, quality management system approvals issued in accordance with the
requirements of Annex VII;
(b) any refusal, restriction, suspension or withdrawal of a Union technical
documentation assessment certificate or a quality management system approval
issued 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 surveillance
authorities regarding conformity assessment activities;
(e) on request, conformity assessment activities performed within the scope of their
notification and any other activity performed, including cross-border activities and
subcontracting.
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2. Each notified body shall inform the other notified bodies of:
(a) quality management system approvals which it has refused, suspended or withdrawn,
and, upon request, of quality system approvals which it has issued;
(b) EU technical documentation assessment certificates or any supplements thereto
which it has refused, withdrawn, suspended or otherwise restricted, and, upon
request, of the certificates and/or supplements thereto which it has issued.
3. Each notified body shall provide the other notified bodies carrying out similar conformity
assessment activities covering the same types of AI systems with relevant information on
issues relating to negative and, on request, positive conformity assessment results.
3a. The obligations referred to in paragraphs 1 to 3 shall be complied with in accordance with
Article 70.
Article 47
Derogation from conformity assessment procedure
1. 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 of
specific 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 reasons
justifying 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 case
of specific, substantial and imminent threat to the life or physical safety of natural persons,
law enforcement authorities or civil protection authorities may put a 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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2. The authorisation referred to in paragraph 1 shall be issued only if the market surveillance
authority 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 the
other 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. Where, within 15 calendar days of receipt of the information referred to in paragraph 2, no
objection has been raised by either a Member State or the Commission in respect of an
authorisation issued by a market surveillance authority of a Member State in accordance
with paragraph 1, that authorisation shall be deemed justified.
4. Where, within 15 calendar days of receipt of the notification referred to in paragraph 2,
objections are raised by a Member State against an authorisation issued by a market
surveillance authority of another Member State, or where the Commission considers the
authorisation to be contrary to Union law or the conclusion of the Member States regarding
the compliance of the system as referred to in paragraph 2 to be unfounded, the
Commission shall without delay enter into consultation with the relevant Member State;
the operator(s) concerned shall be consulted and have the possibility to present their views.
In view thereof, the Commission shall decide whether the authorisation is justified or not.
The Commission shall address its decision to the Member State concerned and the relevant
operator or operators.
5. If the authorisation is considered unjustified, this shall be withdrawn by the market
surveillance authority of the Member State concerned.
6. For high-risk AI systems related to products covered by Union harmonisation legislation
referred 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 machine readable, physical or electronically signed
EU declaration of conformity for each high-risk AI system and keep it at the disposal of
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the national competent authorities for 10 years after the AI high-risk system has been
placed on the market or put into service. The EU declaration of conformity shall identify
the high-risk AI system for which it has been drawn up. A copy of the EU declaration 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 meets
the requirements set out in Chapter 2 of this Title. The EU declaration of conformity shall
contain the information set out in Annex V and shall be translated into a language that can
be easily understood by the national competent authorities of the Member State(s) in which
the high-risk AI system is placed on the market or made available.
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 shall
be 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 shall
keep 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 in
Annex V in order to introduce elements that become necessary in light of technical
progress.
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.
1a. For high-risk AI systems provided digitally, a digital CE marking shall be used, only if it
can be easily accessed via the interface from which the AI system is accessed or via an
easily accessible machine-readable code or other electronic means.
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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 the
notified body responsible for the conformity assessment procedures set out in Article 43.
The identification number of the notified body shall be affixed by the body itself or, under
its instructions, by the provider or by its authorised representative. The identification
number shall also be indicated in any promotional material which mentions that the high-
risk AI system fulfils the requirements for CE marking.
3a. Where high-risk AI systems are subject to other Union law which also provides for the
affixing of the CE marking, the CE marking shall indicate that the high-risk AI system also
fulfil the requirements of that other law.
Article 51
Registration
1. Before placing on the market or putting into service a high-risk AI system listed in Annex
III, with the exception of high risk AI systems referred to in Annex III point 2, the provider
or, where applicable, the authorised representative shall register themselves and their
system in the EU database referred to in Article 60.
1a. Before placing on the market or putting into service an AI system for which the provider
has concluded that it is not high-risk in application of the procedure under Article 6(2a),
the provider or, where applicable, the authorised representative shall register themselves
and that system in the EU database referred to in Article 60.
1b. Before putting into service or using a high-risk AI system listed in Annex III, with the
exception of high-risk AI systems listed in Annex III, point 2, deployers who are public
authorities, agencies or bodies or persons acting on their behalf shall register themselves,
select the system and register its use in the EU database referred to in Article 60.
1c. For high-risk AI systems referred to Annex III, points 1, 6 and 7 in the areas of law
enforcement, migration, asylum and border control management, the registration referred
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to in paragraphs 1 to 1b shall be done in a secure non-public section of the EU database
referred to in Article 60 and include only the following information, as applicable:
- points 1 to 9 of Annex VIII, section A with the exception of points 5a, 7 and 8;
- points 1 to 3 of Annex VIII, section B;
- points 1 to 9 of Annex VIII, section X with the exception of points 6 and 7;
- points 1 to 5 of Annex VIIIa with the exception of point 4.
Only the Commission and national authorities referred to in Art. 63(5) shall have access to
these restricted sections of the EU database.
1d. High risk AI systems referred to in Annex III, point 2 shall be registered at national level.
TITLE IV
TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND
DEPLOYERS OF CERTAIN AI SYSTEMS
Article 52
Transparency obligations for providers and users of certain AI systems and GPAI models
1. Providers shall ensure that AI systems intended to directly interact with natural persons are
designed and developed in such a way that the concerned natural persons are informed that
they are interacting 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 the 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 to appropriate safeguards for the rights and freedoms of third parties unless those
systems are available for the public to report a criminal offence.
1a. Providers of AI systems, including GPAI systems, generating synthetic audio, image,
video or text content, shall ensure the outputs of the AI system are marked in a machine-
readable format and detectable as artificially generated or manipulated. Providers shall
ensure their technical solutions are effective, interoperable, robust and reliable as far as this
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is technically feasible, taking into account specificities and limitations of different types of
content, costs of implementation and the generally acknowledged state-of-the-art, as may
be reflected in relevant technical standards. This obligation shall not apply to the extent the
AI systems perform an assistive function for standard editing or do not substantially alter
the input data provided by the deployer or the semantics thereof, or where authorised by
law to detect, prevent, investigate and prosecute criminal offences.
2. Deployers of an emotion recognition system or a biometric categorisation system shall
inform of the operation of the system the natural persons exposed thereto and process the
personal data in accordance with Regulation (EU) 2016/679, Regulation (EU) 2016/1725
and Directive (EU) 2016/280, as applicable. This obligation shall not apply to AI systems
used for biometric categorization and emotion 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, and in compliance with Union law.
3. Deployers of an AI system that generates or manipulates image, audio or video content
constituting a deep fake, shall disclose that the content has been artificially generated or
manipulated. This obligation shall not apply where the use is authorised by law to detect,
prevent, investigate and prosecute criminal offence. Where the content forms part of an
evidently artistic, creative, satirical, fictional analogous work or programme, the
transparency obligations set out in this paragraph are limited to disclosure of the existence
of such generated or manipulated content in an appropriate manner that does not hamper
the display or enjoyment of the work.
Deployers of an AI system that generates or manipulates text which is published with the
purpose of informing the public on matters of public interest shall disclose that the text has
been artificially generated or manipulated. This obligation shall not apply where the use is
authorised by law to detect, prevent, investigate and prosecute criminal offences or where
the AI-generated content has undergone a process of human review or editorial control and
where a natural or legal person holds editorial responsibility for the publication of the
content.
3a. The information referred to in paragraphs 1 to 3 shall be provided to the concerned natural
persons in a clear and distinguishable manner at the latest at the time of the first interaction
or exposure. The information shall respect the applicable accessibility requirements.
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4. Paragraphs 1, 2 and 3 shall not affect the requirements and obligations set out in Title 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.
4a. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union
level to facilitate the effective implementation of the obligations regarding the detection
and labelling of artificially generated or manipulated content. The Commission is
empowered to adopt implementing acts to approve these codes of practice in accordance
with the procedure laid down in Article 52e paragraphs 6-8. If it deems the code is not
adequate, the Commission is empowered to adopt an implementing act specifying the
common rules for the implementation of those obligations in accordance with the
examination procedure laid down in Article 73 paragraph 2.
TITLE VIIIA
GENERAL PURPOSE AI MODELS
Chapter 1
CLASSIFICATION RULES
Article 52a
Classification of general purpose AI models as general purpose AI models with systemic risk
1. A general purpose AI model shall be classified as general-purpose AI model with systemic
risk if it meets any of the following criteria:
(a) it has high impact capabilities evaluated on the basis of appropriate technical tools
and methodologies, including indicators and benchmarks;
(b) based on a decision of the Commission, ex officio or following a qualified alert by
the scientific panel that a general purpose AI model has capabilities or impact
equivalent to those of point (a).
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2. A general purpose AI model shall be presumed to have high impact capabilities pursuant to
point a) of paragraph 1 when the cumulative amount of compute used for its training
measured in floating point operations (FLOPs) is greater than 10^25.
3. The Commission shall adopt delegated acts in accordance with Article 73(2) to amend the
thresholds listed in the paragraphs above, as well as to supplement benchmarks and
indicators in light of evolving technological developments, such as algorithmic
improvements or increased hardware efficiency, when necessary, for these thresholds to
reflect the state of the art.
Article 52b
Procedure
1. Where a general purpose AI model meets the requirements referred to in points (a) of
Article 52a(1), the relevant provider shall notify the Commission without delay and in any
event within 2 weeks after those requirements are met or it becomes known that these
requirements will be met. That notification shall include the information necessary to
demonstrate that the relevant requirements have been met. If the Commission becomes
aware of a general purpose AI model presenting systemic risks of which it has not been
notified, it may decide to designate it as a model with systemic risk.
2. The provider of a general purpose AI model that meets the requirements referred to in
points (a) of Article 52a(1) may present, with its notification, sufficiently substantiated
arguments to demonstrate that, exceptionally, although it meets the said requirements, the
general-purpose AI model does not present, due to its specific characteristics, systemic
risks and therefore should not be classified as general-purpose AI model with systemic
risk.
3. Where the Commission concludes that the arguments submitted pursuant to paragraph 2
are not sufficiently substantiated and the relevant provider was not able to demonstrate that
the general purpose AI model does not present, due to its specific characteristics, systemic
risks, it shall reject those arguments and the general purpose AI model shall be considered
as general purpose AI model with systemic risk.
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4. The Commission may designate a general purpose AI model as presenting systemic risks,
ex officio or following a qualified alert of the scientific panel pursuant to point (a) of
Article 68h [Alerts of systemic risks by the scientific panel] (1) on the basis of criteria set
out in Annex IXc. The Commission shall be empowered to specify and update the criteria
in Annex IXc by means of delegated acts in accordance with Article 74(2).
4a. Upon a reasoned request of a provider whose model has been designated as a general
purpose AI model with systemic risk pursuant to paragraph 4, the Commission shall take
the request into account and may decide to reassess whether the general purpose AI model
can still be considered to present systemic risks on the basis of the criteria set out in Annex
IXc. Such request shall contain objective, concrete and new reasons that have arisen since
the designation decision. Providers may request reassessment at the earliest six months
after the designation decision. Where the Commission, following its reassessment, decides
to maintain the designation as general-purpose AI model with systemic risk, providers may
request reassessment at the earliest six months after this decision.
5. The Commission shall ensure that a list of general purpose AI models with systemic risk is
published and shall keep that list up to date, without prejudice to the need to respect and
protect intellectual property rights and confidential business information or trade secrets in
accordance with Union and national law.
Chapter 2
OBLIGATIONS FOR PROVIDERS OF GENERAL PURPOSE AI
MODELS
Article 52c
Obligations for providers of general purpose AI models
1. Providers of general purpose AI models shall:
(a) draw up and keep up-to-date the technical documentation of the model, including its
training and testing process and the results of its evaluation, which shall contain, at a
minimum, the elements set out in Annex IXa for the purpose of providing it, upon
request, to the AI Office and the national competent authorities;
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(b) draw up, keep up-to-date and make available information and documentation to
providers of AI systems who intend to integrate the general purpose AI model in
their AI system. Without prejudice to the need to respect and protect intellectual
property rights and confidential business information or trade secrets in accordance
with Union and national law, the information and documentation shall:
(i) enable providers of AI systems to have a good understanding of the capabilities
and limitations of the general purpose AI model and to comply with their
obligations pursuant to this Regulation; and
(ii) contain, at a minimum, the elements set out in Annex IXb.
(c) put in place a policy to respect Union copyright law in particular to identify and
respect, including through state of the art technologies, the reservations of rights
expressed pursuant to Article 4(3) of Directive (EU) 2019/790;
(d) draw up and make publicly available a sufficiently detailed summary about the
content used for training of the general-purpose AI model, according to a template
provided by the AI Office.
-2. The obligations set out in paragraph 1, with the exception of letters (c) and (d), shall not
apply to providers of AI models that are made accessible to the public under a free and
open licence that allows for the access, usage, modification, and distribution of the model,
and whose parameters, including the weights, the information on the model architecture,
and the information on model usage, are made publicly available. This exception shall not
apply to general purpose AI models with systemic risks.
2. Providers of general purpose AI models shall cooperate as necessary with the Commission
and the national competent authorities in the exercise of their competences and powers
pursuant to this Regulation.
3. Providers of general purpose AI models may rely on codes of practice within the meaning
of Article 52e demonstrate compliance with the obligations in paragraph 1, until a
harmonised standard is published. Compliance with a European harmonised standard
grants providers the presumption of conformity. Providers of general purpose AI models
with systemic risks who do not adhere to an approved code of practice shall demonstrate
alternative adequate means of compliance for approval of the Commission.
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4. For the purpose of facilitating compliance with Annex IXa, notably point 2, (d) and (e), the
Commission shall be empowered to adopt delegated acts in accordance with Article 73 to
detail measurement and calculation methodologies with a view to allow comparable and
verifiable documentation.
4a. The Commission is empowered to adopt delegated acts in accordance with Article 73(2) to
amend Annexes IXa and IXb in the light of the evolving technological developments.
4b. Any information and documentation obtained pursuant to the provisions of this Article,
including trade secrets, shall be treated in compliance with the confidentiality obligations
set out in Article 70.
Article 52ca
Authorised representative
1. Prior to placing a general purpose AI model on the Union market providers established
outside the Union shall, by written mandate, appoint an authorised representative which is
established in the Union and shall enable it to perform its tasks under this Regulation.
2. The authorised representative shall perform the tasks specified in the mandate received
from the provider. It shall provide a copy of the mandate to the AI Office upon request, in
one of the official languages of the institutions of the Union. For the purpose of this
Regulation, the mandate shall empower the authorised representative to carry out the
following tasks:
(a) verify that the technical documentation specified in Annex IXa has been drawn up
and all obligations referred to in Articles 52c and, where applicable, Article 52d
have been fulfilled by the provider;
(b) keep a copy of the technical documentation at the disposal of the AI Office and
national competent authorities, for a period ending 10 years after the model has
been placed on the market and the contact details of the provider by which the
authorised representative has been appointed;
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(c) provide the AI Office, upon a reasoned request, with all the information and
documentation, including that kept according to point (a), necessary to
demonstrate the compliance with the obligations in this Title;
(d) cooperate with the AI Office and national competent authorities, upon a reasoned
request, on any action the latter takes in relation to the general purpose AI model
with systemic risks, including when the model is integrated into AI systems
placed on the market or put into service in the Union.
3. The mandate shall empower the authorised representative to be addressed, in addition to or
instead of the provider, by the AI Office or the national competent authorities, on all issues
related to ensuring compliance with this Regulation.
4. The authorised representative shall terminate the mandate if it considers or has reason to
consider that the provider acts contrary to its obligations under this Regulation. In such a
case, it shall also immediately inform the AI Office about the termination of the mandate
and the reasons thereof.
5. The obligation set out in this article shall not apply to providers of general purpose AI
models that are made accessible to the public under a free and open source licence that
allows for the access, usage, modification, and distribution of the model, and whose
parameters, including the weights, the information on the model architecture, and the
information on model usage, are made publicly available, unless the general purpose AI
models present systemic risks.
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Chapter 3
OBLIGATIONS FOR PROVIDERS OF GENERAL PURPOSE AI
MODELS WITH SYSTEMIC RISK
Article 52d
Obligations for providers of general purpose AI models with systemic risk
1. In addition to the obligations listed in Article 52c, providers of general purpose AI models
with systemic risk shall:
(a) perform model evaluation in accordance with standardised protocols and tools
reflecting the state of the art, including conducting and documenting adversarial
testing of the model with a view to identify and mitigate systemic risk;
(b) assess and mitigate possible systemic risks at Union level, including their sources,
that may stem from the development, placing on the market, or use of general
purpose AI models with systemic risk;
(c) keep track of, document and report without undue delay to the AI Office and, as
appropriate, to national competent authorities, relevant information about serious
incidents and possible corrective measures to address them;
(d) ensure an adequate level of cybersecurity protection for the general purpose AI
model with systemic risk and the physical infrastructure of the model.
2. Providers of general purpose AI models with systemic risk may rely on codes of practice
within the meaning of Article E to demonstrate compliance with the obligations in
paragraph 1, until a harmonised standard is published. Compliance with a European
harmonised standard grants providers the presumption of conformity. Providers of general-
purpose AI models with systemic risks who do not adhere to an approved code of practice
shall demonstrate alternative adequate means of compliance for approval of the
Commission.
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3. Any information and documentation obtained pursuant to the provisions of this Article,
including trade secrets, shall be treated in compliance with the confidentiality obligations
set out in Article 70.
Article 52e
Codes of practice
1. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union
level as an element to contribute to the proper application of this Regulation, taking into
account international approaches.
2. The AI Office and the AI Board shall aim to ensure that the codes of practice cover, but
not necessarily be limited to, the obligations provided for in Articles 52c and 52d,
including the following issues:
(a) means to ensure that the information referred to in Article 52c (a) and (b) is kept up
to date in the light of market and technological developments, and the adequate level
of detail for the summary about the content used for training;
(b) the identification of the type and nature of the systemic risks at Union level,
including their sources when appropriate;
(c) the measures, procedures and modalities for the assessment and management of the
systemic risks at Union level, including the documentation thereof. The assessment
and management of the systemic risks at Union level shall be proportionate to the
risks, take into consideration their severity and probability and take into account the
specific challenges of tackling those risks in the light of the possible ways in which
such risks may emerge and materialize along the AI value chain.
3. The AI Office may invite the providers of general purpose AI models, as well as relevant
national competent authorities, to participate in the drawing up of codes of practice. Civil
society organisations, industry, academia and other relevant stakeholders, such as
downstream providers and independent experts, may support the process.
4. The AI Office and the Board shall aim to ensure that the codes of practice clearly set out
their specific objectives and contain commitments or measures, including key performance
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indicators as appropriate, to ensure the achievement of those objectives and take due
account of the needs and interests of all interested parties, including affected persons, at
Union level.
5. The AI Office may invite all providers of general purpose AI models to participate in the
codes of practice. For providers of general purpose AI models not presenting systemic
risks this participation should be limited to obligations foreseen in paragraph 2 point (a) of
this Article, unless they declare explicitly their interest to join the full code.
6. The AI Office shall aim to ensure that participants to the codes of practice report regularly
to the AI Office on the implementation of the commitments and the measures taken and
their outcomes, including as measured against the key performance indicators as
appropriate. Key performance indicators and reporting commitments shall take into
account differences in size and capacity between different participants.
7. The AI Office and the AI Board shall regularly monitor and evaluate the achievement of
the objectives of the codes of practice by the participants and their contribution to the
proper application of this Regulation. The AI Office and the Board shall assess whether the
codes of practice cover the obligations provided for in Articles 52c and 52d, including the
issues listed in paragraph 2 of this Article, and shall regularly monitor and evaluate the
achievement of their objectives. They shall publish their assessment of the adequacy of the
codes of practice. The Commission may, by way of implementing acts, decide to approve
the code of practice and give it a general validity within the Union. Those implementing
acts shall be adopted in accordance with the examination procedure set out in Article
74(2).
8. As appropriate, the AI Office shall also encourage and facilitate review and adaptation of
the codes of practice, in particular in light of emerging standards. The AI Office shall assist
in the assessment of available standards.
9. If, by the time the Regulation becomes applicable, a Code of Practice cannot be finalised,
or if the AI Office deems it is not adequate following under paragraph 7, the Commission
may provide, by means of implementing acts, common rules for the implementation of the
obligations provided for in Articles 52c and 52d, including the issues set out in paragraph
2.
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TITLE V
MEASURES IN SUPPORT OF INNOVATION
Article 53
AI regulatory sandboxes
1. Member States shall ensure that their competent authorities establish at least one AI
regulatory sandbox at national level, which shall be operational 24 months after entry into
force. This sandbox may also be established jointly with one or several other Member
States’ competent authorities. The Commission may provide technical support, advice and
tools for the establishment and operation of AI regulatory sandboxes.
The obligation established in previous paragraph can also be fulfilled by participation in an
existing sandbox insofar as this participation provides equivalent level of national coverage
for the participating Member States.
1a. Additional AI regulatory sandboxes at regional or local levels or jointly with other
Member States' competent authorities may also be established.
1b. The European Data Protection Supervisor may also establish an AI regulatory sandbox for
the EU institutions, bodies and agencies and exercise the roles and the tasks of national
competent authorities in accordance with this chapter.
1c. Member States shall ensure that competent authorities referred to in paragraphs 1 and 1a
allocate sufficient resources to comply with this Article effectively and in a timely manner.
Where appropriate, national competent authorities shall cooperate with other relevant
authorities and may allow for the involvement of other actors within the AI ecosystem.
This Article shall not affect other regulatory sandboxes established under national or Union
law. Member States shall ensure an appropriate level of cooperation between the
authorities supervising those other sandboxes and the national competent authorities.
1d. AI regulatory sandboxes established under Article 53(1) of this Regulation shall, in
accordance with Articles 53 and 53a, provide for a controlled environment that fosters
innovation and facilitates the development, training, testing and validation of innovative AI
systems for a limited time before their placement on the market or putting into service
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pursuant to a specific sandbox plan agreed between the prospective providers and the
competent authority. Such regulatory sandboxes may include testing in real world
conditions supervised in the sandbox.
1e. Competent authorities shall provide, as appropriate, guidance, supervision and support
within the sandbox with a view to identifying risks, in particular to fundamental rights,
health and safety, testing, mitigation measures, and their effectiveness in relation to the
obligations and requirements of this Regulation and, where relevant, other Union and
Member States legislation supervised within the sandbox.
1f. Competent authorities shall provide providers and prospective providers with guidance on
regulatory expectations and how to fulfil the requirements and obligations set out in this
Regulation.
Upon request of the provider or prospective provider of the AI system, the competent
authority shall provide a written proof of the activities successfully carried out in the
sandbox. The competent authority shall also provide an exit report detailing the activities
carried out in the sandbox and the related results and learning outcomes. Providers may use
such documentation to demonstrate the compliance with this Regulation through the
conformity assessment process or relevant market surveillance activities. In this regard, the
exit reports and the written proof provided by the national competent authority shall be
taken positively into account by market surveillance authorities and notified bodies, with a
view to accelerate conformity assessment procedures to a reasonable extent.
1fa. Subject to the confidentiality provisions in Article 70 and with the agreement of the
sandbox provider/prospective provider, the European Commission and the Board shall be
authorised to access the exit reports and shall take them into account, as appropriate, when
exercising their tasks under this Regulation. If both provider and prospective provider and
the national competent authority explicitly agree to this, the exit report can be made
publicly available through the single information platform referred to in this article.
1g. The establishment of AI regulatory sandboxes shall aim to contribute to the following
objectives:
(a) improve legal certainty to achieve regulatory compliance with this Regulation or,
where relevant, other applicable Union and Member States legislation;
(b) support the sharing of best practices through cooperation with the authorities
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involved in the AI regulatory sandbox;
(c) foster innovation and competitiveness and facilitate the development of an AI
ecosystem;
(d) contribute to evidence-based regulatory learning;
(e) facilitate and accelerate access to the Union market for AI systems, in particular
when provided by small and medium-sized enterprises (SMEs), including start-
ups.
2. National competent authorities shall ensure that, to the extent the innovative AI systems
involve the processing of personal data or otherwise fall under the supervisory remit of
other national authorities or competent authorities providing or supporting access to data,
the national data protection authorities, and those other national authorities are associated
to the operation of the AI regulatory sandbox and involved in the supervision of those
aspects to the extent of their respective tasks and powers, as applicable.
3. The AI regulatory sandboxes shall not affect the supervisory and corrective powers of the
competent authorities supervising the sandboxes, including at regional or local level. Any
significant risks to health and safety and fundamental rights identified during the
development and testing of such AI systems shall result in an adequate mitigation. National
competent authorities shall have the power to temporarily or permanently suspend the
testing process, or participation in the sandbox if no effective mitigation is possible and
inform the AI Office of such decision. National competent authorities shall exercise their
supervisory powers 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 the Union.
4. Providers and prospective providers in the AI regulatory sandbox shall remain liable under
applicable Union and Member States liability legislation for any damage inflicted on third
parties as a result of the experimentation taking place in the sandbox. However, provided
that the prospective provider(s) respect the specific plan and the terms and conditions for
their participation and follow in good faith the guidance given by the national competent
authority, no administrative fines shall be imposed by the authorities for infringements of
this Regulation. To the extent that other competent authorities responsible for other Union
and Member States’ legislation have been actively involved in the supervision of the AI
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system in the sandbox and have provided guidance for compliance, no administrative fines
shall be imposed regarding that legislation.
4b. The AI regulatory sandboxes shall be designed and implemented in such a way that, where
relevant, they facilitate cross-border cooperation between national competent authorities.
5. National competent authorities shall coordinate their activities and cooperate within the
framework of the Board.
5a. National competent authorities shall inform the AI Office and the Board of the
establishment of a sandbox and may ask for support and guidance. A list of planned and
existing AI sandboxes shall be made publicly available by the AI Office and kept up to
date in order to encourage more interaction in the regulatory sandboxes and cross-border
cooperation.
5b. National competent authorities shall submit to the AI Office and to the Board, annual
reports, starting one year after the establishment of the AI regulatory sandbox and then
every year until its termination and a final report. Those reports shall provide information
on the progress and results of the implementation of those sandboxes, including best
practices, incidents, lessons learnt and recommendations on their setup and, where
relevant, on the application and possible revision of this Regulation, including its delegated
and implementing acts, and other Union law supervised within the sandbox. Those annual
reports or abstracts thereof shall be made available to the public, online. The Commission
shall, where appropriate, take the annual reports into account when exercising their tasks
under this Regulation.
6. The Commission shall develop a single and dedicated interface containing all relevant
information related to sandboxes to allow stakeholders to interact with regulatory
sandboxes and to raise enquiries with competent authorities, and to seek non-binding
guidance on the conformity of innovative products, services, business models embedding
AI technologies, in accordance with Article 55(1)(c). The Commission shall proactively
coordinate with national competent authorities, where relevant.
Article 53a
Modalities and functioning of AI regulatory sandboxes
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1. In order to avoid fragmentation across the Union, the Commission shall adopt an
implementing act detailing the modalities for the establishment, development,
implementation, operation and supervision of the AI regulatory sandboxes. The
implementing act shall include common 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 and
termination of the AI regulatory sandbox, including the sandbox plan and the exit
report;
(c) the terms and conditions applicable to the participants.
The implementing acts shall ensure that:
(a) regulatory sandboxes are open to any applying prospective provider of an AI
system who fulfils eligibility and selection criteria. The criteria for accessing to
the regulatory sandbox are transparent and fair and establishing authorities inform
applicants of their decision within 3 months of the application;
(b) regulatory sandboxes allow broad and equal access and keep up with demand for
participation; prospective providers may also submit applications in partnerships
with users and other relevant third parties;
(c) the modalities and conditions concerning regulatory sandboxes shall to the best
extent possible support flexibility for national competent authorities to establish
and operate their AI regulatory sandboxes;
(d) access to the AI regulatory sandboxes is free of charge for SMEs and start-ups
without prejudice to exceptional costs that national competent authorities may
recover in a fair and proportionate manner;
(e) they facilitate prospective providers, by means of the learning outcomes of the
sandboxes, to conduct the conformity assessment obligations of this Regulation or
the voluntary application of the codes of conduct referred to in Article 69;
(f) regulatory sandboxes facilitate the involvement of other relevant actors within the
AI ecosystem, such as notified bodies and standardisation organisations (SMEs,
start- ups, enterprises, innovators, testing and experimentation facilities, research
and experimentation labs and digital innovation hubs, centres of excellence,
individual researchers), in order to allow and facilitate cooperation with the
public and private sector;
(g) procedures, processes and administrative requirements for application, selection,
participation and exiting the sandbox are simple, easily intelligible, clearly
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communicated in order to facilitate the participation of SMEs and start-ups with
limited legal and administrative capacities and are streamlined across the Union,
in order to avoid fragmentation and that participation in a regulatory sandbox
established by a Member State, or by the EDPS is mutually and uniformly
recognised and carries the same legal effects across the Union;
(h) participation in the AI regulatory sandbox is 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;
(i) the sandboxes shall facilitate the development of tools and infrastructure for
testing, benchmarking, assessing and explaining dimensions of AI systems
relevant for regulatory learning, such as accuracy, robustness and
cybersecurity as well as measures to mitigate risks to fundamental rights and
the society at large.
3. Prospective providers in the sandboxes, in particular SMEs and start-ups, shall be directed,
where relevant, to pre-deployment services such as guidance on the implementation of this
Regulation, to other value-adding services such as help with standardisation documents
and certification, Testing & Experimentation Facilities, Digital Hubs and Centres of
Excellence.
4. 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 of
such testing and in particular on the appropriate safeguards with the view to protect
fundamental rights, health and safety. Where appropriate, they shall cooperate with other
national competent authorities with a view to ensure consistent practices across the Union.
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 be
processed solely for the purposes of developing, training and testing certain AI systems in
the sandbox when all of the following conditions are met:
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(a) AI systems shall be developed for safeguarding substantial public interest by a public
authority or another natural or legal person governed by public law or by private law
and in one or more of the following areas:
(ii) public safety and public health, including disease detection, diagnosis
prevention, control and treatment and improvement of health care systems;
(iii) a high level of protection and improvement of the quality of the environment,
protection of biodiversity, pollution as well as green transition, climate change
mitigation and adaptation;
(iiia) energy sustainability;
(iiib) safety and resilience of transport systems and mobility, critical infrastructure
and networks;
(iiic) efficiency and quality of public administration and public services;
(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;
(c) there are effective monitoring mechanisms to identify if any high risks to the rights
and freedoms of the data subjects, as referred to in Article 35 of Regulation (EU)
2016/679 and in Article 39 of Regulation (EU) 2018/1725, may arise during the
sandbox experimentation as well as response mechanism to promptly mitigate those
risks and, where necessary, stop the processing;
(d) any personal data to be processed in the context of the sandbox are in a functionally
separate, isolated and protected data processing environment under the control of the
prospective provider and only authorised persons have access to that those data;
(e) providers can only further share the originally collected data in compliance with EU
data protection law. Any personal data crated in the sandbox cannot be shared
outside the sandbox;
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(f) any processing of personal data in the context of the sandbox do not lead to measures
or decisions affecting the data subjects nor affect the application of their rights laid
down in Union law on the protection of personal data;
(g) any personal data processed in the context of the sandbox are protected by means of
appropriate technical and organisational measures and deleted once the participation
in 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 for
the duration of the participation in the sandbox, unless provided otherwise by Union
or 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 part
of the technical documentation in Annex IV;
(j) a short summary of the AI project developed in the sandbox, its objectives and
expected results published on the website of the competent authorities. This
obligation shall not cover sensitive operational data in relation to the activities of law
enforcement, border control, immigration or asylum authorities.
1a. For the purpose of 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, under the control and responsibility of law
enforcement authorities, the processing of personal data in AI regulatory sandboxes shall
be 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 legislation excluding
processing for other purposes than those explicitly mentioned in that legislation, as well as
to Union or Member States laws laying down the basis for the 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.
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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 plan
referred to in this Article, without prejudice to the prohibitions under Article 5.
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).
This provision shall be without prejudice to Union or national law for the testing in real
world conditions of high-risk AI systems related to products covered by legislation listed
in Annex II.
2. Providers or prospective providers may conduct testing of high-risk AI systems referred to
in 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 deployers.
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 and
submitted it to the market surveillance authority in the Member State(s) where the
testing in real world conditions is to be conducted;
(b) the market surveillance authority in the Member State(s) where the testing in real
world conditions is to be conducted has approved the testing in real world conditions
and the real world testing plan. Where the market surveillance authority in that
Member State has not provided with an answer in 30 days, the testing in real world
conditions and the real world testing plan shall be understood as approved. In cases
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where national law does not foresee a tacit approval, the testing in real world
conditions shall be subject to an authorisation;
(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 non-public
part of the EU database referred to in Article 60(3) 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 is
established in the Union or it has appointed a legal representative who is established
in the Union;
(e) data collected and processed for the purpose of the testing in real world conditions
shall only be transferred to third countries outside the Union provided appropriate
and applicable safeguards under Union law are implemented;
(f) the testing in real world conditions does not last longer than necessary to achieve its
objectives and in any case not longer than 6 months, which may be extended for an
additional amount of 6 months, subject to prior notification by the provider to the
market surveillance authority, accompanied by an explanation on the need for such
time extension;
(g) persons belonging to vulnerable groups due to their age, physical or mental disability
are appropriately protected;
(h) where a provider or prospective provider organises the testing in real world
conditions in cooperation with one or more prospective deployers, the latter have
been informed of all aspects of the testing that are relevant to their decision to
participate, and given the relevant instructions on how to use the AI system referred
to in Article 13; the provider or prospective provider and the deployer(s) shall
conclude an agreement specifying their roles and responsibilities with a view to
ensuring compliance with the provisions for testing in real world conditions under
this Regulation and other applicable Union and Member States legislation;
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(i) the subjects of the testing in real world conditions have given informed consent in
accordance 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
and the outcome of the testing in the real world conditions shall not have any
negative effect on the subject and his or her personal data shall be deleted after the
test is performed;
(j) the testing in real world conditions is effectively overseen by the provider or
prospective provider and deployer(s) with persons who are suitably qualified in the
relevant field and have the necessary capacity, training and authority to perform their
tasks;
(k) the predictions, recommendations or decisions of the AI system can be effectively
reversed and disregarded.
5 Any subject of the testing in real world conditions, or his or her legally designated
representative, as appropriate, may, without any resulting detriment and without having to
provide any justification, withdraw from the testing at any time by revoking his or her
informed consent and request the immediate and permanent deletion of their personal data.
The withdrawal of the informed consent shall not affect the activities already carried out.
5a. In accordance with Article 63a, Member States shall confer their market surveillance
authorities the powers of requiring providers and prospective providers information, of
carrying out unannounced remote or on-site inspections and on performing checks on the
development of the testing in real world conditions and the related products. Market
surveillance authorities shall use these powers to ensure a safe development of these tests.
6. Any serious incident identified in the course of the testing in real world conditions shall be
reported to the national market surveillance authority in accordance with Article 62 of this
Regulation. 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 a
procedure for the prompt recall of the AI system upon such termination of the testing in
real world conditions.
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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 the
suspension 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 the
testing 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:
(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 the
subject or his or her legal representative.
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Article 55
Measures for providers and deployers, in particular SMEs, including start-ups
1. Member States shall undertake the following actions:
(a) provide SMEs, including start-ups, having a registered office or a branch in the
Union, with priority access to the AI regulatory sandboxes, to the extent that they
fulfil the eligibility conditions and selection criteria. The priority access shall not
preclude other SMEs including start-ups other than those referred to in the first
subparagraph to access to the AI regulatory sandbox, provided that they fulfil the
eligibility conditions and selection criteria;
(b) organise specific awareness raising and training activities on the application of this
Regulation tailored to the needs of SMEs including start-ups, users and, as
appropriate, local public authorities;
(c) utilise existing dedicated channels and where appropriate, establish new ones for
communication with SMEs including start-ups, users, other innovators and, as
appropriate, local public authorities to provide advice and respond to queries about
the implementation of this Regulation, including as regards participation in AI
regulatory sandboxes;
(ca) facilitate the participation of SMEs and other relevant stakeholders in the
standardisation development process.
2. The specific interests and needs of the SME providers, including start-ups, shall be taken
into account when setting the fees for conformity assessment under Article 43, reducing
those fees proportionately to their size, market size and other relevant indicators.
2a. The AI Office shall undertake the following actions:
(a) upon request of the AI Board, provide standardised templates for the areas covered
by 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;
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(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.
Article 55a
Derogations for specific operators
2b. 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 those enterprises do not have partner enterprises or linked
enterprises as defined in Article 3 of the same Annex may fulfil certain elements of the
quality management system required by Article 17 of this Regulation in a simplified
manner. For this purpose, the Commission shall develop guidelines on the elements of the
quality management system which may be fulfilled in a simplified manner considering the
needs of micro enterprises without affecting the level of protection and the need for
compliance with the requirements for high-risk AI systems.
2c. Paragraph 1 shall not be interpreted as exempting those operators from fulfilling any other
requirements and obligations laid down in this Regulation, including those established in
Articles 9, 10, 11, 12, 13, 14, 15, 61 and 62.
TITLE VI
GOVERNANCE
Article 55b
Governance at Union level
1. The Commission shall develop Union expertise and capabilities in the field of artificial
intelligence. For this purpose, the Commission has established the European AI Office by
Decision […].
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2. Member States shall facilitate the tasks entrusted to the AI Office, as reflected in this
Regulation.
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 observer. The AI Office 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.
2b. Member States shall ensure that their representatives in the Board:
(a) have the relevant competences and powers in their Member State so as to contribute
actively to the achievement of the Board’s tasks referred to in Article 58;
(b) are designated as a single contact point vis-à-vis the Board and, where appropriate,
taking into account Member States’ needs, as a single contact point for stakeholders;
(c) are empowered to facilitate consistency and coordination between national competent
authorities in their Member State as regards the implementation of this Regulation,
including through the collection of relevant data and information for the purpose of
fulfilling their tasks on the Board.
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3. The designated representatives of the Member States shall adopt the Board’s rules of
procedure 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, and the organisation of the Board’s activities and its sub-
groups.
3a. The Board shall establish 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 standing sub-group 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.
The Board may establish other standing or temporary sub-groups as appropriate for the
purpose of examining specific issues. Where appropriate, representatives of the advisory
forum as referred to in Article 58a may be invited to such sub-groups or to specific
meetings of those subgroups in the capacity of observers.
3b. The Board shall be organised and operated so as to safeguard the objectivity and
impartiality of its activities.
4. The Board shall be chaired by one of the representatives of the Member States. The
European AI Office shall provide the Secretariat for the Board, convene the meetings upon
request of the Chair and prepare the agenda in accordance with the tasks of the Board
pursuant to this Regulation and its rules of procedure.
Article 58
Tasks of the Board
The Board shall advise and assist the Commission and the Member States in order to
facilitate the consistent and effective application of this Regulation. For this purpose the
Board may in particular:
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(a) contribute to the coordination among national competent authorities responsible for
the application of this Regulation and, in cooperation and subject to agreement of the
concerned market surveillance authorities, support joint activities of market
surveillance authorities referred to in Article 63(7a);
(b) collect and share technical and regulatory expertise and best practices among
Member States;
(c) provide advice in the implementation of this Regulation, in particular as regards the
enforcement of rules on general purpose AI models;
(d) contribute to the harmonisation of administrative practices in the Member States,
including in relation to the derogation from the conformity assessment procedures
referred to in Article 47, the functioning of regulatory sandboxes and testing in real
world conditions referred to in Articles 53, 54 and 54a;
(e) upon the request of the Commission or on its own initiative, issue recommendations
and written opinions on any relevant matters related to the implementation of this
Regulation and to its consistent and effective application, including:
(i) on the development and application of codes of conduct and code of practice
pursuant to this Regulation as well as the Commission’s guidelines;
(ii) the evaluation and review of this Regulation pursuant to Article 84, including
as regards the serious incident reports referred to in Article 62 and the
functioning of the database referred to in Article 60, the preparation of the
delegated or implementing acts, and possible alignments of this Regulation
with the legal acts listed in Annex II;
(iii) on technical specifications or existing standards regarding the requirements set
out in Title III, Chapter 2;
(iv) on the use of harmonised standards or common specifications referred to in
Articles 40 and 41;
(v) trends, such as European global competitiveness in artificial intelligence, the
uptake of artificial intelligence in the Union and the development of digital
skills;
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(via) trends on the evolving typology of AI value chains, in particular on the
resulting implications in terms of accountability;
(vi) on the potential need for amendment of Annex III in accordance with Article 7
and on the potential need for possible revision of Article 5 pursuant to Article
84, taking into account relevant available evidence and the latest developments
in technology;
(f) support the Commission in promoting AI literacy, public awareness and
understanding of the benefits, risks, safeguards and rights and obligations in relation
to the use of AI systems;
(g) facilitate the development of common criteria and a shared understanding among
market operators and competent authorities of the relevant concepts provided for in
this Regulation, including by contributing to the development of benchmarks;
(h) cooperate, as appropriate, with other Union institutions, bodies, offices and agencies,
as well as relevant Union expert groups and networks in particular in the fields of
product safety, cybersecurity, competition, digital and media services, financial
services, consumer protection, data and fundamental rights protection;
(i) contribute to the effective cooperation with the competent authorities of third
countries and with international organisations;
(j) assist national competent authorities and the Commission, in developing the
organisational and technical expertise required for the implementation of this
Regulation, including by contributing to the assessment of training needs for staff of
Member States involved in implementing this Regulation;
(j1) assist the AI Office in supporting national competent authorities in the establishment
and development of regulatory sandboxes and facilitate cooperation and information-
sharing among regulatory sandboxes;
(k) contribute and provide relevant advice in the development of guidance documents;
(l) advise the Commission in relation to international matters on artificial intelligence;
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(m) provide opinions to the Commission on the qualified alerts regarding general purpose
AI models;
(n) receive opinions by the Member states on the qualified alerts regarding general
purpose AI models and on national experiences and practices on the monitoring and
enforcement of the AI systems, in particular systems integrating the general purpose
AI models.
Article 58a
Advisory forum
1. An advisory forum shall be established to advise and provide technical expertise to the
Board and the Commission to contribute to their tasks under this Regulation.
2. The membership of the advisory forum shall represent a balanced selection of
stakeholders, including industry, start-ups, SMEs, civil society and academia. The
membership of the advisory forum shall be balanced with regard to commercial and non-
commercial interests and, within the category of commercial interests, with regards to
SMEs and other undertakings.
3. The Commission shall appoint the members of the advisory forum, in accordance with the
criteria set out in the previous paragraph, among stakeholders with recognised expertise in
the field of AI.
4. The term of office of the members of the advisory forum shall be two years, which may be
extended by up to no more than four years.
5. The Fundamental Rights Agency, European Union Agency for Cybersecurity, the
European Committee for Standardization (CEN), the European Committee for
Electrotechnical Standardization (CENELEC), and the European Telecommunications
Standards Institute (ETSI) shall be permanent members of the advisory forum.
6. The advisory forum shall draw up its rules of procedure. It shall elect two co-chairs from
among its members, in accordance with criteria set out in paragraph 2. The term of office
of the co-chairs shall be two years, renewable once.
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7. The advisory forum shall hold meetings at least two times a year. The advisory forum may
invite experts and other stakeholders to its meetings.
8. In fulfilling its role as set out in paragraph 1, the advisory forum may prepare opinions,
recommendations and written contributions upon request of the Board or the Commission.
9. The advisory forum may establish standing or temporary subgroups as appropriate for the
purpose of examining specific questions related to the objectives of this Regulation.
10. The advisory forum shall prepare an annual report of its activities. That report shall be
made publicly available.
Chapter 1a
SCIENTIFIC PANEL OF INDEPENDENT EXPERTS
Article 58b
Scientific panel of independent experts
1. The Commission shall, by means of an implementing act, make provisions on the
establishment of a scientific panel of independent experts (the ‘scientific panel’) intended
to support the enforcement activities under this Regulation. Those implementing acts shall
be adopted in accordance with the examination procedure referred to in Article 74(2).
2. The scientific panel shall consist of experts selected by the Commission on the basis of up-
to-date scientific or technical expertise in the field of artificial intelligence necessary for
the tasks set out in paragraph 3, and shall be able to demonstrate meeting all of the
following conditions:
(a) particular expertise and competence and scientific or technical expertise in the field
of artificial intelligence;
(b) independence from any provider of AI systems or general purpose AI models or
systems;
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(c) ability to carry out activities diligently, accurately and objectively.
The Commission, in consultation with the AI Board, shall determine the number of experts
in the panel in accordance with the required needs and shall ensure fair gender and
geographical representation.
3. The scientific panel shall advise and support the European AI Office, in particular with
regard to the following tasks:
(a) support the implementation and enforcement of this Regulation as regards general
purpose AI models and systems, in particular by
(i) alerting the AI Office of possible systemic risks at Union level of general
purpose AI models, in accordance with Article 68h [Alerts of systemic risks
by the scientific panel];
(ii) contributing to the development of tools and methodologies for evaluating
capabilities of general purpose AI models and systems, including through
benchmarks;
(iii) providing advice on the classification of general purpose AI models with
systemic risk;
(iiii) providing advice on the classification of different general purpose AI models
and systems;
(iv) contributing to the development of tools and templates;
(b) support the work of market surveillance authorities, at their request;
(c) support cross-border market surveillance activities as referred to in Article
63(7a), without prejudice of the powers of market surveillance authorities;
(d) support the AI Office when carrying out its duties in the context of the safeguard
clause pursuant to Article 66.
4. The experts shall perform their tasks with impartiality, objectivity and ensure the
confidentiality of information and data obtained in carrying out their tasks and activities.
They shall neither seek nor take instructions from anyone when exercising their tasks
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under paragraph 3. Each expert shall draw up a declaration of interests, which shall be
made publicly available. The AI Office shall establish systems and procedures to actively
manage and prevent potential conflicts of interest.
5. The implementing act referred to in paragraph 1 shall include provisions on the conditions,
procedure and modalities for the scientific panel and its members to issue alerts and
request the assistance of the AI Office to the performance of its tasks.
Article 58c
Access to the pool of experts by the Member States
1. Member States may call upon experts of the scientific panel to support their enforcement
activities under this Regulation.
2. 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 set out in the implementing act referred to in Article 58b(1), taking into account
the objectives of the adequate implementation of this Regulation, cost-effectiveness and
the necessity to ensure an effective access to experts by all Member States.
3. The Commission shall facilitate timely access to the experts by the Member States, as
needed, and ensure that the combination of support activities carried out by EU AI testing
support pursuant to Article 68a and experts pursuant to this Article is efficiently organised
and provides the best possible added value.
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Chapter 2
NATIONAL COMPETENT AUTHORITIES
Article 59
Designation of national competent authorities and single point of contact
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 competent
authorities. These national competent authorities shall exercise their powers independently,
impartially and without bias so as to safeguard the principles of objectivity of their
activities and tasks and to ensure the application and implementation of this Regulation.
The members of these authorities shall refrain from any action incompatible with their
duties. Provided that those principles 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 communicate to the Commission the identity of the notifying
authorities and the market surveillance authorities and the tasks of those authorities and as
well as any subsequent changes thereto. Member States shall make publicly available
information on how competent authorities and single point of contact can be contacted,
through electronic communication means by… [12 months after the date of entry into force
of this Regulation]. Member States shall designate a market surveillance authority to act as
single point of contact for this Regulation and notify the Commission of the identity of the
single point of contact. The Commission shall make a list of the single points of contact
publicly available.
4. Member States shall ensure that the national competent authority is provided with adequate
technical, financial and human resources, and infrastructure to fulfil their tasks effectively
under this Regulation. In particular, the national competent authority shall have a sufficient
number of personnel permanently available whose competences and expertise shall include
an in-depth understanding of artificial intelligence technologies, data and data computing,
personal data protection, cybersecurity, fundamental rights, health and safety risks and
knowledge of existing standards and legal requirements. Member States shall assess and, if
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deemed necessary, update competence and resource requirements referred to in this
paragraph on an annual basis.
4a. National competent authorities shall satisfy an adequate level of cybersecurity measures.
4c. When performing their tasks, the national competent authorities shall act in compliance
with the confidentiality obligations set out in Article 70.
5. By one year after entry into force of this Regulation and once every two years thereafter
Member States shall report to the Commission on the status of the financial and human
resources of the national competent authorities with an assessment of their adequacy. The
Commission shall transmit that information to the Board for discussion and possible
recommendations.
6. The Commission shall facilitate the exchange of experience between national competent
authorities.
7. National competent authorities may provide guidance and advice on the implementation of
this Regulation, in particular to SMEs including start-ups, taking into account the Board's
and the Commission’s guidance and advice, as appropriate. Whenever national competent
authorities intend to provide guidance and advice with regard to an AI system in areas
covered by other Union legislation, the competent national authorities under that Union
legislation shall be consulted, as appropriate.
8. When Union institutions, agencies and bodies fall within the scope of this Regulation, the
European Data Protection Supervisor shall act as the competent authority for their
supervision.
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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 paragraphs 2 and 2a concerning high-risk AI
systems referred to in Article 6(2) which are registered in accordance with Articles 51 and
54a. When setting the functional specifications of such database, the Commission shall
consult the relevant experts, and when updating the functional specifications of such
database, the Commission shall consult the AI Board.
2. The data listed in Annex VIII, Section A, shall be entered into the EU database by the
provider or where applicable the authorised representative.
2a. The data listed in Annex VIII, Section B, shall be entered into the EU database by the
deployer who is or who acts on behalf of public authorities, agencies or bodies, according
to articles 51(1a) and (1b).
3. With the exception of the section referred to in Article 51(1c) and Article 54a(5), the
information contained in the EU database registered in accordance with Article 51 shall be
accessible and publicly available in a user friendly manner. The information should be
easily navigable and machine-readable. The information registered in accordance with
Article 54a shall be accessible only to market surveillance authorities and the Commission,
unless the prospective provider or provider has given consent for making this information
also accessible the public.
4. The EU database shall contain personal data only insofar as necessary for collecting and
processing information in accordance with this Regulation. That information shall include
the names and contact details of natural persons who are responsible for registering the
system and have the legal authority to represent the provider or the deployer, as applicable.
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5. The Commission shall be the controller of the EU database. It shall make available to
providers, prospective providers and deployers adequate technical and administrative
support. The database shall comply with the applicable accessibility requirements.
TITLE VIII
POST-MARKET MONITORING, INFORMATION SHARING,
MARKET SURVEILLANCE
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 that
is proportionate to the nature of the artificial intelligence technologies and the risks of the
high-risk AI system.
2. The post-market monitoring system shall actively and systematically collect, document and
analyse relevant data which may be provided by deployers or which may be collected
through other sources on the performance of high-risk AI systems throughout their
lifetime, and allow the provider to evaluate the continuous compliance of AI systems with
the requirements set out in Title III, Chapter 2. Where relevant, post-market monitoring
shall include an analysis of the interaction with other AI systems. This obligation shall not
cover sensitive operational data of deployers which 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 of
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elements to be included in the plan by six months before the entry into application of this
Regulation.
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 that
legislation, in order to ensure consistency, avoid duplications and minimise additional
burdens, providers shall have a choice to integrate, as appropriate, the necessary elements
described in paragraphs 1, 2 and 3 using the template referred in paragraph 3 into already
existing system and plan under the Union harmonisation legislation listed in Annex II,
Section A, provided it achieves an equivalent level of protection.
The first subparagraph shall also apply high-risk AI systems referred to in point 5 of
Annex 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.
1a. As a general rule, the period for the reporting referred to in paragraph 1 shall take account
of the severity of the serious incident.
1b. The notification referred to in paragraph 1 shall be made immediately after the provider
has established a causal link between the AI system and the serious incident or the
reasonable likelihood of such a link, and, in any event, not later than 15 days after the
provider or, where applicable, the deployer, becomes aware of the serious incident.
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1c. Notwithstanding paragraph 1b, in the event of a widespread infringement or a serious
incident as defined in Article 3(44) point (b) the report referred to in paragraph 1 shall be
provided immediately, and not later than 2 days after the provider or, where applicable, the
deployer becomes aware of that incident.
1d. Notwithstanding paragraph 1b, in the event of death of a person the report shall be
provided immediately after the provider or the deployer has established or as soon as it
suspects a causal relationship between the high-risk AI system and the serious incident but
not later than 10 days after the date on which the provider or, where applicable, the
deployer becomes aware of the serious incident.
1e. Where necessary to ensure timely reporting, the provider or, where applicable, the
deployer, may submit an initial report that is incomplete followed up by a complete report.
1a. Following the reporting of a serious incident pursuant to the first subparagraph, the
provider shall, without delay, perform the necessary investigations in relation to the serious
incident and the AI system concerned. This shall include a risk assessment of the incident
and corrective action. The provider shall co-operate with the competent authorities and
where relevant with the notified body concerned during the investigations referred to in the
first subparagraph and shall not perform any investigation which involves altering the AI
system concerned in a way which may affect any subsequent evaluation of the causes of
the incident, prior to informing the competent authorities of such action.
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 or
bodies referred to in Article 64(3). The Commission shall develop dedicated guidance to
facilitate 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, and shall be
assessed regularly.
2a. The market surveillance authority shall take appropriate measures, as provided in Article
19 of the Regulation 2019/1020, within 7 days from the date it received the notification
referred to in paragraph 1 and follow the notification procedures as provided in the
Regulation 2019/1020.
3. For high-risk AI systems referred to in Annex III that are placed on the market or put into
service by providers that are subject to Union legislative instruments laying down reporting
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obligations equivalent to those set out in this Regulation, the notification of serious
incidents shall be limited to those referred to in Article 3(44)(c).
3a. For high-risk AI systems which are safety components of devices, or are themselves
devices, covered by Regulation (EU) 2017/745 and Regulation (EU) 2017/746 the
notification of serious incidents shall be limited to those referred to in Article 3(44)(c) and
be made to the national competent authority chosen for this purpose by the Member States
where that incident occurred.
3a. National competent authorities shall immediately notify the Commission of any serious
incident, whether or not it has taken action on it, in accordance with Article 20 of
Regulation 2019/1020.
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(1) of this Regulation;
(b) any reference to a product under Regulation (EU) 2019/1020 shall be understood as
including all AI systems falling within the scope of this Regulation.
2. As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020,
the market surveillance authorities shall report annually, to the Commission and relevant
national competition authorities any information identified in the course of market
surveillance activities that may be of potential interest for the application of Union law on
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competition rules. They shall also annually report to the Commission about the use of
prohibited practices that occurred during that year and about the measures taken.
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 the
authority responsible for market surveillance activities designated under those legal acts.
By derogation from the previous paragraph in justified circumstances, Member States may
designate another relevant authority to act as a market surveillance authority provided that
coordination is ensured with the relevant sectoral market surveillance authorities
responsible for the enforcement of the legal acts listed in Annex II.
3a. 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 ensuring an equivalent level of
protection and having the same objective. In such a case, these sectoral procedures shall
apply instead.
3b. Without prejudice to the powers of market surveillance authorities under Article 14 of
Regulation 2019/1020, for the purpose of ensuring the effective enforcement of this
Regulation, market surveillance authorities may exercise the powers referred to in Article
14(4)(d) and (j) of Regulation 2019/1020 remotely as appropriate.
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 surveillance
authority 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 direct
connection with the provision of those financial services.
4a. By way of a derogation from the previous subparagraph, in justified circumstances and
provided that coordination is ensured, another relevant authority may be identified by the
Member 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, to the
European Central Bank any information identified in the course of their market surveillance
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activities that may be of potential interest for the European Central Bank’s prudential
supervisory tasks as specified in that Regulation.
5. For high-risk AI systems listed in point 1 in so far as the systems are used for law
enforcement purposes and for purposes listed in points 6, 7 and 8 of Annex III, Member
States shall designate as market surveillance authorities for the purposes of this Regulation
either the competent data protection supervisory authorities under Regulation 2016/679, or
Directive (EU) 2016/680 or any other authority designated pursuant to the same conditions
laid down in Articles 1 to 44 of Directive or Directive (EU) 2016/680. Market surveillance
activities shall in no way affect the independence of judicial authorities or otherwise
interfere with their activities when acting in their judicial capacity.
6. Where Union institutions, agencies and bodies fall within the scope of this Regulation, the
European Data Protection Supervisor shall act as their market surveillance authority except
in relation to the Court of Justice acting in its judicial capacity.
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.
7a. Market surveillance authorities and the Commission shall be able to propose joint
activities, including joint investigations, to be conducted by either market surveillance
authorities or market surveillance authorities jointly with the Commission, that have the
aim of promoting compliance, identifying non-compliance, raising awareness and
providing guidance in relation to this Regulation with respect to specific categories of
high-risk AI systems that are found to present a serious risk across several Member States
in accordance with Article 9 of the 2019/1020. The AI Office shall provide coordination
support for joint investigations.
7a. 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 surveillance
authorities shall be granted full access by the provider to the documentation as well as the
training, validation and testing datasets used for the development of the high-risk AI
system, including, where appropriate and subject to security safeguards, through
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application programming interfaces (‘API’) or other relevant technical means and tools
enabling remote access.
7b. 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:
(a) access to source code is necessary to assess the conformity of a high-risk AI system
with the requirements set out in Title III, Chapter 2; and
(b) testing/auditing procedures and verifications based on the data and documentation
provided by the provider have been exhausted or proved insufficient.
7c. Any information and documentation obtained by market surveillance authorities shall be
treated in compliance with the confidentiality obligations set out in Article 70.
Article 63a
Mutual Assistance, market surveillance and control of general purpose AI systems
1. Where an AI system is based on a general purpose AI model and the model and the system
are developed by the same provider, the AI office shall have powers to monitor and
supervise compliance of this AI system with the obligations of this Regulation. To carry
monitoring and supervision tasks the AI Office shall have all the powers of a market
surveillance authority within the meaning of the Regulation 2019/1020.
2. Where the relevant market surveillance authorities have sufficient reasons to consider that
general purpose AI systems that can be used directly by deployers for at least one purpose
that is classified as high-risk pursuant to this Regulation, is non-compliant with the
requirements laid down in this Regulation, it shall cooperate with the AI Office to carry out
evaluation of compliance and inform the Board and other market surveillance authorities
accordingly.
3. When a national market surveillance authority is unable to conclude its investigation on the
high-risk AI system because of its inability to access certain information related to the
general purpose AI model despite having made all appropriate efforts to obtain that
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information, it may submit a reasoned request to the AI Office where access to this
information can be enforced. In this case the AI Office shall supply to the applicant
authority without delay, and in any event within 30 days, any information that the AI
Office considers to be relevant in order to establish whether a high-risk AI system is non-
compliant. National market authorities shall safeguard the confidentiality of the
information they obtain in accordance with the Article 70. The procedure provided in
Chapter VI of the Regulation (EU) 1020/2019 shall apply by analogy.
Article 63b
Supervision of testing in real world conditions by market surveillance authorities
1. Market surveillance authorities shall have the competence and powers to ensure that testing
in 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 shall
verify 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 in
real 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).
3. Where a market surveillance authority has been informed by the prospective provider, the
provider or any third party of a serious incident or has other grounds for considering that
the conditions set out in Articles 54a and 54b are not met, it may take any of the following
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 the
testing in real world conditions.
4. Where a market surveillance authority has taken a decision referred to in paragraph 3 of
this Article or has issued an objection within the meaning of Article 54a(4)(b), the decision
or the objection shall indicate the grounds thereof and the modalities and conditions for the
provider or prospective provider to challenge the decision or objection.
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5. Where applicable, where a market surveillance authority has taken a decision referred to in
paragraph 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
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 in
accessible language and format when access to that documentation is necessary for
effectively fulfilling their mandate within the limits of their jurisdiction. The relevant
public authority or body shall inform the market surveillance authority of the Member
State concerned of any such request.
4. By three months after the entering into force of this Regulation, each Member State shall
identify the public authorities or bodies referred to in paragraph 3 and make a list publicly
available. Member States shall notify the list to the Commission and all other Member
States and keep the list up to date.
5. Where the documentation referred to in paragraph 3 is insufficient to ascertain whether a
breach of obligations under Union law intended to protect fundamental rights has occurred,
the public authority or body referred to in paragraph 3 may make a reasoned request to the
market surveillance authority, to organise testing of the high-risk AI system through
technical 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 in
compliance 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 level
1. 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, it shall carry out an
evaluation of the AI system concerned in respect of its compliance with all the
requirements and obligations laid down in this Regulation. Particular attention shall be
given to AI systems presenting a risk to vulnerable groups (referred to in Article 5). When
risks to fundamental rights are identified, the market surveillance authority shall also
inform and fully cooperate with the relevant national public authorities or bodies referred
to in Article 64(3). The relevant operators shall cooperate as necessary with the market
surveillance authority 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 and where
applicable in cooperation with the national public authority referred to in Article 64(3)
finds that the AI system does not comply with the requirements and obligations laid down
in this Regulation, it shall without undue delay require the relevant operator to take all
appropriate corrective actions to bring the AI system into compliance, to withdraw the AI
system from the market, or to recall it within a period it may prescribe and in any event no
later than fifteen working days or as provided for in the relevant Union harmonisation law
as applicable
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 the
second subparagraph.
3. Where the market surveillance authority considers that non-compliance is not restricted to
its national territory, it shall inform the Commission, and the other Member States without
undue delay of the results of the evaluation and of the actions which it has required the
operator to take.
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4. The operator shall ensure that all appropriate corrective action is taken in respect of all the
AI 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 all
appropriate provisional measures to prohibit or restrict the AI system's being made
available on its national market or put into service, to withdraw the product or the
standalone AI system from that market or to recall it. That authority shall without undue
delay notify the Commission and the other Member States of those measures.
6. The notification referred to in paragraph 5 shall include all available details, in particular
the information necessary for the identification of the non-compliant AI system, the origin
of the AI system and the supply chain, the nature of the non-compliance alleged and the
risk involved, the nature and duration of the national measures taken and the arguments put
forward by the relevant operator. In particular, the market surveillance authorities 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 to
in 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;
(ba) non-compliance with provisions set out in Article 52.
7. 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, no
objection has been raised by either a market surveillance authority of a Member State or
the Commission in respect of a provisional measure taken by a market surveillance
authority of another Member State, that measure shall be deemed justified. This is without
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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 thirty days in the event of non-compliance with the
prohibition of the artificial intelligence practices referred to in Article 5.
9. The market surveillance authorities of all Member States shall ensure that appropriate
restrictive measures are taken in respect of the product or the AI system concerned, such as
withdrawal of the product or the AI system from their market, without undue delay.
Article 65a
Procedure for dealing with AI systems classified by the provider as a not high-risk in
application of Annex III
1. Where a market surveillance authority has sufficient reasons to consider that an AI system
classified by the provider as non-high-risk in application of Annex III is high-risk, they
market surveillance authority shall carry out an evaluation of the AI system concerned in
respect of its classification as a high-risk AI system based on the conditions set out in
Annex III and the Commission guidelines.
2. Where, in the course of that evaluation, the market surveillance authority finds that the AI
system concerned is high-risk, it shall without undue delay require the relevant provider to
take all necessary actions to bring the AI system into compliance with the requirements
and obligations laid down in this Regulation as well as take appropriate corrective action
within a period it may prescribe.
3. Where the market surveillance authority considers that the use of the AI system concerned
is not restricted to its national territory, it shall inform the Commission and the other
Member States without undue delay of the results of the evaluation and of the actions
which it has required the provider to take.
4. The provider shall ensure that all necessary action is taken to bring the AI system into
compliance with the requirements and obligations laid down in this Regulation. Where the
provider of an AI system concerned does not bring the AI system into compliance with the
requirements and obligations of this Regulation within the period referred to in paragraph
2, the provider shall be subject to fines in accordance with Article 71.
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5. The provider shall ensure that all appropriate corrective action is taken in respect of all the
AI systems concerned that it has made available on the market throughout the Union.
6. Where the provider of the AI system concerned does not take adequate corrective action
within the period referred to in paragraph 2, then the provisions of Article 65 paragraphs 5
to 9 apply.
7. Where, in the course of that evaluation pursuant to paragraph 1, the market surveillance
authority establishes that the AI system was misclassified by the provider as not high-risk
to circumvent the application of requirements in Title III, Chapter 2, the provider shall be
subject to fines in accordance with Article 71.
8. In exercising their power to monitor the application of this article and in accordance with
Article 11 of Regulation (EU) 2019/1020, market surveillance authorities may perform
appropriate checks, taking into account in particular information stored in the EU database
referred to in Article 60.
Article 66
Union safeguard procedure
1. Where, within three months of receipt of the notification referred to in Article 65(5), or 30
days in the case of non-compliance with the prohibition of the artificial intelligence
practices referred to in Article 5, objections are raised by the market surveillance authority
of a Member State against a measure taken by another market surveillance authority, or
where the Commission considers the measure to be contrary to Union law, the Commission
shall without undue delay enter into consultation with the market surveillance authority of
the relevant Member State 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 not within six months, or 60 days in the case of
non-compliance with the prohibition of the artificial intelligence practices referred to in
Article 5, starting from the notification referred to in Article 65(5) and notify such decision
to the market surveillance authority of the Member State concerned. The Commission shall
also inform all other market surveillance authorities of such decision.
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2. If the measure taken by the relevant Member States is considered justified by the
Commission, 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 considered unjustified by the Commission, 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 the
procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
Article 67
Compliant AI systems which present a risk
1. Where, having performed an evaluation under Article 65, after consulting the relevant
national public authority referred to in Article 64(3), the market surveillance authority of a
Member State finds that although a high-risk AI system is in compliance with this
Regulation, it presents a risk to the health or safety of persons, fundamental rights, or to
other aspects of public interest protection, it shall require the relevant operator to take all
appropriate measures to ensure that the AI system concerned, when placed on the market
or put into service, no longer presents that risk without undue delay, within a period it may
prescribe.
2. The provider or other relevant 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 States shall immediately inform the Commission and the other Member
States. That information shall include all available details, in particular the data necessary
for the identification of the AI system concerned, the origin and the supply chain of the AI
system, the nature of the risk involved and the nature and duration of the national measures
taken.
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4. The Commission shall without undue delay enter into consultation with the Member States
concerned and the relevant operator and shall evaluate the national measures taken. On the
basis of the results of that evaluation, the Commission shall decide whether the measure is
justified or not and, where necessary, propose appropriate measures.
5. The Commission shall immediately communicate its decision to the Member States
concerned and to the relevant operators. It shall also inform of the decision all other
Member States.
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-compliance
concerned, within a period it may prescribe:
(a) the CE marking has been affixed in violation of Article 49;
(b) the CE 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;
(ea) the registration in the EU database has not been carried out;
(eb) where applicable, the authorised representative has not been appointed;
(ec) the technical documentation is not available.
2. Where the non-compliance referred to in paragraph 1 persists, the market surveillance
authority of the Member State concerned shall take appropriate and proportionate measures
to restrict or prohibit the high-risk AI system being made available on the market or ensure
that it is recalled or withdrawn from the market without delay.
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Article 68a
EU AI testing support structures in the area of artificial intelligence
1. The Commission shall designate one or more EU AI testing support structures to perform
the tasks listed under Article 21(6) of Regulation (EU) 1020/2019 in the area of artificial
intelligence.
2. Without prejudice to the tasks referred to in paragraph 1, EU AI testing support structure
shall also provide independent technical or scientific advice at the request of the Board, the
Commission, or market surveillance authorities.
Chapter 3b
REMEDIES
Article 68a
Right to lodge a complaint with a market surveillance authority
1. Without prejudice to other administrative or judicial remedies, complaints to the relevant
market surveillance authority may be submitted by any natural or legal person having
grounds to consider that there has been an infringement of the provisions of this
Regulation.
2. In accordance with 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 68 c
A right to explanation of individual decision-making
1. Any affected person subject to a decision which is taken by the deployer on the basis of the
output from an high-risk AI system listed in Annex III, with the exception of systems listed
under point 2, and which produces legal effects or similarly significantly affects him or her
in a way that they consider to adversely impact their health, safety and fundamental rights
shall have the right to request from the deployer clear and meaningful explanations on the
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role of the AI system in the decision-making procedure and the main elements of the
decision taken.
2. Paragraph 1 shall not apply to the use of AI systems for which exceptions from, or
restrictions to, the obligation under paragraph 1 follow from Union or national law in
compliance with Union law.
3. This Article shall only apply to the extent that the right referred to in paragraph 1 is not
already provided for under Union legislation.
Article 68d
Amendment to Directive (EU) 2020/1828
In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council30,
the following point is added: “(67a) Regulation xxxx/xxxx of the European Parliament and
of the Council [laying down harmonised rules on artificial intelligence (Artificial
Intelligence Act) and amending certain Union legislative acts (OJ L ...)]”.
Article 68 e
Reporting of breaches and protection of reporting persons
Directive (EU) 2019/1937 of the European Parliament and of the Council shall apply to the
reporting of breaches of this Regulation and the protection of persons reporting such
breaches.
30 Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on
representative actions for the protection of the collective interests of consumers and repealing Directive
2009/22/EC (OJ L 409, 4.12.2020, p. 1).
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Chapter 3c
SUPERVISION, INVESTIGATION, ENFORCEMENT AND
MONITORING IN RESPECT OF PROVIDERS OF GENERAL
PURPOSE AI MODELS
Article 68f
Enforcement of obligations on providers of general purpose AI models
1. The Commission shall have exclusive powers to supervise and enforce Chapter/Title
[general purpose AI models] taking into account the procedural guarantees by virtue of
Article 68m. The Commission shall entrust the implementation of these tasks to the
European AI Office, without prejudice to the powers of organisation of the Commission
and the division of competences between Member States and the Union based on the
Treaties.
2. Without prejudice to Article 63a paragraph 3, market surveillance authorities may request
to the Commission to exercise the powers laid down in this Chapter, where this is
necessary and proportionate to assist with the fulfilment of their tasks under this
Regulation.
Article 68g
Monitoring actions
1. For the purposes of carrying out the tasks assigned to it under this Chapter, the AI Office
may take the necessary actions to monitor the effective implementation and compliance
with this Regulation by providers of general purpose AI models, including adherence to
approved codes of practice.
2. Downstream providers shall have the right to lodge a complaint alleging an infringement
of this Regulation. A complaint shall be duly reasoned and at least indicate:
(a) the point of contact of the provider of the general purpose AI model concerned;
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(b) description of the relevant facts, the provisions of this Regulation concerned and the
reason why the downstream provider considers that the provider of the general
purpose AI model concerned infringed this Regulation;
(c) any other information that the downstream provider that sent the request considers
relevant, including, where appropriate, information gathered on its own initiative.
Article 68h
Alerts of systemic risks by the scientific panel
1. The scientific panel may provide a qualified alert to the AI Office where it has reason to
suspect that
(a) a general purpose AI model poses concrete identifiable risk at Union level; or
(b) a general purpose AI model meets the requirements referred to in Article 52a
[Classification of general purpose AI models with systemic risk].
2. Upon such qualified alert, the Commission, through the AI Office and after having
informed the AI Board, may exercise the powers laid down in this Chapter for the purpose
of assessing the matter. The AI Office shall inform the Board of any measure according to
Articles 68i-68m.
3. A qualified alert shall be duly reasoned and at least indicate:
(a) the point of contact of the provider of the general purpose AI model with systemic
risk concerned;
(b) a description of the relevant facts and reasons for the suspicion of the scientific panel;
(c) any other information that the scientific panel considers relevant, including, where
appropriate, information gathered on its own initiative.
Article 68i
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Power to request documentation and information
1. The Commission may request the provider of the general purpose AI model concerned to
provide the documentation drawn up by the provider according to Article 52c [Obligations
for providers of general purpose AI models] and 52d [Obligations on providers of general
purpose AI models with systemic risk] or any additional information that is necessary for
the purpose of assessing compliance of the provider with this Regulation.
2. Before the request for information is sent, the AI Office may initiate a structured dialogue
with the provider of the general purpose AI model.
3. Upon a duly substantiated request from the scientific panel, the Commission may issue a
request for information to a provider of a general purpose AI model, where the access to
information is necessary and proportionate for the fulfilment of the tasks of the scientific
panel according to Article 58b [Scientific panel](2).
4. The request for information shall state the legal basis and the purpose of the request,
specifying what information is required and set the period within which the information is
to be provided, and the fines provided for in Article 72a [fines] for supplying incorrect,
incomplete or misleading information.
5. The provider of the general purpose AI model concerned or their representatives and, in
the case of legal persons, companies or firms, or where they have no legal personality, the
persons authorised to represent them by law or by their constitution shall supply the
information requested on behalf of the provider of the general purpose AI model
concerned. Lawyers duly authorised to act may supply the information on behalf of their
clients. The latter shall remain fully responsible if the information supplied is incomplete,
incorrect or misleading.
Article 68j
Power to conduct evaluations
1. The AI Office, after consulting the Board, may conduct evaluations of the general purpose
AI model concerned
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(a) to assess compliance of the provider with the obligations under this Regulation,
where the information gathered pursuant to Article 68i [Power to request
information] is insufficient; or
(b) to investigate systemic risks at Union level of general purpose AI models with
systemic risk, in particular following a qualified report from the scientific panel in
accordance with point (c) of Article 68f [Enforcement of obligations on providers of
general purpose AI models and general purpose AI models with systemic risk](3).
2. The Commission may decide to appoint independent experts to carry out evaluations on its
behalf, including from the scientific panel pursuant to Article [scientific panel of
independent experts]. All independent experts appointed for this task shall meet the criteria
outlined in Article 58b, paragraph 2.
3. For the purpose of paragraph 1, the Commission may request access to the general purpose
AI model concerned through application programming interfaces (‘API’) or further
appropriate technical means and tools, including through source code.
4. The request for access shall state the legal basis, the purpose and reasons of the request and
set the period within which the access is to be provided, and the fines provided for in
Article 72a [fines] for failure to provide access.
5. The providers of the general purpose AI model concerned and, in the case of legal persons,
companies or firms, or where they have no legal personality, the persons authorised to
represent them by law or by their constitution shall provide the access requested on behalf
of the provider of the general purpose AI model concerned.
6. The modalities and the conditions of the evaluations, including the modalities for involving
independent experts and the procedure for the selection of the latter, shall be set out in
implementing acts. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 74(2).
7. Prior to requesting access to the general purpose AI model concerned, the AI Office may
initiate a structured dialogue with the provider of the general purpose AI model to gather
more information on the internal testing of the model, internal safeguards for preventing
systemic risks, and other internal procedures and measures the provider has taken to
mitigate such risks.
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Article 68k
Power to request measures
1. Where necessary and appropriate, the Commission may request providers to
(a) take appropriate measures to comply with the obligations set out in Title VIIIa,
Chapter 2 [Obligations for provider of general purpose AI models];
(b) require a provider to implement mitigation measures, where the evaluation carried out
in accordance with Article 68j [Power to conduct evaluations] has given rise to
serious and substantiated concern of a systemic risk at Union level;
(c) restrict the making available on the market, withdraw or recall the model.
2. Before a measure is requested, the AI Office may initiate a structured dialogue with the
provider of the general purpose AI model.
3. If, during the structured dialogue under paragraph 2, the provider of the general purpose AI
model with systemic risk offers commitments to implement mitigation measures to address
a systemic risk at Union level, the Commission may by decision make these commitments
binding and declare that there are no further grounds for action.
Article 68m
Procedural rights of economic operators of the general purpose AI model
Article 18 of the Regulation (EU) 2019/1020 apply by analogy to the providers of the
general purpose AI model without prejudice to more specific procedural rights provided
for in this Regulation.
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TITLE IX
CODES OF CONDUCT
Article 69
Codes of conduct for voluntary application of specific requirements
1. The AI Office, and the Member States shall encourage and facilitate the drawing up of
codes of conduct, including related governance mechanisms, intended to foster the
voluntary application to AI systems other than high-risk AI systems of some or all of the
requirements set out in Title III, Chapter 2 of this Regulation taking into account the
available technical solutions and industry best practices allowing for the application of
such requirements.
2. The AI Office and the Member States shall facilitate the drawing up of codes of conduct
concerning the voluntary application, including by deployers, of specific requirements to
all AI systems, on the basis of clear objectives and key performance indicators to measure
the achievement of those objectives, including elements such as, but not limited to:
(a) applicable elements foreseen in European ethic guidelines for trustworthy AI;
(b) assessing and minimizing the impact of AI systems on environmental
sustainability, including as regards energy-efficient programming and
techniques for efficient design, training and use of AI;
(c) promoting AI literacy, in particular of persons dealing with the development,
operation and use of AI;
(d) facilitating an inclusive and diverse design of AI systems, including through the
establishment of inclusive and diverse development teams and the promotion of
stakeholders’ participation in that process;
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(e) assessing and preventing the negative impact of AI systems on vulnerable persons
or groups of persons, including as regards accessibility for persons with a
disability, as well as on gender equality.
3. Codes of conduct may be drawn up by individual providers or deployers of AI systems or
by organisations representing them or by both, including with the involvement of
deployers and any interested stakeholders and their representative organisations, including
civil society organisations and academia. Codes of conduct may cover one or more AI
systems taking into account the similarity of the intended purpose of the relevant systems.
4. The AI Office, and the Member States shall take into account the specific interests and
needs of SMEs, including start-ups, when encouraging and facilitating the drawing up of
codes of conduct.
TITLE X
CONFIDENTIALITY AND PENALTIES
Article 70
Confidentiality
1. The Commission, market surveillance authorities and notified bodies and any other natural
or legal person involved in the application of this Regulation shall, in accordance with
Union or national law, respect the confidentiality of information and data obtained 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
a natural or legal person, including source code, except the cases referred to in
Article 5 of Directive 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;
(ba) public and national security interests;
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(c) integrity of criminal or administrative proceedings;
(da) the integrity of information classified in accordance with Union or national law.
1a. The authorities involved in the application of this Regulation pursuant to paragraph 1 shall
only request data that is strictly necessary for the assessment of the risk posed by the AI
system and for the exercise of their powers in compliance with this Regulation and
Regulation 2019/1020. They shall put in place adequate and effective cybersecurity
measures to protect the security and confidentiality of the information and data obtained
and shall delete the data collected as soon as it is no longer needed for the purpose it was
requested for, in accordance with applicable national or European legislation.
2. Without prejudice to paragraph 1 and 1a, information exchanged on a confidential basis
between the national competent authorities and between national competent authorities and
the Commission shall not be disclosed without the prior consultation of the originating
national competent authority and the deployer 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 exchange of 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 documentation
referred to in Annex IV shall remain within the premises of those authorities. Those
authorities shall ensure that the market surveillance authorities referred to in Article 63(5)
and (6), as applicable, can, upon request, immediately access the documentation or obtain a
copy thereof. Only staff of the market surveillance authority holding the appropriate level
of security clearance shall be allowed to access that documentation or any copy thereof.
3. Paragraphs 1, [1a] 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-border cooperation, nor the obligations of the parties concerned to provide
information under criminal law of the Member States.
4. The Commission and Member States may exchange, where necessary and in accordance
with relevant provisions of international and trade agreements, confidential information
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with regulatory authorities of third countries with which they have concluded bilateral or
multilateral confidentiality arrangements guaranteeing an adequate level of confidentiality.
Article 71
Penalties
1. In compliance with the terms and conditions laid down in this Regulation, Member States
shall lay down the rules on penalties and other enforcement measures, which may also
include warnings and non-monetary measures, applicable to infringements of this
Regulation by operators, and shall take all measures necessary to ensure that they are
properly and effectively implemented and taking into account the guidelines issued by the
Commission pursuant to Article 82b. The penalties provided for shall be effective,
proportionate, and dissuasive. They shall take into account the interests of SMEs including
start-ups and their economic viability.
2. The Member States shall without delay notify the Commission and at the latest by the date
of entry into application of those respective rules and of those respective measures and
shall notify them, without delay, of any subsequent amendment affecting them.
3. Non-compliance with the prohibition of the artificial intelligence practices referred to in
Article 5 shall be subject to administrative fines of up to 35 000 000 EUR or, if the
offender is a company, up to 7 % of its total worldwide annual turnover for the preceding
financial year, whichever is higher.
4. Non-compliance of an AI system with any of the following provisions related to operators
or notified bodies, other than those laid down in Articles 5, shall be subject to
administrative fines of up to 15 000 000 EUR or, if the offender is a company, up to 3% of
its total worldwide annual turnover for the preceding financial year, whichever is higher:
(b) obligations of providers pursuant to Article 16;
(d) obligations of authorised representatives pursuant to Article 25;
(e) obligations of importers pursuant to Article 26;
(f) obligations of distributors pursuant to Article 27;
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(g) obligations of deployers pursuant to Article 29, paragraphs 1 to 6a;
(h) requirements and obligations of notified bodies pursuant to Article 33, 34(1), 34(3),
34(4), 34a;
(i) transparency obligations for providers and users pursuant to Article 52.
5. The supply of incorrect, incomplete or misleading information to notified bodies and
national competent authorities in reply to a request shall be subject to administrative fines
of up to 7 500 000 EUR or, if the offender is a company, up to 1 % of its total worldwide
annual turnover for the preceding financial year, whichever is higher.
5a. In case of SMEs, including start-ups, each fine referred to in this Article shall be up to the
percentages or amount referred to paragraphs 3, 4 and 5, whichever of the two is lower.
6. When deciding whether to impose an administrative fine and on the amount of the
administrative fine in each individual case, all relevant circumstances of the specific
situation shall be taken into account and, as appropriate, regard shall be given to the
following:
(a) the nature, gravity and duration of the infringement and of its consequences, taking
into account the purpose of the AI system, as well as, where appropriate, the number
of affected persons and the level of damage suffered by them;
(b) whether administrative fines have been already applied by other market surveillance
authorities of one or more Member States to the same operator for the same
infringement;
(ba) whether administrative fines have been already applied by other authorities to the
same 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 the
infringement;
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(ca) any other aggravating or mitigating factor applicable to the circumstances of the
case, such as financial benefits gained, or losses avoided, directly or indirectly, from
the infringement;
(ca) the degree of cooperation with the national competent authorities, in order to remedy
the infringement and mitigate the possible adverse effects of the infringement;
(cb) the degree of responsibility of the operator taking into account the technical and
organisational measures implemented by them;
(ce) the manner in which the infringement became known to the national competent
authorities, in particular whether, and if so to what extent, the operator notified the
infringement;
(cf) the intentional or negligent character of the infringement;
(cg) any action taken by the operator to mitigate the harm of damage suffered by the
affected persons.
7. Each Member State shall lay down rules on to what extent administrative fines may be
imposed on public authorities and bodies established in that Member State.
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 or
other bodies as applicable in those Member States. The application of such rules in those
Member States shall have an equivalent effect.
8a. 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.
8b. Member States shall, on an annual basis, report to the Commission about the
administrative fines they have issued during that year, in accordance with this Article, and
any related litigation or judicial proceedings;
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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 be
taken into account and due regard shall be given to the following:
(a) the nature, gravity and duration of the infringement and of its consequences, taking
into account the purpose of the AI system concerned as well as the number of
affected persons and the level of damage suffered by them, and any relevant previous
infringement;
(aa) the degree of responsibility of the Union institution, agency or body, taking into
account technical and organisational measures implemented by them;
(ab) any action taken by the Union institution, agency or body to mitigate the damage
suffered by affected persons;
(b) the degree of 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 with regard to the same subject matter;
(c) any similar previous infringements by the Union institution, agency or body;
(ca) the manner in which the infringement became known to the European Data
Protection Supervisor, in particular whether, and if so to what extent, the Union
institution or body notified the infringement;
(cb) the annual budget of the body.
2. Non-compliance with the prohibition of the artificial intelligence practices referred to in
Article 5 shall be subject to administrative fines of up to EUR 1 500 000.
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3. Non-compliance of the AI system with any requirements or obligations under this
Regulation, other than those laid down in Articles 5, shall be subject to administrative fines
of up to EUR 750 000.
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 closely
with the proceedings.
5. The rights of defence of the parties concerned shall be fully respected in the proceedings.
They shall be entitled to have access to the European Data Protection Supervisor’s file,
subject to the legitimate interest of individuals or undertakings in the protection of their
personal data or business secrets.
6. Funds collected by imposition of fines in this Article shall contribute to the general budget
of the Union. The fines shall not affect the effective operation of the Union institution,
body or agency fined.
6a. The European Data Protection Supervisor shall, on an annual basis, notify the Commission
of the administrative fines it has imposed pursuant to this Article and any litigation or
judicial proceedings.
Article 72a
Fines for providers of general purpose AI models
1. The Commission may impose on providers of general purpose AI models fines not
exceeding 3% of its total worldwide turnover in the preceding financial year or 15
million EUR whichever is higher. Fines should be imposed one year after the entry into
application of the relevant provisions in this Regulation in order to allow providers
sufficient time to adapt when the Commission finds that the provider intentionally or
negligently:
(a) infringes the relevant provisions of this Regulation;
(b) fails to comply with a request for document or information pursuant to
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Article 68i [Power to request documentation and information], or supply
of incorrect, incomplete or misleading information;
(b) fails to comply with a measure requested under Article 68k [Power to request
measures];
(c) fails to make available to the Commission access to the general purpose AI
model or general purpose AI model with systemic risk with a view to
conduct an evaluation pursuant to Article 68j [Power to conduct
evaluations].
In fixing the amount of the fine or periodic penalty payment, regard shall be had to the
nature, gravity and duration of the infringement, taking due account of the principles of
proportionality and appropriateness. The Commission shall also into account commitments
made in accordance with Article 68k(3) or in relevant codes of practice in accordance with
Article 52e [Codes of practice].
2. Before adopting the decision pursuant to paragraph 1 of this Article, the Commission shall
communicate its preliminary findings to the provider of the general purpose AI model or
general purpose AI model with systemic risk and give opportunity to be heard.
2a. Fines imposed in accordance with this article shall be proportionate, dissuasive and
effective.
2b. The information on the fines shall be also communicated to the Board as appropriate.
3. The Court of Justice of the European Union shall have unlimited jurisdiction to review
decisions whereby the Commission has fixed a fine. It may cancel, reduce or increase the
fine imposed.
4. The Commission shall adopt implementing acts concerning the modalities and practical
arrangements for the proceedings in view of possible adoptions of decisions pursuant to
paragraph 1. Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 74(2).
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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 the
conditions laid down in this Article.
2. The power to adopt delegated acts referred to in [Article 4, Article 7(1), 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 … [the date of entry into force of the Regulation].The Commission shall
draw up a report in respect of the delegation of power not later than 9 months before the
end of the five-year period. The delegation of power shall be tacitly extended for periods of
an identical duration, unless the European Parliament or the Council opposes such
extension not later than three months before the end of each period.
3. The delegation of power referred to in {Article 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 or
by the Council. A decision of revocation shall put an end to the delegation of power
specified in that decision. It shall take effect the day following that of its publication in the
Official Journal of the European Union or at a later date specified therein. It shall not
affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the
European Parliament and to the Council.
5. Any delegated act adopted pursuant to [Article 4], Article 7(1), 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 three months of
notification of that act to the European Parliament and the Council or if, before the expiry
of that period, the European Parliament and the Council have both informed the
Commission that they will not object. That period shall be extended by three months at the
initiative of the European Parliament or of the Council.
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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 shall
apply.
TITLE XII
FINAL 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 of Regulation (EU) YYY/XX [on Artificial Intelligence] of the
European Parliament and of the Council*, 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 …).”“
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
intelligence systems which are safety components in the meaning of Regulation (EU)
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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 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*, 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 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*, when carrying out its activities pursuant to paragraph 1 and when adopting
technical specifications and testing standards in accordance with paragraphs 2 and 3, the
Commission shall take into account the requirements set out in Title III, Chapter 2 of that
Regulation.
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* Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.
__________”
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 to
paragraph 11 concerning 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*, 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 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 *, 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 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 …).”
__________”
(2) In Article 19, the following paragraph is added:
“4. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning
Artificial Intelligence systems which are safety components 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 Intelligence systems 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.”
(4) In Article 47, the following paragraph is added:
“3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning
Artificial Intelligence systems which are safety components in the meaning of
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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 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.”
(6) In Article 58, the following paragraph is added:
“3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning
Artificial Intelligence systems which are safety components 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
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*, 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 82a
Guidelines from the Commission on the implementation of this Regulation
1. The Commission shall develop guidelines on the practical implementation of this
Regulation, and in particular on:
(a) the application of the requirements and obligations referred to in Articles 8 - 15 and
Article 28;
(b) the prohibited practices referred to in Article 5;
(c) the practical implementation of the provisions related to substantial modification;
(d) the practical implementation of transparency obligations laid down in Article 52;
(e) detailed information on the relationship of this Regulation with the legislation
referred to in Annex II of this Regulation as well as other relevant Union law,
including as regards consistency in their enforcement;
(f) the application of the definition of an AI system as set out in Article 3(1).
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.
The guidelines referred to in the first subparagraph shall take due account of the generally
acknowledged state of the art on AI, as well as of relevant harmonised standards and
common specifications that are referred to in Articles 40 and 41, or of those harmonised
standards or technical specifications that are set out pursuant to Union harmonisation law.
2. Upon request of the Member States or the AI Office, or on its own initiative, the
Commission shall update already adopted guidelines when deemed necessary.
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Article 83
AI systems already placed on the market or put into service
1. Without prejudice to the application of Article 5 as referred in Article 85 (3) (-aa) 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 the market or put into service before 12
months after the date of application of this Regulation referred to in Article 85(2) shall be
brought into compliance with this Regulation by end of 2030.
The requirements laid down in this Regulation shall be taken into account 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 and whenever those legal acts are
replaced or amended.
2. Without prejudice to the application of Article 5 as referred in Article 85 (3) (-aa ) this
Regulation shall apply to operators of high-risk AI systems, other than the ones referred to
in paragraph 1, that have been placed on the market or put into service before [date of
application of this Regulation referred to in Article 85(2)], only if, from that date, those
systems are subject to significant changes in their designs. In the case of high-risk AI
systems intended to be used by public authorities, providers and deployers of such systems
shall take the necessary steps to comply with the requirements of the present Regulation
four years after the date of entry into application of this Regulation.
3. Providers of general purpose AI models that have been placed on the market before [date
of application of this Regulation referred to in point a) Article 85(3)] shall take the
necessary steps in order to comply with the obligations laid down in this Regulation by [2
years after the date of entry into application of this Regulation referred to in point a) of
85(3)].
Article 84
Evaluation and review
1. The Commission shall assess the need for amendment of the list in Annex III, the list of
prohibited AI practices in Article 5, once a year following the entry into force of this
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Regulation, and until the end of the period of the delegation of power. The Commission
shall submit the findings of that assessment to the European Parliament and the Council.
2. By two years after the date of application of this Regulation referred to in Article 85(2) and
every four years thereafter, the Commission shall evaluate and report to the European
Parliament and to the Council on the need for amendment of the following:
- the need for extension of existing area headings or addition of new area headings in
Annex III;
- the list of AI systems requiring additional transparency measures in Article 52;
- the effectiveness of the supervision and governance system.
2a. By three years after the date of application of this Regulation referred to in Article 85(3)
and every four years thereafter, the Commission shall submit a report on the evaluation and
review of this Regulation to the European Parliament and to the Council. This report shall
include an assessment with regard to the structure of enforcement and the possible need for
an Union agency to resolve any identified shortcomings. On the basis of the findings that
report shall, where appropriate, be accompanied by a proposal for amendment of this
Regulation. The reports shall be made public.
3. The reports referred to in paragraph 2 shall devote specific attention to the following:
(a) the status of the financial, technical and human resources of the national competent
authorities in order to effectively perform the tasks assigned to them 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;
(ba) adopted harmonised standards and common specifications developed to support this
Regulation;
(bb) the number of companies that enter the market after the enter into application of the
regulation and how many of them are SMEs.
3a. By ... [two years after the date of entry into application of this Regulation referred to in
Article 85(2)] the Commission shall evaluate the functioning of the AI office, whether the
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office has been given sufficient powers and competences to fulfil its tasks and whether it
would be relevant and needed for the proper implementation and enforcement of this
Regulation to upgrade the Office and its enforcement competences and to increase its
resources. The Commission shall submit this evaluation report to the European Parliament
and to the Council.
3a. By two 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 review of the
progress on the development of standardization deliverables on energy efficient
development of general-purpose models and asses the need for further measures or actions,
including binding measures or actions. The report shall be submitted to the European
Parliament and to the Council and it shall be made public.
4. Within … [two years after the date of application of this Regulation referred to in Article
85(2)] and every three years thereafter, the Commission shall evaluate the impact and
effectiveness of voluntary codes of conduct to foster the application of the requirements set
out in Title III, Chapter 2 for AI systems other than high-risk AI systems and possibly
other additional requirements for AI systems other than high-risk AI systems, including as
regards environmental sustainability.
5. For the purpose of paragraphs 1 to 4 the Board, the Member States and national competent
authorities shall provide the Commission with information on its request, without undue
delay.
6. In carrying out the evaluations and reviews referred to in paragraphs 1 to 4 the
Commission shall take into account the positions and findings of the Board, of the
European Parliament, of the Council, and of other relevant bodies or sources.
7. The Commission shall, if necessary, submit appropriate proposals to amend this
Regulation, in particular taking into account developments in technology, the effect of AI
systems on health and safety, fundamental rights and in the light of the state of progress in
the information society.
7a. To guide the evaluations and reviews referred to in paragraphs 1 to 4 of this Article, the
Office shall undertake to develop an objective and participative methodology for the
evaluation of risk level based on the criteria outlined in the relevant articles and inclusion
of new systems in: the list in Annex III, including the extension of existing area headings
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or addition of new area headings in that Annex; the list of prohibited practices laid down in
Article 5; and the list of AI systems requiring additional transparency measures pursuant to
Article 52.
7b. Any amendment to this Regulation pursuant to paragraph 7 of this Article, or relevant
future delegated or implementing acts, which concern sectoral legislation listed in Annex II
Section B, shall take into account the regulatory specificities of each sector, and existing
governance, conformity assessment and enforcement mechanisms and authorities
established therein.
7c. By … [five years from the date of application of this Regulation], the Commission shall
carry out an assessment of the enforcement of this Regulation and shall report it to the
European Parliament, the Council and the European Economic and Social Committee,
taking into account the first years of application of the Regulation. On the basis of the
findings that report shall, where appropriate, be accompanied by a proposal for amendment
of this Regulation with regard to the structure of enforcement and the need for an Union
agency to resolve any identified shortcomings.
Article 85
Entry into force and application
1. This Regulation shall enter into force on the twentieth day following that of its publication
in the Official Journal of the European Union.
2. This Regulation shall apply from [24 months following the entering into force of the
Regulation]. With regard to the obligation referred to in Article 53(1), this obligation shall
include either that at least one regulatory sandbox per Member State shall be operational
on this day or that the Member State participates in the sandbox of another Member State *
3. By way of derogation from paragraph 2:
(-a) Title I and II [Prohibitions] shall apply from [six months following the entry
into force of this Regulation];
(a) Title III Chapter 4, Title VI, Title VIIIa [GPAI], Title X [Penalties] shall
apply from [twelve months following the entry into force of this
Regulation];
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(b) Article 6(1) and the corresponding obligations in this Regulation shall apply
from [36 months following the entry into force of this Regulation].
Codes of practices shall be ready at the latest nine months after the entry into force of this
Regulation. The AI Office shall take the necessary steps, including inviting providers
pursuant to Article 52e paragraph 5.
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 II
List of Union harmonisation legislation
Part I
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 and
protective 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 the
market 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 the
market 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 and
Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and
93/42/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).
Part II
Section B. List of other Union harmonisation legislation
13. 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).
14. 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 and
quadricycles (OJ L 60, 2.3.2013, p. 52);
15. 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);
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16. Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on
marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p.
146);
17. Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016
on the interoperability of the rail system within the European Union (OJ L 138, 26.5.2016,
p. 44).
18. Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018
on the approval and market surveillance of motor vehicles and their trailers, and of
systems, components and separate technical units intended for such vehicles, amending
Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC
(OJ L 151, 14.6.2018, p. 1);
18a. 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, and
systems, components and separate technical units intended for such vehicles, as regards
their general safety and the protection of vehicle occupants and vulnerable road users,
amending Regulation (EU) 2018/858 of the European Parliament and of the Council and
repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the
European Parliament and of the Council and Commission Regulations (EC) No 631/2009,
(EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No
1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011,
(EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No
1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1);
19. 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), in so far as the design, production and
placing on the market of aircrafts referred to in points (a) and (b) of Article 2(1) thereof,
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where it concerns unmanned aircraft and their engines, propellers, parts and equipment to
control them remotely, are concerned.
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ANNEX IIa
List of criminal offences referred to in Article 5 (1)(iii)
- terrorism;
- trafficking in human beings;
- sexual exploitation of children and child pornography;
- illicit trafficking in narcotic drugs and psychotropic substances;
- illicit trafficking in weapons, munitions and explosives;
- murder, grievous bodily injury;
- illicit trade in human organs and tissue;
- illicit trafficking in nuclear or radioactive materials;
- kidnapping, illegal restraint and hostage-taking;
- crimes within the jurisdiction of the International Criminal Court;
- unlawful seizure of aircraft/ships;
- rape;
- environmental crime;
- organised or armed robbery;
- sabotage;
- participation in a criminal organisation involved in one or more offences listed above.
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ANNEX III
High-risk AI systems referred to in article 6(2)
High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the
following areas:
1. Biometrics, insofar as their use is permitted under relevant Union or national law:
(a) Remote biometric identification systems.
This shall not include AI systems intended to be used for biometric verification
whose sole purpose is to confirm that a specific natural person is the person he or she
claims to be;
(aa) AI systems intended to be used for biometric categorisation, according to sensitive or
protected attributes or characteristics based on the inference of those attributes or
characteristics;
(ab) AI systems intended to be used for emotion recognition.
2. Critical infrastructure:
(a) AI systems intended to be used as safety components in the management and
operation 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 or admission or to assign natural
persons to educational and vocational training institutions at all levels;
(b) AI systems intended to be used to evaluate learning outcomes, including when those
outcomes are used to steer the learning process of natural persons in educational and
vocational training institutions at all levels;
(ba) AI systems intended to be used for the purpose of assessing the appropriate level of
education that individual will receive or will be able to access, in the context
of/within education and vocational training institution;
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(bb) AI systems intended to be used for monitoring and detecting prohibited behaviour of
students during tests in the context of/within education and vocational training
institutions.
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;
(b) AI intended to be used to make decisions affecting terms of the work related
relationships, promotion and termination of work-related contractual relationships, to
allocate tasks based on individual behaviour or personal traits or characteristics and
to monitor and evaluate performance and behaviour of persons in such relationships.
5. Access to and enjoyment of essential private services and essential public services and
benefits:
(a) AI systems intended to be used by public authorities or on behalf of public
authorities to evaluate the eligibility of natural persons for essential public assistance
benefits and services, including healthcare services, as well as to grant, reduce,
revoke, or reclaim such benefits and services;
(b) AI systems intended to be used to evaluate the creditworthiness of natural persons or
establish their credit score, with the exception of AI systems used for the purpose of
detecting financial fraud;
(c) AI systems intended to evaluate and classify emergency calls by natural persons or to
be used to dispatch, or to establish priority in the dispatching of emergency first
response services, including by police, firefighters and medical aid, as well as of
emergency healthcare patient triage systems;
(ca) AI systems intended to be used for risk assessment and pricing in relation to natural
persons in the case of life and health insurance.
6. Law enforcement, insofar as their use is permitted under relevant Union or national law:
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(a) AI systems intended to be used by or on behalf of law enforcement authorities, or by
Union institutions, agencies, offices or bodies in support of law enforcement
authorities or on their behalf to assess the risk of a natural person to become a victim
of criminal offences;
(b) AI systems intended to be used by or on behalf of law enforcement authorities or by
Union institutions, bodies and agencies in support of Law enforcement authorities as
polygraphs and similar tools;
(d) AI systems intended to be used by or on behalf of law enforcement authorities, or by
Union institutions, agencies, offices or bodies in support of law enforcement
authorities to evaluate 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 or
by Union institutions, agencies, offices or bodies in support of law enforcement
authorities for assessing the risk of a natural person of offending or re-offending not
solely 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
behaviour of natural persons or groups;
(f) AI systems intended to be used by or on behalf of law enforcement authorities or by
Union agencies institutions, agencies, offices or bodies in support of law
enforcement authorities for profiling of 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.
7. Migration, asylum and border control management, insofar as their use is permitted under
relevant Union or national law:
(a) AI systems intended to be used by competent public authorities as polygraphs and
similar tools;
(b) AI systems intended to be used by or on behalf of competent public authorities or by
Union agencies, offices or bodies to assess a risk, including a security risk, a risk of
irregular migration, or a health risk, posed by a natural person who intends to enter or
has entered into the territory of a Member State;
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(d) AI systems intended to be used by or on behalf of competent public authorities or by
Union agencies, offices or bodies to assist competent public authorities for the
examination of applications for asylum, visa and residence permits and associated
complaints with regard to the eligibility of the natural persons applying for a status,
including related assessment of the reliability of evidence;
(da) AI systems intended to be used by or on behalf of competent public authorities,
including Union agencies, offices or bodies, in the context of migration, asylum and
border control management, for the purpose of detecting, recognising or identifying
natural persons with the exception of verification of travel documents.
8. Administration of justice and democratic processes:
(a) AI systems intended to be used by a judicial authority or on their behalf to assist a
judicial authority in researching and interpreting facts and the law and in applying
the law to a concrete set of facts or used in a similar way in alternative dispute
resolution;
(aa) AI systems intended to be used for influencing the outcome of an election or
referendum or the voting behaviour of natural persons in the exercise of their vote in
elections or referenda. This does not include AI systems whose output natural
persons are not directly exposed to, such as tools used to organise, optimise and
structure political campaigns from an administrative and logistic point of view.
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ANNEX IV
Technical documentation referred to in article 11(1)
The technical documentation referred to in Article 11(1) shall contain at least the following
information, as applicable to the relevant AI system:
1. A general description of the AI system including:
(a) its intended purpose, the name of the provider and the version of the system
reflecting its relation to previous versions;
(b) how the AI system interacts or can be used to interact with hardware or software,
including other AI systems, that are 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, API
etc.);
(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;
(fa) a basic description of the user-interface provided to the deployer;
(g) instructions of use for the deployer and a basic description of the user-interface
provided to the deployer where applicable.
2. A detailed description of the elements of the AI system and of the process for its
development, including:
(a) the methods and steps performed for the development of the AI system, including,
where relevant, recourse to pre-trained systems or tools provided by third parties and
how these have been used, integrated or modified by the provider;
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(b) the design specifications of the system, namely the general logic of the AI system
and 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 is
intended 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 and output quality of the system; the decisions about any possible
trade-off made regarding the technical solutions adopted to comply with the
requirements set out in Title 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 general
description of these data sets, information about their provenance, scope and main
characteristics; how the data was obtained and selected; labelling procedures (e.g. for
supervised 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 the
interpretation of the outputs of AI systems by the deployers, 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 technical
solutions adopted to ensure continuous compliance of the AI system with the
relevant requirements set out in Title III, Chapter 2;
(g) the validation and testing procedures used, including information about the validation
and testing data used and their main characteristics; metrics used to measure
accuracy, robustness 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 with regard to pre-
determined changes as referred to under point (f);
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(ga) cybersecurity measures put in place.
3. Detailed information about the monitoring, functioning and control of the AI system, in
particular with regard to: its capabilities and limitations in performance, including the
degrees of accuracy for specific persons or groups of persons on which the system is
intended 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 the
technical measures put in place to facilitate the interpretation of the outputs of AI systems
by the deployers; specifications on input data, as appropriate;
3. A description of the appropriateness of the performance metrics for the specific AI system;
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 have
been 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 the
requirements set out in Title III, Chapter 2, including a list of other relevant standards and
technical 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 monitoring
plan referred to in Article 61(3).
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ANNEX V
EU declaration of conformity
The 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 of
the 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;
4a. Where an AI system involves the processing of personal data, a statement that that AI
system complies with Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU)
2016/680;
5. References to any relevant harmonised standards used or any other common specification
in relation to which conformity is declared;
6. Where applicable, the name and identification number of the notified body, a description
of 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 as
well 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 with
the 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 technical
documentation.
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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 the
technical documentation is the conformity assessment procedure based on points 2 to 5.
2. Overview
The approved quality management system for the design, development and testing of AI
systems pursuant to Article 17 shall be examined in accordance with point 3 and shall be
subject to surveillance as specified in point 5. The technical documentation of the AI system
shall be examined in accordance with point 4.
3. Quality management system
3.1. The application of the provider shall include:
(a) the name and address of the provider and, if the application is lodged by the
authorised 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
the aspects listed under Article 17;
(e) a description of the procedures in place to ensure that the quality management system
remains adequate and effective;
(f) a written declaration that the same application has not been lodged with any other
notified body.
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3.2. The quality management system shall be assessed by the notified body, which shall
determine 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 and
maintained 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 to
in point 3.2 or whether a reassessment is necessary.
The notified body shall notify the provider of its decision. The notification shall contain
the 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 technical
documentation 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 to
under point 3.
4.2. The application shall include:
(a) the name and address of the provider;
(b) a written declaration that the same application has not been lodged with any other
notified body;
(c) the technical documentation referred to in Annex IV.
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4.3. The technical documentation shall be examined by the notified body. Where relevant and
limited to what is necessary to fulfil their tasks, the notified body shall be granted full
access 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 of
conformity 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, the
notified body shall directly carry out adequate tests, as appropriate.
4.5. Where necessary to assess the conformity of the high-risk AI system with the requirements
set out in Title III, Chapter 2, after all other reasonable ways to verify conformity have
been exhausted and have proven to be insufficient, and upon a reasoned request, the
notified body shall also be granted access to the training and trained models of the AI
system, including its relevant parameters. Such access shall be subject to existing Union
law on the protection of intellectual property and trade secrets.
4.6. The decision shall be notified to the provider or its authorised representative. The
notification shall contain the conclusions of the assessment of the technical documentation
and 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 the
examination, the conditions (if any) for its validity and the data necessary for the
identification of the AI system.
The certificate and its annexes shall contain all relevant information to allow the
conformity 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
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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, re-
training of the AI system will be needed prior to the application for a new conformity
assessment. In this case, the reasoned assessment decision of the notified body refusing to
issue the EU technical documentation assessment certificate shall contain specific
considerations on the quality data used to train the AI system, notably on the reasons for
non-compliance.
4.7. Any change to the AI system that could affect the compliance of the AI system with the
requirements 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 shall
be 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 provider
of 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 to
make 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 high-risk AI systems in accordance with
Article 51
SECTION A - Information to be submitted by providers of high-risk AI systems in
accordance with Article 51(1)
The following information shall be provided and thereafter kept up to date with regard to
high-risk AI systems to be registered in accordance with Article 51(1):
1. Name, address and contact details of the provider;
2. Where submission of information is carried out by another person on behalf of the
provider, the name, address and contact details of that person;
3. Name, address and contact details of the authorised representative, where applicable;
4. AI system trade name and any additional unambiguous reference allowing identification
and traceability of the AI system;
5. Description of the intended purpose of the AI system and of the components and functions
supported through this AI system;
5a. A basic and concise description of the information used by the system (data, inputs) and its
operating logic;
6. Status of the AI system (on the market, or in service; no longer placed on the market/in
service, recalled);
7. Type, number and expiry date of the certificate issued by the notified body and the name or
identification number of that notified body, when applicable;
8. A scanned copy of the certificate referred to in point 7, when applicable;
9. Member States in which the AI system is or has been placed on the market, put into service
or made available in the Union;
10. A copy of the EU declaration of conformity referred to in Article 48;
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11. Electronic instructions for use; this information shall not be provided for high-risk AI
systems in the areas of law enforcement and migration, asylum and border control
management referred to in Annex III, points 1, 6 and 7.
12. URL for additional information (optional).
SECTION B - Information to be submitted by deployers of high-risk AI systems in
accordance with Article 51(1b)
The following information shall be provided and thereafter kept up to date with regard to
high-risk AI systems to be registered in accordance with Article 51:
1. The name, address and contact details of the deployer;
2. The name, address and contact details of the person submitting information on behalf of
the deployer;
5. A summary of the findings of the fundamental rights impact assessment conducted in
accordance with Article 29a;
6. The URL of the entry of the AI system in the EU database by its provider;
7. A summary of the data protection impact assessment carried out in accordance with Article
35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680 as specified in
paragraph 6 of Article 29 of this Regulation, where applicable.
SECTION C - Information to be submitted by providers of high-risk AI systems in
accordance with Article 51(1a)
The following information shall be provided and thereafter kept up to date with regard to AI
systems to be registered in accordance with Article 51(1a).
1. Name, address and contact details of the provider;
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1. Where submission of information is carried out by another person on behalf of the
provider, the name, address and contact details of that person;
2. Name, address and contact details of the authorised representative, where applicable;
3. AI system trade name and any additional unambiguous reference allowing identification
and traceability of the AI system;
4. Description of the intended purpose of the AI system;
5. Based on which criterion or criteria provided in Article 6(2a) the AI system is considered
as not high-risk;
6. Short summary of the grounds for considering the AI system as not high-risk in application
of the procedure under Article 6(2a);
7. Status of the AI system (on the market, or in service; no longer placed on the market/in
service, recalled); Member States in which the AI system is or has been placed on the
market, put into service or made available in the Union.
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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 conditions in accordance with Article 54a
The following information shall be provided and thereafter kept up to date with regard to
testing in real 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
testing in real world conditions;
3. A brief description of the AI system, its intended purpose and other information necessary
for the identification of the system;
4. A summary of the main characteristics of the plan for testing in real world conditions;
5. Information on the suspension or termination of the testing in real world conditions.
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ANNEX IX
Union 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 of
illegally staying third-country nationals (OJ L 312, 7.12.2018, p. 1).
(b) Regulation (EU) 2018/1861 of the European Parliament and of the 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 and
Commission 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 the
Regulation is adopted (April/May 2021) by the co-legislators.
3. Eurodac
(a) Amended proposal for a REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL on the establishment of 'Eurodac' for the comparison of
biometric data for the effective application of Regulation (EU) XXX/XXX
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[Regulation on Asylum and Migration Management] and of Regulation (EU)
XXX/XXX [Resettlement Regulation], for identifying an illegally staying third-
country 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 borders
of 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 establishing
a European Travel Information and Authorisation System (ETIAS) (OJ L 236,
19.9.2018, p. 72).
6. European Criminal Records Information System on third-country nationals and stateless
persons
(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).
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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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ANNEX IXa
Technical documentation referred to in Article 52c(1a): technical documentation for
providers of general purpose AI models:
Section 1: Information to be provided by all providers of general-purpose AI
models
The technical documentation referred to in Article X (b) shall contain at least the following
information as appropriate to the size and risk profile of the model:
1. A general description of the general purpose AI model including:
(a) the tasks that the model is intended to perform and the type and nature of AI systems
in which it can be integrated;
(b) acceptable use policies applicable;
(c) the date of release and methods of distribution;
(d) the architecture and number of parameters;
(e) modality (e.g. text, image) and format of inputs and outputs;
(f) the license.
2. A detailed description of the elements of the model referred to in paragraph 1, and
relevant information of the process for the development, including the
following elements:
(a) the technical means (e.g. instructions of use, infrastructure, tools) required for the
general-purpose AI model to be integrated in AI systems;
(b) the design specifications of the model and training process, including training
methodologies and techniques, the key design choices including the rationale and
assumptions made; what the model is designed to optimise for and the relevance of
the different parameters, as applicable;
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(c) information on the data used for training, testing and validation, where applicable,
including type and provenance of data and curation methodologies (e.g. cleaning,
filtering etc), the number of data points, their scope and main characteristics; how the
data was obtained and selected as well as all other measures to detect the
unsuitability of data sources and methods to detect identifiable biases, where
applicable;
(d) the computational resources used to train the model (e.g. number of floating point
operations – FLOPs), training time, and other relevant details related to the training;
(e) known or estimated energy consumption of the model; in case not known, this could
be based on information about computational resources used ;
Section 2: Additional information to be provided by providers of general purpose
AI model with systemic risk
3. Detailed description of the evaluation strategies, including evaluation results, on the
basis of available public evaluation protocols and tools or otherwise of other
evaluation methodologies. Evaluation strategies shall include evaluation criteria,
metrics and the methodology on the identification of limitations.
4. Where applicable, detailed description of the measures put in place for the purpose of
conducting internal and/or external adversarial testing (e.g. red teaming), model
adaptations, including alignment and fine-tuning.
5. Where applicable, detailed description of the system architecture explaining how
software components build or feed into each other and integrate into the overall
processing.
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ANNEX IXb
Transparency information referred to in Article 52c(1b): technical documentation for
providers of general purpose AI models to downstream providers that integrate the model
into their AI system
The information referred to in Article 52c shall contain at least the following:
1. A general description of the general purpose AI model including:
(a) the tasks that the model is intended to perform and the type and nature of AI systems
in which it can be integrated;
(b) acceptable use policies applicable;
(c) the date of release and methods of distribution;
(d) how the model interacts or can be used to interact with hardware or software that is
not part of the model itself, where applicable;
(e) the versions of relevant software related to the use of the general purpose AI model,
where applicable;
(f) architecture and number of parameters,
(g) modality (e.g., text, image) and format of inputs and outputs;
(h) the license for the model.
2. A description of the elements of the model and of the process for its development,
including:
(a) the technical means (e.g. instructions of use, infrastructure, tools) required for the
general-purpose AI model to be integrated in AI systems;
(b) modality (e.g., text, image, etc.) and format of the inputs and outputs and their
maximum size (e.g., context window length, etc.);
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(c) information on the data used for training, testing and validation, where applicable,
including, type and provenance of data and curation methodologies.
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ANNEX IXc
Criteria for the designation of general purpose AI models with systemic risk referred to in
article 52a
For the purpose of determining that a general purpose AI model has capabilities or impact
equivalent to those of points (a) and (b) in Article 52a, the Commission shall take into account the
following criteria:
(a) number of parameters of the model;
(b) quality or size of the data set, for example measured through tokens;
(c) the amount of compute used for training the model, measured in FLOPs or indicated
by a combination of other variables such as estimated cost of training, estimated time
required for the training, or estimated energy consumption for the training;
(d) input and output modalities of the model, such as text to text (large language
models), text to image, multi-modality, and the state-of-the-art thresholds for
determining high-impact capabilities for each modality, and the specific type of
inputs and outputs (e.g. biological sequences);
(e) benchmarks and evaluations of capabilities of the model, including considering the
number of tasks without additional training, adaptability to learn new, distinct tasks,
its degree of autonomy and scalability, the tools it has access to;
(f) it has a high impact on the internal market due to its reach, which shall be presumed
when it has been made available to at least 10 000 registered business users
established in the Union;
(g) number of registered end-users.


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digmin@digmin.dk
Orientering om aftale om forordning om kunstig intelligens
Det er med stor glæde, at jeg kan meddele, at trilogaftalen med Europa Parlamentet om for-
ordningen om kunstig intelligens blev enstemmigt godkendt af medlemslandenes ambassadø-
rer den 2. februar 2024.
Vedlagt til dette brev finder I den endelige tekst, som nu også er offentliggjort. Det forventes,
at Europa Parlamentet ligeledes vil godkende teksten på deres plenarforsamling i løbet af for-
året.
Der har været tale om lange og komplekse forhandlinger, og der er sket en række væsentlige
ændringer i teksten ift. Kommissionens oprindelige forslag. Jeg vil særligt fremhæve følgende:
- Definitionen af kunstig intelligens er blevet klarlagt og indsnævret
- Høj-risiko anvendelserne er blevet klarlagt og indsnævret
- Der kommet krav til kunstig intelligens modeller til generelle formål, herunder ift.
transparens om det ophavsretsbeskyttede materiale de anvender
- Kommissionen har fået til opgave at håndhæve forordningens bestemmelser om kun-
stig intelligens modeller til generelle formål.
Jeg er meget tilfreds med resultatet, som tydeligt reflekterer den risikobaserede tilgang, som
regeringen har lagt vægt på i forhandlingerne i overensstemmelse med forhandlingsoplægget
der blev forelagt Folketingets Europaudvalg i juni 2022. Med aftalen har vi verdens første ram-
mer for kunstig intelligens, og sikret et indre marked, hvor innovationen inden for sikker og
ansvarlig kunstig intelligens kan blomstre. Samtidig adresseres de risici, der er ved bestemte
anvendelser af teknologien, så borgerne kan føles sig trygge ved, at deres grundlæggende ret-
tigheder er beskyttet.
Jeg står til rådighed for en drøftelse med udvalgene, hvis dette måtte ønskes.
Med venlig hilsen
Marie Bjerre
Bilag:
Bilag 1 - Aftaletekst om AI Act (2024)
Sagsnr.
2024 - 468
Doknr.
64993
Dato
09-02-2024
Folketingets Udvalg for Digitalisering og It
Folketingets Europaudvalg
Offentligt
KOM (2021) 0206 - Bilag 8
Europaudvalget 2021