AIAct Final Four-Column21012024

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
2021/0106(COD)
DRAFT [Final draft as updated on 21/01]
21-01-2024 at 17h11
Commission Proposal EP Mandate Council Mandate Draft Agreement

Formula
2021/0106 (COD) 2021/0106 (COD) 2021/0106 (COD) 2021/0106 (COD)

G 1 Text Origin: Commission
G
Proposal
Proposal Title
Proposal for a Proposal for a Proposal for a Proposal for a

REGULATION OF THE REGULATION OF THE REGULATION OF THE REGULATION OF THE
EUROPEAN PARLIAMENT AND EUROPEAN PARLIAMENT AND EUROPEAN PARLIAMENT AND EUROPEAN PARLIAMENT AND
OF THE COUNCIL OF THE COUNCIL OF THE COUNCIL OF THE COUNCIL
LAYING DOWN HARMONISED LAYING DOWN HARMONISED LAYING DOWN HARMONISED LAYING DOWN HARMONISED
RULES ON ARTIFICIAL RULES ON ARTIFICIAL RULES ON ARTIFICIAL RULES ON ARTIFICIAL
G 2 INTELLIGENCE (ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE (ARTIFICIAL
G
INTELLIGENCE ACT) AND INTELLIGENCE ACT) AND INTELLIGENCE ACT) AND INTELLIGENCE ACT) AND
AMENDING CERTAIN UNION AMENDING CERTAIN UNION AMENDING CERTAIN UNION AMENDING CERTAIN UNION
LEGISLATIVE ACTS LEGISLATIVE ACTS LEGISLATIVE ACTS LEGISLATIVE ACTS
Text Origin: Commission
Proposal
Formula
G 3 G
THE EUROPEAN PARLIAMENT THE EUROPEAN PARLIAMENT THE EUROPEAN PARLIAMENT THE EUROPEAN PARLIAMENT
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 2021/0106(COD) 21-01-2024 at 17h11 1/892
AND THE COUNCIL OF THE AND THE COUNCIL OF THE AND THE COUNCIL OF THE AND THE COUNCIL OF THE
EUROPEAN UNION, EUROPEAN UNION, EUROPEAN UNION, EUROPEAN UNION,
Proposal
Citation 1
Having regard to the Treaty on the Having regard to the Treaty on the Having regard to the Treaty on the Having regard to the Treaty on the
Functioning of the European Union, Functioning of the European Union, Functioning of the European Union, Functioning of the European Union,
and in particular Articles 16 and 114 and in particular Articles 16 and 114 and in particular Articles 16 and 114 and in particular Articles 16 and 114
G 4 thereof, thereof, thereof, thereof,
G

Proposal
Citation 2
Having regard to the proposal from Having regard to the proposal from Having regard to the proposal from Having regard to the proposal from
the European Commission, the European Commission, the European Commission, the European Commission,
G 5 G

Proposal
Citation 3
After transmission of the draft After transmission of the draft After transmission of the draft After transmission of the draft
legislative act to the national legislative act to the national legislative act to the national legislative act to the national
G 6 parliaments, parliaments, parliaments, parliaments, G

Proposal
Citation 4
G 7 G
Having regard to the opinion of the Having regard to the opinion of the Having regard to the opinion of the Having regard to the opinion of the
European Economic and Social European Economic and Social European Economic and Social European Economic and Social
Committee1, Committee1, Committee1, Committee1,
_________ _________ _________ _________
1. OJ C […], […], p. […]. 1. OJ C […], […], p. […]. 1. OJ C […], […], p. […]. 1. OJ C […], […], p. […].

Proposal
Citation 4a
Having regard to the opinion of the Having regard to the opinion of the
European Central Bank, European Central Bank1,
G 7a _________ G
1. Reference to ECB opinion
Text Origin: EP Mandate
Citation 4b
Having regard to the joint opinion Having regard to the joint opinion
of the European Data Protection of the European Data Protection
G 7b Board and the European Data Board and the European Data G
Protection Supervisor, Protection Supervisor,

Citation 5
Having regard to the opinion of the Having regard to the opinion of the Having regard to the opinion of the Having regard to the opinion of the
Committee of the Regions1, Committee of the Regions1, Committee of the Regions1, Committee of the Regions1,
G 8 _________ _________ _________ _________ G
1. OJ C […], […], p. […]. 1. OJ C […], […], p. […]. 1. OJ C […], […], p. […]. 1. OJ C […], […], p. […].

Proposal
Citation 5a
5a Having regard to the opinion of

G 8a the European Central Bank1, G
_________
1. Reference to ECB opinion
Citation 6
Acting in accordance with the Acting in accordance with the Acting in accordance with the Acting in accordance with the
ordinary legislative procedure, ordinary legislative procedure, ordinary legislative procedure, ordinary legislative procedure,
G 9 G

Proposal
Formula
Whereas: Whereas: Whereas: Whereas:

G
Proposal
Recital 1
(1) The purpose of this Regulation (1) The purpose of this Regulation (1) The purpose of this Regulation (1) The purpose of this Regulation
is to improve the functioning of the is to improve the functioning of the is to improve the functioning of the is to improve the functioning of the
internal market by laying down a internal market by laying down a internal market by laying down a internal market by laying down a
uniform legal framework in uniform legal framework in uniform legal framework in uniform legal framework in
G 11 G
particular for the development, particular for the development, particular for the development, particular for the development,
marketing and use of artificial marketing and usepromote the marketing and use of artificial marketing and placing on the
intelligence in conformity with uptake of human centric and intelligence in conformity with market, putting into service and the
Union values. This Regulation trustworthy artificial intelligence Union values. This Regulation use of artificial intelligence systems
pursues a number of overriding and to ensure a high level of pursues a number of overriding in the Union in conformity with
reasons of public interest, such as a protection of health, safety, reasons of public interest, such as a Union values. This Regulation
high level of protection of health, fundamental rights, democracy and high level of protection of health, pursues a number of overriding
safety and fundamental rights, and it rule of law and the environment safety and fundamental rights, and it reasons of public interest, such as,
ensures the free movement of AI- from harmful effects of artificial ensures the free movement of AI- to promote the uptake of human
based goods and services cross- intelligence systems in the Union based goods and services cross- centric and trustworthy artificial
border, thus preventing Member while supporting innovation and border, thus preventing Member intelligence while ensuring a high
States from imposing restrictions on improving the functioning of the States from imposing restrictions on level of protection of health, safety
the development, marketing and use internal marketin conformity with the development, marketing and use and, fundamental rights enshrined
of AI systems, unless explicitly Union values. This Regulation of AI systems, unless explicitly in the Charter, including
authorised by this Regulation. pursues a number of overriding authorised by this Regulation. democracy and rule of law and
reasons of public interest, such as a environmental protection, against
high level of protection of health, harmful effects of artificial
safety and fundamental rights, and it intelligence systems in the Union
lays down a uniform legal and to support innovation. This
framework in particular for the regulation and it ensures the free
development, the placing on the movement of AI-based goods and
market, the putting into service and services cross-border, thus
the use of artificial intelligence in preventing Member States from
conformity with Union values and imposing restrictions on the
ensures the free movement of AI- development, marketing and use of
based goods and services cross- Artificial Intelligence systems (AI
border, thus preventing Member systems), unless explicitly
States from imposing restrictions on authorised by this Regulation.
the development, marketing and use
of Artificial Intelligence systems
(AI systems), unless explicitly
authorised by this Regulation.
Certain AI systems can also have
an impact on democracy and rule of
law and the environment. These
concerns are specifically addressed
in the critical sectors and use cases
listed in the annexes to this
Regulation.
Recital 1a
(1a) This Regulation should (1a) This Regulation should be

preserve the values of the Union applied in conformity with the
facilitating the distribution of values of the Union enshrined in
artificial intelligence benefits the Charter facilitating the
across society, protecting protection of individuals,
G 11a individuals, companies, democracy companies, democracy and rule of G
and rule of law and the law and the environment while
environment from risks while boosting innovation and
boosting innovation and employment and making the Union
employment and making the Union a leader in the uptake of
a leader in the field trustworthy AI.
Recital 2
(2) Artificial intelligence systems (2) Artificial intelligence systems (2) Artificial intelligence systems (2) Artificial intelligence systems
(AI systems) can be easily deployed (AI systems) can be easily deployed (AI systems) can be easily deployed (AI systems) can be easily deployed
in multiple sectors of the economy in multiple sectors of the economy in multiple sectors of the economy in multiple sectors of the economy
and society, including cross border, and society, including cross border, and society, including cross border, and society, including cross border,
and circulate throughout the Union. and circulate throughout the Union. and circulate throughout the Union. and circulate throughout the Union.
Certain Member States have already Certain Member States have already Certain Member States have already Certain Member States have already
explored the adoption of national explored the adoption of national explored the adoption of national explored the adoption of national
rules to ensure that artificial rules to ensure that artificial rules to ensure that artificial rules to ensure that artificial
intelligence is safe and is developed intelligence is trustworthy and safe intelligence is safe and is developed intelligence is trustworthy and safe
and used in compliance with and is developed and used in and used in compliance with and is developed and used in
G 12 G
fundamental rights obligations. compliance with fundamental rights fundamental rights obligations. compliance with fundamental rights
Differing national rules may lead to obligations. Differing national rules Differing national rules may lead to obligations. Differing national rules
fragmentation of the internal market may lead to fragmentation of the fragmentation of the internal market may lead to fragmentation of the
and decrease legal certainty for internal market and decrease legal and decrease legal certainty for internal market and decrease legal
operators that develop or use AI certainty for operators that develop operators that develop, import or use certainty for operators that develop,
systems. A consistent and high level or use AI systems. A consistent and AI systems. A consistent and high import or use AI systems. A
of protection throughout the Union high level of protection throughout level of protection throughout the consistent and high level of
should therefore be ensured, while the Union should therefore be Union should therefore be ensured, protection throughout the Union
divergences hampering the free ensured in order to achieve while divergences hampering the should therefore be ensured in order
circulation of AI systems and related trustworthy AI, while divergences free circulation of AI systems and to achieve trustworthy AI, while
products and services within the hampering the free circulation, related products and services within divergences hampering the free
internal market should be prevented, innovation, deployment and uptake the internal market should be circulation, innovation, deployment
by laying down uniform obligations of AI systems and related products prevented, by laying down uniform and uptake of AI systems and
for operators and guaranteeing the and services within the internal obligations for operators and related products and services within
uniform protection of overriding market should be prevented, by guaranteeing the uniform protection the internal market should be
reasons of public interest and of laying down uniform obligations for of overriding reasons of public prevented, by laying down uniform
rights of persons throughout the operators and guaranteeing the interest and of rights of persons obligations for operators and
internal market based on Article 114 uniform protection of overriding throughout the internal market based guaranteeing the uniform protection
of the Treaty on the Functioning of reasons of public interest and of on Article 114 of the Treaty on the of overriding reasons of public
the European Union (TFEU). To the rights of persons throughout the Functioning of the European Union interest and of rights of persons
extent that this Regulation contains internal market based on Article 114 (TFEU). To the extent that this throughout the internal market based
specific rules on the protection of of the Treaty on the Functioning of Regulation contains specific rules on on Article 114 of the Treaty on the
individuals with regard to the the European Union (TFEU). To the the protection of individuals with Functioning of the European Union
processing of personal data extent that this Regulation contains regard to the processing of personal (TFEU). To the extent that this
concerning restrictions of the use of specific rules on the protection of data concerning restrictions of the Regulation contains specific rules on
AI systems for ‘real-time’ remote individuals with regard to the use of AI systems for ‘real-time’ the protection of individuals with
biometric identification in publicly processing of personal data remote biometric identification in regard to the processing of personal
accessible spaces for the purpose of concerning restrictions of the use of publicly accessible spaces for the data concerning restrictions of the
law enforcement, it is appropriate to AI systems for ‘real-time’ remote purpose of law enforcement, it is use of AI systems for ‘real-time’
base this Regulation, in as far as biometric identification in publicly appropriate to base this Regulation, remote biometric identification in
those specific rules are concerned, accessible spaces for the purpose of in as far as those specific rules are publicly accessible spacesfor the
on Article 16 of the TFEU. In light law enforcement, it is appropriate to concerned, on Article 16 of the purpose of law enforcement, for the
of those specific rules and the base this Regulation, in as far as TFEU. In light of those specific use of AI systems for risk
recourse to Article 16 TFEU, it is those specific rules are concerned, rules and the recourse to Article 16 assessments of natural persons for
appropriate to consult the European on Article 16 of the TFEU. In light TFEU, it is appropriate to consult the purpose of law enforcement and
Data Protection Board. of those specific rules and the the European Data Protection Board. for the use of AI systems of
recourse to Article 16 TFEU, it is biometric categorization for the
appropriate to consult the European purpose of law enforcement, it is
Data Protection Board. appropriate to base this Regulation,
in as far as those specific rules are
concerned, on Article 16 of the
TFEU. In light of those specific
rules and the recourse to Article 16
TFEU, it is appropriate to consult
the European Data Protection Board.
Recital 2a
(2a) As artificial intelligence often

relies on the processing of large
volumes of data, and many AI
systems and applications on the
processing of personal data, it is
appropriate to base this Regulation
on Article 16 TFEU, which
G 12a G
enshrines the right to the protection
of natural persons with regard to
the processing of personal data and
provides for the adoption of rules
on the protection of individuals
with regard to the processing of
personal data.
Recital 2b
(2b) 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
G 12b communications, including G
providing conditions for any

personal and non-personal data
storing in and access from terminal
equipment. Those legal acts provide
the basis for sustainable and
responsible data processing,
including where datasets include a
mix of personal and nonpersonal
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. This
Regulation does not affect the
fundamental rights to private life
and the protection of personal data
as provided for by Union law on
data protection and privacy and
enshrined in the Charter of
Fundamental Rights of the
European Union (the ‘Charter’).
Recital 2c
(2c) Artificial intelligence systems

in the Union are subject to relevant
product safety legislation that
provides a framework protecting
consumers against dangerous
products in general and such
legislation should continue to
apply. This Regulation is also
G 12c without prejudice to the rules laid G
down by other Union legal acts

related to consumer protection and
product safety, including including
Regulation (EU) 2017/2394,
Regulation (EU) 2019/1020 and
Directive 2001/95/EC on general
product safety and Directive
2013/11/EU.
Recital 2d
(2d) In accordance with Article

114(2) TFEU, this Regulation
complements and should not
undermine the rights and interests
of employed persons. This
Regulation should therefore not
affect Union law on social policy
and national labour law and
practice, that is any legal and
contractual provision concerning
employment conditions, working
conditions, including health and
safety at work and the relationship
between employers and workers,
including information, consultation
and participation. This Regulation
should not affect the exercise of
G 12d G
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,
in accordance with national law
and/or practice. Nor should it affect
concertation practices, the right to
negotiate, to conclude and enforce
collective agreement or to take
collective action in accordance with
national law and/or practice. It
should in any event not prevent the
Commission from proposing
specific legislation on the rights
and freedoms of workers affected
by AI systems.
Recital 2e
(2e) This Regulation should not

affect the provisions aiming to
G 12e improve working conditions in G
platform work set out in Directive ...

[COD 2021/414/EC].
Recital 2f
(2f) This Regulation should help in

supporting research and innovation
and should not undermine research
and development activity and
respect freedom of scientific
research. It is therefore necessary
to exclude from its scope AI systems
specifically developed for the sole
purpose of scientific research and
G 12f G
development and to ensure that the
Regulation does not otherwise
affect scientific research and
development activity on AI systems.
Under all circumstances, any
research and development activity
should be carried out in accordance
with the Charter, Union law as well
as the national law.
Recital 3
G 13 (3) Artificial intelligence is a fast (3) Artificial intelligence is a fast (3) Artificial intelligence is a fast (3) Artificial intelligence is a fast G
evolving family of technologies that evolving family of technologies that evolving family of technologies that evolving family of technologies that
can contribute to a wide array of can contributeand already can contribute to a wide array of can contributecontributes to a wide
economic and societal benefits contributes to a wide array of economic and societal benefits array of economic, environmental
across the entire spectrum of economic, environmental and across the entire spectrum of and societal benefits across the
industries and social activities. By societal benefits across the entire industries and social activities. By entire spectrum of industries and
improving prediction, optimising spectrum of industries and social improving prediction, optimising social activities. By improving
operations and resource allocation, activities if developed in accordance operations and resource allocation, prediction, optimising operations
and personalising digital solutions with relevant general principles in and personalising digital solutions and resource allocation, and
available for individuals and line with the Charter and the values available for individuals and personalising digital solutions
organisations, the use of artificial on which the Union is founded. By organisations, the use of artificial available for individuals and
intelligence can provide key improving prediction, optimising intelligence can provide key organisations, the use of artificial
competitive advantages to operations and resource allocation, competitive advantages to intelligence can provide key
companies and support socially and and personalising digital solutions companies and support socially and competitive advantages to
environmentally beneficial available for individuals and environmentally beneficial companies and support socially and
outcomes, for example in healthcare, organisations, the use of artificial outcomes, for example in healthcare, environmentally beneficial
farming, education and training, intelligence can provide key farming, education and training, outcomes, for example in healthcare,
infrastructure management, energy, competitive advantages to infrastructure management, energy, farming, food safety, education and
transport and logistics, public companies and support socially and transport and logistics, public training, media, sports, culture,
services, security, justice, resource environmentally beneficial services, security, justice, resource infrastructure management, energy,
and energy efficiency, and climate outcomes, for example in healthcare, and energy efficiency, and climate transport and logistics, public
change mitigation and adaptation. farming, food safety, education and change mitigation and adaptation. services, security, justice, resource
training, media, sports, culture, and energy efficiency,
infrastructure management, energy, environmental monitoring, the
transport and logistics, crisis conservation and restoration of
management, public services, biodiversity and ecosystems and
security, justice, resource and energy climate change mitigation and
efficiency, environmental adaptation .
monitoring, the conservation and
restoration of biodiversity and
ecosystems and climate change
mitigation and adaptation.
Recital 3a
(3a) To contribute to reaching the

G 13a G
carbon neutrality targets, European
companies should seek to utilise all
available technological
advancements that can assist in
realising this goal. Artificial
Intelligence is a technology that has
the potential of being used to
process the ever-growing amount of
data created during industrial,
environmental, health and other
processes. To facilitate investments
in AI-based analysis and
optimisation tools, this Regulation
should provide a predictable and
proportionate environment for low-
risk industrial solutions.
Recital 4
(4) At the same time, depending on (4) At the same time, depending on (4) At the same time, depending on (4) At the same time, depending on
the circumstances regarding its the circumstances regarding its the circumstances regarding its the circumstances regarding its
specific application and use, specific application and use, as well specific application and use, specific application, use, and level
artificial intelligence may generate as the level of technological artificial intelligence may generate of technological development and
risks and cause harm to public development, artificial intelligence risks and cause harm to public use, artificial intelligence may
interests and rights that are protected may generate risks and cause harm interests and rights that are protected generate risks and cause harm to
G 14 by Union law. Such harm might be to public or private interests and by Union law. Such harm might be public interests and fundamental G
material or immaterial. fundamental rights of natural material or immaterial. rights that are protected by Union
persons that are protected by Union law. Such harm might be material or
law. Such harm might be material or immaterial, including physical,
immaterial, including physical, psychological, societal or economic
psychological, societal or economic harm.
harm.
Recital 4a
G 14a (4a) Given the major impact that (4a) Given the major impact that G
artificial intelligence can have on artificial intelligence can have on

society and the need to build trust, it society and the need to build trust, it
is vital for artificial intelligence and is vital for artificial intelligence and
its regulatory framework to be its regulatory framework to be
developed according to Union developed according to Union
values enshrined in Article 2 TEU, values enshrined in Article 2 TEU,
the fundamental rights and the fundamental rights and
freedoms enshrined in the Treaties, freedoms enshrined in the Treaties,
the Charter, and international the Charter. As a pre-requisite,
human rights law. As a pre- artificial intelligence should be a
requisite, artificial intelligence human-centric technology. It
should be a human-centric should serve as a tool for people,
technology. It should not substitute with the ultimate aim of increasing
human autonomy or assume the human well-being.
loss of individual freedom and
should primarily serve the needs of (4aa) In order to ensure a
the society and the common good. consistent and high level of
Safeguards should be provided to protection of public interests as
ensure the development and use of regards health, safety and
ethically embedded artificial fundamental rights, common rules
intelligence that respects Union for all high-risk AI systems should
values and the Charter. 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.
Recital 5
(5) A Union legal framework laying (5) A Union legal framework laying (5) A Union legal framework laying (5) A Union legal framework laying
down harmonised rules on artificial down harmonised rules on artificial down harmonised rules on artificial down harmonised rules on artificial
intelligence is therefore needed to intelligence is therefore needed to intelligence is therefore needed to intelligence is therefore needed to
foster the development, use and foster the development, use and foster the development, use and foster the development, use and
uptake of artificial intelligence in the uptake of artificial intelligence in the uptake of artificial intelligence in the uptake of artificial intelligence in the
internal market that at the same time internal market that at the same time internal market that at the same time internal market that at the same time
meets a high level of protection of meets a high level of protection of meets a high level of protection of meets a high level of protection of
public interests, such as health and public interests, such as health and public interests, such as health and public interests, such as health and
safety and the protection of safety and the, protection of safety and the protection of safety and the protection of
fundamental rights, as recognised fundamental rights, democracy and fundamental rights, as recognised fundamental rights, including
and protected by Union law. To rule of law and the environment, as and protected by Union law. To democracy, rule of law and
achieve that objective, rules recognised and protected by Union achieve that objective, rules environmental protection as
regulating the placing on the market law. To achieve that objective, rules regulating the placing on the market recognised and protected by Union
and putting into service of certain AI regulating the placing on the market, and putting into service of certain AI law. To achieve that objective, rules
systems should be laid down, thus the and putting into service and the systems should be laid down, thus regulating the placing on the market
ensuring the smooth functioning of use of certain AI systems should be ensuring the smooth functioning of and, putting into service and use of
the internal market and allowing laid down, thus ensuring the smooth the internal market and allowing certain AI systems should be laid
G 15 those systems to benefit from the functioning of the internal market those systems to benefit from the down, thus ensuring the smooth G
principle of free movement of goods and allowing those systems to principle of free movement of goods functioning of the internal market
and services. By laying down those benefit from the principle of free and services. By laying down those and allowing those systems to
rules, this Regulation supports the movement of goods and services. rules and building on the work of benefit from the principle of free
objective of the Union of being a These rules should be clear and the High-level Expert Group on movement of goods and services.
global leader in the development of robust in protecting fundamental Artificial Intelligence as reflecetd in These rules should be clear and
secure, trustworthy and ethical rights, supportive of new innovative the Guidelines for Trustworthy robust in protecting fundamental
artificial intelligence, as stated by solutions, and enabling to a Artificial Intelligence in the EU, rights, supportive of new innovative
the European Council1, and it European ecosystem of public and this Regulation supports the solutions, enabling to a European
ensures the protection of ethical private actors creating AI systems objective of the Union of being a ecosystem of public and private
principles, as specifically requested in line with Union values. By laying global leader in the development of actors creating AI systems in line
by the European Parliament2. down those rules as well as secure, trustworthy and ethical with Union values and unlocking
_________ measures in support of innovation artificial intelligence, as stated by the potential of the digital
1. European Council, Special meeting of the with a particular focus on SMEs the European Council1, and it transformation across all regions of
European Council (1 and 2 October 2020) – and start-ups, this Regulation ensures the protection of ethical the Union. By laying down those
Conclusions, EUCO 13/20, 2020, p. 6.
2. European Parliament resolution of 20 supports the objective of promoting principles, as specifically requested rules as well as measures in support
October 2020 with recommendations to the the AI made in Europe, of the by the European Parliament2. of innovation with a particular
Commission on a framework of ethical Union of being a global leader in the _________ focus on SMEs including startups,
aspects of artificial intelligence, robotics and development of secure, trustworthy 1. [1] European Council, Special this Regulation supports the
related technologies, 2020/2012(INL). and ethical artificial intelligence, as meeting of the European Council (1 and 2 objective of promoting the
stated by the European Council1, and October 2020) – Conclusions, EUCO 13/20, European human-centric approach
2020, p. 6.
it ensures the protection of ethical 2. [2] European Parliament resolution to AI and the Union of being a
principles, as specifically requested of 20 October 2020 with recommendations global leader in the development of
by the European Parliament2. to the Commission on a framework of ethical secure, trustworthy and ethical
_________ aspects of artificial intelligence, robotics and artificial intelligence, as stated by
related technologies, 2020/2012(INL).
1. European Council, Special meeting of the the European Council1, and it
European Council (1 and 2 October 2020) – ensures the protection of ethical
2. European Parliament resolution of 20 principles, as specifically requested
October 2020 with recommendations to the by the the European Parliament2.
Commission on a framework of ethical _________
aspects of artificial intelligence, robotics and 1. European Council, Special meeting of the
related technologies, 2020/2012(INL). European Council (1 and 2 October 2020) –
2. 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).
Recital 5a
(5a) The harmonised rules on the (5a) The harmonised rules on the
placing on the market, putting into placing on the market, putting into
service and use of AI systems laid service and use of AI systems laid
down in this Regulation should down in this Regulation should
apply across sectors and, in line apply across sectors and, in line
with its New Legislative Framework with its New Legislative Framework
approach, should be without approach, should be without
G 15a G
prejudice to existing Union law, prejudice to existing Union law,
notably on data protection, notably on data protection,
consumer protection, fundamental consumer protection, fundamental
rights, employment and product rights, employment, and protection
safety, to which this Regulation is of workers, and product safety, to
complementary. As a consequence which this Regulation is
all rights and remedies afforded by complementary. As a consequence
such Union law to consumers and all rights and remedies provided for
other persons who may be by such Union law to consumers,
negatively impacted by AI systems, and other persons who may be
including as regards the negatively impacted by AI systems,
compensation of possible damages including as regards the
pursuant to Council Directive compensation of possible damages
85/374/EEC of 25 July 1985 on the pursuant to Council Directive
approximation of the laws, 85/374/EEC of 25 July 1985 on the
regulations and administrative approximation of the laws,
provisions of the Member States regulations and administrative
concerning liability for defective provisions of the Member States
products, remain unaffected and concerning liability for defective
fully applicable. On top of that, this products, remain unaffected and
Regulation aims to strengthen the fully applicable. Furthermore, in
effectiveness of such existing rights the context of employment and
and remedies by establishing protection of workers, this
specific requirements and Regulation should therefore not
obligations, including in respect of affect Union law on social policy
transparency, technical and national labour law, in
documentation and record-keeping compliance with Union law,
of AI systems. Furthermore, the concerning employment and
obligations placed on various working conditions, including
operators involved in the AI value health and safety at work and the
chain under this Regulation should relationship between employers and
apply without prejudice to national workers. This Regulation should
laws, in compliance with Union also not affect the exercise of
law, having the effect of limiting fundamental rights as recognised in
the use of certain AI systems where the Member States and at Union
such laws fall outside the scope of level, including the right or freedom
this Regulation or pursue other to strike or to take other action
legitimate public interest objectives covered by the specific industrial
than those pursued by this relations systems in Member States
Regulation. For example, national as well as, the right to negotiate, to
labour law and the laws on the conclude and enforce collective
protection of minors (i.e. persons agreements or to take collective
below the age of 18) taking into action in accordance with national
account the United Nations General law. [This Regulation should not
Comment No 25 (2021) on affect the provisions aiming to
children’s rights, insofar as they improve working conditions in
are not specific to AI systems and platform work set out in Directive ...
pursue other legimitate public [COD 2021/414/EC]] On top of
interest objectives, should not be that, this Regulation aims to
affected by this Regulation. 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 legimitate 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 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].
Recital 5a
(5a) Furthermore, in order to

foster the development of AI
systems in line with Union values,
the Union needs to address the
main gaps and barriers blocking
G 15b G
the potential of the digital
transformation including the
shortage of digitally skilled
workers, cybersecurity concerns,
lack of investment and access to
investment, and existing and
potential gaps between large
companies, SME’s and start-ups.
Special attention should be paid to
ensuring that the benefits of AI and
innovation in new technologies are
felt across all regions of the Union
and that sufficient investment and
resources are provided especially to
those regions that may be lagging
behind in some digital indicators.
Recital 6
(6) The notion of AI system should (6) The notion of AI system in this (6) The notion of AI system should (6) The notion of AI system in this
be clearly defined to ensure legal Regulation should be clearly defined be clearly defined to ensure legal Regulation should be clearly defined
certainty, while providing the and closely aligned with the work of certainty, while providing the and closely aligned with the work of
flexibility to accommodate future international organisations working flexibility to accommodate future international organisations working
technological developments. The on artificial intelligence to ensure technological developments. The on artificial intelligence to ensure
definition should be based on the legal certainty, harmonization and definition should be based on the legal certainty, facilitate
key functional characteristics of the wide acceptance, while providing key functional characteristics of the international convergence and wide
software, in particular the ability, for the flexibility to accommodate software, artificial intelligence such acceptance, while providing the
a given set of human-defined futurethe rapid technological as its learning, reasoning or flexibility to accommodate futurethe
objectives, to generate outputs such developments in this field. modelling capabilities, rapid technological developments.
as content, predictions, Moreover, it. The definition should distinguishing it from simpler The definition in this field.
G 16 G
recommendations, or decisions be based on the key functionalkey software systems and programming
which influence the environment characteristics of the software, in approaches. In particular, for the Moreover, it should be based on the
with which the system interacts, be it particular the ability, for a given set purposes of this Regulation AI key functional key characteristics of
in a physical or digital dimension. of human-defined objectives, to systems should have the ability, for the software, in particular the
AI systems can be designed to generate outputs such as content, a givenon the basis of machine ability, for a given set of human-
operate with varying levels of predictions, recommendations, or and/or human-based data and defined objectives, to
autonomy and be used on a stand- decisions which influence the inputs, to infer the way to achieve a generateartificial intelligence
alone basis or as a component of a environment with which the system set of human-definedfinal objectives systems, that distinguish it from
product, irrespective of whether the interacts, be it in a physical or given to them by humans, using simpler traditional software systems
system is physically integrated into digital dimension.artificial machine learning and/or logic- and or programming approaches and
the product (embedded) or serve the intelligence, such as its learning, knowledge based approaches and to should not cover systems that are
functionality of the product without reasoning or modelling capabilities, produce, to generate outputs such as based on the rules defined solely by
being integrated therein (non- so as to distinguish it from simpler content for generative AI systems natural persons to automatically
embedded). The definition of AI software systems or programming (e.g. text, video or images), execute operations. A key
system should be complemented by approaches. AI systems are predictions, recommendations, or characteristic of AI systems is their
a list of specific techniques and designed to operate with varying decisions, influencing which capability to infer. This inference
approaches used for its development, levels of autonomy, meaning that influence the environment with refers to the process of obtaining
which should be kept up-to–date in they have at least some degree of which the system interacts, be it in a the outputs, such as content,
the light of market and technological independence of actions from physical or digital dimension. A predictionspredictions, content,
developments through the adoption human controls and of capabilities system that uses rules defined solely recommendations, or decisions,
of delegated acts by the Commission to operate without human by natural persons to automatically which can influence the environment
to amend that list. intervention. The term “machine- execute operations should not be with which the system interacts, be it
based” refers to the fact that AI considered an AI system. AI in a physical or digital dimension.
systems run on machines. The systems can be designed to operate AI systems can be designed to
reference to explicit or implicit with varying levels of autonomy and operate with varying levels of
objectives underscores that AI be used on a stand-alone basis or as autonomy and be used on a stand-
systems can be designed to operate a component of a product, alone basis or as a component of a
with varying levels of autonomy and irrespective of whether the system is product, irrespective of whether the
be used on a stand-alone basis or as physically integrated into the system is physically integrated into
a component of a product, product (embedded) or serve the the product (embedded) or serve the
irrespective of whether the system is functionality of the product without functionality of the product without
physically integrated into the being integrated therein (non- being integrated therein (non-
product (embedded) or serve the embedded). The definition of AI embedded). The definition ofphysical
functionalityoperate according to system should be complemented by a and virtual environments and to a
explicit human-defined objectives list of specific techniques and capability of AI systems to derive
or to implicit objectives. The approaches used for its models and/or algorithms from
objectives of the AI system may be development, which should be kept inputs/data. The techniques that
different from the intended purpose up-to–date in the light of market and enable inference while building an
of the AI system in a specific technological developments through AI system include machine learning
context. The reference to the adoption of delegated acts by the approaches that learn from data
predictions includes content, which Commission to amend that how to achieve certain objectives;
is considered in this Regulation a listconcept of the autonomy of an and logic- and knowledge-based
form of prediction as one of the AI system relates to the degree to approaches that infer from encoded
product without being integrated which such a system functions knowledge or symbolic
therein (non-embedded). The without human involvement. representation of the task to be
definition of AI systempossible solved. The capacity of an AI
outputs produced by an AI system. system to infer goes beyond basic
For the purposes of this Regulation, data processing, enable learning,
environments should be reasoning or modelling.
complemented by a list of specific
techniques and approaches used for The term “machine-based” refers to
its development, which should be the fact that AI systems run on
kept up-to–date in the light of market machines. The reference to explicit
and technological developments or implicit objectives underscores
through the adoption of delegated that AI systems can operate
acts by the Commission to amend according to explicit defined
that listunderstood as the contexts objectives or to implicit objectives.
in which the AI systems operate, The objectives of the AI system
whereas outputs generated by the should be complemented by a list of
AI system, meaning predictions, may be different from the intended
recommendations or decisions, purpose of the AI system in a
respond to the objectives of the specific techniques and approaches
system, on the basis of inputs from used for its development,
said environment. Such output whichcontext. For the purposes of
further influences said this Regulation, environments
environment, even by merely should be kept up-to–date in the
introducing new information to it. light of market and technological
developments through the adoption
of delegated acts by the Commission
to amend that listunderstood 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 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).
Text Origin: GSC
Recital 6a
(6a) Machine learning approaches

focus on the development of
systems capable of learning and
inferring from data to solve an
application problem without being
explicitly programmed with a set of
step-by-step instructions from input
to output. Learning refers to the
computational process of
G 16a optimizing from data the G
parameters of the model, which is a

mathematical construct generating
an output based on input data. The
range of problems addressed by
machine learning typically involves
tasks for which other approaches
fail, either because there is no
suitable formalisation of the
problem, or because the resolution
of the problem is intractable with
non-learning approaches. Machine
learning approaches include for
instance supervised, unsupervised
and reinforcement learning, using
a variety of methods including deep
learning with neural networks,
statistical techniques for learning
and inference (including for
instance logistic regression,
Bayesian estimation) and search
and optimisation methods.
Recital 6a
(6a) AI systems often have

machine learning capacities that
allow them to adapt and perform
new tasks autonomously. Machine
learning refers to the computational
process of optimizing the
parameters of a model from data,
which is a mathematical construct
generating an output based on
input data. Machine learning
G 16b approaches include, for instance, G
supervised, unsupervised and

reinforcement learning, using a
variety of methods including deep
learning with neural networks. This
Regulation is aimed at addressing
new potential risks that may arise
by delegating control to AI systems,
in particular to those AI systems
that can evolve after deployment.
The function and outputs of many
of these AI systems are based on
abstract mathematical relationships
that are difficult for humans to
understand, monitor and trace back
to specific inputs. These complex
and opaque characteristics (black
box element) impact accountability
and explainability. Comparably
simpler techniques such as
knowledge-based approaches,
Bayesian estimation or decision-
trees may also lead to legal gaps
that need to be addressed by this
Regulation, in particular when they
are used in combination with
machine learning approaches in
hybrid systems.
Recital 6b
(6b) Logic- and knowledge based

approaches focus on the
development of systems with logical
reasoning capabilities on
knowledge to solve an application
problem. Such systems typically
involve a knowledge base and an
inference engine that generates
G 16c G
outputs by reasoning on the
knowledge base. The knowledge
base, which is usually encoded by
human experts, represents entities
and logical relationships relevant
for the application problem through
formalisms based on rules,
ontologies, or knowledge graphs.
The inference engine acts on the
knowledge base and extracts new
information through operations
such as sorting, searching,
matching or chaining. Logic- and
knowledge based approaches
include for instance knowledge
representation, inductive (logic)
programming, knowledge bases,
inference and deductive engines,
(symbolic) reasoning, expert
systems and search and
optimisation methods.
Recital 6b
(6b) AI systems can be used as

stand-alone software system,
integrated into a physical product
(embedded), used to serve the
functionality of a physical product
without being integrated therein
(non-embedded) or used as an AI
G 16d G
component of a larger system. If
this larger system would not
function without the AI component
in question, then the entire larger
system should be considered as one
single AI system under this
Regulation.
Recital 6c
(6c) In order to ensure uniform

G 16e G
conditions for the implementation
of this Regulation as regards
machine learning approaches and
logic- and knowledged based
approaches and to take account of
market and technological
developments, implementing powers
should be conferred on the
Commission.
Recital 6a
(6d) The notion of ‘user’ referred (6a) The notion of ‘deployer’

to in this Regulation should be referred to in this Regulation
interpreted as any natural or legal should be interpreted as any
person, including a public natural or legal person, including a
authority, agency or other body, public authority, agency or other
using an AI system under whose body, using an AI system under its
G 16f G
authority the system is used. authority, except where the AI
Depending on the type of AI system, system is used in the course of a
the use of the system may affect personal non professional activity.
persons other than the user. Depending on the type of AI system,
the use of the system may affect
persons other than the deployer.
Recital 7
(7) The notion of biometric data (7) The notion of biometric data (7) The notion of biometric data (7) The notion of biometric data
used in this Regulation is in line used in this Regulation is in line used in this Regulation is in line with used in this Regulation is in line with
with and should be interpreted with and should be interpreted and should be interpreted and should be interpreted
consistently with the notion of consistently with the notion of consistently with the notion of consistently within light of the
G 17 biometric data as defined in Article biometric data as defined in Article biometric data as defined in Article notion of biometric data as defined G
4(14) of Regulation (EU) 2016/679 4(14) of Regulation (EU) 2016/679 4(14) of Regulation (EU) 2016/679 in Article 4(14) of Regulation (EU)
of the European Parliament and of of the European Parliament and of of the European Parliament and of 2016/679 of the European
the Council1, Article 3(18) of the Council1. Biometrics-based data the Council1, Article 3(18) of Parliament and of the Council
1
Regulation (EU) 2018/1725 of the are additional data resulting from Regulation (EU) 2018/1725 of the , Article 3(18) of Regulation (EU)
European Parliament and of the specific technical processing European Parliament and of the 2018/1725 of the European
Council2 and Article 3(13) of relating to physical, physiological Council2 and Article 3(13) of Parliament and of the Council
2 2
Directive (EU) 2016/680 of the or behavioural signals of a natural Directive (EU) 2016/680 of the and Article 3(13) of Directive
European Parliament and of the person, such as facial expressions, European Parliament and of the (EU) 2016/680 of the European
Council3. movements, pulse frequency, voice, Council3. Parliament and of the Council
3
_________ key strikes or gait, which may or _________ .Biometric data can allow for the
1. Regulation (EU) 2016/679 of the may not allow or confirm the 1. [1] Regulation (EU) 2016/679 of authentication, identification or
European Parliament and of the Council of unique identification of a natural the European Parliament and of the Council categorisation of natural persons
27 April 2016 on the protection of natural of 27 April 2016 on the protection of natural
persons with regard to the processing of person, Article 3(18) of Regulation persons with regard to the processing of and for the recognition of emotions
personal data and on the free movement of (EU) 2018/1725 of the European personal data and on the free movement of of natural persons.3.
such data, and repealing Directive 95/46/EC Parliament and of the Council2 and such data, and repealing Directive 95/46/EC _________
(General Data Protection Regulation) (OJ L Article 3(13) of Directive (EU) (General Data Protection Regulation) (OJ L 1. Regulation (EU) 2016/679 of the
119, 4.5.2016, p. 1). 119, 4.5.2016, p. 1). European Parliament and of the Council of
2. Regulation (EU) 2018/1725 of the
2016/680 of the European 2. [2] Regulation (EU) 2018/1725 of 27 April 2016 on the protection of natural
European Parliament and of the Council of Parliament and of the Council3. the European Parliament and of the Council persons with regard to the processing of
23 October 2018 on the protection of natural _________ of 23 October 2018 on the protection of personal data and on the free movement of
persons with regard to the processing of 1. Regulation (EU) 2016/679 of the natural persons with regard to the processing such data, and repealing Directive 95/46/EC
personal data by the Union institutions, European Parliament and of the Council of of personal data by the Union institutions, (General Data Protection Regulation) (OJ L
bodies, offices and agencies and on the free 27 April 2016 on the protection of natural bodies, offices and agencies and on the free 119, 4.5.2016, p. 1).
movement of such data, and repealing persons with regard to the processing of movement of such data, and repealing 2. Regulation (EU) 2018/1725 of the
Regulation (EC) No 45/2001 and Decision personal data and on the free movement of Regulation (EC) No 45/2001 and Decision European Parliament and of the Council of
No 1247/2002/EC (OJ L 295, 21.11.2018, p. such data, and repealing Directive 95/46/EC No 1247/2002/EC (OJ L 295, 21.11.2018, p. 23 October 2018 on the protection of natural
39) (General Data Protection Regulation) (OJ L 39) persons with regard to the processing of
3. Directive (EU) 2016/680 of the European 119, 4.5.2016, p. 1). 3. [3] Directive (EU) 2016/680 of the personal data by the Union institutions,
Parliament and of the Council of 27 April 2. Regulation (EU) 2018/1725 of the European Parliament and of the Council of bodies, offices and agencies and on the free
2016 on the protection of natural persons European Parliament and of the Council of 27 April 2016 on the protection of natural movement of such data, and repealing
with regard to the processing of personal 23 October 2018 on the protection of natural persons with regard to the processing of Regulation (EC) No 45/2001 and Decision
data by competent authorities for the persons with regard to the processing of personal data by competent authorities for No 1247/2002/EC (OJ L 295, 21.11.2018, p.
purposes of the prevention, investigation, personal data by the Union institutions, the purposes of the prevention, investigation, 39)
detection or prosecution of criminal offences bodies, offices and agencies and on the free detection or prosecution of criminal offences 3. Directive (EU) 2016/680 of the European
or the execution of criminal penalties, and on movement of such data, and repealing or the execution of criminal penalties, and on Parliament and of the Council of 27 April
the free movement of such data, and Regulation (EC) No 45/2001 and Decision the free movement of such data, and 2016 on the protection of natural persons
repealing Council Framework Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. repealing Council Framework Decision with regard to the processing of personal
2008/977/JHA (Law Enforcement Directive) 39) 2008/977/JHA (Law Enforcement Directive) data by competent authorities for the
(OJ L 119, 4.5.2016, p. 89). 3. Directive (EU) 2016/680 of the European (OJ L 119, 4.5.2016, p. 89). purposes of the prevention, investigation,
Parliament and of the Council of 27 April detection or prosecution of criminal offences
2016 on the protection of natural persons or the execution of criminal penalties, and on
with regard to the processing of personal the free movement of such data, and
data by competent authorities for the repealing Council Framework Decision
purposes of the prevention, investigation, 2008/977/JHA (Law Enforcement Directive)
detection or prosecution of criminal offences (OJ L 119, 4.5.2016, p. 89).
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).
Recital 7a
(7a) The notion of biometric (7a) The notion of biometric

identification as used in this identification as used in this
Regulation should be defined as the Regulation should be defined as the
automated recognition of physical, automated recognition of physical,
physiological, behavioural, and physiological and behavioural
psychological human features such human features such as the face,
as the face, eye movement, facial eye movement, body shape, voice,
expressions, body shape, voice, prosody, gait, posture, heart rate,
speech, gait, posture, heart rate, blood pressure, odour, keystrokes
blood pressure, odour, keystrokes, characteristics, for the purpose of
psychological reactions (anger, establishing an individual’s identity
distress, grief, etc.) for the purpose by comparing biometric data of that
of establishing an individual’s individual to stored biometric data
identity by comparing biometric of individuals in a reference
G 17a G
data of that individual to stored database, irrespective of whether
biometric data of individuals in a the individual has given its consent
database (one-to-many or not.
identification), irrespective of This excludes AI systems intended
whether the individual has given its to be used for biometric
consent or not. 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.
Recital 7b
(7b) The notion of biometric (7b) The notion of biometric

categorisation as used in this categorisation as used in this
Regulation should be defined as Regulation should be defined as
assigning natural persons to assigning natural persons to
specific categories or inferring their specific categories on the basis of
characteristics and attributes such their biometric data. Such specific
as gender, sex, age, hair colour, eye categories can relate to aspects
colour, tattoos, ethnic or social such as sex, age, hair colour, eye
origin, health, mental or physical colour, tattoos, behavioural or
ability, behavioural or personality, personality traits, language,
traits language, religion, or religion, membership of a national
membership of a national minority minority, sexual or political
or sexual or political orientation on orientation. This does not include
the basis of their biometric or biometric categorization systems
biometric-based data, or which can that are a purely ancillary feature
be inferred from such data. intrinsically linked to another
commercial service meaning that
G 17b the feature cannot, for objective G
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.
Recital 8
(8) The notion of remote biometric (8) The notion of remote biometric (8) The notion of remote biometric (8) The notion of remote biometric
identification system as used in this identification system as used in this identification system as used in this identification system as used in this
Regulation should be defined Regulation should be defined Regulation should be defined Regulation should be defined
functionally, as an AI system functionally, as an AI system functionally, as an AI system functionally, as an AI system
intended for the identification of intended for the identification of intended for the identification of intended for the identification of
natural persons at a distance through natural persons at a distance through natural persons typically at a natural persons without their active
the comparison of a person’s the comparison of a person’s distance, without their active involvement, typically at a distance,
biometric data with the biometric biometric data with the biometric involvement, through the through the comparison of a
data contained in a reference data contained in a reference comparison of a person’s biometric person’s biometric data with the
database, and without prior database, and without prior data with the biometric data biometric data contained in a
knowledge whether the targeted knowledge whether the targeted contained in a reference database, reference database, andirrespectively
person will be present and can be person will be present and can be and without prior knowledge of the particular technology,
G 18 G
identified, irrespectively of the identified, irrespectively of the whether the targeted person will be processes or types of biometric data
particular technology, processes or particular technology, processes or present and can be identified, used. Such remote biometric
types of biometric data used. types of biometric data used, irrespectively of the particular identification systems are typically
Considering their different exlcuding verification systems technology, processes or types of used to perceive multiple persons or
characteristics and manners in which which merely compare the biometric data used. their behaviour simultaneously in
they are used, as well as the different biometric data of an individual to Consideringdata repository, order to facilitate significantly the
risks involved, a distinction should their previously provided biometric irrespectively of the particular identification of natural persons
be made between ‘real-time’ and data (one-to-one). Considering their technology, processes or types of without prior knowledge whether the
‘post’ remote biometric different characteristics and manners biometric data used. Such remote targeted person will be present and
identification systems. In the case of in which they are used, as well as the biometric identification systems are can be identified, irrespectively of
‘real-time’ systems, the capturing of different risks involved, a distinction typically used to perceive (scan) the particular technology, processes
the biometric data, the comparison should be made between ‘real-time’ multiple persons or their behaviour or types of biometric data used.
and the identification occur all and ‘post’ remote biometric simultaneously in order to facilitate Considering their different
instantaneously, near- identification systems. In the case of significantly the identification of a characteristics and manners in
instantaneously or in any event ‘real-time’ systems, the capturing of number of persons without their which they are used, as well as the
without a significant delay. In this the biometric data, the comparison different characteristics and different risks involved, a distinction
regard, there should be no scope for and the identification occur all manners in which they are should be made between ‘real-time’
circumventing the rules of this instantaneously, near- usedactive involvement. Such a and ‘post’ remotetheir active
Regulation on the ‘real-time’ use of instantaneously or in any event definition excludes involvement. This excludes AI
the AI systems in question by without a significant delay. In this verification/authentication systems systems intended to be used for
providing for minor delays. ‘Real- regard, there should be no scope for whose sole purpose would be to biometric verification, which
time’ systems involve the use of circumventing the rules of this confirm that a specific natural includes authentication, whose sole
‘live’ or ‘near-‘live’ material, such Regulation on the ‘real-time’ use of person is the person he or she purpose is to confirm that a specific
as video footage, generated by a the AI systems in question by claims to be, as well as systems that natural person is the person he or
camera or other device with similar providing for minor delays. ‘Real- are used to confirm the identity of a she claims to be and to confirm the
functionality. In the case of ‘post’ time’ systems involve the use of natural person for the sole purpose identity of a natural person for the
systems, in contrast, the biometric ‘live’ or ‘near-‘live’ material, such of having access to a service, a sole purpose of having access to a
data have already been captured and as video footage, generated by a device or premises. This exclusion service, unlocking a device or
the comparison and identification camera or other device with similar is justified by the fact that such having security access to premises.
occur only after a significant delay. functionality. In the case of ‘post’ systems are likely to have a minor This exclusion is justified by the
This involves material, such as systems, in contrast, the biometric impact on fundamental rights of fact that such systems are likely to
pictures or video footage generated data have already been captured and natural persons compared tothe have a minor impact on
by closed circuit television cameras the comparison and identification different risks involved, a distinction fundamental rights of natural
or private devices, which has been occur only after a significant delay. should be made between ‘real-time’ persons compared to the remote
generated before the use of the This involves material, such as and ‘post’ remote biometric biometric identification systems
system in respect of the natural pictures or video footage generated identification systems which may be which may be used for the
persons concerned. by closed circuit television cameras used for the processing of the processing of the biometric
or private devices, which has been biometric data of a large number of identification systemsdata of a large
generated before the use of the persons. In the case of ‘real-time’ number of persons without their
system in respect of the natural systems, the capturing of the active involvement. In the case of
persons concerned. Given that the biometric data, the comparison and ‘real-time’ systems, the capturing of
notion of biometric identification is the identification occur all the biometric data, the comparison
independent from the individual’s instantaneously, near- and the identification occur all
consent, this definition applies even instantaneously or in any event instantaneously, near-
when warning notices are placed in without a significant delay. In this instantaneously or in any event
the location that is under regard, there should be no scope for without a significant delay. In this
surveillance of the remote biometric circumventing the rules of this regard, there should be no scope for
identification system, and is not de Regulation on the ‘real-time’ use of circumventing the rules of this
facto annulled by pre-enrolment. the AI systems in question by Regulation on the ‘real-time’ use of
providing for minor delays. ‘Real- the AI systems in question by
time’ systems involve the use of providing for minor delays. ‘Real-
‘live’ or ‘near-‘live’ material, such time’ systems involve the use of
as video footage, generated by a ‘live’ or ‘near-‘live’ material, such
camera or other device with similar as video footage, generated by a
functionality. In the case of ‘post’ camera or other device with similar
systems, in contrast, the biometric functionality. In the case of ‘post’
data have already been captured and systems, in contrast, the biometric
the comparison and identification data have already been captured and
occur only after a significant delay. the comparison and identification
This involves material, such as occur only after a significant delay.
pictures or video footage generated This involves material, such as
by closed circuit television cameras pictures or video footage generated
or private devices, which has been by closed circuit television cameras
generated before the use of the or private devices, which has been
system in respect of the natural generated before the use of the
persons concerned. system in respect of the natural
persons concerned.
Recital 8a
(8a) The identification of natural

persons at a distance is understood
to distinguish remote biometric
identification systems from close
proximity individual verification
systems using biometric
G 18a identification means, whose sole G
purpose is to confirm whether or

not a specific natural person
presenting themselves for
identification is permitted, such as
in order to gain access to a service,
a device, or premises.
Recital 8a
(8a) The notion of emotion

recognition system for the purpose
of in 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 refers for
G 18b example to systems used in G
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.
Recital 9
G 19 G
(9) For the purposes of this (9) For the purposes of this (9) For the purposes of this (9) For the purposes of this
Regulation the notion of publicly Regulation the notion of publicly Regulation the notion of publicly Regulation the notion of publicly
accessible space should be accessible space should be accessible space should be accessible space should be
understood as referring to any understood as referring to any understood as referring to any understood as referring to any
physical place that is accessible to physical place that is accessible to physical place that is accessible to physical place that is accessible to
the public, irrespective of whether the public, irrespective of whether the public, an undetermined the public, an undetermined
the place in question is privately or the place in question is privately or number of natural persons, and number of natural persons, and
publicly owned. Therefore, the publicly owned and regardless of irrespective of whether the place in irrespective of whether the place in
notion does not cover places that are the potential capacity restrictions. question is privately or publicly question is privately or publicly
private in nature and normally not Therefore, the notion does not cover owned. Therefore, the notion does owned. Therefore, the notion does
freely accessible for third parties, places that are private in nature and not cover places that are private in not cover places that are private in
including law enforcement normally not freely accessible for nature and normally not freely nature and normally not freely
authorities, unless those parties have third parties, including law accessible for third parties, accessible for third parties,
been specifically invited or enforcement authorities, unless those including law enforcement including law enforcement
authorised, such as homes, private parties have been specifically invited authorities, unless those parties have authorities, unless those parties have
clubs, offices, warehouses and or authorised, such as homes, private been specifically invited or been specifically invited or
factories. Online spaces are not clubs, offices, warehouses and authorised, such as homes, private authorised, such as homes, private
covered either, as they are not factories. Online spaces are not clubs, offices, warehouses and clubs, offices, warehouses and
physical spaces. However, the mere covered either, as they are not factoriesand irrepective of the factories and irrespective of the
fact that certain conditions for physical spaces. However, the mere activity for which the place may be activity for which the place may be
accessing a particular space may fact that certain conditions for used, such as commerce (for used, such as commerce (for
apply, such as admission tickets or accessing a particular space may instance, shops, restaurants, cafés), instance, shops, restaurants, cafés),
age restrictions, does not mean that apply, such as admission tickets or services (for instance, banks, services (for instance, banks,
the space is not publicly accessible age restrictions, does not mean that professional activities, hospitality), professional activities, hospitality),
within the meaning of this the space is not publicly accessible sport (for instance, swimming sport (for instance, swimming
Regulation. Consequently, in within the meaning of this pools, gyms, stadiums), transport pools, gyms, stadiums), transport
addition to public spaces such as Regulation. Consequently, in (for instance, bus, metro and (for instance, bus, metro and
streets, relevant parts of government addition to public spaces such as railway stations, airports, means of railway stations, airports, means of
buildings and most transport streets, relevant parts of government transport ), entertainment (for transport ), entertainment (for
infrastructure, spaces such as buildings and most transport instance, cinemas, theatres, instance, cinemas, theatres,
cinemas, theatres, shops and infrastructure, spaces such as museums, concert and conference museums, concert and conference
shopping centres are normally also cinemas, theatres, sports grounds, halls) leisure or otherwise (for halls) leisure or otherwise (for
publicly accessible. Whether a given schools, universities, relevant parts instance, public roads and squares, instance, public roads and squares,
space is accessible to the public of hospitals and banks, amusement parks, forests, playgrounds). parks, forests, playgrounds).
should however be determined on a parks, festivals, shops and shopping Online spaces are not covered Online spaces are not covered
case-by-case basis, having regard to centres are normally also publicly either, as they are not physical either, as they are not physical
the specificities of the individual accessible. Whether a given space is spaces. However, the mere fact that spaces. However, the mere fact that
situation at hand. accessible to the public should A place should be classified as A place should be classified as
however be determined on a case- publicly accessible also if, publicly accessible also if,
by-case basis, having regard to the regardless of potential capacity or regardless of potential capacity or
specificities of the individual security restrictions, access is security restrictions, access is
situation at hand. subject to certain predetermined subject to certain predetermined
conditions, which can be fulfilled by conditions, which can be fulfilled by
an undetermined number of an undetermined number of
persons for accessing a particular persons for accessing a particular
space may apply, such as admission space may apply, such as admission
tickets or age restrictions, purchase tickets or age restrictions, purchase
of a ticket or title of transport, prior of a ticket or title of transport, prior
registration or having a certain age. registration or having a certain age.
By contrast, a place should not be By contrast, a place should not be
considered publicly accessible if considered publicly accessible if
access is limited to specific and access is limited to specific and
defined natural persons through defined natural persons through
either Union or national law either Union or national law
directly related to public safety or directly related to public safety or
security or through the clear security or through the clear
manifestation of will by the person manifestation of will by the person
having the relevant authority on the having the relevant authority on the
place. The factual possibility of place. The factual possibility of
access alone (e.g. an unlocked door, access alone (e.g. an unlocked door,
an open gate in a fence) does not an open gate in a fence) does not
meanimply that the space is notplace meanimply that the space is not
is publicly accessible within the place is publicly accessible within
meaning of this Regulation. the meaning of this Regulation.
Consequently, in addition to Consequently, in addition to public
publicin the presence of indications spaces such as streets,in the
or circumstances suggesting the presence of indications or
contrary (e.g. signs prohibiting or circumstances suggesting the
restricting access). Company and contrary (e.g. signs prohibiting or
factory premises as well as offices restricting access). Company and
and workplaces that are intended to factory premises as well as offices
be accessed only by relevant and workplaces that are intended to
employees and service providers are be accessed only by relevant parts of
places that are not publicly government buildings and most
accessible. Publicly accessible transport infrastructure, spaces
spaces such as streets, relevant parts employees and service providers are
of government buildings and most places that are not publicly
transport infrastructure, spaces accessible. Publicly accessible
should not include prisons or spaces should not include prisons
border control areas. Some other or border control. Some other areas
areas may be composed of both not may be composed of both not
publicly accessible and publicly publicly accessible and publicly
accessible areas, such as cinemas, accessible areas, such as cinemas,
theatres, shops and shopping centres theatres, shops and shopping centres
are normally also publicly are normally also publicly
accessiblethe hallway of a private accessiblethe hallway of a private
residential building necessary to residential building necessary to
access a doctor's office or an access a doctor's office or an
airport. Online spaces are not airport. Online spaces are not
covered either, as they are not covered either, as they are not
physical spaces. Whether a given physical spaces. Whether a given
space is accessible to the public space is accessible to the public
should however be determined on a should however be determined on a
case-by-case basis, having regard to case-by-case basis, having regard to
the specificities of the individual the specificities of the individual
situation at hand. situation at hand.
Recital 9a
(9a) It is important to note that AI

systems should make best efforts to
respect general principles
establishing a high-level framework
that promotes a coherent human-
G 19a centric approach to ethical and G
trustworthy AI in line with the

Charter of Fundamental Rights of
the European Union and the values
on which the Union is founded,
including the protection of
fundamental rights, human agency
and oversight, technical robustness
and safety, privacy and data
governance, transparency, non-
discrimination and fairness and
societal and environmental
wellbeing.
Recital 9b
(9b) ‘AI literacy’ refers to skills, (9b) In order to obtain the greatest
knowledge and understanding that benefits from AI systems while
allows providers, users and affected protecting fundamental rights,
persons, taking into account their health and safety and to enable
respective rights and obligations in democratic control, AI literacy
the context of this Regulation, to should equip providers, deployers
make an informed deployment of and affected persons with the
AI systems, as well as to gain necessary notions to make informed
awareness about the opportunities decisions regarding AI systems.
and risks of AI and possible harm it These notions may vary with regard
can cause and thereby promote its to the relevant context and can
democratic control. AI literacy include understanding the correct
should not be limited to learning application of technical elements
G 19b G
about tools and technologies, but during the AI system’s development
should also aim to equip providers phase, the measures to be applied
and users with the notions and during its use, the suitable ways in
skills required to ensure compliance which to interpret the AI system’s
with and enforcement of this output, and, in the case of affected
Regulation. It is therefore persons, the knowledge necessary to
necessary that the Commission, the understand how decisions taken
Member States as well as providers with the assistance of AI will impact
and users of AI systems, in them. In the context of the
cooperation with all relevant application this Regulation, AI
stakeholders, promote the literacy should provide all relevant
development of a sufficient level of actors in the AI value chain with
AI literacy, in all sectors of society, the insights required to ensure the
for people of all ages, including appropriate compliance and its
women and girls, and that progress correct enforcement. Furthermore,
in that regard is closely followed. 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 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 .
Recital 10
(10) In order to ensure a level (10) In order to ensure a level (10) In order to ensure a level (10) In order to ensure a level
playing field and an effective playing field and an effective playing field and an effective playing field and an effective
protection of rights and freedoms of protection of rights and freedoms of protection of rights and freedoms of protection of rights and freedoms of
individuals across the Union, the individuals across the Union and on individuals across the Union, the individuals across the Union, the
G 20 G
rules established by this Regulation international level, the rules rules established by this Regulation rules established by this Regulation
should apply to providers of AI established by this Regulation should apply to providers of AI should apply to providers of AI
systems in a non-discriminatory should apply to providers of AI systems in a non-discriminatory systems in a non-discriminatory
manner, irrespective of whether they systems in a non-discriminatory manner, irrespective of whether they manner, irrespective of whether they
are established within the Union or manner, irrespective of whether they are established within the Union or are established within the Union or
in a third country, and to users of AI are established within the Union or in a third country, and to users of AI in a third country, and to
systems established within the in a third country, and to systems established within the usersdeployers of AI systems
Union. usersdeployers of AI systems Union. established within the Union.
established within the Union. In
order for the Union to be true to its
fundamental values, AI systems
intended to be used for practices
that are considered unacceptable by
this Regulation, should equally be
deemed to be unacceptable outside
the Union because of their
particularly harmful effect to
fundamental rights as enshrined in
the Charter. Therefore it is
appropriate to prohibit the export of
such AI systems to third countries
by providers residing in the Union.
Recital 11
(11) In light of their digital nature, (11) In light of their digital nature, (11) In light of their digital nature, (11) In light of their digital nature,
certain AI systems should fall within certain AI systems should fall within certain AI systems should fall within certain AI systems should fall within
the scope of this Regulation even the scope of this Regulation even the scope of this Regulation even the scope of this Regulation even
when they are neither placed on the when they are neither placed on the when they are neither placed on the when they are neither placed on the
market, nor put into service, nor market, nor put into service, nor market, nor put into service, nor market, nor put into service, nor
used in the Union. This is the case used in the Union. This is the case used in the Union. This is the case used in the Union. This is the case
for example of an operator for example of an operator for example of an operator for example of an operator
G 21 established in the Union that established in the Union that established in the Union that established in the Union that G
contracts certain services to an contracts certain services to an contracts certain services to an contracts certain services to an
operator established outside the operator established outside the operator established outside the operator established outside the
Union in relation to an activity to be Union in relation to an activity to be Union in relation to an activity to be Union in relation to an activity to be
performed by an AI system that performed by an AI system that performed by an AI system that performed by an AI system that
would qualify as high-risk and would qualify as high-risk and would qualify as high-risk and would qualify as high-risk and
whose effects impact natural persons whose effects impact natural persons whose effects impact natural persons whose effects impact natural persons
located in the Union. In those located in the Union. In those located in the Union. In those located in the Union. In those
circumstances, the AI system used circumstances, the AI system used circumstances, the AI system used circumstances, the AI system used
by the operator outside the Union by the operator outside the Union by the operator outside the Union by the operator outside the Union
could process data lawfully collected could process data lawfully collected could process data lawfully collected could process data lawfully collected
in and transferred from the Union, in and transferred from the Union, in and transferred from the Union, in and transferred from the Union,
and provide to the contracting and provide to the contracting and provide to the contracting and provide to the contracting
operator in the Union the output of operator in the Union the output of operator in the Union the output of operator in the Union the output of
that AI system resulting from that that AI system resulting from that that AI system resulting from that that AI system resulting from that
processing, without that AI system processing, without that AI system processing, without that AI system processing, without that AI system
being placed on the market, put into being placed on the market, put into being placed on the market, put into being placed on the market, put into
service or used in the Union. To service or used in the Union. To service or used in the Union. To service or used in the Union. To
prevent the circumvention of this prevent the circumvention of this prevent the circumvention of this prevent the circumvention of this
Regulation and to ensure an Regulation and to ensure an Regulation and to ensure an Regulation and to ensure an
effective protection of natural effective protection of natural effective protection of natural effective protection of natural
persons located in the Union, this persons located in the Union, this persons located in the Union, this persons located in the Union, this
Regulation should also apply to Regulation should also apply to Regulation should also apply to Regulation should also apply to
providers and users of AI systems providers and users deployers of AI providers and users of AI systems providers and usersdeployers of AI
that are established in a third systems that are established in a that are established in a third systems that are established in a
country, to the extent the output third country, to the extent the country, to the extent the output third country, to the extent the
produced by those systems is used in output produced by those systems is produced by those systems is used in output produced by those systems is
the Union. Nonetheless, to take into intended to be used in the Union. the Union. Nonetheless, to take into intended to be used in the Union.
account existing arrangements and Nonetheless, to take into account account existing arrangements and Nonetheless, to take into account
special needs for cooperation with existing arrangements and special special needs for future cooperation existing arrangements and special
foreign partners with whom needs for cooperation with foreign with foreign partners with whom needs for future cooperation with
information and evidence is partners with whom information and information and evidence is foreign partners with whom
exchanged, this Regulation should evidence is exchanged, this exchanged, this Regulation should information and evidence is
not apply to public authorities of a Regulation should not apply to not apply to public authorities of a exchanged, this Regulation should
third country and international public authorities of a third country third country and international not apply to public authorities of a
organisations when acting in the and international organisations when organisations when acting in the third country and international
framework of international acting in the framework of framework of international organisations when acting in the
agreements concluded at national or international agreements concluded agreements concluded at national or framework of cooperation or
European level for law enforcement at national or European level for law European level for law enforcement international agreements concluded
and judicial cooperation with the enforcement and judicial and judicial cooperation with the at national or European level for law
Union or with its Member States. cooperation with the Union or with Union or with its Member States. enforcement and judicial
Such agreements have been its Member States. Such agreements Such agreements have been cooperation with the Union or with
concluded bilaterally between have been concluded bilaterally concluded bilaterally between its Member States, under the
Member States and third countries or between Member States and third Member States and third countries or condition that this third country or
between the European Union, countries or between the European between the European Union, international organisations provide
Europol and other EU agencies and Union, Europol and other EU Europol and other EU agencies and adequate safeguards with respect to
third countries and international agencies and third countries and third countries and international the protection of fundamental
organisations. international organisations. This organisations. Recipient Member rights and freedoms of individuals.
exception should nevertheless be States authorities and Union Where relevant, this may also cover
limited to trusted countries and institutions, offices, bodies and activities of entities entrusted by the
international organisation that bodies making use of such outputs third countries to carry out specific
share Union values. in the Union remain accountable to tasks in support of such law
ensure their use comply with Union enforcement and judicial
law. When those international cooperation. Such framework for
agreements are revised or new ones cooperation or . Such agreements
are concluded in the future, the have been concluded established
contracting parties should bilaterally between Member States
undertake the utmost effort to align and third countries or between the
those agreements with the European Union, Europol and other
requirements of this Regulation. EU agencies and third countries and
international organisations. The
authorities competent for
supervision of the law enforcement
and judicial authorities under 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.
Recital 12
(12) This Regulation should also (12) This Regulation should also (12) This Regulation should also (12) This Regulation should also
apply to Union institutions, offices, apply to Union institutions, offices, apply to Union institutions, offices, apply to Union institutions, offices,
bodies and agencies when acting as a bodies and agencies when acting as a bodies and agencies when acting as a bodies and agencies when acting as a
provider or user of an AI system. AI provider or userdeployer of an AI provider or user of an AI system. AI provider or userdeployer of an AI
systems exclusively developed or system. AI systems exclusively systems exclusively developed or system. AI systems exclusively
used for military purposes should be developed or used for military used for military purposes should be developed or used for military
excluded from the scope of this purposes should be excluded from excluded from the scope of this purposes should be excluded from
Regulation where that use falls the scope of this Regulation where Regulation where that use falls the scope of this Regulation where
under the exclusive remit of the that use falls under the exclusive under the exclusive remit of the that use falls under the exclusive
Common Foreign and Security remit of the Common Foreign and Common Foreign and Security remit of the Common Foreign and
G 22 G
Policy regulated under Title V of the Security Policy regulated under Title Policy regulated under Title V of the Security Policy regulated under Title
Treaty on the European Union V of the Treaty on the European Treaty on the European Union V of the Treaty on the European
(TEU). This Regulation should be Union (TEU). This Regulation (TEU). This Regulation should be Union (TEU). This Regulation
without prejudice to the provisions should be without prejudice to the without prejudice to the provisions should be without prejudice to the
regarding the liability of provisions regarding the liability of regarding the liability of provisions regarding the liability of
intermediary service providers set intermediary service providers set intermediary service providers set intermediary service providers set
out in Directive 2000/31/EC of the out in Directive 2000/31/EC of the out in Directive 2000/31/EC of the out in Directive 2000/31/EC of the
European Parliament and of the European Parliament and of the European Parliament and of the European Parliament and of the
Council [as amended by the Digital Council [as amended by the Digital Council [as amended by the Digital Council [as amended by the Digital
Services Act]. Services Act]. Services Act]. Services Act].
Recital 12a
(12a) If and insofar AI systems are (12a) If and insofar AI systems are
placed on the market, put into placed on the market, put into
service, or used with or without service, or used with or without
modification of such systems for modification of such systems for
G 22a G
military, defence or national military, defence or national
security purposes, those should be security purposes, those should be
excluded from the scope of this excluded from the scope of this
Regulation regardless of which type Regulation regardless of which type
of entity is carrying out those of entity is carrying out those
activities, such as whether it is a activities, such as whether it is a
public or private entity. As regards public or private entity. As regards
military and defence purposes, such military and defence purposes, such
exclusion is justified both by Article exclusion is justified both by Article
4(2) TEU and by the specifities of 4(2) TEU and by the specifities of
the Member States’ and the the Member States’ and the
common Union defence policy common Union defence policy
covered by Chapter 2 of Title V of covered by Chapter 2 of Title V of
the Treaty on European Union the Treaty on European Union
(TEU) that are subject to public (TEU) that are subject to public
international law, which is international law, which is
therefore the more appropriate therefore the more appropriate
legal framework for the regulation legal framework for the regulation
of AI systems in the context of the of AI systems in the context of the
use of lethal force and other AI use of lethal force and other AI
systems in the context of military systems in the context of military
and defence activities. As regards and defence activities. As regards
national security purposes, the national security purposes, the
exclusion is justified both by the exclusion is justified both by the
fact that national security remains fact that national security remains
the sole responsibility of Member the sole responsibility of Member
States in accordance with Article States in accordance with Article
4(2) TEU and by the specific nature 4(2) TEU and by the specific nature
and operational needs of national and operational needs of national
security activities and specific security activities and specific
national rules applicable to those national rules applicable to those
activities. Nonetheless, if an AI activities. Nonetheless, if an AI
system developed, placed on the system developed, placed on the
market, put into service or used for market, put into service or used for
security purposes is used outside security purposes is used outside
those temporarily or permanently those temporarily or permanently
for other purposes (for example, for other purposes (for example,
civilian or humanitarian purposes, civilian or humanitarian purposes,
law enforcement or public security law enforcement or public security
purposes), such a system would fall purposes), such a system would fall
within the scope of this Regulation. within the scope of this Regulation.
In that case, the entity using the In that case, the entity using the
system for other than military, system for other than military,
defence or national security defence or national security
purposes should ensure compliance purposes should ensure compliance
of the system with this Regulation, of the system with this Regulation,
unless the system is already unless the system is already
compliant with this Regulation. AI compliant with this Regulation. AI
systems placed on the market or put systems placed on the market or put
into service for an excluded (i.e. into service for an excluded (i.e.
security) and one or more non security) and one or more non
excluded purposes (e.g. civilian excluded purposes (e.g. civilian
purposes, law enforcement, etc.), purposes, law enforcement, etc.),
fall within the scope of this fall within the scope of this
Regulation and providers of those Regulation and providers of those
systems should ensure compliance systems should ensure compliance
with this Regulation. In those cases, with this Regulation. In those cases,
the fact that an AI system may fall the fact that an AI system may fall
within the scope of this Regulation within the scope of this Regulation
should not affect the possibility of should not affect the possibility of
entities carrying out national entities carrying out national
security, defence and military security, defence and military
activities, regardless of the type of activities, regardless of the type of
entity carrying out those activities, entity carrying out those activities,
to use AI systems for national to use AI systems for national
security, military and defence security, military and defence
purposes, the use of which is purposes, the use of which is
excluded from the scope of this excluded from the scope of this
Regulation. An AI system placed on Regulation. An AI system placed on
the market for civilian or law the market for civilian or law
enforcement purposes which is used enforcement purposes which is used
with or without modification for with or without modification for
security purposes should not fall security purposes should not fall
within the scope of this Regulation, within the scope of this Regulation,
regardless of the type of entity regardless of the type of entity
carrying out those activities. carrying out those activities.
Recital 12b
(12b) This Regulation should be

without prejudice to the provisions
regarding the liability of
intermediary service providers set
G 22b G
out in Directive 2000/31/EC of the
European Parliament and of the
Council [as amended by the Digital
Services Act].
Recital 12c
(12c) This Regulation should not (12c) This Regulation should

undermine research and support innovation, respect freedom
development activity and should of science, and should not
respect freedom of science. It is undermine research and
therefore necessary to exclude from development activity. It is therefore
its scope AI systems specifically necessary to exclude from its scope
developed and put into service for AI systems and models specifically
the sole purpose of scientific developed and put into service for
research and development and to the sole purpose of scientific
ensure that the Regulation does not research and development.
G 22c G
otherwise affect scientific research Moreover, it is necessary to ensure
and development activity on AI that the Regulation does not
systems. As regards product otherwise affect scientific research
oriented research activity by and development activity on AI
providers, the provisions of this systems or models prior to being
Regulation should also not apply. placed on the market or put into
This is without prejudice to the service. As regards product oriented
obligation to comply with this research, testing and development
Regulation when an AI system activity regarding AI systems or
falling into the scope of this models, the provisions of this
Regulation is placed on the market Regulation should also not apply
or put into service as a result of prior to these systems and models
such research and development being put into service or placed on
activity and to the application of the market. This is without
provisions on regulatory sandboxes prejudice to the obligation to
and testing in real world conditions. comply with this Regulation when
Furthermore, without prejudice to an AI system falling into the scope
the foregoing regarding AI systems of this Regulation is placed on the
specifically developed and put into market or put into service as a
service for the sole purpose of result of such research and
scientific research and development activity and to the
development, any other AI system application of provisions on
that may be used for the conduct of regulatory sandboxes and testing in
any reaserch and development real world conditions. Furthermore,
activity should remain subject to the without prejudice to the foregoing
provisions of this Regulation. regarding AI systems specifically
Under all circumstances, any developed and put into service for
research and development activity the sole purpose of scientific
should be carried out in accordance research and development, any
with recognised ethical and other AI system that may be used
professional standards for scientific for the conduct of any research and
research. 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.
Recital 12d
(12a) The developers of free and

G 22d G
open-source AI components should
not be mandated under this
Regulation to comply with
requirements targeting the AI value
chain and, in particular, not
towards the provider that has used
that free and open-source AI
component. Developers of free and
open-source AI components should
however be encouraged to
implement widely adopted
documentation practices, such as
model and data cards, as a way to
accelerate information sharing
along the AI value chain, allowing
the promotion of trustworthy AI
systems in the Union.
Recital 12e
(12d) In the light of the nature and

complexity of the value chain for AI
systems, it is essential to clarify the
role of actors who may contribute to
the development of AI systems,
notably high-risk AI systems. In
particular, it is necessary to clarify
that general purpose AI systems are
G 22e AI systems that are intended by the G
provider to perform generally

applicable functions, such as
image/speech recognition, and in a
plurality of contexts. They 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, such systems
should be subject to proportionate
and more specific requirements and
obligations under this Regulation
while ensuring a high level of
protection of fundamental rights,
health and safety. In addition, the
providers of general purpose AI
systems, irrespective of whether
they may be used as high-risk AI
systems as such by other providers
or as components of high-risk AI
systems, should cooperate, as
appropriate, 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. In order to take into
account the specific characteristics
of general purpose AI systems and
the fast evolving market and
technological developments in the
field, implementing powers should
be conferred on the Commission to
specify and adapt the application of
the requirements established under
this Regulation to general purpose
AI systems and to specify the
information to be shared by the
systems in order to enable the
providers of the respective high-risk
AI system to comply with their
obligations under this Regulation.
Recital 12f
G 22f G
Recital 12g
G 22g G
Recital 12h
G 22h G
Recital 13
(13) In order to ensure a consistent (13) In order to ensure a consistent (13) In order to ensure a consistent
and high level of protection of public and high level of protection of public and high level of protection of public
interests as regards health, safety and interests as regards health, safety and interests as regards health, safety and
fundamental rights, common fundamental rights as well as fundamental rights, common
normative standards for all high-risk democracy and rule of law and the normative standards for all high-risk
AI systems should be established. environment, common normative AI systems should be established.
Those standards should be consistent standards for all high-risk AI Those standards should be consistent
with the Charter of fundamental systems should be established. with the Charter of fundamental
rights of the European Union (the Those standards should be consistent rights of the European Union (the
Charter) and should be non- with the Charter, the European Charter) and should be non-
G 23 G
discriminatory and in line with the Green Deal, the Joint Declaration discriminatory and in line with the
Union’s international trade on Digital of fundamental Rights of Union’s international trade
commitments. the European Union (the commitments.
Charterand the Ethics Guidelines
for Trustworthy Artificial
Intelligence (AI) of the High-Level
Expert Group on Artificial
Intelligence, and should be non-
discriminatory and in line with the
Union’s international trade
commitments.
Recital 14
(14) In order to introduce a (14) In order to introduce a (14) In order to introduce a (14) In order to introduce a
proportionate and effective set of proportionate and effective set of proportionate and effective set of proportionate and effective set of
binding rules for AI systems, a binding rules for AI systems, a binding rules for AI systems, a binding rules for AI systems, a
clearly defined risk-based approach clearly defined risk-based approach clearly defined risk-based approach clearly defined risk-based approach
should be followed. That approach should be followed. That approach should be followed. That approach should be followed. That approach
should tailor the type and content of should tailor the type and content of should tailor the type and content of should tailor the type and content of
such rules to the intensity and scope such rules to the intensity and scope such rules to the intensity and scope such rules to the intensity and scope
of the risks that AI systems can of the risks that AI systems can of the risks that AI systems can of the risks that AI systems can
G 24 G
generate. It is therefore necessary to generate. It is therefore necessary to generate. It is therefore necessary to generate. It is therefore necessary to
prohibit certain artificial intelligence prohibit certain unacceptable prohibit certain artificial intelligence prohibit certain unacceptable
practices, to lay down requirements artificial intelligence practices, to lay practices, to lay down requirements artificial intelligence practices, to lay
for high-risk AI systems and down requirements for high-risk AI for high-risk AI systems and down requirements for high-risk AI
obligations for the relevant systems and obligations for the obligations for the relevant systems and obligations for the
operators, and to lay down relevant operators, and to lay down operators, and to lay down relevant operators, and to lay down
transparency obligations for certain transparency obligations for certain transparency obligations for certain transparency obligations for certain
AI systems. AI systems. AI systems. AI systems.
Recital 14a
(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
G 24a G
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
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.
Recital 15
(15) Aside from the many beneficial (15) Aside from the many beneficial (15) Aside from the many beneficial (15) Aside from the many beneficial
uses of artificial intelligence, that uses of artificial intelligence, that uses of artificial intelligence, that uses of artificial intelligence, that
technology can also be misused and technology can also be misused and technology can also be misused and technology can also be misused and
provide novel and powerful tools for provide novel and powerful tools for provide novel and powerful tools for provide novel and powerful tools for
manipulative, exploitative and social manipulative, exploitative and social manipulative, exploitative and social manipulative, exploitative and social
control practices. Such practices are control practices. Such practices are control practices. Such practices are control practices. Such practices are
particularly harmful and should be particularly harmful and abusive and particularly harmful and should be particularly harmful and abusive and
G 25 prohibited because they contradict should be prohibited because they prohibited because they contradict should be prohibited because they G
Union values of respect for human contradict Union values of respect Union values of respect for human contradict Union values of respect
dignity, freedom, equality, for human dignity, freedom, dignity, freedom, equality, for human dignity, freedom,
democracy and the rule of law and equality, democracy and the rule of democracy and the rule of law and equality, democracy and the rule of
Union fundamental rights, including law and Union fundamental rights, Union fundamental rights, including law and Union fundamental rights,
the right to non-discrimination, data including the right to non- the right to non-discrimination, data including the right to non-
protection and privacy and the rights discrimination, data protection and protection and privacy and the rights discrimination, data protection and
of the child. privacy and the rights of the child. of the child. privacy and the rights of the child.
Recital 16
(16) The placing on the market, (16) The placing on the market, (16) AI-enabled manipulative (16) AI-enabled manipulative
G 26 putting into service or use of certain putting into service or use of certain techniques can be used to persuade techniques can be used to persuade G
AI systems intended to distort AI systems intended to distortwith persons to engage in unwanted persons to engage in unwanted
human behaviour, whereby physical the objective to or the effect of behaviours, or to deceive them by behaviours, or to deceive them by
or psychological harms are likely to materially distorting human nudging them into decisions in a nudging them into decisions in a
occur, should be forbidden. Such AI behaviour, whereby physical or way that subverts and impairs their way that subverts and impairs their
systems deploy subliminal psychological harms are likely to autonomy, decision-making and autonomy, decision-making and
components individuals cannot occur, should be forbidden. This free choices. The placing on the free choices. The placing on the
perceive or exploit vulnerabilities of limitation should be understood to market, putting into service or use of market, putting into service or use of
children and people due to their age, include neuro-technologies assisted certain AI systems intended to certain AI systems intended to
physical or mental incapacities. by AI systems that are used to distortmaterially distorting human distortwith the objective to or the
They do so with the intention to monitor, use, or influence neural behaviour, whereby physical or effect of materially distorting
materially distort the behaviour of a data gathered through brain- psychological harms are likely to human behaviour, whereby
person and in a manner that causes computer interfaces insofar as they occur, are particularly dangerous significant harms, in particular
or is likely to cause harm to that or are materially distorting the and should therefore be forbidden. having sufficiently important
another person. The intention may behaviour of a natural person in a Such AI systems deploy subliminal adverse impacts on physical,
not be presumed if the distortion of manner that causes or is likely to components individualssuch as psychological health or financial
human behaviour results from cause that person or another person audio, image, video stimuli that interests or psychological harms are
factors external to the AI system significant harm. Such AI systems persons cannot perceive as those likely to occur, are particularly
which are outside of the control of deploy subliminal components stimuli are beyond human dangerous and should therefore be
the provider or the user. Research individuals cannot perceive or perception or other subliminal forbidden. Such AI systems deploy
for legitimate purposes in relation to exploit vulnerabilities of children techniques that subvert or impair subliminal components
such AI systems should not be and peopleindividuals and specific person’s autonomy, decision- individualssuch as audio, image,
stifled by the prohibition, if such groups of persons due to their making or free choices in ways that video stimuli that persons cannot
research does not amount to use of known or predicted personality people are not consciously aware perceive as those stimuli are beyond
the AI system in human-machine traits, age, physical or mental of, or even if aware not able to human perception or other
relations that exposes natural incapacities, social or economic control or resist, for example in manipulative or deceptive
persons to harm and such research is situation. They do so with the cases of machine-brain interfaces techniques that subvert or impair
carried out in accordance with intention to or the effect of or virtual reality. In addition, AI person’s autonomy, decision-
recognised ethical standards for materially distortdistorting the systems may also otherwise or making or free choices in ways that
scientific research. behaviour of a person and in a exploit vulnerabilities of children people are not consciously aware
manner that causes or is likely to and peoplea specific group of of, or even if aware they are still
cause significant harm to that or persons due to their age, physical or deceived or not able to control or
another person or groups of persons, mental incapacities. They do resist. This could be for example,
including harms that may be sodisability within the meaning of facilitated by machine-brain
accumulated over time. The Directive (EU) 2019/882, or a interfaces or virtual reality as they
intention to distort the behaviour specific social or economic allow for a higher degree of control
may not be presumed if the situation that is likely to make those of what stimuli are presented to
distortion of human behaviour persons more vulnerable to persons, insofar as they may be
results from factors external to the exploitation such as persons living materially distorting their
AI system which are outside of the in extreme poverty, ethnic or behaviour in a significantly
control of the provider or the user, religious minorities. Such AI harmful manner.
such as factors that may not be systems can be placed on the In addition, AI systems may also
reasonably foreseen and mitigated market, put into service or used otherwise or exploit vulnerabilities
by the provider or the deployer of with the intention to objective to or of children and peoplea person or a
the AI system. In any case, it is not the effect of materially specific group of persons due to
necessary for the provider or the distortdistorting the behaviour of a their age, physical or mental
deployer to have the intention to person and in a manner that causes incapacities. They do sodisability
cause the significant harm, as long or is reasonably likely to cause within the meaning of Directive
as such harm results from the physical or phycological harm to (EU) 2019/882, or a specific social
manipulative or exploitative AI- that or another person or groups of or economic situation that is likely
enabled practices. The prohibitions persons, including harms that may to make those persons more
for such AI practices is be accumulated over time. The vulnerable to exploitation such as
complementary to the provisions intention to distort the behaviour persons living in extreme poverty,
contained in Directive 2005/29/EC, may not be presumed if the ethnic or religious minorities. Such
according to which unfair distortion of human behaviour AI systems can be placed on the
commercial practices are results from factors external to the market, put into service or used
prohibited, irrespective of whether AI system which are outside of the with the intention to objective to or
they carried out having recourse to control of the provider or the user, the effect of materially
AI systems or otherwise. In such meaning factors that may not be distortdistorting the behaviour of a
setting, lawful commercial reasonably foreseen and mitigated person and in a manner that causes
practices, for example in the field of by the provider or the user of the AI or is reasonably likely to cause
advertising, that are in compliance system. In any case, it is not significant harm to that or another
with Union law should not in necessary for the provider or the person or groups of persons,
themselves be regarded as violating user to have the intention to cause including harms that may be
prohibition. Research for legitimate the physical or psychological harm, accumulated over time and should
purposes in relation to such AI as long as such harm results from therefore be prohibited. The
systems should not be stifled by the the manipulative or exploitative AI- intention to distort the behaviour
prohibition, if such research does not enabled practices. The prohibitions may not be presumed if the
amount to use of the AI system in for such AI practices are distortion of human behaviour
human-machine relations that complementary to the provisions results from factors external to the
exposes natural persons to harm and contained in Directive 2005/29/EC, AI system which are outside of the
such research is carried out in notably that unfair commercial control of the provider or the user.
accordance with recognised ethical practices leading to economic or Research for legitimate purposes in
standards for scientific research and financial harms to consumers are relation to such AI systems should
on the basis of specific informed prohibited under all circumstances, not be stifled by the prohibition, if
consent of the individuals that are irrespective of whether they are put such research does not amount to
exposed to them or, where in place through AI systems or use of the AI system in human-
applicable, of their legal guardian. otherwise. The prohibitions of machine relations that exposes
manipulative and exploitative natural persons to harm and such
practices in this Regulation should research isdeployer, meaning
not affect lawful practices in the factors that may not be reasonably
context of medical treatment such foreseen and mitigated by the
as psychological treatment of a provider or the deployer of the AI
mental disease or physical system. In any case, it is not
rehabilitation, when those practices necessary for the provider or the
are. Research for legitimate deployer to have the intention to
purposes in relation to such AI cause significant harm, as long as
systems should not be stifled by the such harm results from the
prohibition, if such research does manipulative or exploitative AI-
not amount to use of the AI system in enabled practices. The prohibitions
human-machine relations that for such AI practices are
exposes natural persons to harm and complementary to the provisions
such research is carried out in contained in Directive 2005/29/EC,
accordance with recognised notably unfair commercial
ethicalthe applicable medical practices leading to economic or
standards for scientific researchand financial harms to consumers are
legislation. In addition, common prohibited under all circumstances,
and legitimate commercial practices irrespective of whether they are put
that are in compliance with the in place through AI systems or
applicable law should not in otherwise.
themselves be regarded as The prohibitions of manipulative
constituting harmful manipulative and exploitative practices in this
AI practices. 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 recognised
ethicalthe 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 for
scientific research.
Recital 16a
(16a) AI systems that categorise (16a) Biometric categorisation

natural persons by assigning them systems that are based on
to specific categories, according to individuals’ biometric data, such as
known or inferred sensitive or an individual person’s face or
protected characteristics are fingerprint, to deduce or infer an
particularly intrusive, violate individuals’ political opinions, trade
human dignity and hold great risk union membership, religious or
of discrimination. Such philosophical beliefs, race, sex life
characteristics include gender, or sexual orientation should be
gender identity, race, ethnic origin, prohibited. This prohibition does
G 26a migration or citizenship status, not cover the lawful labelling, G
political orientation, sexual filtering or categorisation of

orientation, religion, disability or biometric datasets acquired in line
any other grounds on which with Union or national law
discrimination is prohibited under according to biometric data, such as
Article 21 of the Charter of the sorting of images according to
Fundamental Rights of the hair colour or eye colour, which
European Union, as well as under can for example be used in the area
Article 9 of Regulation of law enforcement.
(EU)2016/769. Such systems should
therefore be prohibited.
Recital 17
G 27 G
(17) AI systems providing social (17) AI systems providing social (17) AI systems providing social (17) AI systems providing social
scoring of natural persons for scoring of natural persons for scoring of natural persons for scoring of natural persons for
general purpose by public authorities general purpose by public authorities general purpose by public general purpose by public
or on their behalf may lead to or on their behalf may lead to authorities or on their behalfby authorities or on their behalf or
discriminatory outcomes and the discriminatory outcomes and the private actors may lead to private actors may lead to
exclusion of certain groups. They exclusion of certain groups. They discriminatory outcomes and the discriminatory outcomes and the
may violate the right to dignity and may violate the right to dignity and exclusion of certain groups. They exclusion of certain groups. They
non-discrimination and the values of non-discrimination and the values of may violate the right to dignity and may violate the right to dignity and
equality and justice. Such AI equality and justice. Such AI non-discrimination and the values of non-discrimination and the values of
systems evaluate or classify the systems evaluate or classify the equality and justice. Such AI equality and justice. Such AI
trustworthiness of natural persons trustworthiness of natural persons or systems evaluate or classify the systems evaluate or classify the
based on their social behaviour in groups based on multiple data trustworthiness of natural persons trustworthiness of natural
multiple contexts or known or points and time occurrences related based on their social behaviour in personsnatural persons or groups
predicted personal or personality to their social behaviour in multiple multiple contexts or known or thereof based on multiple data
characteristics. The social score contexts or known, inferred or predicted personal or personality points related to their social
obtained from such AI systems may predicted personal or personality characteristics. The social score behaviour in multiple contexts or
lead to the detrimental or characteristics. The social score obtained from such AI systems may known, inferred or predicted
unfavourable treatment of natural obtained from such AI systems may lead to the detrimental or personal or personality
persons or whole groups thereof in lead to the detrimental or unfavourable treatment of natural characteristics over certain periods
social contexts, which are unrelated unfavourable treatment of natural persons or whole groups thereof in of time. The social score obtained
to the context in which the data was persons or whole groups thereof in social contexts, which are unrelated from such AI systems may lead to
originally generated or collected or social contexts, which are unrelated to the context in which the data was the detrimental or unfavourable
to a detrimental treatment that is to the context in which the data was originally generated or collected or treatment of natural persons or
disproportionate or unjustified to the originally generated or collected or to a detrimental treatment that is whole groups thereof in social
gravity of their social behaviour. to a detrimental treatment that is disproportionate or unjustified to the contexts, which are unrelated to the
Such AI systems should be therefore disproportionate or unjustified to the gravity of their social behaviour. AI context in which the data was
prohibited. gravity of their social behaviour. systems entailing such originally generated or collected or
Such AI systems should be therefore unacceptable scoring practicesSuch to a detrimental treatment that is
prohibited. AI systems should be therefore disproportionate or unjustified to the
prohibited. This prohibition should gravity of their social behaviour. AI
not affect lawful evaluation systems entailing such
practices of natural persons done unacceptable scoring practices
for one or more specific purpose in leading to such detrimental or
compliance with the law. unfavorable outcomes Such AI
systems 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.
Recital 18
(18) The use of AI systems for (18) The use of AI systems for (18) The use of AI systems for (18) The use of AI systems for
‘real-time’ remote biometric ‘real-time’ remote biometric ‘real-time’ remote biometric ‘real-time’ remote biometric
identification of natural persons in identification of natural persons in identification of natural persons in identification of natural persons in
publicly accessible spaces for the publicly accessible spaces for the publicly accessible spaces for the publicly accessible spaces for the
purpose of law enforcement is purpose of law enforcement is purpose of law enforcement is purpose of law enforcement is
considered particularly intrusive in considered is particularly intrusive considered particularly intrusive in considered particularly intrusive in
the rights and freedoms of the into the rights and freedoms of the the rights and freedoms of the to the rights and freedoms of the
concerned persons, to the extent that concerned persons, to the extent that concerned persons, to the extent that concerned persons, to the extent that
it may affect the private life of a it mayand can ultimately affect the it may affect the private life of a it may affect the private life of a
large part of the population, evoke a private life of a large part of the large part of the population, evoke a large part of the population, evoke a
feeling of constant surveillance and population, evoke a feeling of feeling of constant surveillance and feeling of constant surveillance and
indirectly dissuade the exercise of constant surveillance, give parties indirectly dissuade the exercise of indirectly dissuade the exercise of
the freedom of assembly and other deploying biometric identification the freedom of assembly and other the freedom of assembly and other
fundamental rights. In addition, the in publicly accessible spaces a fundamental rights. In addition, the fundamental rights .
G 28 immediacy of the impact and the position of uncontrollable power immediacy of the impact and the Technical inaccuracies of AI G
limited opportunities for further and indirectly dissuade the exercise limited opportunities for further systems intended for the remote
checks or corrections in relation to of the freedom of assembly and checks or corrections in relation to biometric identification of natural
the use of such systems operating in other fundamental rights at the core the use of such systems operating in persons can lead to biased results
‘real-time’ carry heightened risks for to the Rule of Law. Technical ‘real-time’ carry heightened risks for and entail discriminatory effects.
the rights and freedoms of the inaccuracies of AI systems intended the rights and freedoms of the This is particularly relevant when it
persons that are concerned by law for the remote biometric persons that are concerned by law comes to age, ethnicity, race, sex or
enforcement activities. identification of natural persons enforcement activities. disabilities.
can lead to biased results and entail In addition, the immediacy of the
discriminatory effects. This is impact and the limited opportunities
particularly relevant when it comes for further checks or corrections in
to age, ethnicity, sex or disabilities. relation to the use of such systems
In addition, the immediacy of the operating in ‘real-time’ carry
impact and the limited opportunities heightened risks for the rights and
for further checks or corrections in freedoms of the persons that are
relation to the use of such systems concerned by law enforcement
operating in ‘real-time’ carry activities.
heightened risks for the rights and
freedoms of the persons that are
concerned by law enforcement
activities. The use of those systems
in publicly accessible places should
therefore be prohibited. Similarly,
AI systems used for the analysis of
recorded footage of publicly
accessible spaces through ‘post’
remote biometric identification
systems should also be prohibited,
unless there is pre-judicial
authorisation for use in the context
of law enforcement, when strictly
necessary for the targeted search
connected to a specific serious
criminal offense that already took
place, and only subject to a pre-
judicial authorisation.
Recital 19
(19) The use of those systems for (19) The use of those systems for (19) The use of those systems for
the purpose of law enforcement deleted the purpose of law enforcement the purpose of law enforcement
should therefore be prohibited, should therefore be prohibited, should therefore be prohibited,
except in three exhaustively listed except in three exhaustively listed except in three exhaustively listed
and narrowly defined situations, and narrowly defined situations, and narrowly defined situations,
where the use is strictly necessary to where the use is strictly necessary to where the use is strictly necessary to
G 29 G
achieve a substantial public interest, achieve a substantial public interest, achieve a substantial public interest,
the importance of which outweighs the importance of which outweighs the importance of which outweighs
the risks. Those situations involve the risks. Those situations involve the risks. Those situations involve
the search for potential victims of the search for potential victims of the search for potential certain
crime, including missing children; crime, including missing children; victims of crime, including missing
certain threats to the life or physical certain threats to the life or physical childrenpeople; certain threats to the
safety of natural persons or of a safety of natural persons or of a life or physical safety of natural
terrorist attack; and the detection, terrorist attack; and the detection, persons or of a terrorist attack; and
localisation, identification or localisation, identification or the detection, localisation,
prosecution of perpetrators or prosecution of perpetrators or identification or prosecution or
suspects of the criminal offences suspects of the criminal offences identification of perpetrators or
referred to in Council Framework referred to in Council Framework suspects of the criminal offences
Decision 2002/584/JHA1 if those Decision 2002/584/JHA1 if those referred to in Council Framework
criminal offences are punishable in criminal offences are punishable in Decision 2002/584/JHA1 Annex IIa
the Member State concerned by a the Member State concerned by a if those criminal offences are
custodial sentence or a detention custodial sentence or a detention punishable in the Member State
order for a maximum period of at order for a maximum period of at concerned by a custodial sentence or
least three years and as they are least three years and as they are a detention order for a maximum
defined in the law of that Member defined in the law of that Member period of at least three four years
State. Such threshold for the State. Such threshold for the and as they are defined in the law of
custodial sentence or detention order custodial sentence or detention order that Member State. Such threshold
in accordance with national law in accordance with national law for the custodial sentence or
contributes to ensure that the offence contributes to ensure that the offence detention order in accordance with
should be serious enough to should be serious enough to national law contributes to ensure
potentially justify the use of ‘real- potentially justify the use of ‘real- that the offence should be serious
time’ remote biometric identification time’ remote biometric identification enough to potentially justify the use
systems. Moreover, of the 32 systems. Moreover, of the 32 of ‘real-time’ remote biometric
criminal offences listed in the criminal offences listed in the identification systems. Moreover,
Council Framework Decision Council Framework Decision the list of criminal offences as
2002/584/JHA, some are in practice 2002/584/JHA, some are in practice referred in Annex IIa is based on of
likely to be more relevant than likely to be more relevant than the 32 criminal offences listed in the
others, in that the recourse to ‘real- others, in that the recourse to ‘real- Council Framework Decision
time’ remote biometric identification time’ remote biometric identification 2002/584/JHA1, taking into account
will foreseeably be necessary and will foreseeably be necessary and that , some are in practice likely to
proportionate to highly varying proportionate to highly varying be more relevant than others, in that
degrees for the practical pursuit of degrees for the practical pursuit of the recourse to ‘real-time’ remote
the detection, localisation, the detection, localisation, biometric identification will
identification or prosecution of a identification or prosecution of a foreseeably be necessary and
perpetrator or suspect of the perpetrator or suspect of the proportionate to highly varying
different criminal offences listed and different criminal offences listed and degrees for the practical pursuit of
having regard to the likely having regard to the likely the detection, localisation,
differences in the seriousness, differences in the seriousness, identification or prosecution or
probability and scale of the harm or probability and scale of the harm or identification of a perpetrator or
possible negative consequences. possible negative consequences. In suspect of the different criminal
_________ addition, this Regulation should offences listed and having regard to
1. Council Framework Decision preserve the ability for law the likely differences in the
2002/584/JHA of 13 June 2002 on the enforcement, border control, seriousness, probability and scale of
European arrest warrant and the surrender
procedures between Member States (OJ L immigration or asylum authorities the harm or possible negative
190, 18.7.2002, p. 1). to carry out identity checks in the consequences.
presence of the person that is
concerned in accordance with the An imminent threat to life or
conditions set out in Union and physical safety of natural persons
national law for such checks. In could also result from a serious
particular, law enforcement, border disruption of critical infrastructure,
control, immigration or asylum as defined in Article 2, point (a) of
authorities should be able to use Directive 2008/114/EC, where the
information systems, in accordance disruption or destruction of such
with Union or national law, to critical infrastructure would result
identify a person who, during an in an imminent threat to life or
identity check, either refuses to be physical safety of a person,
identified or is unable to state or including through serious harm to
prove his or her identity, without the provision of basic supplies to
being required by this Regulation to the population or to the exercise of
obtain prior authorisation. This the core function of the State.
could be, for example, a person
involved in a crime, being In addition, this Regulation should
unwilling, or unable due to an preserve the ability for law
accident or a medical condition, to enforcement, border control,
disclose their identity to law immigration or asylum authorities
enforcement authorities. to carry out identity checks in the
_________ presence of the person that is
1. [1] Council Framework Decision concerned in accordance with the
2002/584/JHA of 13 June 2002 on the conditions set out in Union and
procedures between Member States (OJ L national law for such checks. In
190, 18.7.2002, p. 1). 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.
_________
1. Council Framework Decision
2002/584/JHA of 13 June 2002 on the
procedures between Member States (OJ L
190, 18.7.2002, p. 1).
Recital 20
(20) In order to ensure that those (20) In order to ensure that those (20) In order to ensure that those
systems are used in a responsible deleted systems are used in a responsible systems are used in a responsible
and proportionate manner, it is also and proportionate manner, it is also and proportionate manner, it is also
important to establish that, in each of important to establish that, in each of important to establish that, in each of
those three exhaustively listed and those three exhaustively listed and those three exhaustively listed and
narrowly defined situations, certain narrowly defined situations, certain narrowly defined situations, certain
elements should be taken into elements should be taken into elements should be taken into
account, in particular as regards the account, in particular as regards the account, in particular as regards the
G 30 nature of the situation giving rise to nature of the situation giving rise to nature of the situation giving rise to G
the request and the consequences of the request and the consequences of the request and the consequences of
the use for the rights and freedoms the use for the rights and freedoms the use for the rights and freedoms
of all persons concerned and the of all persons concerned and the of all persons concerned and the
safeguards and conditions provided safeguards and conditions provided safeguards and conditions provided
for with the use. In addition, the use for with the use. In addition, the use for with the use. In addition, the use
of ‘real-time’ remote biometric of ‘real-time’ remote biometric of ‘real-time’ remote biometric
identification systems in publicly identification systems in publicly identification systems in publicly
accessible spaces for the purpose of accessible spaces for the purpose of accessible spaces for the purpose of
law enforcement should be subject law enforcement should be subject law enforcement should only be
to appropriate limits in time and to appropriate limits in time and deployed to confirm the specifically
space, having regard in particular to space, having regard in particular to target individual’s identity and
the evidence or indications regarding the evidence or indications regarding should be limited to what is strictly
the threats, the victims or the threats, the victims or necessary concerning the period of
perpetrator. The reference database perpetrator. The reference database time as well as geographic and
of persons should be appropriate for of persons should be appropriate for personal scope be subject to
each use case in each of the three each use case in each of the three appropriate limits in time and space,
situations mentioned above. situations mentioned above. 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
database of persons should be
appropriate for each use case in each
of the three situations mentioned
above.
Recital 21
(21) Each use of a ‘real-time’ (21) Each use of a ‘real-time’ (21) Each use of a ‘real-time’
remote biometric identification deleted remote biometric identification remote biometric identification
system in publicly accessible spaces system in publicly accessible spaces system in publicly accessible spaces
G 31 for the purpose of law enforcement for the purpose of law enforcement for the purpose of law enforcement G
should be subject to an express and should be subject to an express and should be subject to an express and
specific authorisation by a judicial specific authorisation by a judicial specific authorisation by a judicial
authority or by an independent authority or by an independent authority or by an independent
administrative authority of a administrative authority of a administrative authority whose
Member State. Such authorisation Member State. Such authorisation decision is binding of a Member
should in principle be obtained prior should in principle be obtained prior State. Such authorisation should in
to the use, except in duly justified to the use, except of the system with principle be obtained prior to the
situations of urgency, that is, a view to identify a person or use, except of the system with a view
situations where the need to use the persons. Exceptions to this rule to identify a person or persons.
systems in question is such as to should be allowed in duly justified Exceptions to this rule should be
make it effectively and objectively situations of urgency, that is, allowed in duly justified situations
impossible to obtain an authorisation situations where the need to use the of urgency, that is, situations where
before commencing the use. In such systems in question is such as to the need to use the systems in
situations of urgency, the use should make it effectively and objectively question is such as to make it
be restricted to the absolute impossible to obtain an authorisation effectively and objectively
minimum necessary and be subject before commencing the use. In such impossible to obtain an authorisation
to appropriate safeguards and situations of urgency, the use should before commencing the use. In such
conditions, as determined in national be restricted to the absolute situations of urgency, the use should
law and specified in the context of minimum necessary and be subject be restricted to the absolute
each individual urgent use case by to appropriate safeguards and minimum necessary and be subject
the law enforcement authority itself. conditions, as determined in national to appropriate safeguards and
In addition, the law enforcement law and specified in the context of conditions, as determined in national
authority should in such situations each individual urgent use case by law and specified in the context of
seek to obtain an authorisation as the law enforcement authority itself. each individual urgent use case by
soon as possible, whilst providing In addition, the law enforcement the law enforcement authority itself.
the reasons for not having been able authority should in such situations In addition, the law enforcement
to request it earlier. seek to obtain an authorisation as authority should in such situations
soon as possible, whilst providing seek to obtain an request such
the reasons for not having been able authorisation as soon as possible,
to request it earlier. 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.
Recital 21a
(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
G 31a the ‘real-time biometric G
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’.
Recital 22
G 32 G
(22) Furthermore, it is appropriate (22) Furthermore, it is appropriate (22) Furthermore, it is appropriate
to provide, within the exhaustive deleted to provide, within the exhaustive to provide, within the exhaustive
framework set by this Regulation framework set by this Regulation framework set by this Regulation
that such use in the territory of a that such use in the territory of a that such use in the territory of a
Member State in accordance with Member State in accordance with Member State in accordance with
this Regulation should only be this Regulation should only be this Regulation should only be
possible where and in as far as the possible where and in as far as the possible where and in as far as the
Member State in question has Member State in question has Member State in question has
decided to expressly provide for the decided to expressly provide for the decided to expressly provide for the
possibility to authorise such use in possibility to authorise such use in possibility to authorise such use in
its detailed rules of national law. its detailed rules of national law. its detailed rules of national law.
Consequently, Member States Consequently, Member States Consequently, Member States
remain free under this Regulation remain free under this Regulation remain free under this Regulation
not to provide for such a possibility not to provide for such a possibility not to provide for such a possibility
at all or to only provide for such a at all or to only provide for such a at all or to only provide for such a
possibility in respect of some of the possibility in respect of some of the possibility in respect of some of the
objectives capable of justifying objectives capable of justifying objectives capable of justifying
authorised use identified in this authorised use identified in this authorised use identified in this
Regulation. Regulation. Regulation. These national rules
should be notified to the
Commission at the latest 30 days
following their adoption.
Recital 23
(23) The use of AI systems for (23) The use of AI systems for (23) The use of AI systems for
‘real-time’ remote biometric deleted ‘real-time’ remote biometric ‘real-time’ remote biometric
identification of natural persons in identification of natural persons in identification of natural persons in
publicly accessible spaces for the publicly accessible spaces for the publicly accessible spaces for the
purpose of law enforcement purpose of law enforcement purpose of law enforcement
G 33 G
necessarily involves the processing necessarily involves the processing necessarily involves the processing
of biometric data. The rules of this of biometric data. The rules of this of biometric data. The rules of this
Regulation that prohibit, subject to Regulation that prohibit, subject to Regulation that prohibit, subject to
certain exceptions, such use, which certain exceptions, such use, which certain exceptions, such use, which
are based on Article 16 TFEU, are based on Article 16 TFEU, are based on Article 16 TFEU,
should apply as lex specialis in should apply as lex specialislex should apply as lex specialis in
respect of the rules on the processing specialis in respect of the rules on respect of the rules on the processing
of biometric data contained in the processing of biometric data of biometric data contained in
Article 10 of Directive (EU) contained in Article 10 of Directive Article 10 of Directive (EU)
2016/680, thus regulating such use (EU) 2016/680, thus regulating such 2016/680, thus regulating such use
and the processing of biometric data use and the processing of biometric and the processing of biometric data
involved in an exhaustive manner. data involved in an exhaustive involved in an exhaustive manner.
Therefore, such use and processing manner. Therefore, such use and Therefore, such use and processing
should only be possible in as far as it processing should only be possible should only be possible in as far as it
is compatible with the framework set in as far as it is compatible with the is compatible with the framework set
by this Regulation, without there framework set by this Regulation, by this Regulation, without there
being scope, outside that framework, without there being scope, outside being scope, outside that framework,
for the competent authorities, where that framework, for the competent for the competent authorities, where
they act for purpose of law authorities, where they act for they act for purpose of law
enforcement, to use such systems purpose of law enforcement, to use enforcement, to use such systems
and process such data in connection such systems and process such data and process such data in connection
thereto on the grounds listed in in connection thereto on the grounds thereto on the grounds listed in
Article 10 of Directive (EU) listed in Article 10 of Directive (EU) Article 10 of Directive (EU)
2016/680. In this context, this 2016/680. In this context, this 2016/680. In this context, this
Regulation is not intended to provide Regulation is not intended to provide Regulation is not intended to provide
the legal basis for the processing of the legal basis for the processing of the legal basis for the processing of
personal data under Article 8 of personal data under Article 8 of personal data under Article 8 of
Directive 2016/680. However, the Directive 2016/680. However, the Directive 2016/680. However, the
use of ‘real-time’ remote biometric use of ‘real-time’ remote biometric use of ‘real-time’ remote biometric
identification systems in publicly identification systems in publicly identification systems in publicly
accessible spaces for purposes other accessible spaces for purposes other accessible spaces for purposes other
than law enforcement, including by than law enforcement, including by than law enforcement, including by
competent authorities, should not be competent authorities, should not be competent authorities, should not be
covered by the specific framework covered by the specific framework covered by the specific framework
regarding such use for the purpose of regarding such use for the purpose of regarding such use for the purpose of
law enforcement set by this law enforcement set by this law enforcement set by this
Regulation. Such use for purposes Regulation. Such use for purposes Regulation. Such use for purposes
other than law enforcement should other than law enforcement should other than law enforcement should
therefore not be subject to the therefore not be subject to the therefore not be subject to the
requirement of an authorisation requirement of an authorisation requirement of an authorisation
under this Regulation and the under this Regulation and the under this Regulation and the
applicable detailed rules of national applicable detailed rules of national applicable detailed rules of national
law that may give effect to it. law that may give effect to it. law that may give effect to it.
Recital 24
(24) Any processing of biometric (24) Any processing of biometric (24) Any processing of biometric (24) Any processing of biometric
data and other personal data data and other personal data data and other personal data data and other personal data
involved in the use of AI systems for involved in the use of AI systems for involved in the use of AI systems for involved in the use of AI systems for
biometric identification, other than biometric identification, other than biometric identification, other than biometric identification, other than
in connection to the use of ‘real- in connection to the use of ‘real- in connection to the use of ‘real- in connection to the use of ‘real-
time’ remote biometric identification time’ remote biometric identification time’ remote biometric identification time’ remote biometric identification
systems in publicly accessible spaces systems in publicly accessible spaces systems in publicly accessible spaces systems in publicly accessible spaces
for the purpose of law enforcement for the purpose of law enforcement for the purpose of law enforcement for the purpose of law enforcement
as regulated by this Regulation, as regulated by this Regulation, as regulated by this Regulation, as regulated by this Regulation,
including where those systems are including where those systems are including where those systems are including where those systems are
used by competent authorities in used by competent authorities in used by competent authorities in used by competent authorities in
publicly accessible spaces for other publicly accessible spaces for other publicly accessible spaces for other publicly accessible spaces for other
purposes than law enforcement, purposes than law enforcement, should continue to comply with all should continue to comply with all
should continue to comply with all should continue to comply with all requirements resulting from Article requirements resulting from Article
requirements resulting from Article requirements resulting from Article 10 of Directive (EU) 2016/680. For 10 of Directive (EU) 2016/680.
9(1) of Regulation (EU) 2016/679, 9(1) of Regulation (EU) 2016/679, purposes other than law For purposes other than law
G 34 G
Article 10(1) of Regulation (EU) Article 10(1) of Regulation (EU) enforcement, should continue to enforcement, should continue to
2018/1725 and Article 10 of 2018/1725 and Article 10 of comply with all requirements comply with all requirements
Directive (EU) 2016/680, as Directive (EU) 2016/680, as resulting from Article 9(1) of resulting from Article 9(1) of
applicable. applicable. Regulation (EU) 2016/679, and Regulation (EU) 2016/679, and
Article 10(1) of Regulation (EU) Article 10(1) of Regulation (EU)
2018/1725 and Article 10 of 2018/1725 andprohibit the
Directive (EU) 2016/680, as processing of biometric data subject
applicableprohibit the processing of to limited exceptions as provided in
biometric data for the purpose of those articles. In application of
uniquely identifying a natural Article 10 of Directive (EU)
person, unless one of the situations 2016/680, as applicable9(1) of
in the respective second paragraphs Regulation (EU) 2016/679, the use
of those two articles applies. of remote biometric identification
for purposes other than law
enforcement has already been
subject to prohibition decisions by
national data protection authorities.
Recital 25
(25) In accordance with Article 6a (25) In accordance with Article 6a (25) In accordance with Article 6a (25) In accordance with Article 6a
of Protocol No 21 on the position of of Protocol No 21 on the position of of Protocol No 21 on the position of of Protocol No 21 on the position of
the United Kingdom and Ireland in the United Kingdom and Ireland in the United Kingdom and Ireland in the United Kingdom and Ireland in
respect of the area of freedom, respect of the area of freedom, respect of the area of freedom, respect of the area of freedom,
security and justice, as annexed to security and justice, as annexed to security and justice, as annexed to security and justice, as annexed to
the TEU and to the TFEU, Ireland is the TEU and to the TFEU, Ireland is the TEU and to the TFEU, Ireland is the TEU and to the TFEU, Ireland is
not bound by the rules laid down in not bound by the rules laid down in not bound by the rules laid down in not bound by the rules laid down in
Article 5(1), point (d), (2) and (3) of Article 5(1), point (d), (2) and (3) of Article 5(1), point (d), (2), (3) and Article 5(1), point (d), (2), (3), (3a),
this Regulation adopted on the basis this Regulation adopted on the basis (4) and (3) of this Regulation (4) and (5), Article 5(1)(ba) to the
of Article 16 of the TFEU which of Article 16 of the TFEU which adopted on the basis of Article 16 of extent it applies to the use of
relate to the processing of personal relate to the processing of personal the TFEU which relate to the biometric categorisation systems for
data by the Member States when data by the Member States when processing of personal data by the activities in the field of police
carrying out activities falling within carrying out activities falling within Member States when carrying out cooperation and judicial
the scope of Chapter 4 or Chapter 5 the scope of Chapter 4 or Chapter 5 activities falling within the scope of cooperation in criminal matters,
of Title V of Part Three of the of Title V of Part Three of the Chapter 4 or Chapter 5 of Title V of Article 5(1)(da) to the extent it
TFEU, where Ireland is not bound TFEU, where Ireland is not bound Part Three of the TFEU, where applies to the use of AI systems
G 35 G
by the rules governing the forms of by the rules governing the forms of Ireland is not bound by the rules covered by that provision and
judicial cooperation in criminal judicial cooperation in criminal governing the forms of judicial Article 29(6a) and (3) of this
matters or police cooperation which matters or police cooperation which cooperation in criminal matters or Regulation adopted on the basis of
require compliance with the require compliance with the police cooperation which require Article 16 of the TFEU which relate
provisions laid down on the basis of provisions laid down on the basis of compliance with the provisions laid to the processing of personal data by
Article 16 of the TFEU. Article 16 of the TFEU. down on the basis of Article 16 of the Member States when carrying
the TFEU. 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.
Recital 26
(26) In accordance with Articles 2 (26) In accordance with Articles 2 (26) In accordance with Articles 2 (26) In accordance with Articles 2
and 2a of Protocol No 22 on the and 2a of Protocol No 22 on the and 2a of Protocol No 22 on the and 2a of Protocol No 22 on the
position of Denmark, annexed to the position of Denmark, annexed to the position of Denmark, annexed to the position of Denmark, annexed to the
TEU and TFEU, Denmark is not TEU and TFEU, Denmark is not TEU and TFEU, Denmark is not TEU and TFEU, Denmark is not
bound by rules laid down in Article bound by rules laid down in Article bound by rules laid down in Article bound by rules laid down in Article
5(1), point (d), (2) and (3) of this 5(1), point (d), (2) and (3) of this 5(1), point (d), (2), (3) and (4) and 5(1), point (d), (2), (3), (3a), (4) and
Regulation adopted on the basis of Regulation adopted on the basis of (3) of this Regulation adopted on the (5), Article 5(1)(ba) to the extent it
Article 16 of the TFEU, or subject to Article 16 of the TFEU, or subject to basis of Article 16 of the TFEU, or applies to the use of biometric
their application, which relate to the their application, which relate to the subject to their application, which categorisation systems for activities
processing of personal data by the processing of personal data by the relate to the processing of personal in the field of police cooperation
Member States when carrying out Member States when carrying out data by the Member States when and judicial cooperation in criminal
G 36 activities falling within the scope of activities falling within the scope of carrying out activities falling within matters, Article 5(1)(da) to the G
Chapter 4 or Chapter 5 of Title V of Chapter 4 or Chapter 5 of Title V of the scope of Chapter 4 or Chapter 5 extent it applies to the use of AI
Part Three of the TFEU. Part Three of the TFEU. of Title V of Part Three of the systems covered by that provision
TFEU. and Article 29(6a) and (3) 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.
Recital 26a
(26a) AI systems used by law (26a) In line with the presumption

enforcement authorities or on their of innocence, natural persons in the
behalf to make predictions, profiles EU should always be judged on
G 36a or risk assessments based on their actual behaviour. Natural G
profiling of natural persons or data persons should never be judged on

analysis based on personality traits AI-predicted behaviour based solely
and characteristics, including the on their profiling, personality traits
person’s location, or past criminal or characteristics, such as
behaviour of natural persons or nationality, place of birth, place of
groups of persons for the purpose residence, number of children, debt,
of predicting the occurrence or their type of car, without a
reoccurrence of an actual or reasonable suspicion of that person
potential criminal offence(s) or being involved in a criminal activity
other criminalised social behaviour based on objective verifiable facts
or administrative offences, and without human assessment
including fraud-predicition systems, thereof. Therefore, risk assessments
hold a particular risk of of natural persons in order to assess
discrimination against certain the risk of them offending or for
persons or groups of persons, as predicting the occurrence of an
they violate human dignity as well actual or potential criminal offence
as the key legal principle of solely based on the profiling of a
presumption of innocence. Such AI natural person or on assessing their
systems should therefore be personality traits and
prohibited. 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.
Recital 26b
G 36b (26b) The indiscriminate and (26b) The placing on the market, G
untargeted scraping of biometric putting into service for this specific

data from social media or CCTV purpose, or use of AI systems that
footage to create or expand facial create or expand facial recognition
recognition databases add to the databases through the untargeted
feeling of mass surveillance and scraping of facial images from the
can lead to gross violations of internet or CCTV footage should be
fundamental rights, including the prohibited, as this practice adds to
right to privacy. The use of AI the feeling of mass surveillance and
systems with this intended purpose can lead to gross violations of
should therefore be prohibited. fundamental rights, including the
right to privacy.
Recital 26c
(26c) There are serious concerns (26c) There are serious concerns
about the scientific basis of AI about the scientific basis of AI
systems aiming to detect emotions, systems aiming to identify or infer
physical or physiological features emotions, particularly as expression
such as facial expressions, of emotions vary considerably
movements, pulse frequency or across cultures and situations, and
voice. Emotions or expressions of even within a single individual.
emotions and perceptions thereof Among the key shortcomings of
vary considerably across cultures such systems are the limited
and situations, and even within a reliability, the lack of specificity
single individual. Among the key and the limited generalizability.
G 36c G
shortcomings of such technologies, Therefore, AI systems identifying or
are the limited reliability (emotion inferring emotions or intentions of
categories are neither reliably natural persons on the basis of their
expressed through, nor biometric data may lead to
unequivocally associated with, a discriminatory outcomes and can be
common set of physical or intrusive to the rights and freedoms
physiological movements), the lack of the concerned persons.
of specificity (physical or Considering the imbalance of
physiological expressions do not power in the context of work or
perfectly match emotion categories) education, combined with the
and the limited generalisability (the intrusive nature of these systems,
effects of context and culture are such systems could lead to
not sufficiently considered). detrimental or unfavourable
Reliability issues and consequently, treatment of certain natural persons
major risks for abuse, may or whole groups thereof. Therefore,
especially arise when deploying the the placing on the market, putting
system in real-life situations related into service, or use of AI systems
to law enforcement, border intended to be used to detect the
management, workplace and emotional state of individuals in
education institutions. Therefore, situations related to the workplace
the placing on the market, putting and education should be prohibited.
into service, or use of AI systems This prohibition should not cover
intended to be used in these AI systems placed on the market
contexts to detect the emotional strictly for medical or safety
state of individuals should be reasons, such as systems intended
prohibited. for therapeutical use.
Recital 26d
(26d) Practices that are prohibited (26d) Practices that are prohibited
by Union legislation, including data by Union legislation, including data
protection law, non-discrimination protection law, non-discrimination
G 36d G
law, consumer protection law, and law, consumer protection law, and
competition law, should not be competition law, should not be
affected by this Regulation. affected by this Regulation.
Recital 27
(27) High-risk AI systems should (27) High-risk AI systems should (27) High-risk AI systems should (27) High-risk AI systems should
only be placed on the Union market only be placed on the Union market only be placed on the Union market only be placed on the Union market
or put into service if they comply or, put into service or used if they or put into service if they comply or, put into service or used if they
with certain mandatory comply with certain mandatory with certain mandatory comply with certain mandatory
G 37 G
requirements. Those requirements requirements. Those requirements requirements. Those requirements requirements. Those requirements
should ensure that high-risk AI should ensure that high-risk AI should ensure that high-risk AI should ensure that high-risk AI
systems available in the Union or systems available in the Union or systems available in the Union or systems available in the Union or
whose output is otherwise used in whose output is otherwise used in whose output is otherwise used in whose output is otherwise used in
the Union do not pose unacceptable the Union do not pose unacceptable the Union do not pose unacceptable the Union do not pose unacceptable
risks to important Union public risks to important Union public risks to important Union public risks to important Union public
interests as recognised and protected interests as recognised and protected interests as recognised and protected interests as recognised and protected
by Union law. AI systems identified by Union law, including by Union law. AI systems identified by Union law. Following the New
as high-risk should be limited to fundamental rights, democracy, the as high-risk should be limited to Legislative Framework approach,
those that have a significant harmful rule or law or the environment. In those that have a significant harmful as clarified in Commission notice
impact on the health, safety and order to ensure alignment with impact on the health, safety and the ‘Blue Guide’ on the
fundamental rights of persons in the sectoral legislation and avoid fundamental rights of persons in the implementation of EU product rules
Union and such limitation minimises duplications, requirements for Union and such limitation minimises 2022 (C/2022/3637) the general
any potential restriction to high-risk AI systems should take any potential restriction to rule is that several pieces of the EU
international trade, if any. into account sectoral legislation international trade, if any. legislation, such as Regulation
laying down requirements for high- (EU) 2017/745 on Medical Devices
risk AI systems included in the and Regulation (EU) 2017/746 on
scope of this Regulation, such as In Vitro Diagnostic Devices or
Regulation (EU) 2017/745 on Directive 2006/42/EC on
Medical Devices and Regulation Machinery, may have to be taken
(EU) 2017/746 on In Vitro into consideration for one product,
Diagnostic Devices or Directive since the making available or
2006/42/EC on Machinery. AI putting into service can only take
systems identified as high-risk place when the product complies
should be limited to those that have with all applicable Union
a significant harmful impact on the harmonisation legislation. To
health, safety and fundamental rights ensure consistency and avoid
of persons in the Union and such unnecessary administrative burden
limitation minimises any potential or costs, providers of a product that
restriction to international trade, if contains one or more high-risk
any. Given the rapid pace of artificial intelligence system, to
technological development, as well which the requirements of this
as the potential changes in the use Regulation as well as requirements
of AI systems, the list of high-risk of the Union harmonisation
areas and use-cases in Annex III legislation listed in Annex II,
should nonetheless be subject to Section A apply, should have a
permanent review through the flexibility on operational decisions
exercise of regular assessment. 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.
Recital 28
(28) AI systems could produce (28) AI systems could producehave (28) AI systems could produce (28) AI systems could producehave
adverse outcomes to health and an adverse outcomesimpact to health adverse outcomes to health and an adverse outcomesimpact to health
safety of persons, in particular when and safety of persons, in particular safety of persons, in particular when and safety of persons, in particular
such systems operate as components when such systems operate as safety such systems operate as components when such systems operate as safety
of products. Consistently with the components of products. of products. Consistently with the components of products.
objectives of Union harmonisation Consistently with the objectives of objectives of Union harmonisation Consistently with the objectives of
legislation to facilitate the free Union harmonisation legislation to legislation to facilitate the free Union harmonisation legislation to
movement of products in the internal facilitate the free movement of movement of products in the internal facilitate the free movement of
market and to ensure that only safe products in the internal market and market and to ensure that only safe products in the internal market and
and otherwise compliant products to ensure that only safe and and otherwise compliant products to ensure that only safe and
find their way into the market, it is otherwise compliant products find find their way into the market, it is otherwise compliant products find
important that the safety risks that their way into the market, it is important that the safety risks that their way into the market, it is
G 38 G
may be generated by a product as a important that the safety risks that may be generated by a product as a important that the safety risks that
whole due to its digital components, may be generated by a product as a whole due to its digital components, may be generated by a product as a
including AI systems, are duly whole due to its digital components, including AI systems, are duly whole due to its digital components,
prevented and mitigated. For including AI systems, are duly prevented and mitigated. For including AI systems, are duly
instance, increasingly autonomous prevented and mitigated. For instance, increasingly autonomous prevented and mitigated. For
robots, whether in the context of instance, increasingly autonomous robots, whether in the context of instance, increasingly autonomous
manufacturing or personal assistance robots, whether in the context of manufacturing or personal assistance robots, whether in the context of
and care should be able to safely manufacturing or personal assistance and care should be able to safely manufacturing or personal assistance
operate and performs their functions and care should be able to safely operate and performs their functions and care should be able to safely
in complex environments. Similarly, operate and performs their functions in complex environments. Similarly, operate and performs their functions
in the health sector where the stakes in complex environments. Similarly, in the health sector where the stakes in complex environments. Similarly,
for life and health are particularly in the health sector where the stakes for life and health are particularly in the health sector where the stakes
high, increasingly sophisticated for life and health are particularly high, increasingly sophisticated for life and health are particularly
diagnostics systems and systems high, increasingly sophisticated diagnostics systems and systems high, increasingly sophisticated
supporting human decisions should diagnostics systems and systems supporting human decisions should diagnostics systems and systems
be reliable and accurate. The extent supporting human decisions should be reliable and accurate. The extent supporting human decisions should
of the adverse impact caused by the be reliable and accurate. The extent of the adverse impact caused by the be reliable and accurate. The extent
AI system on the fundamental rights of the adverse impact caused by the AI system on the fundamental rights of the adverse impact caused by the
protected by the Charter is of AI system on the fundamental rights protected by the Charter is of AI system on the fundamental rights
particular relevance when protected by the Charter is of particular relevance when protected by the Charter is of
classifying an AI system as high- particular relevance when classifying an AI system as high- particular relevance when
risk. Those rights include the right to classifying an AI system as high-risk. risk. Those rights include the right to classifying an AI system as high-risk.
human dignity, respect for private Those rights include the right to human dignity, respect for private Those rights include the right to
and family life, protection of human dignity, respect for private and family life, protection of human dignity, respect for private
personal data, freedom of expression and family life, protection of personal data, freedom of expression and family life, protection of
and information, freedom of personal data, freedom of expression and information, freedom of personal data, freedom of expression
assembly and of association, and and information, freedom of assembly and of association, and and information, freedom of
non-discrimination, consumer assembly and of association, and non-discrimination, consumer assembly and of association, and
protection, workers’ rights, rights of non-discrimination, consumer protection, workers’ rights, rights of non-discrimination, consumer
persons with disabilities, right to an protection, workers’ rights, rights of persons with disabilities, right to an protection, workers’ rights, rights of
effective remedy and to a fair trial, persons with disabilities, right to an effective remedy and to a fair trial, persons with disabilities, right to an
right of defence and the presumption effective remedy and to a fair trial, right of defence and the presumption effective remedy and to a fair trial,
of innocence, right to good right of defence and the presumption of innocence, right to good right of defence and the presumption
administration. In addition to those of innocence, right to good administration. In addition to those of innocence, right to good
rights, it is important to highlight administration. In addition to those rights, it is important to highlight administration. In addition to those
that children have specific rights as rights, it is important to highlight that children have specific rights as rights, it is important to highlight
enshrined in Article 24 of the EU that children have specific rights as enshrined in Article 24 of the EU that children have specific rights as
Charter and in the United Nations enshrined in Article 24 of the EU Charter and in the United Nations enshrined in Article 24 of the EU
Convention on the Rights of the Charter and in the United Nations Convention on the Rights of the Charter and in the United Nations
Child (further elaborated in the Convention on the Rights of the Child (further elaborated in the Convention on the Rights of the
UNCRC General Comment No. 25 Child (further elaborated in the UNCRC General Comment No. 25 Child (further elaborated in the
as regards the digital environment), UNCRC General Comment No. 25 as regards the digital environment), UNCRC General Comment No. 25
both of which require consideration as regards the digital environment), both of which require consideration as regards the digital environment),
of the children’s vulnerabilities and both of which require consideration of the children’s vulnerabilities and both of which require consideration
provision of such protection and care of the children’s vulnerabilities and provision of such protection and care of the children’s vulnerabilities and
as necessary for their well-being. provision of such protection and as necessary for their well-being. provision of such protection and
The fundamental right to a high level care as necessary for their well- The fundamental right to a high level care as necessary for their well-
of environmental protection being. The fundamental right to a of environmental protection being. The fundamental right to a
enshrined in the Charter and high level of environmental enshrined in the Charter and high level of environmental
implemented in Union policies protection enshrined in the Charter implemented in Union policies protection enshrined in the Charter
should also be considered when and implemented in Union policies should also be considered when and implemented in Union policies
assessing the severity of the harm should also be considered when assessing the severity of the harm should also be considered when
that an AI system can cause, assessing the severity of the harm that an AI system can cause, assessing the severity of the harm
including in relation to the health that an AI system can cause, including in relation to the health that an AI system can cause,
and safety of persons. including in relation to the health and safety of persons. including in relation to the health
and safety of persons. and safety of persons.
Recital 28a
(28a) The extent of the adverse (28a) The extent of the adverse
impact caused by the AI system on impact caused by the AI system on
the fundamental rights protected by the fundamental rights protected by
the Charter is of particular the Charter is of particular
relevance when classifying an AI relevance when classifying an AI
system as high-risk. Those rights system as high-risk. Those rights
include the right to human dignity, include the right to human dignity,
respect for private and family life, respect for private and family life,
protection of personal data, protection of personal data,
freedom of expression and freedom of expression and
information, freedom of assembly information, freedom of assembly
and of association, and non- and of association, and non-
discrimination, right to education discrimination, right to education
G 38a G
consumer protection, workers’ consumer protection, workers’
rights, rights of persons with rights, rights of persons with
disabilities, gender equality, disabilities, gender equality,
intellectual property rights, right to intellectual property rights, right to
an effective remedy and to a fair an effective remedy and to a fair
trial, right of defence and the trial, right of defence and the
presumption of innocence, right to presumption of innocence, right to
good administration. In addition to good administration. In addition to
those rights, it is important to those rights, it is important to
highlight that children have specific highlight that children have specific
rights as enshrined in Article 24 of rights as enshrined in Article 24 of
the EU Charter and in the United the EU Charter and in the United
Nations Convention on the Rights Nations Convention on the Rights
of the Child (further elaborated in of the Child (further elaborated in
the UNCRC General Comment No. the UNCRC General Comment No.
25 as regards the digital 25 as regards the digital
environment), both of which environment), both of which
require consideration of the require consideration of the
children’s vulnerabilities and children’s vulnerabilities and
provision of such protection and provision of such protection and
care as necessary for their well- care as necessary for their well-
being. The fundamental right to a being. The fundamental right to a
high level of environmental high level of environmental
protection enshrined in the Charter protection enshrined in the Charter
and implemented in Union policies and implemented in Union policies
should also be considered when should also be considered when
assessing the severity of the harm assessing the severity of the harm
that an AI system can cause, that an AI system can cause,
including in relation to the health including in relation to the health
and safety of persons or to the and safety of persons.
environment.
Recital 29
(29) As regards high-risk AI (29) As regards high-risk AI (29) As regards high-risk AI (29) As regards high-risk AI
systems that are safety components systems that are safety components systems that are safety components systems that are safety components
of products or systems, or which are of products or systems, or which are of products or systems, or which are of products or systems, or which are
themselves products or systems themselves products or systems themselves products or systems themselves products or systems
falling within the scope of falling within the scope of falling within the scope of falling within the scope of
Regulation (EC) No 300/2008 of the Regulation (EC) No 300/2008 of the Regulation (EC) No 300/2008 of the Regulation (EC) No 300/2008 of the
G 39 Council1, Regulation (EU) No Council1, Regulation (EU) No Council1, Regulation (EU) No Council1, Regulation (EU) No G
167/2013 of the European 167/2013 of the European 167/2013 of the European 167/2013 of the European
Parliament and of the Council2, Parliament and of the Council2, Parliament and of the Council2, Parliament and of the Council2,
Regulation (EU) No 168/2013 of the Regulation (EU) No 168/2013 of the Regulation (EU) No 168/2013 of the Regulation (EU) No 168/2013 of the
Council3, Directive 2014/90/EU of Council3, Directive 2014/90/EU of Council3, Directive 2014/90/EU of Council3, Directive 2014/90/EU of
the European Parliament and of the the European Parliament and of the the European Parliament and of the the European Parliament and of the
Council4, Directive (EU) 2016/797 Council4, Directive (EU) 2016/797 Council4, Directive (EU) 2016/797 Council4, Directive (EU) 2016/797
of the European Parliament and of of the European Parliament and of of the European Parliament and of of the European Parliament and of
the Council5, Regulation (EU) the Council5, Regulation (EU) the Council5, Regulation (EU) the Council5, Regulation (EU)
Parliament and of the Council6, Parliament and of the Council6, Parliament and of the Council6, Parliament and of the Council6,
Regulation (EU) 2018/1139 of the Regulation (EU) 2018/1139 of the Regulation (EU) 2018/1139 of the Regulation (EU) 2018/1139 of the
Council7, and Regulation (EU) Council7, and Regulation (EU) Council7, and Regulation (EU) Council7, and Regulation (EU)
Parliament and of the Council8, it is Parliament and of the Council8, it is Parliament and of the Council8, it is Parliament and of the Council8, it is
appropriate to amend those acts to appropriate to amend those acts to appropriate to amend those acts to appropriate to amend those acts to
ensure that the Commission takes ensure that the Commission takes ensure that the Commission takes ensure that the Commission takes
into account, on the basis of the into account, on the basis of the into account, on the basis of the into account, on the basis of the
technical and regulatory specificities technical and regulatory specificities technical and regulatory specificities technical and regulatory specificities
of each sector, and without of each sector, and without of each sector, and without of each sector, and without
interfering with existing governance, interfering with existing governance, interfering with existing governance, interfering with existing governance,
conformity assessment and conformity assessment, market conformity assessment and conformity assessment and
enforcement mechanisms and surveillance and enforcement enforcement mechanisms and enforcement mechanisms and
authorities established therein, the mechanisms and authorities authorities established therein, the authorities established therein, the
mandatory requirements for high- established therein, the mandatory mandatory requirements for high- mandatory requirements for high-
risk AI systems laid down in this requirements for high-risk AI risk AI systems laid down in this risk AI systems laid down in this
Regulation when adopting any systems laid down in this Regulation Regulation when adopting any Regulation when adopting any
relevant future delegated or when adopting any relevant future relevant future delegated or relevant future delegated or
implementing acts on the basis of delegated or implementing acts on implementing acts on the basis of implementing acts on the basis of
those acts. the basis of those acts. those acts. those acts.
_________ _________ _________ _________
1. Regulation (EC) No 300/2008 of the 1. Regulation (EC) No 300/2008 of the 1. [1] Regulation (EC) No 300/2008 1. Regulation (EC) No 300/2008 of the
European Parliament and of the Council of European Parliament and of the Council of of the European Parliament and of the European Parliament and of the Council of
11 March 2008 on common rules in the field 11 March 2008 on common rules in the field Council of 11 March 2008 on common rules 11 March 2008 on common rules in the field
of civil aviation security and repealing of civil aviation security and repealing in the field of civil aviation security and of civil aviation security and repealing
Regulation (EC) No 2320/2002 (OJ L 97, Regulation (EC) No 2320/2002 (OJ L 97, repealing Regulation (EC) No 2320/2002 Regulation (EC) No 2320/2002 (OJ L 97,
9.4.2008, p. 72). 9.4.2008, p. 72). (OJ L 97, 9.4.2008, p. 72). 9.4.2008, p. 72).
2. Regulation (EU) No 167/2013 of the 2. Regulation (EU) No 167/2013 of the 2. [2] Regulation (EU) No 167/2013 2. Regulation (EU) No 167/2013 of the
European Parliament and of the Council of 5 European Parliament and of the Council of 5 of the European Parliament and of the European Parliament and of the Council of 5
February 2013 on the approval and market February 2013 on the approval and market Council of 5 February 2013 on the approval February 2013 on the approval and market
surveillance of agricultural and forestry surveillance of agricultural and forestry and market surveillance of agricultural and surveillance of agricultural and forestry
vehicles (OJ L 60, 2.3.2013, p. 1). vehicles (OJ L 60, 2.3.2013, p. 1). forestry vehicles (OJ L 60, 2.3.2013, p. 1). vehicles (OJ L 60, 2.3.2013, p. 1).
3. Regulation (EU) No 168/2013 of the 3. Regulation (EU) No 168/2013 of the 3. [3] Regulation (EU) No 168/2013 3. Regulation (EU) No 168/2013 of the
European Parliament and of the Council of European Parliament and of the Council of of the European Parliament and of the European Parliament and of the Council of
15 January 2013 on the approval and market 15 January 2013 on the approval and market Council of 15 January 2013 on the approval 15 January 2013 on the approval and market
surveillance of two- or three-wheel vehicles surveillance of two- or three-wheel vehicles and market surveillance of two- or three- surveillance of two- or three-wheel vehicles
and quadricycles (OJ L 60, 2.3.2013, p. 52). and quadricycles (OJ L 60, 2.3.2013, p. 52). wheel vehicles and quadricycles (OJ L 60, and quadricycles (OJ L 60, 2.3.2013, p. 52).
4. Directive 2014/90/EU of the European 4. Directive 2014/90/EU of the European 2.3.2013, p. 52). 4. Directive 2014/90/EU of the European
Parliament and of the Council of 23 July Parliament and of the Council of 23 July 4. [4] Directive 2014/90/EU of the Parliament and of the Council of 23 July
2014 on marine equipment and repealing 2014 on marine equipment and repealing European Parliament and of the Council of 2014 on marine equipment and repealing
Council Directive 96/98/EC (OJ L 257, Council Directive 96/98/EC (OJ L 257, 23 July 2014 on marine equipment and Council Directive 96/98/EC (OJ L 257,
28.8.2014, p. 146). 28.8.2014, p. 146). repealing Council Directive 96/98/EC (OJ L 28.8.2014, p. 146).
5. Directive (EU) 2016/797 of the European 5. Directive (EU) 2016/797 of the European 257, 28.8.2014, p. 146). 5. Directive (EU) 2016/797 of the European
Parliament and of the Council of 11 May Parliament and of the Council of 11 May 5. [5] Directive (EU) 2016/797 of the Parliament and of the Council of 11 May
2016 on the interoperability of the rail 2016 on the interoperability of the rail European Parliament and of the Council of 2016 on the interoperability of the rail
system within the European Union (OJ L system within the European Union (OJ L 11 May 2016 on the interoperability of the system within the European Union (OJ L
138, 26.5.2016, p. 44). 138, 26.5.2016, p. 44). rail system within the European Union (OJ L 138, 26.5.2016, p. 44).
6. Regulation (EU) 2018/858 of the 6. Regulation (EU) 2018/858 of the 138, 26.5.2016, p. 44). 6. Regulation (EU) 2018/858 of the
European Parliament and of the Council of European Parliament and of the Council of 6. [6] Regulation (EU) 2018/858 of European Parliament and of the Council of
30 May 2018 on the approval and market 30 May 2018 on the approval and market the European Parliament and of the Council 30 May 2018 on the approval and market
surveillance of motor vehicles and their surveillance of motor vehicles and their of 30 May 2018 on the approval and market surveillance of motor vehicles and their
trailers, and of systems, components and trailers, and of systems, components and surveillance of motor vehicles and their trailers, and of systems, components and
separate technical units intended for such separate technical units intended for such trailers, and of systems, components and separate technical units intended for such
vehicles, amending Regulations (EC) No vehicles, amending Regulations (EC) No separate technical units intended for such vehicles, amending Regulations (EC) No
715/2007 and (EC) No 595/2009 and 715/2007 and (EC) No 595/2009 and vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and
repealing Directive 2007/46/EC (OJ L 151, repealing Directive 2007/46/EC (OJ L 151, 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151,
14.6.2018, p. 1). 14.6.2018, p. 1). repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).
7. Regulation (EU) 2018/1139 of the 7. Regulation (EU) 2018/1139 of the 14.6.2018, p. 1). 7. Regulation (EU) 2018/1139 of the
European Parliament and of the Council of 4 European Parliament and of the Council of 4 7. [7] Regulation (EU) 2018/1139 of European Parliament and of the Council of 4
July 2018 on common rules in the field of July 2018 on common rules in the field of the European Parliament and of the Council July 2018 on common rules in the field of
civil aviation and establishing a European civil aviation and establishing a European of 4 July 2018 on common rules in the field civil aviation and establishing a European
Union Aviation Safety Agency, and Union Aviation Safety Agency, and of civil aviation and establishing a European Union Aviation Safety Agency, and
amending Regulations (EC) No 2111/2005, amending Regulations (EC) No 2111/2005, Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005,
(EC) No 1008/2008, (EU) No 996/2010, (EC) No 1008/2008, (EU) No 996/2010, amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010,
(EU) No 376/2014 and Directives (EU) No 376/2014 and Directives (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives
2014/30/EU and 2014/53/EU of the 2014/30/EU and 2014/53/EU of the (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the
European Parliament and of the Council, and European Parliament and of the Council, and 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and
repealing Regulations (EC) No 552/2004 and repealing Regulations (EC) No 552/2004 and European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and
(EC) No 216/2008 of the European (EC) No 216/2008 of the European repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European
Parliament and of the Council and Council Parliament and of the Council and Council (EC) No 216/2008 of the European Parliament and of the Council and Council
Regulation (EEC) No 3922/91 (OJ L 212, Regulation (EEC) No 3922/91 (OJ L 212, Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212,
22.8.2018, p. 1). 22.8.2018, p. 1). Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).
8. Regulation (EU) 2019/2144 of the 8. Regulation (EU) 2019/2144 of the 22.8.2018, p. 1). 8. Regulation (EU) 2019/2144 of the
European Parliament and of the Council of European Parliament and of the Council of 8. [8] Regulation (EU) 2019/2144 of European Parliament and of the Council of
27 November 2019 on type-approval 27 November 2019 on type-approval the European Parliament and of the Council 27 November 2019 on type-approval
requirements for motor vehicles and their requirements for motor vehicles and their of 27 November 2019 on type-approval requirements for motor vehicles and their
trailers, and systems, components and trailers, and systems, components and requirements for motor vehicles and their trailers, and systems, components and
separate technical units intended for such separate technical units intended for such trailers, and systems, components and separate technical units intended for such
vehicles, as regards their general safety and vehicles, as regards their general safety and separate technical units intended for such vehicles, as regards their general safety and
the protection of vehicle occupants and the protection of vehicle occupants and vehicles, as regards their general safety and the protection of vehicle occupants and
vulnerable road users, amending Regulation vulnerable road users, amending Regulation the protection of vehicle occupants and vulnerable road users, amending Regulation
(EU) 2018/858 of the European Parliament (EU) 2018/858 of the European Parliament vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament
and of the Council and repealing Regulations and of the Council and repealing Regulations (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 78/2009, (EC) No 79/2009 and and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and
(EC) No 661/2009 of the European (EC) No 661/2009 of the European (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European
Parliament and of the Council and Parliament and of the Council and (EC) No 661/2009 of the European Parliament and of the Council and
Commission Regulations (EC) No 631/2009, Commission Regulations (EC) No 631/2009, Parliament and of the Council and Commission Regulations (EC) No 631/2009,
(EU) No 406/2010, (EU) No 672/2010, (EU) (EU) No 406/2010, (EU) No 672/2010, (EU) Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU)
No 1003/2010, (EU) No 1005/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) (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 1008/2010, (EU) No 1009/2010, (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 No 19/2011, (EU) No 109/2011, (EU) No 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 458/2011, (EU) No 65/2012, (EU) No 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 130/2012, (EU) No 347/2012, (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) 351/2012, (EU) No 1230/2012 and (EU) 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). 2015/166 (OJ L 325, 16.12.2019, p. 1). 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1).
2015/166 (OJ L 325, 16.12.2019, p. 1).
Proposal
Recital 30
(30) As regards AI systems that are (30) As regards AI systems that are (30) As regards AI systems that are (30) As regards AI systems that are
safety components of products, or safety components of products, or safety components of products, or safety components of products, or
which are themselves products, which are themselves products, which are themselves products, which are themselves products,
falling within the scope of certain falling within the scope of certain falling within the scope of certain falling within the scope of certain
Union harmonisation legislation, it is Union harmonisation legislationlaw Union harmonisation legislation, it is Union harmonisation legislation
appropriate to classify them as high- listed in Annex II, it is appropriate appropriate to classify them as high- listed in Annex II, it is appropriate
risk under this Regulation if the to classify them as high-risk under risk under this Regulation if the to classify them as high-risk under
product in question undergoes the this Regulation if the product in product in question undergoes the this Regulation if the product in
conformity assessment procedure question undergoes the conformity conformity assessment procedure question undergoes the conformity
G 40 with a third-party conformity assessment procedure in order to with a third-party conformity assessment procedure with a third- G
assessment body pursuant to that ensure compliance with essential assessment body pursuant to that party conformity assessment body
relevant Union harmonisation safety requirements with a third- relevant Union harmonisation pursuant to that relevant Union
legislation. In particular, such party conformity assessment body legislation. In particular, such harmonisation legislation. In
products are machinery, toys, lifts, pursuant to that relevant Union products are machinery, toys, lifts, particular, such products are
equipment and protective systems harmonisation legislationlaw. In equipment and protective systems machinery, toys, lifts, equipment and
intended for use in potentially particular, such products are intended for use in potentially protective systems intended for use
explosive atmospheres, radio machinery, toys, lifts, equipment and explosive atmospheres, radio in potentially explosive atmospheres,
equipment, pressure equipment, protective systems intended for use equipment, pressure equipment, radio equipment, pressure
recreational craft equipment, in potentially explosive atmospheres, recreational craft equipment, equipment, recreational craft
cableway installations, appliances radio equipment, pressure cableway installations, appliances equipment, cableway installations,
burning gaseous fuels, medical equipment, recreational craft burning gaseous fuels, medical appliances burning gaseous fuels,
devices, and in vitro diagnostic equipment, cableway installations, devices, and in vitro diagnostic medical devices, and in vitro
medical devices. appliances burning gaseous fuels, medical devices. diagnostic medical devices.
medical devices, and in vitro
diagnostic medical devices.
Recital 31
(31) The classification of an AI (31) The classification of an AI (31) The classification of an AI (31) The classification of an AI
system as high-risk pursuant to this system as high-risk pursuant to this system as high-risk pursuant to this system as high-risk pursuant to this
Regulation should not necessarily Regulation should not necessarily Regulation should not necessarily Regulation should not necessarily
mean that the product whose safety mean that the product whose safety mean that the product whose safety mean that the product whose safety
component is the AI system, or the component is the AI system, or the component is the AI system, or the component is the AI system, or the
AI system itself as a product, is AI system itself as a product, is AI system itself as a product, is AI system itself as a product, is
considered ‘high-risk’ under the considered ‘high-risk’ under the considered ‘high-risk’ under the considered ‘high-risk’ under the
criteria established in the relevant criteria established in the relevant criteria established in the relevant criteria established in the relevant
Union harmonisation legislation that Union harmonisation legislationlaw Union harmonisation legislation that Union harmonisation legislation that
applies to the product. This is that applies to the product. This is applies to the product. This is applies to the product. This is
notably the case for Regulation (EU) notably the case for Regulation (EU) notably the case for Regulation (EU) notably the case for Regulation (EU)
Parliament and of the Council1 and Parliament and of the Council1 and Parliament and of the Council1 and Parliament and of the Council1 and
G 41 Regulation (EU) 2017/746 of the Regulation (EU) 2017/746 of the Regulation (EU) 2017/746 of the Regulation (EU) 2017/746 of the G
Council2, where a third-party Council2, where a third-party Council2, where a third-party Council2, where a third-party
conformity assessment is provided conformity assessment is provided conformity assessment is provided conformity assessment is provided
for medium-risk and high-risk for medium-risk and high-risk for medium-risk and high-risk for medium-risk and high-risk
products. products. products. products.
_________ _________ _________ _________
1. Regulation (EU) 2017/745 of the 1. Regulation (EU) 2017/745 of the 1. [1] Regulation (EU) 2017/745 of 1. Regulation (EU) 2017/745 of the
European Parliament and of the Council of 5 European Parliament and of the Council of 5 the European Parliament and of the Council European Parliament and of the Council of 5
April 2017 on medical devices, amending April 2017 on medical devices, amending of 5 April 2017 on medical devices, April 2017 on medical devices, amending
Directive 2001/83/EC, Regulation (EC) No Directive 2001/83/EC, Regulation (EC) No amending Directive 2001/83/EC, Regulation Directive 2001/83/EC, Regulation (EC) No
178/2002 and Regulation (EC) No 178/2002 and Regulation (EC) No (EC) No 178/2002 and Regulation (EC) No 178/2002 and Regulation (EC) No
1223/2009 and repealing Council Directives 1223/2009 and repealing Council Directives 1223/2009 and repealing Council Directives 1223/2009 and repealing Council Directives
90/385/EEC and 93/42/EEC (OJ L 117, 90/385/EEC and 93/42/EEC (OJ L 117, 90/385/EEC and 93/42/EEC (OJ L 117, 90/385/EEC and 93/42/EEC (OJ L 117,
5.5.2017, p. 1). 5.5.2017, p. 1). 5.5.2017, p. 1). 5.5.2017, p. 1).
April 2017 on in vitro diagnostic medical April 2017 on in vitro diagnostic medical of 5 April 2017 on in vitro diagnostic April 2017 on in vitro diagnostic medical
devices and repealing Directive 98/79/EC devices and repealing Directive 98/79/EC medical devices and repealing Directive devices and repealing Directive 98/79/EC
and Commission Decision 2010/227/EU (OJ and Commission Decision 2010/227/EU (OJ 98/79/EC and Commission Decision and Commission Decision 2010/227/EU (OJ
L 117, 5.5.2017, p. 176). L 117, 5.5.2017, p. 176). 2010/227/EU (OJ L 117, 5.5.2017, p. 176). L 117, 5.5.2017, p. 176).

Proposal
Recital 32
(32) As regards stand-alone AI (32) As regards stand-alone AI (32) As regards stand-alone AI (32) As regards stand-alone AI
systems, meaning high-risk AI systems, meaning high-risk AI systems, meaning high-risk AI systems, meaning high-risk AI
systems other than those that are systems other than those that are systems other than those that are systems other than those that are
safety components of products, or safety components of products, or safety components of products, or safety components of products, or
which are themselves products, it is which are themselves products and which are themselves products, it is which are themselves products, it is
appropriate to classify them as high- that are listed in one of the areas appropriate to classify them as high- appropriate to classify them as high-
risk if, in the light of their intended and use cases in Annex III, it is risk if, in the light of their intended risk if, in the light of their intended
purpose, they pose a high risk of appropriate to classify them as high- purpose, they pose a high risk of purpose, they pose a high risk of
harm to the health and safety or the risk if, in the light of their intended harm to the health and safety or the harm to the health and safety or the
fundamental rights of persons, purpose, they pose a highsignificant fundamental rights of persons, fundamental rights of persons,
taking into account both the severity risk of harm to the health and safety taking into account both the severity taking into account both the severity
of the possible harm and its or the fundamental rights of persons of the possible harm and its of the possible harm and its
probability of occurrence and they and, where the AI system is used as probability of occurrence, and they probability of occurrence and they
G 42 G
are used in a number of specifically a safety component of a critical are used in a number of specifically are used in a number of specifically
pre-defined areas specified in the infrastructure, to the environment . pre-defined areas specified in the pre-defined areas specified in the
Regulation. The identification of Such significant risk of harm Regulation. The identification of Regulation. The identification of
those systems is based on the same should be identified by assessing on those systems is based on the same those systems is based on the same
methodology and criteria envisaged the one hand the effect of such risk methodology and criteria envisaged methodology and criteria envisaged
also for any future amendments of with respect to its level of severity, also for any future amendments of also for any future amendments of
the list of high-risk AI systems. intensity, , taking into account both the list of high-risk AI systems. It is the list of high-risk AI systems that
the severity of the possible harm and also important to clarify that within the Commission should be
its probability of occurrence and the high-risk scenarios referred to empowered to adopt, via delegated
they are used in a number of in Annex III there may be systems acts, to take into account the rapid
specifically pre-defined areas that do not lead to a significant risk pace of technological development,
specified in the Regulationduration to the legal interests protected as well as the potential changes in
combined altogether and on the under those scenarios, taking into the use of AI systems.
other hand whether the risk can account the output produced by the
affect an individual, a plurality of AI system. Therefore only when
persons or a particular group of such output has a high degree of
persons. Such combination could importance (i.e. is not purely
for instance result in a high severity accessory) in respect of the relevant
but low probability to affect a action or decision so as to generate
natural person, or a high a significant risk to the legal
probability to affect a group of interests protected, the AI system
persons with a low intensity over a generating such output should be
long period of time, depending on considered as high-risk. For
the context. The identification of instance, when the information
those systems is based on the same provided by an AI systems to the
methodology and criteria envisaged human consists of the profiling of
also for any future amendments of natural persons within the meaning
the list of high-risk AI systems. of of Article 4(4) Regulation (EU)
2016/679 and Article 3(4) of
Directive (EU) 2016/680 and Article
3(5) of Regulation (EU) 2018/1725,
such information should not
typically be considered of accessory
nature in the context of high risk
AI systems as referred to in Annex
III. However, if the output of the AI
system has only negligible or minor
relevance for human action or
decision, it may be considered
purely accessory, including for
example, AI systems used for
translation for informative
purposes or for the management of
documents.
Recital 32a
(32a) Providers whose AI systems (32a) It is also important to clarify

G 42a G
fall under one of the areas and use that there may be specific cases in
cases listed in Annex III that which AI systems referred to pre-
consider their system does not pose defined areas specified in this
a significant risk of harm to the Regulation do not lead to a
health, safety, fundamental rights significant risk of harm to the legal
or the environment should inform interests protected under those
the national supervisory authorities areas, because they do not
by submitting a reasoned materially influence the decision-
notification. This could take the making or do not harm those
form of a one-page summary of the interests substantially. For the
relevant information on the AI purpose of this Regulation an AI
system in question, including its system not materially influencing
intended purpose and why it would the outcome of decision-making
not pose a significant risk of harm should be understood as an AI
to the health, safety, fundamental system that does not impact the
rights or the environment. The substance, and thereby the
Commission should specify criteria outcome, of decision-making,
to enable companies to assess whether human or automated. This
whether their system would pose could be the case if one or more of
such risks, as well as develop an the following conditions are
easy to use and standardised fulfilled. The first criterion should
template for the notification. be that the AI system is intended to
Providers should submit the perform a narrow procedural task,
notification as early as possible and such as an AI system that
in any case prior to the placing of transforms unstructured data into
the AI system on the market or its structured data, an AI system that
putting into service, ideally at the classifies incoming documents into
development stage, and they should categories or an AI system that is
be free to place it on the market at used to detect duplicates among a
any given time after the large number of applications. These
notification. However, if the tasks are of such narrow and
authority estimates the AI system in limited nature that they pose only
question was misclassified, it limited risks which are not
should object to the notification increased through the use in a
within a period of three months. context listed in Annex III. The
The objection should be second criterion should be that the
substantiated and duly explain why task performed by the AI system is
the AI system has been intended to improve the result of a
misclassified. The provider should previously completed human
retain the right to appeal by activity that may be relevant for the
providing further arguments. If purpose of the use case listed in
after the three months there has Annex III. Considering these
been no objection to the characteristics, the AI system only
notification, national supervisory provides an additional layer to a
authorities could still intervene if human activity with consequently
the AI system presents a risk at lowered risk. For example, this
national level, as for any other AI criterion would apply to AI systems
system on the market. National that are intended to improve the
supervisory authorities should language used in previously drafted
submit annual reports to the AI documents, for instance in relation
Office detailing the notifications to professional tone, academic style
received and the decisions taken. 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 signficant 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
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.
Recital 33
(33) Technical inaccuracies of AI (33) Technical inaccuracies of AI (33) Technical inaccuracies of AI

systems intended for the remote deleted systems intended for the remote systems intended for the remote
biometric identification of natural biometric identification of natural biometric identification of natural
persons can lead to biased results persons can lead to biased results persons can lead to biased results
and entail discriminatory effects. and entail discriminatory effects. and entail discriminatory effects.
This is particularly relevant when it This is particularly relevant when it This is particularly relevant when it
comes to age, ethnicity, sex or comes to age, ethnicity, race, sex or comes to age, ethnicity, sex or
disabilities. Therefore, ‘real-time’ disabilities. Therefore, ‘real-time’ disabilities. Therefore, ‘real-time’
G 43 G
and ‘post’ remote biometric and ‘post’ remote biometric and ‘post’ remote biometric
identification systems should be identification systems should be identification systems should be
classified as high-risk. In view of the classified as high-risk. In view of the classified as high-risk. In view of the
risks that they pose, both types of risks that they pose, both types of risks that they pose, both types of
remote biometric identification remote biometric identification remote biometric identification
systems should be subject to specific systems should be subject to specific systems should be subject to specific
requirements on logging capabilities requirements on logging capabilities requirements on logging capabilities
and human oversight. and human oversight. and human oversight.
Recital 33a
G 43a (33a) As biometric data constitute a (33a) As biometric data constitutes G
special category of sensitive a special category of sensitive

personal data in accordance with personal data, it is appropriate to
Regulation 2016/679, it is classify as high-risk several critical
appropriate to classify as high-risk use-cases of biometric systems,
several critical use-cases of insofar as their use is permitted
biometric and biometrics-based under relevant Union and national
systems. AI systems intended to be law.
used for biometric identification of Technical inaccuracies of AI
natural persons and AI systems systems intended for the remote
intended to be used to make biometric identification of natural
inferences about personal persons can lead to biased results
characteristics of natural persons and entail discriminatory effects.
on the basis of biometric or This is particularly relevant when it
biometrics-based data, including comes to age, ethnicity, race, sex or
emotion recognition systems, with disabilities. Therefore, remote
the exception of those which are biometric identification systems
prohibited under this Regulation should be classified as high-risk in
should therefore be classified as view of the risks that they pose. This
high-risk. This should not include excludes AI systems intended to be
AI systems intended to be used for used for biometric verification,
biometric verification, which which includes authentication,
includes authentication, whose sole whose sole purpose is to confirm
purpose is to confirm that a specific that a specific natural person is the
natural person is the person he or person he or she claims to be and to
she claims to be and to confirm the confirm the identity of a natural
identity of a natural person for the person for the sole purpose of
sole purpose of having access to a having access to a service,
service, a device or premises (one- unlocking a device or having secure
to-one verification). Biometric and access to premises.
biometrics-based systems which are
provided for under Union law to In addition, AI systems intended to
enable cybersecurity and personal be used for biometric categorisation
data protection measures should according to sensitive attributes or
not be considered as posing a characteristics protected under
significant risk of harm to the Article 9(1) of Regulation (EU)
health, safety and fundamental 2016/679 based on biometric data,
rights. 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.
Recital 34
(34) As regards the management (34) As regards the management (34) As regards the management (34) As regards the management
and operation of critical and operation of critical and operation of critical and operation of critical
infrastructure, it is appropriate to infrastructure, it is appropriate to infrastructure, it is appropriate to infrastructure, it is appropriate to
classify as high-risk the AI systems classify as high-risk the AI systems classify as high-risk the AI systems classify as high-risk the AI systems
intended to be used as safety intended to be used as safety intended to be used as safety intended to be used as safety
components in the management and components in the management and components in the management and components in the management and
operation of road traffic and the operation of road traffic and the operation of critical digital operation of critical digital
supply of water, gas, heating and supply of water, gas, heating infrastructure as listed in Annex I infrastructure as listed in Annex I
electricity, since their failure or electricity and critical digital point 8 of the Directive on the point 8 of the Directive on the
malfunctioning may put at risk the infrastructure and electricity, since resilience of critical entities, road resilience of critical entities, road
life and health of persons at large their failure or malfunctioning may traffic and the supply of water, gas, traffic and the supply of water, gas,
G 44 scale and lead to appreciable infringe the security and integrity heating and electricity, since their heating and electricity, since their G
disruptions in the ordinary conduct of such critical infrastructure or put failure or malfunctioning may put at failure or malfunctioning may put at
of social and economic activities. at risk the life and health of persons risk the life and health of persons at risk the life and health of persons at
at large scale and lead to appreciable large scale and lead to appreciable large scale and lead to appreciable
disruptions in the ordinary conduct disruptions in the ordinary conduct disruptions in the ordinary conduct
of social and economic activities. of social and economic activities. of social and economic activities.
Safety components of critical Safety components of critical Safety components of critical
infrastructure, including critical infrastructure, including critical infrastructure, including critical
digital infrastructure, are systems digital infrastrucure, are systems digital infrastrucure, are systems
used to directly protect the physical used to directly protect the physical used to directly protect the physical
integrity of critical infrastructure or integrity of critical infrastructure or integrity of critical infrastructure or
health and safety of persons and health and safety of persons and health and safety of persons and
property. Failure or malfunctioning property but which are not property but which are not
of such components might directly necessary in order for the system to necessary in order for the system to
lead to risks to the physical integrity function. Failure or malfunctioning function. Failure or malfunctioning
of critical infrastructure and thus to of such components might directly of such components might directly
risks to the health and safety of lead to risks to the physical integrity lead to risks to the physical integrity
persons and property. Components of critical infrastructure and thus to of critical infrastructure and thus to
intended to be used solely for risks to health and safety of persons risks to health and safety of persons
cybersecurity purposes should not and property. Components intended and property. Components intended
qualify as safety components. to be used solely for cybersecurity to be used solely for cybersecurity
Examples of such safety purposes should not qualify as purposes should not qualify as
components may include systems safety components. Examples of safety components. Examples of
for monitoring water pressure or safety components of such critical safety components of such critical
fire alarm controlling systems in infrastructure may include systems infrastructure may include systems
cloud computing centres. for monitoring water pressure or for monitoring water pressure or
fire alarm controlling systems in fire alarm controlling systems in
cloud computing centres. cloud computing centres.
Recital 35
(35) AI systems used in education (35) Deployment of AI systems in (35) AI systems used in education (35) Deployment of AI systems in
or vocational training, notably for education is important in order to or vocational training, notably for education is important to promote
determining access or assigning help modernise entire education determining access, admission or high-quality digital education and
persons to educational and systems, to increase educational assigning persons to educational and training and to allow all learners
vocational training institutions or to quality, both offline and online and vocational training institutions or to and teachers to acquire and share
evaluate persons on tests as part of to accelerate digital education, thus evaluate persons on tests as part of the necessary digital skills and
or as a precondition for their also making it available to a or as a precondition for their competences, including media
education should be considered broader audience. AI systems used educationprogrammes at all levels literacy, and critical thinking, to
G 45 high-risk, since they may determine in education or vocational training, or to evaluate learning outcomes of take an active part in the economy, G
the educational and professional notably for determining access or persons should be considered high- society, and in democratic
course of a person’s life and materially influence decisions on risk, since they may determine the processes. However, AI systems
therefore affect their ability to secure admission or assigning persons to educational and professional course used in education or vocational
their livelihood. When improperly educational and vocational training of a person’s life and therefore affect training, notably for determining
designed and used, such systems institutions or to evaluate persons on their ability to secure their access or admission, for assigning
may violate the right to education tests as part of or as a precondition livelihood. When improperly persons to educational and
and training as well as the right not for their education or to assess the designed and used, such systems vocational training institutions or
to be discriminated against and appropriate level of education for may violate the right to education programmes at all levels, for
perpetuate historical patterns of an individual and materially and training as well as the right not evaluating learning outcomes of to
discrimination. influence the level of education and to be discriminated against and evaluate persons, for assessing the
training that individuals will receive perpetuate historical patterns of appropriate level of education for
or be able to access or to monitor discrimination. an individual and materially
and detect prohibited behaviour of influencing the level of education
students during tests should be and training that individuals will
considered high-riskclassified as receive or be able to access or for
high-risk AI systems, since they monitoring and detecting prohibited
may determine the educational and behaviour of students during tests
professional course of a person’s life on tests as part of or as a
and therefore affect their ability to precondition for their education
secure their livelihood. When should be considered high-
improperly designed and used, such riskclassified as high-risk AI
systems can be particularly systems, since they may determine
intrusive and may violate the right the educational and professional
to education and training as well as course of a person’s life and
the right not to be discriminated therefore affect their ability to secure
against and perpetuate historical their livelihood. When improperly
patterns of discrimination, for designed and used, such systems can
example against women, certain be particularly intrusive and may
age groups, persons with violate the right to education and
disabilities, or persons of certain training as well as the right not to be
racial or ethnic origins or sexual discriminated against and perpetuate
orientation. 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.
Recital 36
(36) AI systems used in (36) AI systems used in (36) AI systems used in (36) AI systems used in
employment, workers management employment, workers management employment, workers management employment, workers management
G 46 G
and access to self-employment, and access to self-employment, and access to self-employment, and access to self-employment,
notably for the recruitment and notably for the recruitment and notably for the recruitment and notably for the recruitment and
selection of persons, for making selection of persons, for making selection of persons, for making selection of persons, for making
decisions on promotion and decisions or materially influence decisions on promotion and decisions on affecting terms of the
termination and for task allocation, decisions on initiation, on termination and for task allocation work related relationship
monitoring or evaluation of persons promotion and termination and for based on individual behavior or promotion and termination and for
in work-related contractual personalised task allocation based personal traits or characteristics, task allocation, of work-related
relationships, should also be on individual behaviour, personal monitoring or evaluation of persons contractual relationships for
classified as high-risk, since those traits or biometric data, monitoring in work-related contractual allocating tasks based on individual
systems may appreciably impact or evaluation of persons in work- relationships, should also be behaviour, personal traits or
future career prospects and related contractual relationships, classified as high-risk, since those characteristics and for monitoring
livelihoods of these persons. should also be classified as high- systems may appreciably impact or evaluation of persons in work-
Relevant work-related contractual risk, since those systems may future career prospects and related contractual relationships,
relationships should involve appreciably impact future career livelihoods of these persons. should also be classified as high-
employees and persons providing prospects and, livelihoods of these Relevant work-related contractual risk, since those systems may
services through platforms as persons and workers’ rights. relationships should involve appreciably impact future career
referred to in the Commission Work Relevant work-related contractual employees and persons providing prospects and, livelihoods of these
Programme 2021. Such persons relationships should meaningfully services through platforms as persons and workers’ rights.
should in principle not be considered involve employees and persons referred to in the Commission Work Relevant work-related contractual
users within the meaning of this providing services through platforms Programme 2021. Such persons relationships should meaningfully
Regulation. Throughout the as referred to in the Commission should in principle not be considered involve employees and persons
recruitment process and in the Work Programme 2021. Such users within the meaning of this providing services through platforms
evaluation, promotion, or retention persons should in principle not be Regulation. Throughout the as referred to in the Commission
of persons in work-related considered users within the meaning recruitment process and in the Work Programme 2021. Such
contractual relationships, such of this Regulation. Throughout the evaluation, promotion, or retention persons should in principle not be
systems may perpetuate historical recruitment process and in the of persons in work-related considered users within the meaning
patterns of discrimination, for evaluation, promotion, or retention contractual relationships, such of this Regulation. Throughout the
example against women, certain age of persons in work-related systems may perpetuate historical recruitment process and in the
groups, persons with disabilities, or contractual relationships, such patterns of discrimination, for evaluation, promotion, or retention
persons of certain racial or ethnic systems may perpetuate historical example against women, certain age of persons in work-related
origins or sexual orientation. AI patterns of discrimination, for groups, persons with disabilities, or contractual relationships, such
systems used to monitor the example against women, certain age persons of certain racial or ethnic systems may perpetuate historical
performance and behaviour of these groups, persons with disabilities, or origins or sexual orientation. AI patterns of discrimination, for
persons may also impact their rights persons of certain racial or ethnic systems used to monitor the example against women, certain age
to data protection and privacy. origins or sexual orientation. AI performance and behaviour of these groups, persons with disabilities, or
systems used to monitor the persons may also impact their rights persons of certain racial or ethnic
performance and behaviour of these to data protection and privacy. origins or sexual orientation. AI
persons may also impactundermine systems used to monitor the
the essence of their fundamental performance and behaviour of these
rights to data protection and privacy. persons may also impactundermine
This Regulation applies without their fundamental rights to data
prejudice to Union and Member protection and privacy.
State competences to provide for
more specific rules for the use of
AI-systems in the employment
context.
Recital 37
(37) Another area in which the use (37) Another area in which the use (37) Another area in which the use (37) Another area in which the use
of AI systems deserves special of AI systems deserves special of AI systems deserves special of AI systems deserves special
consideration is the access to and consideration is the access to and consideration is the access to and consideration is the access to and
enjoyment of certain essential enjoyment of certain essential enjoyment of certain essential enjoyment of certain essential
private and public services and private and public services, private and public services and private and public services and
benefits necessary for people to fully including healthcare services, and benefits necessary for people to fully benefits necessary for people to fully
participate in society or to improve essential services, including but not participate in society or to improve participate in society or to improve
one’s standard of living. In limited to housing, electricity, one’s standard of living. In one’s standard of living.
particular, AI systems used to heating/cooling and internet, and particular, AI systems used to In particular, AI systems used to
evaluate the credit score or benefits necessary for people to fully evaluate the credit score or evaluate the credit score or
creditworthiness of natural persons participate in society or to improve creditworthiness of natural persons creditworthiness of natural persons
should be classified as high-risk AI one’s standard of living. In should be classified as high-risk AI should be classified as high-risk AI
systems, since they determine those particular, AI systems used to systems, since they determine those systems, since they determine those
G 47 G
persons’ access to financial evaluate the credit score or persons’ access to financial persons’ access to financial
resources or essential services such creditworthiness of natural persons resources or essential services such resources or essentialapplying for
as housing, electricity, and should be classified as high-risk AI as housing, electricity, and or receiving essential public
telecommunication services. AI systems, since they determine those telecommunication services. AI assistance benefits and services
systems used for this purpose may persons’ access to financial systems used for this purpose may from public authorities namely
lead to discrimination of persons or resources or essential services such lead to discrimination of persons or healthcare services, social security
groups and perpetuate historical as housing, electricity, and groups and perpetuate historical benefits, social such as housing,
patterns of discrimination, for telecommunication services. AI patterns of discrimination, for electricity, and telecommunication
example based on racial or ethnic systems used for this purpose may example based on racial or ethnic services. AI systems used for this
origins, disabilities, age, sexual lead to discrimination of persons or origins, disabilities, age, sexual purpose may lead to discrimination
orientation, or create new forms of groups and perpetuate historical orientation, or create new forms of of persons or groups and perpetuate
discriminatory impacts. Considering patterns of discrimination, for discriminatory impacts. Considering historical patterns of discrimination,
the very limited scale of the impact example based on racial or ethnic the very limited scale of the impact for example based on racial or
and the available alternatives on the origins, gender, disabilities, age, and the available alternatives on the ethnic origins, disabilities, age,
market, it is appropriate to exempt sexual orientation, or create new market, it is appropriate to exempt sexual orientation, or create new
AI systems for the purpose of forms of discriminatory impacts. AI systems for the purpose of forms of discriminatory impacts.
creditworthiness assessment and Considering the very limited scale of creditworthiness assessment and Considering the very limited scale of
credit scoring when put into service the impact and the available credit scoring when put into service the impact and the available
by small-scale providers for their alternatives on the market, it is by small-scale providersmicro or alternatives on the market, it is
own use. Natural persons applying appropriate to exempt AI small entreprises, as defined in the appropriate to exempt AI systems for
for or receiving public assistance systemsHowever, AI systems Annex of Commission the purpose of creditworthiness
benefits and services from public provided for by Union law for the Recommendation 2003/361/EC for assessment and credit scoring when
authorities are typically dependent purpose of creditworthiness their own use. Natural persons put into service by small-scale
on those benefits and services and in assessment and credit scoring when applying for or receiving essential providers for their own use. Natural
a vulnerable position in relation to put into service by small-scale public assistance benefits and persons applying for or receiving
the responsible authorities. If AI providers for their own usedetecting services from public authorities are public providing protection in cases
systems are used for determining fraud in the offering of financial typically dependent on those benefits such as maternity, illness, industrial
whether such benefits and services services should not be considered as and services and in a vulnerable accidents, dependency or old age
should be denied, reduced, revoked high-risk under this Regulation. position in relation to the responsible and loss of employment and social
or reclaimed by authorities, they Natural persons applying for or authorities. If AI systems are used and housing assistance benefits and
may have a significant impact on receiving public assistance benefits for determining whether such services from public authorities, are
persons’ livelihood and may infringe and services from public authorities, benefits and services should be typically dependent on those benefits
their fundamental rights, such as the including healthcare services and denied, reduced, revoked or and services and in a vulnerable
right to social protection, non- essential services, including but not reclaimed by authorities, position in relation to the responsible
discrimination, human dignity or an limited to housing, electricity, theyincluding whether beneficiaries authorities. If AI systems are used
effective remedy. Those systems heating/cooling and internet, are are legitimately entitled to such for determining whether such
should therefore be classified as typically dependent on those benefits benefits or services, those systems benefits and services should be
high-risk. Nonetheless, this and services and in a vulnerable may have a significant impact on granted, denied, reduced, revoked or
Regulation should not hamper the position in relation to the responsible persons’ livelihood and may infringe reclaimed by authorities,
development and use of innovative authorities. If AI systems are used their fundamental rights, such as the theyincluding whether beneficiaries
approaches in the public for determining whether such right to social protection, non- are legitimately entitled to such
administration, which would stand to benefits and services should be discrimination, human dignity or an benefits or services, those systems
benefit from a wider use of denied, reduced, revoked or effective remedy. Those systems may have a significant impact on
compliant and safe AI systems, reclaimed by authorities, they may should therefore be classified as persons’ livelihood and may infringe
provided that those systems do not have a significant impact on high-risk. Nonetheless, this their fundamental rights, such as the
entail a high risk to legal and natural persons’ livelihood and may infringe Regulation should not hamper the right to social protection, non-
persons. Finally, AI systems used to their fundamental rights, such as the development and use of innovative discrimination, human dignity or an
dispatch or establish priority in the right to social protection, non- approaches in the public effective remedy. Those systems and
dispatching of emergency first discrimination, human dignity or an administration, which would stand to should therefore be classified as
response services should also be effective remedy. Similarly, AI benefit from a wider use of high-risk. Nonetheless, this
classified as high-risk since they systems intended to be used to make compliant and safe AI systems, Regulation should not hamper the
make decisions in very critical decisions or materially influence provided that those systems do not development and use of innovative
situations for the life and health of decisions on the eligibility of entail a high risk to legal and natural approaches in the public
persons and their property. natural persons for health and life persons. Finally, AI systems used to administration, which would stand to
insurance may also have a dispatch or establish priority in the benefit from a wider use of
significant impact on persons’ dispatching of emergency first compliant and safe AI systems,
livelihood and may infringe their response services should also be provided that those systems do not
fundamental rights such as by classified as high-risk since they entail a high risk to legal and natural
limiting access to healthcare or by make decisions in very critical persons.
perpetuating discrimination based situations for the life and health of In addition, AI systems used to
on personal characteristics. Those persons and their property. AI evaluate the credit score or
systems should therefore be systems are also increasingly used creditworthiness of natural persons
classified as high-risk. Nonetheless, for risk assessment in relation to should be classified as high-risk AI
this Regulation should not hamper natural persons and pricing in the systems, since they determine those
the development and use of case of life and health insurance persons’ access to financial
innovative approaches in the public which, if not duly designed, resources or essential services such
administration, which would stand to developed and used, can lead to as housing, electricity, and
benefit from a wider use of serious consequences for people’s telecommunication services. AI
compliant and safe AI systems, life and health, including financial systems used for this purpose may
provided that those systems do not exclusion and discrimination. To lead to discrimination of persons or
entail a high risk to legal and natural ensure a consistent approach within groups and perpetuate historical
persons. Finally, AI systems used to the financial services sector, the patterns of discrimination, for
evaluate and classify emergency above mentioned exception for example based on racial or ethnic
calls by natural persons or to micro or small enterprises for their origins, gender, disabilities, age,
dispatch or establish priority in the own use should apply, insofar as sexual orientation, or create new
dispatching of emergency first they themselves provide and put forms of discriminatory impacts.
response services should also be into service an AI system for the However, AI systems provided for
classified as high-risk since they purpose of selling their own by Union law for the purpose of
make decisions in very critical insurance products. detecting fraud in the offering of
situations for the life and health of financial services and for
persons and their property. 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.
Recital 37a
(37a) Given the role and

responsibility of police and judicial
authorities, and the impact of
decisions they take for the purposes
G 47a of the prevention, investigation, G
detection or prosecution of criminal

offences or the execution of
criminal penalties, some specific
use-cases of AI applications in law
enforcement has to be classified as
high-risk, in particular in instances
where there is the potential to
significantly affect the lives or the
fundamental rights of individuals.
Recital 38
(38) Actions by law enforcement (38) Actions by law enforcement (38) Actions by law enforcement (38) Given their role and
authorities involving certain uses of authorities involving certain uses of authorities involving certain uses of responsibility, actions by law
AI systems are characterised by a AI systems are characterised by a AI systems are characterised by a enforcement authorities involving
significant degree of power significant degree of power significant degree of power certain uses of AI systems are
imbalance and may lead to imbalance and may lead to imbalance and may lead to characterised by a significant degree
surveillance, arrest or deprivation of surveillance, arrest or deprivation of surveillance, arrest or deprivation of of power imbalance and may lead to
a natural person’s liberty as well as a natural person’s liberty as well as a natural person’s liberty as well as surveillance, arrest or deprivation of
other adverse impacts on other adverse impacts on other adverse impacts on a natural person’s liberty as well as
fundamental rights guaranteed in the fundamental rights guaranteed in the fundamental rights guaranteed in the other adverse impacts on
Charter. In particular, if the AI Charter. In particular, if the AI Charter. In particular, if the AI fundamental rights guaranteed in the
system is not trained with high system is not trained with high system is not trained with high Charter. In particular, if the AI
quality data, does not meet adequate quality data, does not meet adequate quality data, does not meet adequate system is not trained with high
requirements in terms of its accuracy requirements in terms of its requirements in terms of its accuracy quality data, does not meet adequate
or robustness, or is not properly performance, its accuracy or or robustness, or is not properly requirements in terms of its
G 48 G
designed and tested before being put robustness, or is not properly designed and tested before being put performance, its accuracy or
on the market or otherwise put into designed and tested before being put on the market or otherwise put into robustness, or is not properly
service, it may single out people in a on the market or otherwise put into service, it may single out people in a designed and tested before being put
discriminatory or otherwise incorrect service, it may single out people in a discriminatory or otherwise incorrect on the market or otherwise put into
or unjust manner. Furthermore, the discriminatory or otherwise incorrect or unjust manner. Furthermore, the service, it may single out people in a
exercise of important procedural or unjust manner. Furthermore, the exercise of important procedural discriminatory or otherwise incorrect
fundamental rights, such as the right exercise of important procedural fundamental rights, such as the right or unjust manner. Furthermore, the
to an effective remedy and to a fair fundamental rights, such as the right to an effective remedy and to a fair exercise of important procedural
trial as well as the right of defence to an effective remedy and to a fair trial as well as the right of defence fundamental rights, such as the right
and the presumption of innocence, trial as well as the right of defence and the presumption of innocence, to an effective remedy and to a fair
could be hampered, in particular, and the presumption of innocence, could be hampered, in particular, trial as well as the right of defence
where such AI systems are not could be hampered, in particular, where such AI systems are not and the presumption of innocence,
sufficiently transparent, explainable where such AI systems are not sufficiently transparent, explainable could be hampered, in particular,
and documented. It is therefore sufficiently transparent, explainable and documented. It is therefore where such AI systems are not
appropriate to classify as high-risk a and documented. It is therefore appropriate to classify as high-risk a sufficiently transparent, explainable
number of AI systems intended to be appropriate to classify as high-risk a number of AI systems intended to be and documented. It is therefore
used in the law enforcement context number of AI systems intended to be used in the law enforcement context appropriate to classify as high-risk,
where accuracy, reliability and used in the law enforcement context where accuracy, reliability and insofar as their use is permitted
transparency is particularly where accuracy, reliability and transparency is particularly under relevant Union and national
important to avoid adverse impacts, transparency is particularly important to avoid adverse impacts, law, a number of AI systems
retain public trust and ensure important to avoid adverse impacts, retain public trust and ensure intended to be used in the law
accountability and effective redress. retain public trust and ensure accountability and effective redress. enforcement context where
In view of the nature of the activities accountability and effective redress. In view of the nature of the activities accuracy, reliability and
in question and the risks relating In view of the nature of the activities in question and the risks relating transparency is particularly
thereto, those high-risk AI systems in question and the risks relating thereto, those high-risk AI systems important to avoid adverse impacts,
should include in particular AI thereto, those high-risk AI systems should include in particular AI retain public trust and ensure
systems intended to be used by law should include in particular AI systems intended to be used by law accountability and effective redress.
enforcement authorities for systems intended to be used by law enforcement authorities for In view of the nature of the activities
individual risk assessments, enforcement authorities for individual risk assessments, in question and the risks relating
polygraphs and similar tools or to individual risk assessments, polygraphs and similar tools or to thereto, those high-risk AI systems
detect the emotional state of natural polygraphs and similar tools or to detect the emotional state of natural should include in particular AI
person, to detect ‘deep fakes’, for the detect the emotional state of natural person, to detect ‘deep fakes’, for the systems intended to be used by or on
evaluation of the reliability of person, to detect ‘deep fakes’, for the evaluation of the reliability of behalf of law enforcement
evidence in criminal proceedings, evaluation of the reliability of evidence in criminal proceedings, authorities for individual risk
for predicting the occurrence or evidence in criminal proceedings, for predicting the occurrence or assessments, polygraphs and similar
reoccurrence of an actual or for predicting the occurrence or reoccurrence of an actual or tools or to detect the emotional state
potential criminal offence based on reoccurrence of an actual or potential criminal offence based on of or by Union agencies, offices or
profiling of natural persons, or potential criminal offence based on profiling of natural persons, or bodies in support of law
assessing personality traits and profiling of natural persons, or assessing personality traits and enforcement authorities for
characteristics or past criminal assessing personality traits and characteristics or past criminal assessing the risk of a natural
behaviour of natural persons or characteristics or past criminal behaviour of natural persons or person, to detect ‘deep fakes’ to
groups, for profiling in the course of behaviour of natural persons or groups, for profiling in the course of become a victim of criminal
detection, investigation or groupsor on behalf of law detection, investigation or offences, as polygraphs and similar
prosecution of criminal offences, as enforcement authorities or by prosecution of criminal offences, as tools , for the evaluation of the
well as for crime analytics regarding Union agencies, offices or bodies in well as for crime analytics regarding reliability of evidence in in the
natural persons. AI systems support of law enforcement natural persons. AI systems course of investigation or
specifically intended to be used for authorities, as polygraphs and specifically intended to be used for prosecution of criminal proceedings,
administrative proceedings by tax similar tools insofar as their use is administrative proceedings by tax for predicting the occurrence or
and customs authorities should not permitted under relevant Union and and customs authorities as well as by reoccurrence of an actual or
be considered high-risk AI systems national law, for the evaluation of financial intelligence units carrying potential criminal offenceoffences,
used by law enforcement authorities the reliability of evidence in out adminstrative tasks analysing and, insofar not prohibited under
for the purposes of prevention, criminal proceedings, for profiling information pursuant to Union this regulation, for assessing the
detection, investigation and in the course of detection, anti-money laundering legislation risk of a natural person of
prosecution of criminal offences. investigation or prosecution of should not be considered high-risk offending or reoffending not solely
criminal offences, as well as for AI systems used by law enforcement based on profiling of natural
crime analytics regarding natural authorities for the purposes of persons, or nor based on assessing
persons. AI systems specifically prevention, detection, investigation personality traits and characteristics
intended to be used for and prosecution of criminal or past criminal behaviour of natural
administrative proceedings by tax offences. persons or groups, for profiling in
and customs authorities should not the course of detection, investigation
be consideredclassified as high-risk or prosecution of criminal offences,
AI systems used by law enforcement as well as for crime analytics
authorities for the purposes of regarding natural persons. AI
prevention, detection, investigation systems specifically intended to be
and prosecution of criminal used for administrative proceedings
offences. The use of AI tools by law by tax and customs authorities as
enforcement and judicial well as by financial intelligence
authorities should not become a units carrying out adminstrative
factor of inequality, social fracture tasks analysing information
or exclusion. The impact of the use pursuant to Union anti-money
of AI tools on the defence rights of laundering legislation should not be
suspects should not be ignored, consideredclassified as high-risk AI
notably the difficulty in obtaining systems used by law enforcement
meaningful information on their authorities for the purposes of
functioning and the consequent prevention, detection, investigation
difficulty in challenging their and prosecution of criminal
results in court, in particular by offences. The use of AI tools by law
individuals under investigation. 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.
Recital 39
(39) AI systems used in migration, (39) AI systems used in migration, (39) AI systems used in migration, (39) AI systems used in migration,
asylum and border control asylum and border control asylum and border control asylum and border control
management affect people who are management affect people who are management affect people who are management affect people who are
often in particularly vulnerable often in particularly vulnerable often in particularly vulnerable often in particularly vulnerable
position and who are dependent on position and who are dependent on position and who are dependent on position and who are dependent on
the outcome of the actions of the the outcome of the actions of the the outcome of the actions of the the outcome of the actions of the
competent public authorities. The competent public authorities. The competent public authorities. The competent public authorities. The
accuracy, non-discriminatory nature accuracy, non-discriminatory nature accuracy, non-discriminatory nature accuracy, non-discriminatory nature
and transparency of the AI systems and transparency of the AI systems and transparency of the AI systems and transparency of the AI systems
used in those contexts are therefore used in those contexts are therefore used in those contexts are therefore used in those contexts are therefore
particularly important to guarantee particularly important to guarantee particularly important to guarantee particularly important to guarantee
the respect of the fundamental rights the respect of the fundamental rights the respect of the fundamental rights the respect of the fundamental rights
of the affected persons, notably their of the affected persons, notably their of the affected persons, notably their of the affected persons, notably their
rights to free movement, non- rights to free movement, non- rights to free movement, non- rights to free movement, non-
discrimination, protection of private discrimination, protection of private discrimination, protection of private discrimination, protection of private
life and personal data, international life and personal data, international life and personal data, international life and personal data, international
G 49 G
protection and good administration. protection and good administration. protection and good administration. protection and good administration.
It is therefore appropriate to classify It is therefore appropriate to classify It is therefore appropriate to classify It is therefore appropriate to classify
as high-risk AI systems intended to as high-risk AI systems intended to as high-risk AI systems intended to as high-risk, insofar as their use is
be used by the competent public be used by theor on behalf of be used by the competent public permitted under relevant Union and
authorities charged with tasks in the competent public authorities or by authorities charged with tasks in the national law AI systems intended to
fields of migration, asylum and Union agencies, offices or bodies fields of migration, asylum and be used by theor on behalf of
border control management as charged with tasks in the fields of border control management as competent public authorities or by
polygraphs and similar tools or to migration, asylum and border polygraphs and similar tools or to Union agencies, offices or bodies
detect the emotional state of a control management as polygraphs detect the emotional state of a charged with tasks in the fields of
natural person; for assessing certain and similar tools or to detect the natural person; for assessing certain migration, asylum and border
risks posed by natural persons emotional state of a natural risks posed by natural persons control management as polygraphs
entering the territory of a Member person;insofar as their use is entering the territory of a Member and similar tools or to detect the
State or applying for visa or asylum; permitted under relevant Union and State or applying for visa or asylum; emotional state of a natural person;,
for verifying the authenticity of the national law, for assessing certain for verifying the authenticity of the for assessing certain risks posed by
relevant documents of natural risks posed by natural persons relevant documents of natural natural persons entering the territory
persons; for assisting competent entering the territory of a Member persons; for assisting competent of a Member State or applying for
public authorities for the State or applying for visa or asylum; public authorities for the visa or asylum; for verifying the
examination of applications for for verifying the authenticity of the examination of applications for authenticity of the relevant
asylum, visa and residence permits relevant documents of natural asylum, visa and residence permits documents of natural persons;, for
and associated complaints with persons; for assisting competent and associated complaints with assisting competent public
regard to the objective to establish public authorities for the regard to the objective to establish authorities for the examination,
the eligibility of the natural persons examination and assessment of the the eligibility of the natural persons including related assessment of the
applying for a status. AI systems in veracity of evidence in relation to of applying for a status. AI systems in reliability of evidence, of of
the area of migration, asylum and applications for asylum, visa and the area of migration, asylum and applications for asylum, visa and
border control management covered residence permits and associated border control management covered residence permits and associated
by this Regulation should comply complaints with regard to the by this Regulation should comply complaints with regard to the
with the relevant procedural objective to establish the eligibility with the relevant procedural objective to establish the eligibility
requirements set by the Directive of the natural persons applying for a requirements set by the Directive of the natural persons applying for a
2013/32/EU of the European status; for monitoring, surveilling 2013/32/EU of the European status, for the purpose of detecting,
Parliament and of the Council1, the or processing personal data in the Parliament and of the Council1, the recognising or identifying natural
Regulation (EC) No 810/2009 of the context of border management Regulation (EC) No 810/2009 of the persons in the context of migration,
European Parliament and of the activities, for the purpose of European Parliament and of the asylum and border control
Council2 and other relevant detecting, recognising or identifying Council2 and other relevant management with the exception of
legislation. natural persons; for the forecasting legislation. travel documents. AI systems in the
_________ or prediction of trends related to _________ area of migration, asylum and border
1. Directive 2013/32/EU of the European migration movements and border 1. Directive 2013/32/EU of the European control management covered by this
Parliament and of the Council of 26 June crossings. AI systems in the area of Parliament and of the Council of 26 June Regulation should comply with the
2013 on common procedures for granting 2013 on common procedures for granting
and withdrawing international protection (OJ migration, asylum and border and withdrawing international protection (OJ relevant procedural requirements set
L 180, 29.6.2013, p. 60). control management covered by this L 180, 29.6.2013, p. 60). by the Directive 2013/32/EU of the
2. Regulation (EC) No 810/2009 of the Regulation should comply with the 2. Regulation (EC) No 810/2009 of the European Parliament and of the
European Parliament and of the Council of relevant procedural requirements set European Parliament and of the Council of Council1, the Regulation (EC) No
13 July 2009 establishing a Community 13 July 2009 establishing a Community
Code on Visas (Visa Code) (OJ L 243,
by the Directive 2013/32/EU of the Code on Visas (Visa Code) (OJ L 243,
810/2009 of the European
15.9.2009, p. 1). European Parliament and of the 15.9.2009, p. 1). Parliament and of the Council2 and
Council1, the Regulation (EC) No other relevant legislation. The use of
810/2009 of the European AI systems in migration, asylum
Parliament and of the Council2 and and border control management
other relevant legislation. The use of should in no circumstances be used
AI systems in migration, asylum by Member States or Union
and border control management institutions, agencies or bodies as a
should in no circumstances be used means to circumvent their
by Member States or Union international obligations under the
institutions, agencies or bodies as a Convention of 28 July 1951 relating
means to circumvent their to the Status of Refugees as
international obligations under the amended by the Protocol of 31
Convention of 28 July 1951 relating January 1967, nor should they be
to the Status of Refugees as used to in any way infringe on the
amended by the Protocol of 31 principle of non-refoulement, or
January 1967, nor should they be deny safe and effective legal
used to in any way infringe on the avenues into the territory of the
principle of non-refoulement, or or Union, including the right to
deny safe and effective legal international protection.
avenues into the territory of the _________
Union, including the right to 1. Directive 2013/32/EU of the European
international protection. Parliament and of the Council of 26 June
2013 on common procedures for granting
_________ and withdrawing international protection (OJ
1. Directive 2013/32/EU of the European L 180, 29.6.2013, p. 60).
Parliament and of the Council of 26 June 2. Regulation (EC) No 810/2009 of the
2013 on common procedures for granting European Parliament and of the Council of
and withdrawing international protection (OJ 13 July 2009 establishing a Community
L 180, 29.6.2013, p. 60). Code on Visas (Visa Code) (OJ L 243,
2. Regulation (EC) No 810/2009 of the 15.9.2009, p. 1).
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).
Recital 40
(40) Certain AI systems intended (40) Certain AI systems intended (40) Certain AI systems intended (40) Certain AI systems intended
for the administration of justice and for the administration of justice and for the administration of justice and for the administration of justice and
democratic processes should be democratic processes should be democratic processes should be democratic processes should be
classified as high-risk, considering classified as high-risk, considering classified as high-risk, considering classified as high-risk, considering
their potentially significant impact their potentially significant impact their potentially significant impact their potentially significant impact
on democracy, rule of law, on democracy, rule of law, on democracy, rule of law, on democracy, rule of law,
G 50 individual freedoms as well as the individual freedoms as well as the individual freedoms as well as the individual freedoms as well as the G
right to an effective remedy and to a right to an effective remedy and to a right to an effective remedy and to a right to an effective remedy and to a
fair trial. In particular, to address the fair trial. In particular, to address the fair trial. In particular, to address the fair trial. In particular, to address the
risks of potential biases, errors and risks of potential biases, errors and risks of potential biases, errors and risks of potential biases, errors and
opacity, it is appropriate to qualify opacity, it is appropriate to qualify opacity, it is appropriate to qualify opacity, it is appropriate to qualify
as high-risk AI systems intended to as high-risk AI systems intended to as high-risk AI systems intended to as high-risk AI systems intended to
assist judicial authorities in be used by a judicial authority or assist judicial authorities in be used by a judicial authority or on
researching and interpreting facts administrative body or on their researching and interpreting facts its behalf to assist judicial
and the law and in applying the law behalf to assist judicial authorities and the law and in applying the law authorities in researching and
to a concrete set of facts. Such or administrative bodies in to a concrete set of facts. Such interpreting facts and the law and in
qualification should not extend, researching and interpreting facts qualification should not extend, applying the law to a concrete set of
however, to AI systems intended for and the law and in applying the law however, to AI systems intended for facts. AI systems intended to be
purely ancillary administrative to a concrete set of facts or used in a purely ancillary administrative used by alternative dispute
activities that do not affect the actual similar way in alternative dispute activities that do not affect the actual resolution bodies for those purposes
administration of justice in resolution. The use of artificial administration of justice in should also be considered high-risk
individual cases, such as intelligence tools can support, but individual cases, such as when the outcomes of the
anonymisation or pseudonymisation should not replace the decision- anonymisation or pseudonymisation alternative dispute resolution
of judicial decisions, documents or making power of judges or judicial of judicial decisions, documents or proceedings produce legal effects
data, communication between independence, as the final decision- data, communication between for the parties. The use of artificial
personnel, administrative tasks or making must remain a human- personnel, administrative tasks or intelligence tools can supportthe
allocation of resources. driven activity and decision. Such allocation of resources. decision-making power of judges or
qualification should not extend, judicial independence, but should
however, to AI systems intended for not replace it, as the final decision-
purely ancillary administrative making must remain a human-
activities that do not affect the actual driven activity and decision. Such
administration of justice in qualification should not extend,
individual cases, such as however, to AI systems intended for
anonymisation or pseudonymisation purely ancillary administrative
of judicial decisions, documents or activities that do not affect the actual
data, communication between administration of justice in
personnel, administrative tasks or individual cases, such as
allocation of resources. anonymisation or pseudonymisation
of judicial decisions, documents or
data, communication between
personnel, administrative tasks or
allocation of resources.
Recital 40a
(40a) In order to address the risks (40a) Without prejudice to the

of undue external interference to rules provided for in [Regulation
G 50a G
the right to vote enshrined in xxx on the transparency and
Article 39 of the Charter, and of targeting of political advertising],
disproportionate effects on and in order to address the risks of
democratic processes, democracy, undue external interference to the
and the rule of law, AI systems right to vote enshrined in Article 39
intended to be used to influence the of the Charter, and of adverse
outcome of an election or effects on democracy, and the rule
referendum or the voting behaviour of law, AI systems intended to be
of natural persons in the exercise of used to influence the outcome of an
their vote in elections or referenda election or referendum or the
should be classified as high-risk AI voting behaviour of natural persons
systems. with the exception of AI in the exercise of their vote in
systems whose output natural elections or referenda should be
persons are not directly exposed to, classified as high-risk AI systems
such as tools used to organise, with the exception of AI systems
optimise and structure political whose output natural persons are
campaigns from an administrative not directly exposed to, such as
and logistical point of view. tools used to organise, optimise and
structure political campaigns from
an administrative and logistical
point of view.
Recital 40b
(40b) Considering the scale of

natural persons using the services
provided by social media platforms
designated as very large online
platforms, such online platforms
can be used in a way that strongly
influences safety online, the
G 50b G
shaping of public opinion and
discourse, election and democratic
processes and societal concerns. It
is therefore appropriate that AI
systems used by those online
platforms in their recommender
systems are subject to this
Regulation so as to ensure that the
AI systems comply with the
requirements laid down under this
Regulation, including the technical
requirements on data governance,
technical documentation and
traceability, transparency, human
oversight, accuracy and robustness.
Compliance with this Regulation
should enable such very large
online platforms to comply with
their broader risk assessment and
risk-mitigation obligations in
Article 34 and 35 of Regulation EU
2022/2065. The obligations in this
Regulation are without prejudice to
should complement the obligations
required under the Regulation (EU)
2022/2065 when the social media
platform has been designated as a
very large online platform. Given
the European-wide impact of social
media platforms designated as very
large online platforms, the
authorities designated under
Regulation (EU) 2022/2065 should
act as enforcement authorities for
the purposes of enforcing this
provision.
Recital 41
(41) The fact that an AI system is (41) The fact that an AI system is (41) The fact that an AI system is (41) The fact that an AI system is
G 51 classified as high risk under this classified as a high risk AI system classified as high risk under this classified as a high risk AI system G
Regulation should not be interpreted under this Regulation should not be Regulation should not be interpreted under this Regulation should not be
as indicating that the use of the interpreted as indicating that the use as indicating that the use of the interpreted as indicating that the use
system is necessarily lawful under of the system is necessarily lawful or system is necessarily lawful under of the system is necessarily lawful
other acts of Union law or under unlawful under other acts of Union other acts of Union law or under under other acts of Union law or
national law compatible with Union law or under national law national law compatible with Union under national law compatible with
law, such as on the protection of compatible with Union law, such as law, such as on the protection of Union law, such as on the protection
personal data, on the use of on the protection of personal data, personal data, on the use of of personal data, on the use of
polygraphs and similar tools or other on the use of polygraphs and similar polygraphs and similar tools or other polygraphs and similar tools or other
systems to detect the emotional state tools or other systems to detect the systems to detect the emotional state systems to detect the emotional state
of natural persons. Any such use emotional state of natural persons. of natural persons. Any such use of natural persons. Any such use
should continue to occur solely in Any such use should continue to should continue to occur solely in should continue to occur solely in
accordance with the applicable occur solely in accordance with the accordance with the applicable accordance with the applicable
requirements resulting from the applicable requirements resulting requirements resulting from the requirements resulting from the
Charter and from the applicable acts from the Charter and from the Charter and from the applicable acts Charter and from the applicable acts
of secondary Union law and national applicable acts of secondary Union of secondary Union law and national of secondary Union law and national
law. This Regulation should not be law and national law. This law. This Regulation should not be law. This Regulation should not be
understood as providing for the legal Regulation should not be understood understood as providing for the legal understood as providing for the legal
ground for processing of personal as providing for the legal ground for ground for processing of personal ground for processing of personal
data, including special categories of processing of personal data, data, including special categories of data, including special categories of
personal data, where relevant. including special categories of personal data, where relevant, unless personal data, where relevant, unless
personal data, where relevant. it is specifically provided for it is specifically provided for
otherwise in this Regulation. otherwise in this Regulation.
Recital 41a
(41a) A number of legally binding

rules at European, national and
international level already apply or
are relevant to AI systems today,
including but not limited to EU
primary law (the Treaties of the
G 51a G
European Union and its Charter of
Fundamental Rights), EU
secondary law (such as the General
Data Protection Regulation, the
Product Liability Directive, the
Regulation on the Free Flow of
Non-Personal Data, anti-
discrimination Directives,
consumer law and Safety and
Health at Work Directives), the UN
Human Rights treaties and the
Council of Europe conventions
(such as the European Convention
on Human Rights), and national
law. Besides horizontally applicable
rules, various domain-specific rules
exist that apply to particular AI
applications (such as for instance
the Medical Device Regulation in
the healthcare sector).
Recital 42
(42) To mitigate the risks from (42) To mitigate the risks from (42) To mitigate the risks from (42) To mitigate the risks from
high-risk AI systems placed or high-risk AI systems placed or high-risk AI systems placed or high-risk AI systems placed or
otherwise put into service on the otherwise put into service on the otherwise put into service on the otherwiseon the market or put into
Union market for users and affected Union market for usersdeployers and Union market for users and affected service on the Union market for
persons, certain mandatory affected persons, certain mandatory persons, certain mandatory users and affected personsand to
requirements should apply, taking requirements should apply, taking requirements should apply, taking ensure a high level of
into account the intended purpose of into account the intended purpose of into account the intended purpose of trustworthiness, certain mandatory
the use of the system and according the use, the reasonably foreseeable the use of the system and according requirements should apply to high
to the risk management system to be misuse of the system and according to the risk management system to be risk AI systems, taking into account
G 52 established by the provider. to the risk management system to be established by the provider. In the intended purpose of theand the G
established by the provider. These particular, the risk management context of use of the AI system and
requirements should be objective- system should consist of a according to the risk management
driven, fit for purpose, reasonable continuous iterative process system to be established by the
and effective, without adding undue planned and run throughout the provider. The measures adopted by
regulatory burdens or costs on entire lifecycle of a high-risk AI the providers to comply with the
operators. system. This process should ensure mandatory requirements of this
that the provider identifies and Regulation should take into
analyses the risks to the health, account the generally acknowledge
safety and fundamental rights of state of the art on artificial
the persons who may be affected by intelligence, be proportionate and
the system in light of its intended effective to meet the objectives of
purpose, including the possible this Regulation.
risks arising from the interaction Following the New Legislative
between the AI system and the Framework approach, as clarified
environment within which it in Commission notice the ‘Blue
operates, and accordingly adopts Guide’ on the implementation of
suitable risk management measures EU product rules 2022
in the light of state of the art. (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
Annex II, Section A. This however
should not in any way undermine
the obligation of the provider to
comply with all the applicable
requirements.
Recital 42a
(42a) The risk management system

G 52a G
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 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.
Recital 43
(43) Requirements should apply to (43) Requirements should apply to (43) Requirements should apply to (43) Requirements should apply to
high-risk AI systems as regards the high-risk AI systems as regards the high-risk AI systems as regards the high-risk AI systems as regards risk
quality of data sets used, technical quality and relevance of data sets quality of data sets used, technical management, the quality and
documentation and record-keeping, used, technical documentation and documentation and record-keeping, relevance of data sets used, technical
transparency and the provision of record-keeping, transparency and the transparency and the provision of documentation and record-keeping,
information to users, human provision of information to information to users, human transparency and the provision of
oversight, and robustness, accuracy usersdeployers, human oversight, oversight, and robustness, accuracy information to usersdeployers ,
and cybersecurity. Those and robustness, accuracy and and cybersecurity. Those human oversight, and robustness,
requirements are necessary to cybersecurity. Those requirements requirements are necessary to accuracy and cybersecurity. Those
effectively mitigate the risks for are necessary to effectively mitigate effectively mitigate the risks for requirements are necessary to
G 53 G
health, safety and fundamental the risks for health, safety and health, safety and fundamental effectively mitigate the risks for
rights, as applicable in the light of fundamental rights, as well as the rights, as applicable in the light of health, safety and fundamental
the intended purpose of the system, environment, democracy and rule the intended purpose of the system, rights, as applicable in the light of
and no other less trade restrictive of law, as applicable in the light of and no other less trade restrictive the intended purpose of the system,
measures are reasonably available, the intended purpose or reasonably measures are reasonably available, and no other less trade restrictive
thus avoiding unjustified restrictions foreseeable misuse of the system, thus avoiding unjustified restrictions measures are reasonably available,
to trade. and no other less trade restrictive to trade. thus avoiding unjustified restrictions
measures are reasonably available, to trade.
thus avoiding unjustified restrictions
to trade.
Recital 44
(44) High data quality is essential (44) High dataAccess to data of (44) High data quality is essential (44) High quality data and access
for the performance of many AI high quality is essential forplays a for the performance of many AI to high High data quality is essential
systems, especially when techniques vital role in providing structure and systems, especially when techniques fordata plays a vital role in
G 54 involving the training of models are in ensuring the performance of involving the training of models are providing structure and in ensuring G
used, with a view to ensure that the many AI systems, especially when used, with a view to ensure that the the performance of many AI
high-risk AI system performs as techniques involving the training of high-risk AI system performs as systems, especially when techniques
intended and safely and it does not models are used, with a view to intended and safely and it does not involving the training of models are
become the source of discrimination ensure that the high-risk AI system become the source of discrimination used, with a view to ensure that the
prohibited by Union law. High performs as intended and safely and prohibited by Union law. High high-risk AI system performs as
quality training, validation and it does not become thea source of quality training, validation and intended and safely and it does not
testing data sets require the discrimination prohibited by Union testing data sets require the become the a source of
implementation of appropriate data law. High quality training, validation implementation of appropriate data discrimination prohibited by Union
governance and management and testing data sets require the governance and management law. High quality datasets for
practices. Training, validation and implementation of appropriate data practices. Training, validation and training, validation and testing
testing data sets should be governance and management testing data sets should be require the implementation of
sufficiently relevant, representative practices. Training, and where sufficiently relevant, representative appropriate data governance and
and free of errors and complete in applicable, validation and testing and have the appropriate statistical management practices. Datasets for
view of the intended purpose of the data sets, including the labels, properties, including as regards the training, validation and testing,
system. They should also have the should be sufficiently relevant, persons or groups of persons on including the labels, should be
appropriate statistical properties, representative, appropriately vetted which the high-risk AI system is relevant, sufficiently representative,
including as regards the persons or for and free of errors and as intended to be used. These datasets and to the best extent possible
groups of persons on which the high- complete as possible in view of the should also be as free of errors and training, validation and testing data
risk AI system is intended to be intended purpose of the system. complete as possible in view of the sets require the implementation of
used. In particular, training, They should also have the intended purpose of the system. They appropriate data governance and
validation and testing data sets appropriate statistical properties, should also have the appropriate management practices. training,
should take into account, to the including as regards the persons or statistical properties, including as validation and testing data sets
extent required in the light of their groups of persons on whichin regards the persons or groups of should be sufficiently relevant,
intended purpose, the features, relation to whom the high-risk AI persons on which the high-risk AI representative and free of errors and
characteristics or elements that are system is intended to be used, with system is intendedAI system, taking complete in view of the intended
particular to the specific specific attention to the mitigation into account, in a proportionate purpose of the system. TheyIn order
geographical, behavioural or of possible biases in the datasets, manner, technical feasibility and to facilitate compliance with EU
functional setting or context within that might lead to risks to state of the art, the availability of data protection law, such as
which the AI system is intended to fundamental rights or data and the implementation of Regulation (EU) 2016/679, data
be used. In order to protect the right discriminatory outcomes for the appropriate risk management governance and management
of others from the discrimination persons affected by the high-risk AI measures so that possible practices should include, in the case
that might result from the bias in AI system. Biases can for example be shortcomings of the datasets are of personal data, transparency
systems, the providers shouldbe able inherent in underlying datasets, duly addressed. The requirement about the original purpose of the
to process also special categories of especially when historical data is for the datasets to be used. In data collection,
personal data, as a matter of being used, introduced by the particular,complete and free of The datasets should also have the
substantial public interest, in order to developers of the algorithms, or errors should not affect the use of appropriate statistical properties,
ensure the bias monitoring, detection generated when the systems are privacy-preserving techniques in including as regards the persons or
and correction in relation to high- implemented in real world settings. the context of the the development groups of persons in relation to
risk AI systems. Results provided by AI systems are and testing of AI systems. Training, whom on which the high-risk AI
influenced by such inherent biases validation and testing data sets system is intended to be used. In
that are inclined to gradually should take into account, to the particular, training, validation and
increase and thereby perpetuate extent required in the light ofby their testing data sets should take into
and amplify existing discrimination, intended purpose, the features, account, to the , with specific
in particular for persons belonging characteristics or elements that are attention to the mitigation of
to certain vulnerable or ethnic particular to the specific possible biases in the datasets, that
groups, or racialised communities. geographical, behavioural or are likely to affect the health and
In particular, training, validation and functional setting or context within safety of persons, negatively impact
testing data sets should take into which the AI system is intended to fundamental rights or lead to
account, to the extent required in the be used. In order to protect the right discrimination prohibited under
light of their intended purpose, the of others from the discrimination Union law, especially where data
features, characteristics or elements that might result from the bias in AI outputs influence inputs for future
that are particular to the specific systems, the providers operations (‘feedback loops’) .
geographical, contextal, behavioural shouldbeshould be able to process Biases can for example be inherent
or functional setting or context also special categories of personal in underlying datasets, especially
within which the AI system is data, as a matter of substantial public when historical data is being used,
intended to be used. In order to interest within the meaning of or generated when the systems are
protect the right of others from the Article 9(2)(g) of Regulation (EU) implemented in real world settings.
discrimination that might result from 2016/679 and Article 10(2)g) of Results provided by AI systems
the bias in AI systems, the providers Regulation (EU) 2018/1725, in could be influenced by such
shouldbeshould, exceptionally and order to ensure the bias monitoring, inherent biases that are inclined to
following the application of all detection and correction in relation gradually increase and thereby
applicable conditions laid down to high-risk AI systems. perpetuate and amplify existing
under this Regulation and in discrimination, in particular for
Regulation (EU) 2016/679, persons belonging to certain
Directive (EU) 2016/680 and vulnerable groups including racial
Regulation (EU) 2018/1725, be able or ethnic groups. The requirement
to process also special categories of for the datasets to be to the best
personal data, as a matter of extent possible complete and free of
substantial public interest, in order to errors should not affect the use of
ensure the bias monitoring,negative privacy-preserving techniques in
bias detection and correction in the context of the development and
relation to high-risk AI systems. testing of AI systems. In particular,
Negative bias should be understood datasets should take into account,
as bias that create direct or indirect to the extent required by extent
discriminatory effect against a required in the light of their intended
natural person The requirements purpose, the features, characteristics
related to data governance can be or elements that are particular to the
complied with by having recourse to specific geographical, contextual,
third-parties that offer certified behavioural or functional setting or
compliance services including context within which the AI system
verification of data governance, is intended to be used. In order to
data set integrity, and data training, protect the right of others from the
validation and testing practices. discrimination that might result from
the bias in AI systems, the providers
shouldbe able to process also
special categories of personalThe
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.
data, as a matter of substantial
public interest, in order to ensure
the bias monitoring, detection and
correction in relation to high-risk AI
systems.
Recital 44a
(44a) When applying the principles

referred to in Article 5(1)(c) of
Regulation 2016/679 and Article
4(1)(c) of Regulation 2018/1725, in
G 54a G
particular the principle of data
minimisation, in regard to training,
validation and testing data sets
under this Regulation, due regard
should be had to the full life cycle
of the AI system.
Recital 45
(45) For the development of high- (45) For the development and (45) For the development of high- (45) For the development and
risk AI systems, certain actors, such assessment of high-risk AI systems, risk AI systems, certain actors, such assessment of high-risk AI systems,
as providers, notified bodies and certain actors, such as providers, as providers, notified bodies and certain actors, such as providers,
other relevant entities, such as digital notified bodies and other relevant other relevant entities, such as digital notified bodies and other relevant
innovation hubs, testing entities, such as digital innovation innovation hubs, testing entities, such as digital innovation
experimentation facilities and hubs, testing experimentation experimentation facilities and hubs, testing experimentation
researchers, should be able to access facilities and researchers, should be researchers, should be able to access facilities and researchers, should be
and use high quality datasets within able to access and use high quality and use high quality datasets within able to access and use high quality
their respective fields of activities datasets within their respective fields their respective fields of activities datasets within their respective fields
which are related to this Regulation. of activities which are related to this which are related to this Regulation. of activities which are related to this
European common data spaces Regulation. European common data European common data spaces Regulation. European common data
established by the Commission and spaces established by the established by the Commission and spaces established by the
the facilitation of data sharing Commission and the facilitation of the facilitation of data sharing Commission and the facilitation of
between businesses and with data sharing between businesses and between businesses and with data sharing between businesses and
government in the public interest with government in the public government in the public interest with government in the public
G 55 will be instrumental to provide interest will be instrumental to will be instrumental to provide interest will be instrumental to G
trustful, accountable and non- provide trustful, accountable and trustful, accountable and non- provide trustful, accountable and
discriminatory access to high quality non-discriminatory access to high discriminatory access to high quality non-discriminatory access to high
data for the training, validation and quality data for the training, data for the training, validation and quality data for the training,
testing of AI systems. For example, validation and testing of AI systems. testing of AI systems. For example, validation and testing of AI systems.
in health, the European health data For example, in health, the European in health, the European health data For example, in health, the European
space will facilitate non- health data space will facilitate non- space will facilitate non- health data space will facilitate non-
discriminatory access to health data discriminatory access to health data discriminatory access to health data discriminatory access to health data
and the training of artificial and the training of artificial and the training of artificial and the training of artificial
intelligence algorithms on those intelligence algorithms on those intelligence algorithms on those intelligence algorithms on those
datasets, in a privacy-preserving, datasets, in a privacy-preserving, datasets, in a privacy-preserving, datasets, in a privacy-preserving,
secure, timely, transparent and secure, timely, transparent and secure, timely, transparent and secure, timely, transparent and
trustworthy manner, and with an trustworthy manner, and with an trustworthy manner, and with an trustworthy manner, and with an
appropriate institutional governance. appropriate institutional governance. appropriate institutional governance. appropriate institutional governance.
Relevant competent authorities, Relevant competent authorities, Relevant competent authorities, Relevant competent authorities,
including sectoral ones, providing or including sectoral ones, providing or including sectoral ones, providing or including sectoral ones, providing or
supporting the access to data may supporting the access to data may supporting the access to data may supporting the access to data may
also support the provision of high- also support the provision of high- also support the provision of high- also support the provision of high-
quality data for the training, quality data for the training, quality data for the training, quality data for the training,
validation and testing of AI systems. validation and testing of AI systems. validation and testing of AI systems. validation and testing of AI systems.
Recital 45a
(45a) The right to privacy and to (45a) The right to privacy and to
protection of personal data must be protection of personal data must be
guaranteed throughout the entire guaranteed throughout the entire
lifecycle of the AI system. In this lifecycle of the AI system. In this
regard, the principles of data regard, the principles of data
minimisation and data protection by minimisation and data protection by
design and by default, as set out in design and by default, as set out in
Union data protection law, are Union data protection law, are
essential when the processing of applicable when personal data are
data involves significant risks to the processed. Measures taken by
fundamental rights of individuals. providers to ensure compliance with
Providers and users of AI systems those principles may include not
should implement state-of-the-art only anonymisation and encryption,
G 55a G
technical and organisational but also the use of technology that
measures in order to protect those permits algorithms to be brought to
rights. Such measures should the data and allows training of AI
include not only anonymisation and systems without the transmission
encryption, but also the use of between parties or copying of the
increasingly available technology raw or structured data themselves,
that permits algorithms to be without prejudice to the
brought to the data and allows requirements on data governance
valuable insights to be derived provided for in this Regulation.
without the transmission between
parties or unnecessary copying of
the raw or structured data
themselves.
Recital 45b
G 55b G
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.
Recital 46
(46) Having information on how (46) Having comprehensible (46) Having information on how (46) Having comprehensible
high-risk AI systems have been information on how high-risk AI high-risk AI systems have been information on how high-risk AI
developed and how they perform systems have been developed and developed and how they perform systems have been developed and
G 56 throughout their lifecycle is essential how they perform throughout their throughout their lifecycle is essential how they perform throughout their G
to verify compliance with the lifecyclelifetime is essential to verify to verify compliance with the lifecycle lifetime is essential to
requirements under this Regulation. compliance with the requirements requirements under this Regulation. enable traceability of those systems,
This requires keeping records and under this Regulation. This requires This requires keeping records and verify compliance with the
the availability of a technical keeping records and the availability the availability of a technical requirements under this Regulation,
documentation, containing of a technical documentation, documentation, containing as well as monitoring of their
information which is necessary to containing information which is information which is necessary to operations and post market
assess the compliance of the AI necessary to assess the compliance assess the compliance of the AI monitoring. This requires keeping
system with the relevant of the AI system with the relevant system with the relevant records and the availability of a
requirements. Such information requirements. Such information requirements. Such information technical documentation, containing
should include the general should include the general should include the general information which is necessary to
characteristics, capabilities and characteristics, capabilities and characteristics, capabilities and assess the compliance of the AI
limitations of the system, algorithms, limitations of the system, algorithms, limitations of the system, algorithms, system with the relevant
data, training, testing and validation data, training, testing and validation data, training, testing and validation requirements and facilitate post
processes used as well as processes used as well as processes used as well as market monitoring. Such
documentation on the relevant risk documentation on the relevant risk documentation on the relevant risk information should include the
management system. The technical management system. The technical management system. The technical general characteristics, capabilities
documentation should be kept up to documentation should be kept up to documentation should be kept up to and limitations of the system,
date. date appropriately throughout the date. Furthermore, providers or algorithms, data, training, testing
lifecycle of the AI system. AI users should keep logs and validation processes used as
systems can have a large important automatically generated by the well as documentation on the
environmental impact and high high-risk AI system, including for relevant risk management system
energy consumption during their instance output data, start date and and drawn in a clear and
lifecyle. In order to better time etc., to the extent that such a comprehensive form.. The technical
apprehend the impact of AI systems system and the related logs are documentation should be kept up to
on the environment, the technical under their control, for a period date, appropriately throughout the
documentation drafted by providers that is appropriate to enable them to lifetime of the AI system.
should include information on the fulfil their obligations. Furthermore, high risk AI systems
energy consumption of the AI should technically allow for
system, including the consumption automatic recording of events (logs)
during development and expected over the duration of the lifetime of
consumption during use. Such the system.
information should take into
account the relevant Union and
national legislation. This reported
information should be
comprehensible, comparable and
verifiable and to that end, the
Commission should develop
guidelines on a harmonised
metholodogy for calculation and
reporting of this information. To
ensure that a single documentation
is possible, terms and definitions
related to the required
documentation and any required
documentation in the relevant
Union legislation should be aligned
as much as possible.
Recital 46a
(46a) AI systems should take into

account state-of-the art methods
and relevant applicable standards to
reduce the energy use, resource use
and waste, as well as to increase
their energy efficiency and the
overall efficiency of the system. The
environmental aspects of AI
systems that are significant for the
purposes of this Regulation are the
energy consumption of the AI
system in the development, training
G 56a and deployment phase as well as the G
recording and reporting and storing

of this data. The design of AI
systems should enable the
measurement and logging of the
consumption of energy and
resources at each stage of
development, training and
deployment. The monitoring and
reporting of the emissions of AI
systems must be robust,
transparent, consistent and
accurate. In order to ensure the
uniform application of this
Regulation and stable legal
ecosystem for providers and
deployers in the Single Market, the
Commission should develop a
common specification for the
methodology to fulfil the reporting
and documentation requirement on
the consumption of energy and
resources during development,
training and deployment. Such
common specifications on
measurement methodology can
develop a baseline upon which the
Commission can better decide if
future regulatory interventions are
needed, upon conducting an impact
assessment that takes into account
existing law.
Recital 46b
(46b) In order to achieve the

objectives of this Regulation, and
contribute to the Union’s
environmental objectives while
ensuring the smooth functioning of
the internal market, it may be
necessary to establish
G 56b G
recommendations and guidelines
and, eventually, targets for
sustainability. For that purpose the
Commission is entitled to develop a
methodology to contribute towards
having Key Performance Indicators
(KPIs) and a reference for the
Sustainable Development Goals
(SDGs). The goal should be in the
first instance to enable fair
comparison between AI
implementation choices providing
incentives to promote using more
efficient AI technologies addressing
energy and resource concerns. To
meet this objective this Regulation
should provide the means to
establish a baseline collection of
data reported on the emissions from
development and training and for
deployment.
Recital 47
(47) To address the opacity that (47) To address the opacity that (47) To address the opacity that (47) To address theconcerns related
may make certain AI systems may make certain AI systems may make certain AI systems to opacity that may makeand
incomprehensible to or too complex incomprehensible to or too complex incomprehensible to or too complex complexity of certain AI systems
for natural persons, a certain degree for natural persons, a certain degree for natural persons, a certain degree incomprehensible to or too complex
of transparency should be required of transparency should be required of transparency should be required for natural persons, a certain degree
for high-risk AI systems. Users for high-risk AI systems. Users for high-risk AI systems. Users of and help deployers to fulfil their
should be able to interpret the should be able to interpret the should be able to interpret the obligations under this Regulation,
system output and use it system output and use it system output and use it transparency should be required for
appropriately. High-risk AI systems appropriately. High-risk AI systems appropriately. High-risk AI systems high-risk AI systems before they are
G 57 should therefore be accompanied by should therefore be accompanied by should therefore be accompanied by placed on the market or put it into G
relevant documentation and relevant documentation and relevant documentation and service. High-risk AI systems. Users
instructions of use and include instructions of use and include instructions of use and include should be able to interpret
concise and clear information, concise and clear information, concise and clear information, thedesigned in a manner to enable
including in relation to possible risks including in relation to possible risks including in relation to possible risks deployers to understand how the AI
to fundamental rights and to fundamental rights and to fundamental rights and system output and use it
discrimination, where appropriate. discrimination, where appropriate. discrimination of the persons who appropriately. High-riskworks,
may be affected by the system in evaluate its functionality, and
light of its intended purpose, where comprehend its strengths and
appropriate. To facilitate the limitations. High risk AI systems,
understanding of the instructions of should therefore be accompanied by
use by users, they should contain relevant documentation
illustrative examples, as andappropriate information in the
appropriate. form of instructions of use. Such
information should and include
concise and clearthe 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 in
relation to possibledeployer 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
and discrimination, 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.
Recital 47a
(47a) Such requirements on

transparency and on the
explicability of AI decision-making
should also help to counter the
G 57a G
deterrent effects of digital
asymmetry and so-called ‘dark
patterns’ targeting individuals and
their informed consent.
Recital 48
G 58 G
(48) High-risk AI systems should be (48) High-risk AI systems should be (48) High-risk AI systems should be (48) High-risk AI systems should be
designed and developed in such a designed and developed in such a designed and developed in such a designed and developed in such a
way that natural persons can oversee way that natural persons can oversee way that natural persons can oversee way that natural persons can oversee
their functioning. For this purpose, their functioning. For this purpose, their functioning. For this purpose, their functioning, ensure that they
appropriate human oversight appropriate human oversight appropriate human oversight are used as intended and that their
measures should be identified by the measures should be identified by the measures should be identified by the impacts are addressed over the
provider of the system before its provider of the system before its provider of the system before its system’s lifecycle. For this purpose,
placing on the market or putting into placing on the market or putting into placing on the market or putting into appropriate human oversight
service. In particular, where service. In particular, where service. In particular, where measures should be identified by the
appropriate, such measures should appropriate, such measures should appropriate, such measures should provider of the system before its
guarantee that the system is subject guarantee that the system is subject guarantee that the system is subject placing on the market or putting into
to in-built operational constraints to in-built operational constraints to in-built operational constraints service. In particular, where
that cannot be overridden by the that cannot be overridden by the that cannot be overridden by the appropriate, such measures should
system itself and is responsive to the system itself and is responsive to the system itself and is responsive to the guarantee that the system is subject
human operator, and that the natural human operator, and that the natural human operator, and that the natural to in-built operational constraints
persons to whom human oversight persons to whom human oversight persons to whom human oversight that cannot be overridden by the
has been assigned have the has been assigned have the has been assigned have the system itself and is responsive to the
necessary competence, training and necessary competence, training and necessary competence, training and human operator, and that the natural
authority to carry out that role. authority to carry out that role. authority to carry out that role. persons to whom human oversight
Considering the significant has been assigned have the
consequences for persons in case of necessary competence, training and
incorrect matches by certain authority to carry out that role. It is
biometric identification systems, it also essential, as appropriate, to
is appropriate to provide for an ensure that high-risk AI systems
enhanced human oversight include mechanisms to guide and
requirement for those systems so inform a natural person to whom
that no action or decision may be human oversight has been assigned
taken by the user on the basis of the to make informed decisions if, when
identification resulting from the and how to intervene in order to
system unless this has been avoid negative consequences or
separately verified and confirmed risks, or stop the system if it does
by at least two natural persons. not perform as intended.
Those persons could be from one or Considering the significant
more entities and include the consequences for persons in case of
person operating or using the incorrect matches by certain
system. This requirement should biometric identification systems, it
not pose unnecessary burden or is appropriate to provide for an
delays and it could be sufficient that enhanced human oversight
the separate verifications by the requirement for those systems so
different persons are automatically that no action or decision may be
recorded in the logs generated by taken by the deployer on the basis
the system. 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.
Recital 49
perform consistently throughout perform consistently throughout perform consistently throughout perform consistently throughout
their lifecycle and meet an their lifecycle and meet an their lifecycle and meet an their lifecycle and meet an
G 59 appropriate level of accuracy, appropriate level of accuracy, appropriate level of accuracy, appropriate level of accuracy, G
robustness and cybersecurity in robustness and cybersecurity in robustness and cybersecurity in robustness and cybersecurity, in the
accordance with the generally accordance with the generally accordance with the generally light of their intended purpose and
acknowledged state of the art. The acknowledged state of the art. acknowledged state of the art. The in accordance with the generally
level of accuracy and accuracy Performance metrics and their level of accuracy and accuracy acknowledged state of the art. The
metrics should be communicated to expected level should be defined metrics should be communicated to Commission and relevant
the users. with the primary objective to the users. organisations and stakeholders are
mitigate risks and negative impact encouraged to take due
of the AI system. The expected The consideration of mitigation of risks
level of accuracy and and negative impacts of the AI
accuracyperformance metrics system. The expected The level of
should be communicated in a clear, performance metrics should be
transparent, easily understandable declared in the accompanying
and intelligible way to the instructions of use. Providers are
deployers. The declaration of urged to communicate this
performance metrics cannot be information to deployers in a clear
considered proof of future levels, and easily understandable way, free
but relevant methods need to be of misunderstandings or misleading
applied to ensure consistent levels statements.
during use While standardisation
organisations exist to establish The EU legislation on legal
standards, coordination on metrology, including on Measuring
benchmarking is needed to Instruments Directive (MID) and
establish how these standardised Non-automatic weighing
requirements and characteristics of instruments (NAWI) Directive, aims
AI systems should be communicated to ensure the accuracy of
to the usersmeasured. The measurements and to help the
European Artificial Intelligence transparency and fairness of
Office should bring together commercial transactions. In this
national and international context, in cooperation with
metrology and benchmarking relevant stakeholders and
authorities and provide non- organisation, such as metrology
binding guidance to address the and benchmarking authorities, the
technical aspects of how to measure Commission should encourage, as
the appropriate levels of appropriate, the development of
performance and robustness. 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.accuracy and
accuracy metrics should be
communicated to the users.
Recital 50
(50) The technical robustness is a (50) The technical robustness is a (50) The technical robustness is a (50) The technical robustness is a
key requirement for high-risk AI key requirement for high-risk AI key requirement for high-risk AI key requirement for high-risk AI
systems. They should be resilient systems. They should be resilient systems. They should be resilient systems. They should be resilient
against risks connected to the against risks connected to the against risks connected to thein against risks connected to thein
limitations of the system (e.g. errors, limitations of the system (e.g. errors, relation to harmful or otherwise relation to harmful or otherwise
faults, inconsistencies, unexpected faults, inconsistencies, unexpected undesirable behaviour that may undesirable behaviour that may
situations) as well as against situations) as well as against result from limitations of the result from limitations of the
malicious actions that may malicious actions that may systemwithin the systems or the systemwithin the systems or the
compromise the security of the AI compromise the security of the AI environment in which the systems environment in which the systems
system and result in harmful or system and result in harmful or operate (e.g. errors, faults, operate (e.g. errors, faults,
otherwise undesirable behaviour. otherwise undesirable behaviour. inconsistencies, unexpected inconsistencies, unexpected
Failure to protect against these risks Failure to protect against these risks situations). High-risk AI systems situations). Therefore, technical and
could lead to safety impacts or could lead to safety impacts or should therefore be designed and organisational measures should be
negatively affect the fundamental negatively affect the fundamental developed with appropriate taken to ensure robustness of high-
G 60 rights, for example due to erroneous rights, for example due to erroneous technical solutions to prevent or risk AI systems, for example by G
decisions or wrong or biased outputs decisions or wrong or biased outputs minimize that as well as against designing and developing
generated by the AI system. generated by the AI system. Users of malicious actions that may appropriate technical solutions to
the AI system should take steps to compromise the security of the AI prevent or minimize as well as
ensure that the possible trade-off system and result in harmful or against malicious actions that may
between robustness and accuracy otherwise undesirable behaviour, compromise the security of the AI
does not lead to discriminatory or such as for instance mechanisms system and result in harmful or
negative outcomes for minority enabling the system to safely otherwise undesirable behaviour.
subgroups. interrupt its operation (fail-safe Those technical solution may
plans) in the presence of certain include for instance mechanisms
anomalies or when operation takes enabling the system to safely
place outside certain predetermined interrupt its operation (fail-safe
boundaries. Failure to protect plans) in the presence of certain
against these risks could lead to anomalies or when operation takes
safety impacts or negatively affect place outside certain predetermined
the fundamental rights, for example boundaries. Failure to protect
due to erroneous decisions or wrong against these risks could lead to
or biased outputs generated by the safety impacts or negatively affect
AI system. the fundamental rights, for example
due to erroneous decisions or wrong
or biased outputs generated by the
AI system.
Recital 51
(51) Cybersecurity plays a crucial (51) Cybersecurity plays a crucial (51) Cybersecurity plays a crucial (51) Cybersecurity plays a crucial
role in ensuring that AI systems are role in ensuring that AI systems are role in ensuring that AI systems are role in ensuring that AI systems are
resilient against attempts to alter resilient against attempts to alter resilient against attempts to alter resilient against attempts to alter
their use, behaviour, performance or their use, behaviour, performance or their use, behaviour, performance or their use, behaviour, performance or
compromise their security properties compromise their security properties compromise their security properties compromise their security properties
by malicious third parties exploiting by malicious third parties exploiting by malicious third parties exploiting by malicious third parties exploiting
the system’s vulnerabilities. the system’s vulnerabilities. the system’s vulnerabilities. the system’s vulnerabilities.
Cyberattacks against AI systems can Cyberattacks against AI systems can Cyberattacks against AI systems can Cyberattacks against AI systems can
leverage AI specific assets, such as leverage AI specific assets, such as leverage AI specific assets, such as leverage AI specific assets, such as
training data sets (e.g. data training data sets (e.g. data training data sets (e.g. data training data sets (e.g. data
poisoning) or trained models (e.g. poisoning) or trained models (e.g. poisoning) or trained models (e.g. poisoning) or trained models (e.g.
adversarial attacks), or exploit adversarial attacks or confidentiality adversarial attacks), or exploit adversarial attacks or membership
vulnerabilities in the AI system’s attacks), or exploit vulnerabilities in vulnerabilities in the AI system’s inference), or exploit vulnerabilities
G 61 G
digital assets or the underlying ICT the AI system’s digital assets or the digital assets or the underlying ICT in the AI system’s digital assets or
infrastructure. To ensure a level of underlying ICT infrastructure. To infrastructure. To ensure a level of the underlying ICT infrastructure.
cybersecurity appropriate to the ensure a level of cybersecurity cybersecurity appropriate to the To ensure a level of cybersecurity
risks, suitable measures should appropriate to the risks, suitable risks, suitable measures should appropriate to the risks, suitable
therefore be taken by the providers measures should therefore be taken therefore be taken by the providers measures, such as security controls,
of high-risk AI systems, also taking by the providers of high-risk AI of high-risk AI systems, also taking should therefore be taken by the
into account as appropriate the systems, as well as the notified into account as appropriate the providers of high-risk AI systems,
underlying ICT infrastructure. bodies, competent national underlying ICT infrastructure. also taking into account as
authorities and market surveillance appropriate the underlying ICT
authorities, also taking into account infrastructure.
as appropriate the underlying ICT
infrastructure. High-risk AI should
be accompanied by security
solutions and patches for the
lifetime of the product, or in case of
the absence of dependence on a
specific product, for a time that
needs to be stated by the
manufacturer.
Recital 51a
(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 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
G 61a and Annex I of the Regulation G
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.
Recital 52
(52) As part of Union harmonisation (52) As part of Union harmonisation (52) As part of Union harmonisation (52) As part of Union harmonisation
legislation, rules applicable to the legislation, rules applicable to the legislation, rules applicable to the legislation, rules applicable to the
placing on the market, putting into placing on the market, putting into placing on the market, putting into placing on the market, putting into
service and use of high-risk AI service and use of high-risk AI service and use of high-risk AI service and use of high-risk AI
G 62 G
systems should be laid down systems should be laid down systems should be laid down systems should be laid down
consistently with Regulation (EC) consistently with Regulation (EC) consistently with Regulation (EC) consistently with Regulation (EC)
No 765/2008 of the European No 765/2008 of the European No 765/2008 of the European No 765/2008 of the European
Parliament and of the Council1 Parliament and of the Council1 Parliament and of the Council1 Parliament and of the Council1
setting out the requirements for setting out the requirements for setting out the requirements for setting out the requirements for
accreditation and the market accreditation and the market accreditation and the market accreditation and the market
surveillance of products, Decision surveillance of products, Decision surveillance of products, Decision surveillance of products, Decision
No 768/2008/EC of the European No 768/2008/EC of the European No 768/2008/EC of the European No 768/2008/EC of the European
Parliament and of the Council2 on a Parliament and of the Council2 on a Parliament and of the Council2 on a Parliament and of the Council2 on a
common framework for the common framework for the common framework for the common framework for the
marketing of products and marketing of products and marketing of products and marketing of products and
Regulation (EU) 2019/1020 of the Regulation (EU) 2019/1020 of the Regulation (EU) 2019/1020 of the Regulation (EU) 2019/1020 of the
Council3 on market surveillance and Council3 on market surveillance and Council3 on market surveillance and Council3 on market surveillance and
compliance of products (‘New compliance of products (‘New compliance of products (‘New compliance of products (‘New
Legislative Framework for the Legislative Framework for the Legislative Framework for the Legislative Framework for the
marketing of products’). marketing of products’). marketing of products’). marketing of products’).
_________ _________ _________ _________
1. Regulation (EC) No 765/2008 of the 1. Regulation (EC) No 765/2008 of the 1. [1] Regulation (EC) No 765/2008 1. Regulation (EC) No 765/2008 of the
European Parliament and of the Council of 9 European Parliament and of the Council of 9 of the European Parliament and of the European Parliament and of the Council of 9
July 2008 setting out the requirements for July 2008 setting out the requirements for Council of 9 July 2008 setting out the July 2008 setting out the requirements for
accreditation and market surveillance accreditation and market surveillance requirements for accreditation and market accreditation and market surveillance
relating to the marketing of products and relating to the marketing of products and surveillance relating to the marketing of relating to the marketing of products and
repealing Regulation (EEC) No 339/93 (OJ repealing Regulation (EEC) No 339/93 (OJ products and repealing Regulation (EEC) No repealing Regulation (EEC) No 339/93 (OJ
L 218, 13.8.2008, p. 30). L 218, 13.8.2008, p. 30). 339/93 (OJ L 218, 13.8.2008, p. 30). L 218, 13.8.2008, p. 30).
2. Decision No 768/2008/EC of the 2. Decision No 768/2008/EC of the 2. [2] Decision No 768/2008/EC of 2. Decision No 768/2008/EC of the
July 2008 on a common framework for the July 2008 on a common framework for the of 9 July 2008 on a common framework for July 2008 on a common framework for the
marketing of products, and repealing Council marketing of products, and repealing Council the marketing of products, and repealing marketing of products, and repealing Council
Decision 93/465/EEC (OJ L 218, 13.8.2008, Decision 93/465/EEC (OJ L 218, 13.8.2008, Council Decision 93/465/EEC (OJ L 218, Decision 93/465/EEC (OJ L 218, 13.8.2008,
p. 82). p. 82). 13.8.2008, p. 82). p. 82).
European Parliament and of the Council of European Parliament and of the Council of the European Parliament and of the Council European Parliament and of the Council of
20 June 2019 on market surveillance and 20 June 2019 on market surveillance and of 20 June 2019 on market surveillance and 20 June 2019 on market surveillance and
compliance of products and amending compliance of products and amending compliance of products and amending compliance of products and amending
Directive 2004/42/EC and Regulations (EC) Directive 2004/42/EC and Regulations (EC) Directive 2004/42/EC and Regulations (EC) Directive 2004/42/EC and Regulations (EC)
No 765/2008 and (EU) No 305/2011 (Text No 765/2008 and (EU) No 305/2011 (Text No 765/2008 and (EU) No 305/2011 (Text No 765/2008 and (EU) No 305/2011 (Text
with EEA relevance) (OJ L 169, 25.6.2019, with EEA relevance) (OJ L 169, 25.6.2019, with EEA relevance) (OJ L 169, 25.6.2019, with EEA relevance) (OJ L 169, 25.6.2019,
p. 1–44). p. 1–44). p. 1–44). p. 1–44).

Proposal
Recital 52a
G 62a G
(52a) In line with New Legislative
Framework principles, specific
obligations for relevant operators
within the AI value chain should be
set to ensure legal certainty and
facilitate compliance with this
Regulation. In certain situations
those operators could act in more
than one role at the same time and
should therefore fufil cumulatively
all relevant obligations associated
with those roles. For example, an
operator could act as a distributor
and an importer at the same time.
Recital 53
(53) It is appropriate that a specific (53) It is appropriate that a specific (53) It is appropriate that a specific (53) It is appropriate that a specific
natural or legal person, defined as natural or legal person, defined as natural or legal person, defined as natural or legal person, defined as
the provider, takes the responsibility the provider, takes the responsibility the provider, takes the responsibility the provider, takes the responsibility
for the placing on the market or for the placing on the market or for the placing on the market or for the placing on the market or
G 63 putting into service of a high-risk AI putting into service of a high-risk AI putting into service of a high-risk AI putting into service of a high-risk AI G
system, regardless of whether that system, regardless of whether that system, regardless of whether that system, regardless of whether that
natural or legal person is the person natural or legal person is the person natural or legal person is the person natural or legal person is the person
who designed or developed the who designed or developed the who designed or developed the who designed or developed the
system. system. system. system.
Recital 53a
(53a) As signatories to the United (53a) As signatories to the United

Nations Convention on the Rights Nations Convention on the Rights
G 63a of Persons with Disabilities of Persons with Disabilities G
(UNCRPD), the Union and the (UNCRPD), the Union and the
Member States are legally obliged Member States are legally obliged
to protect persons with disabilities to protect persons with disabilities
from discrilmination and promote from discrimination and promote
their equality, to ensure that their equality, to ensure that
persons with disabilities have persons with disabilities have
access, on an equal basis wirh access, on an equal basis with
others, to information and others, to information and
communications technologies and communications technologies and
systems, and to ensure respect for systems, and to ensure respect for
privacy for persons with disabilities. privacy for persons with disabilities.
Given the growing importance and Given the growing importance and
use of AI systems, the application of use of AI systems, the application of
universal design principles to all universal design principles to all
new technologies and services new technologies and services
should ensure full, equal, and should ensure full and equal access
unrestricted access for everyone for everyone potentially affected by
potentially affected by or using AI or using AI technologies, including
technologies, including persons persons with disabilities, in a way
with disabilities, in a way that takes that takes full account of their
full account of their inherent inherent dignity and diversity. It is
dignity and diversity. It is therefore therefore essential that Providers
essential that Providers ensure full ensure full compliance with
compliance with accessibility accessibility requirements,
requirements, including Directive including Directive (EU) 2016/2102
(EU) 2016/2102 and Directive (EU) and Directive (EU) 2019/882.
2019/882. Providers should ensure Providers should ensure
compliance with these requirements compliance with these requirements
by design. Therefore, the necessary by design. Therefore, the necessary
measures should be integrated as measures should be integrated as
much as possible into the design of much as possible into the design of
the high-risk AI system. the high-risk AI system.
Recital 54
(54) The provider should establish a (54) The provider should establish a (54) The provider should establish a (54) The provider should establish a
G 64 sound quality management system, sound quality management system, sound quality management system, sound quality management system, G
ensure the accomplishment of the ensure the accomplishment of the ensure the accomplishment of the ensure the accomplishment of the
required conformity assessment required conformity assessment required conformity assessment required conformity assessment
procedure, draw up the relevant procedure, draw up the relevant procedure, draw up the relevant procedure, draw up the relevant
documentation and establish a robust documentation and establish a robust documentation and establish a robust documentation and establish a robust
post-market monitoring system. post-market monitoring system. For post-market monitoring system. post-market monitoring system.
Public authorities which put into providers that have already in place Public authorities which put into Providers of high risk AI systems
service high-risk AI systems for quality management systems based service high-risk AI systems for that are subject to obligations
their own use may adopt and on standards such as ISO 9001 or their own use may adopt and regarding quality management
implement the rules for the quality other relevant standards, no implement the rules for the quality systems under relevant sectorial
management system as part of the duplicative quality management management system as part of the Union law should have the
quality management system adopted system in full should be expected quality management system adopted possibility to include the elements
at a national or regional level, as but rather an adaptation of their at a national or regional level, as of the quality management system
appropriate, taking into account the existing systems to certain aspects appropriate, taking into account the provided for in this Regulation as
specificities of the sector and the linked to compliance with specific specificities of the sector and the part of the existing quality
competences and organisation of the requirements of this Regulation. competences and organisation of the management system provided for in
public authority in question. This should also be reflected in public authority in question. that other sectorial Union
future standardization activities or legislation. The complementarity
guidance adopted by the between this Regulation and
Commission in this respect. Public existing sectorial Union law should
authorities which put into service also be taken into account in future
high-risk AI systems for their own standardization activities or
use may adopt and implement the guidance adopted by the
rules for the quality management Commission. Public authorities
system as part of the quality which put into service high-risk AI
management system adopted at a systems for their own use may adopt
national or regional level, as and implement the rules for the
appropriate, taking into account the quality management system as part
specificities of the sector and the of the quality management system
competences and organisation of the adopted at a national or regional
public authority in question. level, as appropriate, taking into
account the specificities of the sector
and the competences and
organisation of the public authority
in question.
Recital 54a
G 64a G
(54a) To ensure legal certainty, it is
necessary to clarify that, under
certain specific conditions, any
natural or legal person should be
considered a provider of a new
high-risk AI system and therefore
assume all the relevant obligations.
For example, this would be the case
if that person puts its name or
trademark on a high-risk AI system
already placed on the market or put
into service, or if that person
modifies the intended purpose of an
AI system which is not high-risk
and is already placed on the market
or put into service, in a way that
makes the modified system a high-
risk AI system. 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.
Recital 54a
G 64b G
Recital 55
(55) Where a high-risk AI system (55) Where a high-risk AI system (55) Where a high-risk AI system
that is a safety component of a that is a safety component of a that is a safety component of a
product which is covered by a product which is covered by a product which is covered by a
relevant New Legislative relevant New Legislative relevant New Legislative
Framework sectorial legislation is Framework sectorial legislation is Framework sectorial legislation is
not placed on the market or put into not placed on the market or put into not placed on the market or put into
service independently from the service independently from the service independently from the
product, the manufacturer of the product, the manufacturer of the product, the manufacturer of the
G 65 final product as defined under the final product as defined under the final productproduct manufacturer G
relevant New Legislative relevant New Legislative as defined under the relevant New
Framework legislation should Framework legislation should Legislative Framework legislation
comply with the obligations of the comply with the obligations of the should comply with the obligations
provider established in this provider established in this of the provider established in this
Regulation and notably ensure that Regulation and notably ensure that Regulation and notably ensure that
the AI system embedded in the final the AI system embedded in the final the AI system embedded in the final
product complies with the product complies with the product complies with the
requirements of this Regulation. requirements of this Regulation. requirements of this Regulation.
Recital 56
(56) To enable enforcement of this (56) To enable enforcement of this (56) To enable enforcement of this (56) To enable enforcement of this
Regulation and create a level- Regulation and create a level- Regulation and create a level- Regulation and create a level-
playing field for operators, and playing field for operators, and playing field for operators, and playing field for operators, and
taking into account the different taking into account the different taking into account the different taking into account the different
forms of making available of digital forms of making available of digital forms of making available of digital forms of making available of digital
G 66 G
products, it is important to ensure products, it is important to ensure products, it is important to ensure products, it is important to ensure
that, under all circumstances, a that, under all circumstances, a that, under all circumstances, a that, under all circumstances, a
person established in the Union can person established in the Union can person established in the Union can person established in the Union can
provide authorities with all the provide authorities with all the provide authorities with all the provide authorities with all the
necessary information on the necessary information on the necessary information on the necessary information on the
compliance of an AI system. compliance of an AI system. compliance of an AI system. compliance of an AI system.
Therefore, prior to making their AI Therefore, prior to making their AI Therefore, prior to making their AI Therefore, prior to making their AI
systems available in the Union, systems available in the Union, systems available in the Union, systems available in the Union,
where an importer cannot be where an importer cannot be where an importer cannot be where an importer cannot be
identified, providers established identified, providers established identified, providers established identified, providers established
outside the Union shall, by written outside the Union shall, by written outside the Union shall, by written outside the Union shall, by written
mandate, appoint an authorised mandate, appoint an authorised mandate, appoint an authorised mandate, appoint an authorised
representative established in the representative established in the representative established in the representative established in the
Union. Union. Union. 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.
Recital 56a
(56a) For providers who are not

established in the Union, the
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 and in serving as their
G 66a G
contact person established in the
Union. Given that pivotal role, and
in order to ensure that
responsibility is assumed for the
purposes of enforcement of this
Regulation, it is appropriate to
make the authorised representative
jointly and severally liable with the
provider for defective high-risk AI
systems. The liability of the
authorised representative provided
for in this Regulation is without
prejudice to the provisions of
Directive 85/374/EEC on liability
for defective products.
Recital 56a
(56a) In the light of the nature and

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,
G 66b such as importers and distributors G
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.
Recital 57
G 67 (57) In line with New Legislative (57) In line with New Legislative (57) In line with New Legislative G
Framework principles, specific Framework principles, specific deleted Framework principles, To ensure
obligations for relevant economic obligations for relevant economic legal certainty, it is necessary to
operators, such as importers and operators, such as importers and clarify that, under certain specific
distributors, should be set to ensure distributors, should be set to ensure conditions, any distributor,
legal certainty and facilitate legal certainty and facilitate importer, deployer or other third-
regulatory compliance by those regulatory compliance by those party should be considered a
relevant operators. relevant operators. 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 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
for relevant economic operators,
such as importers and distributors,
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
Regulationbe set to ensure legal
certainty and facilitate regulatory
compliance by those relevant
operators.
Recital 57a
(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
G 67a such systems should, irrespective of G
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.
Recital 57b
(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
G 67b system, the former provider should G
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.
Recital 57c
(57c) In addition, where a high-

risk AI system that is a safety
G 67c G
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 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.
Recital 57d
(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
G 67d G
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.
Recital 57e
(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 particuliar towards the
provider that has used or integrated
them, when those tools, services,
processes, or AI components are
G 67e G
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.
Recital 57f
(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-
G 67f risk AI systems, to facilitate the G
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.
Recital 58
(58) Given the nature of AI systems (58) Given the nature of AI systems (58) Given the nature of AI systems (58) Given the nature of AI systems
and the risks to safety and and the risks to safety and and the risks to safety and and the risks to safety and
fundamental rights possibly fundamental rights possibly fundamental rights possibly fundamental rights possibly
associated with their use, including associated with their use, including associated with their use, including associated with their use, including
as regard the need to ensure proper as regardregards the need to ensure as regard the need to ensure proper as regardregards the need to ensure
monitoring of the performance of an proper monitoring of the monitoring of the performance of an proper monitoring of the
G 68 AI system in a real-life setting, it is performance of an AI system in a AI system in a real-life setting, it is performance of an AI system in a G
appropriate to set specific real-life setting, it is appropriate to appropriate to set specific real-life setting, it is appropriate to
responsibilities for users. Users set specific responsibilities for users. responsibilities for users. Users set specific responsibilities for users.
should in particular use high-risk AI Usersdeployers. Deployers should in should in particular use high-risk AI Users deployers . Deployers should
systems in accordance with the particular use high-risk AI systems systems in accordance with the in particular take appropriate
instructions of use and certain other in accordance with the instructions instructions of use and certain other technical and organisational
obligations should be provided for of use and certain other obligations obligations should be provided for measures to ensure they use high-
with regard to monitoring of the should be provided for with regard with regard to monitoring of the risk AI systems in accordance with
functioning of the AI systems and to monitoring of the functioning of functioning of the AI systems and the instructions of use and certain
with regard to record-keeping, as the AI systems and with regard to with regard to record-keeping, as other obligations should be provided
appropriate. record-keeping, as appropriate. appropriate. These obligations for with regard to monitoring of the
should be without prejudice to other functioning of the AI systems and
user obligations in relation to high- with regard to record-keeping, as
risk AI systems under Union or appropriate. Furthermore,
national law, and should not apply deployers should ensure that the
where the use is made in the course persons assigned to implement the
of a personal non-professional instructions for use and human
activity. 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.
Recital 58a
(58a) It is appropriate to clarify

that this Regulation does not affect
the obligations of providers and
users of AI systems in their role as
data controllers or processors
stemming from Union law on the
G 68a protection of personal data in so far G
as the design, the development or

the use of AI systems involves the
processing of personal data. It is
also appropriate to clarify that data
subjects continue to enjoy all the
rights and guarantees awarded to
them by such Union law, including
the rights related to solely
automated individual decision-
making, including profiling.
Harmonised rules for the placing
on the market, the putting into
service and 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.
Recital 58b
(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
G 68b G
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.
Recital 58c
(58a) Whilst risks related to AI (58b) Whilst risks related to AI

systems can result from the way systems can result from the way
such systems are designed, risks such systems are designed, risks
can as well stem from how such AI can as well stem from how such AI
systems are used. Deployers of systems are used. Deployers of
high-risk AI system therefore play a high-risk AI system therefore play a
critical role in ensuring that critical role in ensuring that
fundamental rights are protected, fundamental rights are protected,
complementing the obligations of complementing the obligations of
the provider when developing the the provider when developing the
AI system. Deployers are best AI system. Deployers are best
G 68c placed to understand how the high- placed to understand how the high- G
risk AI system will be used risk AI system will be used

concretely and can therefore concretely and can therefore
identify potential significant risks identify potential significant risks
that were not foreseen in the that were not foreseen in the
development phase, due to a more development phase, due to a more
precise knowledge of the context of precise knowledge of the context of
use, the people or groups of people use, the people or groups of people
likely to be affected, including likely to be affected, including
marginalised and vulnerable vulnerable groups. Deployers of
groups. Deployers should identify high risk AI systems referred to in
appropriate governance structures Annex III also play a critical role in
in that specific context of use, such informing natural persons and
as arrangements for human should, when they make decisions
oversight, complaint-handling or assist in making decisions
procedures and redress procedures, related to natural persons , where
because choices in the governance applicable, inform the natural
structures can be instrumental in persons that they are subject to the
mitigating risks to fundamental use of the high risk AI system. This
rights in concrete use-cases. In information should include the
order to efficiently ensure that intended purpose and the type of
fundamental rights are protected, decisions it makes. The deployer
the deployer of high-risk AI systems should also inform the natural
should therefore carry out a person about its right to an
fundamental rights impact explanation provided under this
assessment prior to putting it into Regulation. With regard to high
use. The impact assessment should risk AI systems used for law
be accompanied by a detailed plan enforcement purposes, this
describing the measures or tools obligation should be implemented
that will help mitigating the risks to in accordance with Article 13 of
fundamental rights identified at the Directive 2016/680.
latest from the time of putting it
into use. If such plan cannot be
identified, the deployer should
refrain from putting the system into
use. When performing this impact
assessment, the deployer should
notify the national supervisory
authority and, to the best extent
possible relevant stakeholders as
well as representatives of groups of
persons likely to be affected by the
AI system in order to collect
relevant information which is
deemed necessary to perform the
impact assessment and are
encouraged to make the summary
of their fundamental rights impact
assessment publicly available on
their online website. This
obligations should not apply to
SMEs which, given the lack of
resrouces, might find it difficult to
perform such consultation.
Nevertheless, they should also strive
to invole such representatives when
carrying out their fundamental
rights impact assessment.In
addition, given the potential impact
and the need for democratic
oversight and scrutiny, deployers of
high-risk AI systems that are public
authorities or Union institutions,
bodies, offices and agencies, as well
deployers who are undertakings
designated as a gatekeeper under
Regulation (EU) 2022/1925 should
be required to register the use of
any high-risk AI system in a public
database. Other deployers may
voluntarily register.
Recital 58d
G 68d G
Recital 58e
(58d) Any processing of biometric

data involved in the use of AI
systems for biometric identification
G 68e for the purpose of law enforcement G
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.
Recital 58f
(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
G 68f should always be used in a way that G
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
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
Recital 58g
(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
G 68g use . Services important for G
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
risk.The impact assessment should
apply to the first 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.
Recital 59
G 69 (59) It is appropriate to envisage (59) It is appropriate to envisage G
that the user of the AI system should that the userdeployer of the AI deleted
be the natural or legal person, public system should be the natural or legal
authority, agency or other body person, public authority, agency or
under whose authority the AI system other body under whose authority
is operated except where the use is the AI system is operated except
made in the course of a personal where the use is made in the course
non-professional activity. of a personal non-professional
activity.
Recital 60
(60) In the light of the complexity (60) Within the AI value chain
of the artificial intelligence value multiple entities often supply tools deleted
chain, relevant third parties, notably and services but also components or
the ones involved in the sale and the processes that are then
supply of software, software tools incorporated by the provider into
and components, pre-trained models the AI system, including in relation
and data, or providers of network to data collection and pre-
services, should cooperate, as processing, model training, model
appropriate, with providers and users retraining, model testing and
to enable their compliance with the evaluation, integration into
obligations under this Regulation software, or other aspects of model
and with competent authorities development. The involved entities
G 70 established under this Regulation. may make their offering G
commercially available directly or

indirectly, through interfaces, such
as Application Programming
Interfaces (API), and distributed
under free and open source licenses
but also more and more by AI
workforce platforms, trained
parameters resale, DIY kits to build
models or the offering of paying
access to a model serving
architecture to develop and train
models. In the light of thethis
complexity of the artificial
intelligenceAI value chain, all
relevant third parties, notably the
onesin particular those that are
involved in the development, sale
and the commercial supply of
software, software tools and,
components, pre-trained models and
dataor data incorporated into the
AI system, or providers of network
services, should without
compromising their own
intellectual property rights or trade
secrets, make available the required
information, training or expertise
and cooperate, as appropriate, with
providers and users to enable their
control over all compliance with the
obligationsrelevant aspects of the
AI system that falls under this
Regulation. To allow a cost-effective
AI value chain governance, the
level of control shall be explicitly
disclosed by each third party that
supplies the provider with a tool,
service, component or process that
is later incorporated by the provider
into the AI system and with
competent authorities established
under this Regulation.
Recital 60ea
(60a) Software and data that are

G 70a openly shared and where users can G
freely access, use, modify and

redistribute them or modified
versions thereof, can contribute to
research and innovation in the
market. Research by the
Commission also shows that free
and open-source software can
contribute between EUR 65 billion
to EUR 95 billion to the European
Union’s GDP and that it can
provide significant growth
opportunities for the European
economy. Users are allowed to run,
copy, distribute, study, change and
improve software and data,
including models by way of free and
open-source licences. To foster the
development and deployment of AI,
especially by SMEs, start-ups,
academic research but also by
individuals, this Regulation should
not apply to such free and open-
source AI components except to the
extent that they are placed on the
market or put into service by a
provider as part of a high-risk AI
system or of an AI system that falls
under Title II or IV of this
Regulation.
Recital 60eb
(60b) Neither the collaborative

development of free and open-
G 70b source AI components nor making G
them available on open repositories

should constitute a placing on the
market or putting into service. A
commercial activity, within the
understanding of making available
on the market, might however be
characterised by charging a price,
with the exception of transactions
between micro enterprises, for a
free and open-source AI component
but also by charging a price for
technical support services, by
providing a software platform
through which the provider
monetises other services, or by the
use of personal data for reasons
other than exclusively for
improving the security,
compatibility or interoperability of
the software.
Recital 60c
(60c) Where one party is in a

stronger bargaining position, there
is a risk that that party could
leverage such position to the
detriment of the other contracting
party when negotiating the supply
of tools, services, components or
G 70c processes that are used or G
integrated in a high risk AI system

or the remedies for the breach or
the termination of related
obligations. Such contractual
imbalances particularly harm
micro, small and medium-sized
enterprises as well as start-ups,
unless they are owned or sub-
contracted by an enterprise which is
able to compensate the sub-
contractor appropriately, as they
are without a meaningful ability to
negotiate the conditions of the
contractual agreement, and may
have no other choice than to accept
‘take-it-or-leave-it’ contractual
terms. Therefore, unfair contract
terms regulating the supply of tools,
that are used or integrated in a high
risk AI system or the remedies for
the breach or the termination of
related obligations should not be
binding to such micro, small or
medium-sized enterprises and start-
ups when they have been
unilaterally imposed on them.
Recital 60d
(60d) Rules on contractual terms

should take into account the
principle of contractual freedom as
an essential concept in business-to-
business relationships. Therefore,
not all contractual terms should be
G 70d subject to an unfairness test, but G
only to those terms that are

unilaterally imposed on micro,
small and medium-sized enterprises
and start-ups. This concerns ‘take-
it-or-leave-it’ situations where one
party supplies a certain contractual
term and the micro, small or
medium-sized enterprise and start-
up cannot influence the content of
that term despite an attempt to
negotiate it. A contractual term that
is simply provided by one party and
accepted by the micro, small,
medium-sized enterprise or a start-
up or a term that is negotiated and
subsequently agreed in an amended
way between contracting parties
should not be considered as
unilaterally imposed.
Recital 60e
(60e) Furthermore, the rules on

unfair contractual terms should
only apply to those elements of a
contract that are related to supply
processes that are used or
integrated in a high risk AI system
G 70e G
or the remedies for the breach or
the termination of related
obligations. Other parts of the same
contract, unrelated to these
elements, should not be subject to
the unfairness test laid down in this
Regulation.
Recital 60f
(60f) Criteria to identify unfair

G 70f G
contractual terms should be applied
only to excessive contractual terms,
where a stronger bargaining
position is abused. The vast
majority of contractual terms that
are commercially more favourable
to one party than to the other,
including those that are normal in
business-to-business contracts, are
a normal expression of the
principle of contractual freedom
and continue to apply. If a
contractual term is not included in
the list of terms that are always
considered unfair, the general
unfairness provision applies. In this
regard, the terms listed as unfair
terms should serve as a yardstick to
interpret the general unfairness
provision.
Recital 60g
(60g) Foundation models are a

recent development, in which AI
models are developed from
algorithms designed to optimize for
generality and versatility of output.
Those models are often trained on a
broad range of data sources and
G 70g G
large amounts of data to
accomplish a wide range of
downstream tasks, including some
for which they were not specifically
developed and trained. The
foundation model can be unimodal
or multimodal, trained through
various methods such as supervised
learning or reinforced learning. AI
systems with specific intended
purpose or general purpose AI
systems can be an implementation
of a foundation model, which
means that each foundation model
can be reused in countless
downstream AI or general purpose
AI systems. These models hold
growing importance to many
downstream applications and
systems.
Recital 60h
(60h) In the case of foundation

models provided as a service such
as through API access, the
cooperation with downstream
providers should extend throughout
the time during which that service
is provided and supported, in order
to enable appropriate risk
mitigation, unless the provider of
the foundation model transfers the
G 70h G
training model as well as extensive
and appropriate information on the
datasets and the development
process of the system or restricts the
service, such as the API access, in
such a way that the downstream
provider is able to fully comply with
this Regulation without further
support from the original provider
of the foundation model.
Recital 60i
(60i) In light of the nature and

system, it is essential to clarify the
role of actors contributing to the
development of AI systems. There is
significant uncertainty as to the
way foundation models will evolve,
both in terms of typology of models
and in terms of self-governance.
Therefore, it is essential to clarify
the legal situation of providers of
foundation models. Combined with
their complexity and unexpected
impact, the downstream AI
provider’s lack of control over the
foundation model’s development
and the consequent power
G 70i G
imbalance and in order to ensure a
fair sharing of responsibilities
along the AI value chain, such
models should be subject to
proportionate and more specific
requirements and obligations under
this Regulation, namely foundation
models should assess and mitigate
possible risks and harms through
appropriate design, testing and
analysis, should implement data
governance measures, including
assessment of biases, and should
comply with technical design
requirements to ensure appropriate
levels of performance,
predictability, interpretability,
corrigibility, safety and
cybersecurity and should comply
with environmental standards.
These obligations should be
accompanied by standards. Also,
foundation models should have
information obligations and
prepare all necessary technical
documentation for potential
downstream providers to be able to
comply with their obligations under
this Regulation. Generative
foundation models should ensure
transparency about the fact the
content is generated by an AI
system, not by humans. These
specific requirements and
obligations do not amount to
considering foundation models as
high risk AI systems, but should
guarantee that the objectives of this
Regulation to ensure a high level of
protection of fundamental rights,
health and safety, environment,
democracy and rule of law are
achieved. Pre-trained models
developed for a narrower, less
general, more limited set of
applications that cannot be adapted
for a wide range of tasks such as
simple multi-purpose AI systems
should not be considered
foundation models for the purposes
of this Regulation, because of their
greater interpretability which
makes their behaviour less
unpredictable.
Recital 60j
(60j) Given the nature of

foundation models, expertise in
conformity assessment is lacking
and third-party auditing methods
are still under development . The
sector itself is therefore developing
new ways to assess fundamental
models that fulfil in part the
objective of auditing (such as model
evaluation, red-teaming or machine
learning verification and validation
techniques). Those internal
assessments for foundation models
should be should be broadly
applicable (e.g. independent of
distribution channels, modality,
development methods), to address
G 70j G
risks specific to such models taking
into account industry state-of-the-
art practices and focus on
developing sufficient technical
understanding and control over the
model, the management of
reasonably foreseeable risks, and
extensive analysis and testing of the
model through appropriate
measures, such as by the
involvement of independent
evaluators. As foundation models
are a new and fast-evolving
development in the field of artificial
intelligence, it is appropriate for the
Commission and the AI Office to
monitor and periodically asses the
legislative and governance
framework of such models and in
particular of generative AI systems
based on such models, which raise
significant questions related to the
generation of content in breach of
Union law, copyright rules, and
potential misuse. It should be
clarified that this Regulation should
be without prejudice to Union law
on copyright and related rights,
including Directives 2001/29/EC,
2004/48/ECR and (EU) 2019/790 of
the European Parliament and of
the Council.
Recital 60c
(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
G 70k G
capability to competently perform a
wide range of distinct tasks. These
models are typically trained on
large amounts of data, through
various methods, such as self-
supervised, unsupervised or
reinforcement learning. General-
purpose AI models may be placed
on the market in various ways,
including through libraries,
application programming interfaces
(APIs), as direct download, or as
physical copy. These models may be
further modified or fine-tuned into
new models. Although AI models
are essential components of AI
systems, they do not constitute AI
systems on their own. AI models
require the addition of further
components, such as for example a
user interface, to become AI
systems. AI models are typically
integrated into and form part of AI
systems. This Regulation provides
specific rules for general purpose
AI models and for general purpose
AI models that pose systemic risks,
which should apply also when these
models 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.
Text Origin: GSC
Recital 60d
(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
G 70l G
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.
Text Origin: GSC
Recital 60e
(60c) Large generative AI models

are a typical example for a general-
purpose AI model, given that they
allow for flexible generation of
G 70m content (such as in the form of text, G
audio, images or video) that can

readily accommodate a wide range
of distinctive tasks.
Text Origin: GSC
Recital 60f
G 70n G
Recital 60g
(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
G 70o capability to serve a variety of G
purposes. A general-purpose AI
system can be used directly, or it
may be integrated into other AI
systems.
Text Origin: GSC
Recital 60h
(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 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
G 70p G
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 (XY) and
Annex (XX). The Commission
should be enabled to amend the
Annexes by delegated acts in the
light of the evolving technological
developments.
Text Origin: GSC
Recital 60i
(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
G 70q transparency and openness if their G
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 free and open source AI
components. The fact of making AI
components available through open
repositories should not, in itself,
constitute a monetisation.
Recital 60f
(60f) The providers of general

G 70r purpose AI models that are released G
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
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 tranparency-
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.
Text Origin: GSC
Recital 60g
(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 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
G 70s G
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.
Text Origin: GSC
Recital 60l
G 70t G
Recital 60i
(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
G 70u such models require access to vast G
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,
models need to obtain an
authorisation from rightholders if
they want to carry out text and data
mining over such works.
Text Origin: GSC
Recital 60j
(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,
G 70v providers of general purpose AI G
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.
Text Origin: GSC
Recital 60k
(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
G 70w G
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.
Text Origin: GSC
Recital 60ka
(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
G 70x G
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.
Recital 60l
G 70y Text Origin: GSC

G
Recital 60m
(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
G 70z dissemination of illegal, false, or G
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.
Text Origin: GSC
Recital 60n
(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
G 70aa G
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 and may decide to reassess
whether the general-purpose AI
model can still be considered to
present systemic risks.
Text Origin: GSC
Recital 60o
(60o) It is also necessary to clarify

a procedure for the classification of
G 70ab G
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,
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.
Text Origin: GSC
Recital 60p
(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
G 70ac to designate it so. A system of G
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.
Text Origin: GSC
Recital 60q
G 70ad G
(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 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,
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.
Text Origin: GSC
Recital 60r
(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
G 70ae G
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.
Text Origin: GSC
Recital 60x
(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
G 70af Office should collaborate with G
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 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.
Text Origin: GSC
Recital 60t
(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
G 70ag G
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.
Text Origin: GSC
Recital 60u
(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
G 70ah that embed such systems or models G
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
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.
Text Origin: GSC
Recital 60aa
(60aa) Considering the quick pace

of innovation and the technological
evolution of digital services in scope
of different instruments of Union
G 70ai law in particular having in mind G
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.
Recital 60v
(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
G 70aj G
Regulation (EU) 2022/2065. This
applies in particular as regards the
obligations of providers of very
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.
Text Origin: GSC
Recital 61
(61) Standardisation should play a (61) Standardisation should play a (61) Standardisation should play a (61) Standardisation should play a
key role to provide technical key role to provide technical key role to provide technical key role to provide technical
solutions to providers to ensure solutions to providers to ensure solutions to providers to ensure solutions to providers to ensure
compliance with this Regulation. compliance with this Regulation. compliance with this Regulation, in compliance with this Regulation, in
Compliance with harmonised Compliance with harmonised line with the state of the art. line with the state of the art, to
standards as defined in Regulation standards as defined in Regulation Compliance with harmonised promote innovation as well as
(EU) No 1025/2012 of the European (EU) No 1025/2012 of the European standards as defined in Regulation competitiveness and growth in the
Parliament and of the Council1 Parliament and of the Council1 (EU) No 1025/2012 of the European single market. Compliance with
should be a means for providers to should be a means for providers to Parliament and of the Council1, harmonised standards as defined in
demonstrate conformity with the demonstrate conformity with the which are normally expected to Regulation (EU) No 1025/2012 of
requirements of this Regulation. requirements of this Regulation. reflect the state of the art, should be the European Parliament and of the
However, the Commission could However, the Commission could a means for providers to demonstrate Council1, which are normally
adopt common technical adopt common technical conformity with the requirements of expected to reflect the state of the
G 71 G
specifications in areas where no specifications in areas where no this Regulation. However, in the art, should be a means for providers
harmonised standards exist or where harmonised standards exist or where absence of relevant references to to demonstrate conformity with the
they are insufficient. they are insufficientTo ensure the harmonised standards, the requirements of this Regulation. A
_________ effectiveness of standards as policy Commission could adoptshould be balanced representation of interests
1. Regulation (EU) No 1025/2012 of the tool for the Union and considering able to establish, via implementing involving all relevant stakeholders
European Parliament and of the Council of the importance of standards for acts, common technical in the development of standards, in
25 October 2012 on European
standardisation, amending Council ensuring conformity with the specifications in areas where particular SME’s, consumer
Directives 89/686/EEC and 93/15/EEC and requirements of this Regulation and nospecifications for certain organisations and environmental
Directives 94/9/EC, 94/25/EC, 95/16/EC, for the competitiveness of requirements under this Regulation and social stakeholders in
97/23/EC, 98/34/EC, 2004/22/EC, undertakings, it is necessary to as an exceptional fall back solution accordance with Article 5 and 6 of
2007/23/EC, 2009/23/EC and 2009/105/EC
of the European Parliament and of the
ensure a balanced representation of to facilitate the provider’s Regulation 1025/2012 should
Council and repealing Council Decision interests by involving all relevant obligation to comply with the therefore be encouraged.
87/95/EEC and Decision No 1673/2006/EC stakeholders in the development of requirements of this Regulation, In order to facilitate compliance,
of the European Parliament and of the standards. The standardisation when the standardisation process is the standardisation requests should
Council (OJ L 316, 14.11.2012, p. 12). process should be transparent in blocked or when there are delays in be issued by the Commission
terms of legal and natural persons the establishment of an appropriate without undue delay. When
participating in the standardisation harmonised standard. If such delay preparing the standardisation
activities. is due to the technical complexity of request, the Commission should
_________ the standard in question, this consult the AI advisory Forum and
1. Regulation (EU) No 1025/2012 of the should be considered by the the Board in order to collect
European Parliament and of the Council of Commission before contemplating relevant expertise.
standardisation, amending Council the establishment of common
Directives 89/686/EEC and 93/15/EEC and specifications. An appropriate However, In the absence of relevant
Directives 94/9/EC, 94/25/EC, 95/16/EC, involvement of small and medium references to harmonised
97/23/EC, 98/34/EC, 2004/22/EC, enterprises in the elaboration of standards, the Commission could
2007/23/EC, 2009/23/EC and 2009/105/EC
standards exist or where they are adoptshould be able to establish, via
Council and repealing Council Decision insufficientsupporting the implementing acts, and after
87/95/EEC and Decision No 1673/2006/EC implementation of this Regulation consultation of the AI Advisory
of the European Parliament and of the is essential to promote innovation forum, common specifications for
Council (OJ L 316, 14.11.2012, p. 12). and competitiveness in the field of certain requirements under this
artificial intelligence within the Regulation. The common technical
Union. Such involvement should be specifications in areas where
appropriately ensured in nospecification should be an
accordance with Article 5 and 6 of exceptional fall back solution to
Regulation 1025/2012. facilitate the provider’s obligation
_________ to comply with the requirements of
1. [1] Regulation (EU) No 1025/2012 this Regulation, when the
of the European Parliament and of the standardisation request has not
Council of 25 October 2012 on European
standardisation, amending Council been accepted by any of the
Directives 89/686/EEC and 93/15/EEC and European standardisation
Directives 94/9/EC, 94/25/EC, 95/16/EC, organisations, or when the relevant
97/23/EC, 98/34/EC, 2004/22/EC, harmonized standards insufficiently
2007/23/EC, 2009/23/EC and 2009/105/EC
address fundamental rights
Council and repealing Council Decision concerns, or when the harmonised
87/95/EEC and Decision No 1673/2006/EC standards exist or where they are
of the European Parliament and of the insufficientstandarts do not comply
Council (OJ L 316, 14.11.2012, p. 12). 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.
_________
1. Regulation (EU) No 1025/2012 of the
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
Council and repealing Council Decision
87/95/EEC and Decision No 1673/2006/EC
Council (OJ L 316, 14.11.2012, p. 12).
Recital 61a
(61a) It is appropriate that, without (61a) It is appropriate that, without

prejudice to the use of harmonised prejudice to the use of harmonised
standards and common standards and common
specifications, providers benefit specifications, providers of of high-
G 71a from a presumption of conformity risk AI system that has been trained G
with the relevant requirement on and tested on data reflecting the

data when their high-risk AI system specific geographical, behavioural,
has been trained and tested on data contextual or functional setting
reflecting the specific geographical, within which the AI system is
behavioural or functional setting intended to be used, should be
within which the AI system is presumed to be in compliance with
intended to be used. Similarly, in the respective measure provided for
line with Article 54(3) of under the requirement on data
Regulation (EU) 2019/881 of the governance set out in this
European Parliament and of the Regulation.
Council, high-risk AI systems that
have been certified or for which a Without prejudice to the
statement of conformity has been requirements related to robustness
issued under a cybersecurity and accuracy set out in this
scheme pursuant to that Regulation Regulation, in line with Article
and the references of which have 54(3) of Regulation (EU) 2019/881
been published in the Official of the European Parliament and of
Journal of the European Union the Council, high-risk AI systems
should be presumed to be in that have been certified or for
compliance with the cybersecurity which a statement of conformity
requirement of this Regulation. has been issued under a
This remains without prejudice to cybersecurity scheme pursuant to
the voluntary nature of that that Regulation and the references
cybersecurity scheme. 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.
Recital 61a
G 71b (61a) In order to facilitate G
compliance, the first

standardisation requests should be
issued by the Commission two
months after the entry into force of
this Regulation at the latest. This
should serve to improve legal
certainty, thereby promoting
investment and innovation in AI, as
well as competitiveness and growth
of the Union market, while
enhancing multistakeholder
governance representing all
relevant European stakeholders
such as the AI Office, European
standardisation organisations and
bodies or experts groups established
under relevant sectorial Union law
as well as industry, SMEs, start-
ups, civil society, researchers and
social partners, and should
ultimately facilitate global
cooperation on standardisation in
the field of AI in a manner
consistent with Union values. When
preparing the standardisation
request, the Commission should
consult the AI Office and the AI
advisory Forum in order to collect
relevant expertise.
Recital 61b
(61b) When AI systems are

intended to be used at the
G 71c G
workplace, harmonised standards
should be limited to technical
specifications and procedures.
Recital 61c
(61c) The Commission should be

able to adopt common
specifications under certain
conditions, when no relevant
harmonised standard exists or to
address specific fundamental rights
concerns. Through the whole
drafting process, the Commission
should regularly consult the AI
G 71d G
Office and its advisory forum, the
European standardisation
organisations and bodies or expert
groups established under relevant
sectorial Union law as well as
relevant stakeholders, such as
industry, SMEs, start-ups, civil
society, researchers and social
partners.
Recital 61d
(61d) When adopting common

specifications, the Commission
should strive for regulatory
alignment of AI with likeminded
global partners, which is key to
G 71e G
fostering innovation and cross-
border partnerships within the field
of AI, as coordination with
likeminded partners in
international standardisation bodies
is of great importance.
Recital 62
(62) In order to ensure a high level (62) In order to ensure a high level (62) In order to ensure a high level (62) In order to ensure a high level
of trustworthiness of high-risk AI of trustworthiness of high-risk AI of trustworthiness of high-risk AI of trustworthiness of high-risk AI
systems, those systems should be systems, those systems should be systems, those systems should be systems, those systems should be
subject to a conformity assessment subject to a conformity assessment subject to a conformity assessment subject to a conformity assessment
prior to their placing on the market prior to their placing on the market prior to their placing on the market prior to their placing on the market
or putting into service. or putting into service. To increase or putting into service. or putting into service.
G 72 the trust in the value chain and to G
give certainty to businesses about

the performance of their systems,
third-parties that supply AI
components may voluntarily apply
for a third-party conformity
assessment.
Recital 63
(63) It is appropriate that, in order (63) It is appropriate that, in order (63) It is appropriate that, in order (63) It is appropriate that, in order
to minimise the burden on operators to minimise the burden on operators to minimise the burden on operators to minimise the burden on operators
and avoid any possible duplication, and avoid any possible duplication, and avoid any possible duplication, and avoid any possible duplication,
for high-risk AI systems related to for high-risk AI systems related to for high-risk AI systems related to for high-risk AI systems related to
products which are covered by products which are covered by products which are covered by products which are covered by
existing Union harmonisation existing Union harmonisation existing Union harmonisation existing Union harmonisation
legislation following the New legislation following the New legislation following the New legislation following the New
G 73 Legislative Framework approach, Legislative Framework approach, Legislative Framework approach, Legislative Framework approach, G
the compliance of those AI systems the compliance of those AI systems the compliance of those AI systems the compliance of those AI systems
with the requirements of this with the requirements of this with the requirements of this with the requirements of this
Regulation should be assessed as Regulation should be assessed as Regulation should be assessed as Regulation should be assessed as
part of the conformity assessment part of the conformity assessment part of the conformity assessment part of the conformity assessment
already foreseen under that already foreseen under that already foreseen under that already foreseen under that
legislation. The applicability of the legislation. The applicability of the legislation. The applicability of the legislation. The applicability of the
requirements of this Regulation requirements of this Regulation requirements of this Regulation requirements of this Regulation
should thus not affect the specific should thus not affect the specific should thus not affect the specific should thus not affect the specific
logic, methodology or general logic, methodology or general logic, methodology or general logic, methodology or general
structure of conformity assessment structure of conformity assessment structure of conformity assessment structure of conformity assessment
under the relevant specific New under the relevant specific New under the relevant specific New under the relevant specific New
Legislative Framework legislation. Legislative Framework legislation. Legislative Framework legislation. Legislative Framework legislation.
This approach is fully reflected in This approach is fully reflected in This approach is fully reflected in This approach is fully reflected in
the interplay between this the interplay between this the interplay between this the interplay between this
Regulation and the [Machinery Regulation and the [Machinery Regulation and the [Machinery Regulation and the [Machinery
Regulation]. While safety risks of AI Regulation]. While safety risks of AI Regulation]. While safety risks of AI Regulation]. While safety risks of AI
systems ensuring safety functions in systems ensuring safety functions in systems ensuring safety functions in systems ensuring safety functions in
machinery are addressed by the machinery are addressed by the machinery are addressed by the machinery are addressed by the
requirements of this Regulation, requirements of this Regulation, requirements of this Regulation, requirements of this Regulation,
certain specific requirements in the certain specific requirements in the certain specific requirements in the certain specific requirements in the
[Machinery Regulation] will ensure [Machinery Regulation] will ensure [Machinery Regulation] will ensure [Machinery Regulation] will ensure
the safe integration of the AI system the safe integration of the AI system the safe integration of the AI system the safe integration of the AI system
into the overall machinery, so as not into the overall machinery, so as not into the overall machinery, so as not into the overall machinery, so as not
to compromise the safety of the to compromise the safety of the to compromise the safety of the to compromise the safety of the
machinery as a whole. The machinery as a whole. The machinery as a whole. The machinery as a whole. The
[Machinery Regulation] applies the [Machinery Regulation] applies the [Machinery Regulation] applies the [Machinery Regulation] applies the
same definition of AI system as this same definition of AI system as this same definition of AI system as this same definition of AI system as this
Regulation. Regulation. Regulation. With regard to high- Regulation.
risk AI systems related to products
covered by Regulations 745/2017
and 746/2017 on medical devices,
the applicability of the requirements
of this Regulation should be
without prejudice and take into
account the risk management logic
and benefit-risk assessment
performed under the medical device
framework.
Recital 64
(64) Given the more extensive (64) Given the complexity of high- (64) Given the more extensive (64) Given the more
G 74 G
experience of professional pre- risk AI systems and the risks that experience of professional pre- extensivecomplexity of high-risk AI
market certifiers in the field of are associated to them, it is market certifiers in the field of systems and the risks that are
product safety and the different essential to develop a more product safety and the different associated to them, it is important to
nature of risks involved, it is adequate capacity for the nature of risks involved, it is develop an adequate system of
appropriate to limit, at least in an application of third party appropriate to limit, at least in an conformity assessment procedure
initial phase of application of this conformity assessment for high-risk initial phase of application of this for high risk AI systems involving
Regulation, the scope of application AI systems. However, given the Regulation, the scope of application notified bodies, so called third party
of third-party conformity assessment currentmore extensive experience of of third-party conformity assessment conformity assessment. However,
for high-risk AI systems other than professional pre-market certifiers in for high-risk AI systems other than given the current experience of
those related to products. Therefore, the field of product safety and the those related to products. Therefore, professional pre-market certifiers in
the conformity assessment of such different nature of risks involved, it the conformity assessment of such the field of product safety and the
systems should be carried out as a is appropriate to limit, at least in an systems should be carried out as a different nature of risks involved, it
general rule by the provider under its initial phase of application of this general rule by the provider under its is appropriate to limit, at least in an
own responsibility, with the only Regulation, the scope of application own responsibility, with the only initial phase of application of this
exception of AI systems intended to of third-party conformity assessment exception of AI systems intended to Regulation, the scope of application
be used for the remote biometric for high-risk AI systems other than be used for the remote biometric of third-party conformity assessment
identification of persons, for which those related to products. Therefore, identification of persons, for which for high-risk AI systems other than
the involvement of a notified body in the conformity assessment of such the involvement of a notified body in those related to products. Therefore,
the conformity assessment should be systems should be carried out as a the conformity assessment should be the conformity assessment of such
foreseen, to the extent they are not general rule by the provider under its foreseen, to the extent they are not systems should be carried out as a
prohibited. own responsibility, with the only prohibited. general rule by the provider under its
exception of AI systems intended to own responsibility, with the only
be used for the remote biometric exception of AI systems intended to
identification of persons, or AI be used for the remote biometric
systems intended to be used to make identification of persons, for which
inferences about personal the involvement of a notified body in
characteristics of natural persons the conformity assessment should be
on the basis of biometric or foreseen, to the extent they are not
biometrics-based data, including prohibitedbiometrics.
emotion recognition systems for
which the involvement of a notified
body in the conformity assessment
should be foreseen, to the extent
they are not prohibited.
Recital 65
G 75 G
(65) In order to carry out third-party (65) In order to carry out third-party (65) In order to carry out third-party (65) In order to carry out third-party
conformity assessment for AI conformity assessment for AI conformity assessment for AI conformity assessment for AI
systems intended to be used for the systems intended to be used for the systems intended to be used for the systems intended to be used for the
remote biometric identification of remote biometric identification of remote biometric identification of remote biometric identification of
persons, notified bodies should be personsassessments when so persons, notified bodies should be personsassessments when so
designated under this Regulation by required, notified bodies should be designatednotified under this required, notified bodies should be
the national competent authorities, designated under this Regulation by Regulation by the national designated notified under this
provided they are compliant with a the national competent authorities, competent authorities, provided they Regulation by the national
set of requirements, notably on provided they are compliant with a are compliant with a set of competent authorities, provided they
independence, competence and set of requirements, notably on requirements, notably on are compliant with a set of
absence of conflicts of interests. independence, competence and, independence, competence and requirements, notably on
absence of conflicts of interests and absence of conflicts of interests. independence, competence and,
minimum cybersecurity Notification of those bodies should absence of conflicts of interests and
requirements. Member States be sent by national competent suitable cybersecurity requirements.
should encourage the designation authorities to the Commission and Notification of those bodies should
of a sufficient number of the other Member States by means be sent by national competent
conformity assessment bodies, in of the electronic notification tool authorities to the Commission and
order to make the certification developed and managed by the the other Member States by means
feasible in a timely manner. The Commission pursuant to Article of the electronic notification tool
procedures of assessment, R23 of Decision 768/2008. developed and managed by the
designation, notification and Commission pursuant to Article
monitoring of conformity R23 of Decision 768/2008.
assessment bodies should be
implemented as uniformly as
possible in Member States, with a
view to removing administrative
border barriers and ensuring that
the potential of the internal market
is realised.
Recital 65a
(65a) In line with Union (65a) In line with Union

commitments under the World commitments under the World
G 75a G
Trade Organization Agreement on Trade Organization Agreement on
Technical Barriers to Trade, it is Technical Barriers to Trade, it is
adequate to maximise the adequate to facilitate the mutual
acceptance of test results produced recognition of conformity
by competent conformity assessment results produced by
assessment bodies, independent of competent conformity assessment
the territory in which they are bodies, independent of the territory
established, where necessary to in which they are established,
demonstrate conformity with the provided that those conformity
applicable requirements of the assessment bodies established
Regulation. The Commission under the law of a third country
should actively explore possible meet the applicable requirements of
international instruments for that the Regulation and the Union has
purpose and in particular pursue concluded an agreement to that
the possible establishment of extent. In this context, the
mutual recognition agreements Commission should actively explore
with countries which are on a possible international instruments
comparable level of technical for that purpose and in particular
development, and have compatible pursue the conclusion of mutual
approach concerning AI and recognition agreements with third
conformity assessment. countries.
Recital 66
(66) In line with the commonly (66) In line with the commonly (66) In line with the commonly (66) In line with the commonly
established notion of substantial established notion of substantial established notion of substantial established notion of substantial
modification for products regulated modification for products regulated modification for products regulated modification for products regulated
by Union harmonisation legislation, by Union harmonisation legislation, by Union harmonisation legislation, by Union harmonisation legislation,
it is appropriate that an AI system it is appropriate that an high-risk AI it is appropriate that an AI system it is appropriate that an AI system
undergoes a new conformity system undergoes a new conformity undergoes a new conformity undergoes a new conformity
assessment whenever a change assessment whenever aan assessment whenever a change assessment whenever a change
G 76 G
occurs which may affect the unplanned change occurs which occurs which may affect the occurs which may affect the
compliance of the system with this goes beyond controlled or compliance of thea high risk AI compliance of thea high risk AI
Regulation or when the intended predetermined changes by the system with this Regulation (e.g. system with this Regulation (e.g.
purpose of the system changes. In provider including continuous change of operating system or change of operating system or
addition, as regards AI systems learning and which may create a software architecture), or when the software architecture), or when the
which continue to ‘learn’ after being new unacceptable risk and intended purpose of the system intended purpose of the system
placed on the market or put into significantlymay affect the changes. In addition, as regards, changes, that AI system should be
service (i.e. they automatically adapt compliance of the high-risk AI that AI system should be considered considered a new AI system which
how functions are carried out), it is system with this Regulation or when a new AI system which should should undergo a new conformity
necessary to provide rules the intended purpose of the system undergo a new conformity assessment. However, changes
establishing that changes to the changes. In addition, as regards AI assessment. However, changes occuring to the algorithm and the
algorithm and its performance that systems which continue to ‘learn’ occuring to the algorithm and the performance of. In addition, as
have been pre-determined by the after being placed on the market or performance of AI systems which regards AI systems which continue
provider and assessed at the moment put into service (i.e. they continue to ‘learn’ after being placed to ‘learn’ after being placed on the
of the conformity assessment should automatically adapt how functions on the market or put into service (i.e. market or put into service (i.e. they
not constitute a substantial are carried out), it is necessary to they automatically adaptadapting automatically adaptadapting how
modification. provide rules establishing that how functions are carried out), it is functions are carried out), it is
changes to the algorithm and its necessary to provide rules necessary to provide rules
performance that have been pre- establishing that should not establishing that changes to the
determined by the provider and constitute a substantial algorithm and its performance that
assessed at the moment of the modification, provided that those should not constitute a substantial
conformity assessment should not changes to the algorithm and its modification, provided that those
constitute a substantial modification. performance that have been pre- changes have been pre-determined
The same should apply to updates determined by the provider and by the provider and assessed at the
of the AI system for security assessed at the moment of the moment of the conformity
reasons in general and to protect conformity assessment should not assessment should not constitute a
against evolving threats of constitute a substantial substantial modification.
manipulation of the system, modification..
provided that they do not amount to
a substantial modification.
Recital 67
bear the CE marking to indicate their bear the CE marking to indicate their bear the CE marking to indicate their bear the CE marking to indicate their
conformity with this Regulation so conformity with this Regulation so conformity with this Regulation so conformity with this Regulation so
that they can move freely within the that they can move freely within the that they can move freely within the that they can move freely within the
internal market. Member States internal market. For physical high- internal market. Member States internal market. For high-risk AI
G 77 G
should not create unjustified risk AI systems, a physical CE should not create unjustified systems embedded in a product, a
obstacles to the placing on the marking should be affixed, and may obstacles to the placing on the physical CE marking should be
market or putting into service of be complemented by a digital CE market or putting into service of affixed, and may be complemented
high-risk AI systems that comply marking. For digital only high-risk high-risk AI systems that comply by a digital CE marking. For high-
with the requirements laid down in AI systems, a digital CE marking with the requirements laid down in risk AI systems only provided
this Regulation and bear the CE should be used. Member States this Regulation and bear the CE digitally, a digital CE marking
marking. should not create unjustified marking. should be used. Member States
obstacles to the placing on the should not create unjustified
market or putting into service of obstacles to the placing on the
high-risk AI systems that comply market or putting into service of
with the requirements laid down in high-risk AI systems that comply
this Regulation and bear the CE with the requirements laid down in
marking. this Regulation and bear the CE
marking.
Recital 68
(68) Under certain conditions, rapid (68) Under certain conditions, rapid (68) Under certain conditions, rapid (68) Under certain conditions, rapid
availability of innovative availability of innovative availability of innovative availability of innovative
technologies may be crucial for technologies may be crucial for technologies may be crucial for technologies may be crucial for
health and safety of persons and for health and safety of persons, the health and safety of persons and for health and safety of persons, the
society as a whole. It is thus environment and climate change society as a whole. It is thus protection of the environment and
appropriate that under exceptional and for society as a whole. It is thus appropriate that under exceptional climate change and for society as a
reasons of public security or appropriate that under exceptional reasons of public security or whole. It is thus appropriate that
protection of life and health of reasons of public security or protection of life and health of under exceptional reasons of public
natural persons and the protection of protection of life and health of natural persons and the protection of security or public security or
industrial and commercial property, natural persons, environmental industrial and commercial property, protection of life and health of
Member States could authorise the protection and the protection of Member States could authorise the natural persons, environmental
placing on the market or putting into industrial and commercial placing on the market or putting into protection and the protection of key
G 78 G
service of AI systems which have propertycritical infrastructure, service of AI systems which have industrial and infrastructural assets
not undergone a conformity Member States could authorise the not undergone a conformity industrial and commercial property,
assessment. placing on the market or putting into assessment. Market Surveillance Authorities
service of AI systems which have Member States could authorise the
not undergone a conformity placing on the market or putting into
assessment. 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.
Recital 69
(69) In order to facilitate the work (69) In order to facilitate the work (69) In order to facilitate the work (69) In order to facilitate the work
of the Commission and the Member of the Commission and the Member of the Commission and the Member of the Commission and the Member
States in the artificial intelligence States in the artificial intelligence States in the artificial intelligence States in the artificial intelligence
field as well as to increase the field as well as to increase the field as well as to increase the field as well as to increase the
transparency towards the public, transparency towards the public, transparency towards the public, transparency towards the public,
providers of high-risk AI systems providers of high-risk AI systems providers of high-risk AI systems providers of high-risk AI systems
other than those related to products other than those related to products other than those related to products other than those related to products
falling within the scope of relevant falling within the scope of relevant falling within the scope of relevant falling within the scope of relevant
existing Union harmonisation existing Union harmonisation existing Union harmonisation existing Union harmonisation
legislation, should be required to legislation, should be required to legislation, should be required to legislation, as well as providers who
register their high-risk AI system in register their high-risk AI system register themselves and information consider that an AI system referred
a EU database, to be established and and foundation models in a EU about their high-risk AI system in a to in annex III is by derogation not
managed by the Commission. The database, to be established and EU database, to be established and high-risk, should be required to
G 79 Commission should be the controller managed by the Commission. This managed by the Commission. register their high-risk themselves G
of that database, in accordance with database should be freely and Before using a high-risk AI system and information about their AI
Regulation (EU) 2018/1725 of the publicly accessible, easily listed in Annex III, users of high- system in a EU database, to be
European Parliament and of the understandable and machine- risk AI systems that are public established and managed by the
Council1. In order to ensure the full readable. The database should also authorities, agencies or bodies, with Commission. Before using a high-
functionality of the database, when be user-friendly and easily the exception of law enforcement, risk AI system listed in Annex III,
deployed, the procedure for setting navigable, with search border control, immigration or deployers of high-risk AI systems
the database should include the functionalities at minimum asylum authorities, and authorities that are public authorities, agencies
elaboration of functional allowing the general public to that are users of high-risk AI or bodies, shall register themselves
specifications by the Commission search the database for specific systems in the area of critical in such database and select the
and an independent audit report. high-risk systems, locations, infrastructure shall also register system that they envisage to use..
_________ categories of risk under Annex IV themselves in such database and Other deployers should be entitled
1. Regulation (EU) 2016/679 of the and keywords. Deployers who are select the system that they envisage to do so voluntarily. This section of
European Parliament and of the Council of public authorities or Union to use. The Commission should be the database should be publicly
27 April 2016 on the protection of natural
institutions, bodies, offices and the controller of that database, in accessible, free of charge, the
persons with regard to the processing of agencies or deployers acting on accordance with Regulation (EU) information should be easily
personal data and on the free movement of their behalf and deployers who are 2018/1725 of the European navigatable, understandable and
such data, and repealing Directive 95/46/EC
(General Data Protection Regulation) (OJ L undertakings designated as a Parliament and of the Council1. In machine-readable. The database
119, 4.5.2016, p. 1). gatekeeper under Regulation order to ensure the full functionality should also be user-friendly, for
(EU)2022/1925 should also register of the database, when deployed, the example by providing search
in the EU database before putting procedure for setting the database functionalities, including through
into service or using a high-risk AI should include the elaboration of keywords, allowing the general
system for the first time and functional specifications by the public to find relevant information
following each substantial Commission and an independent included in Annex VIII and on the
modification. Other deployers audit report. areas of risk under Annex III to
should be entitled to do so _________ which the high-risk AI systems
voluntarily. Any substantial 1. [1] Regulation (EU) 2016/679 of correspond. . Any substantial
modification of high-risk AI the European Parliament and of the Council modification of high-risk AI
of 27 April 2016 on the protection of natural
systems shall also be registered in persons with regard to the processing of systems should also be registered in
the EU database. The Commission personal data and on the free movement of the EU database. For high risk AI
should be the controller of that such data, and repealing Directive 95/46/EC systems in the area of law
database, in accordance with (General Data Protection Regulation) (OJ L enforcement, migration, asylum
119, 4.5.2016, p. 1).
Regulation (EU) 2018/1725 of the and border control management,
European Parliament and of the the registration obligations should
Council1. In order to ensure the full be fulfilled in a secure non-public
functionality of the database, when section of the database. Access to
deployed, the procedure for setting the secure non-public section
the database should include the should be strictly limited to the
elaboration of functional Commission as well as to market
specifications by the Commission surveillance authorities with regard
and an independent audit report. The to their national section of that
Commission should take into database. High risk AI systems in
account cybersecurity and hazard- the area of critical infrastructure
related risks when carrying out its should only be registered at
tasks as data controller on the EU national level. The Commission
database. In order to maximise the should be the controller of the EU
availability and use of the database that database, in accordance with
by the public, the database, Regulation (EU) 2018/1725 of the
including the information made European Parliament and of the
available through it, should comply Council1. In order to ensure the full
with requirements under the functionality of the database, when
Directive 2019/882. deployed, the procedure for setting
_________ the database should include the
1. Regulation (EU) 2016/679 of the elaboration of functional
European Parliament and of the Council of specifications by the Commission
persons with regard to the processing of and an independent audit report. The
personal data and on the free movement of Commission should take into
such data, and repealing Directive 95/46/EC account cybersecurity and hazard-
(General Data Protection Regulation) (OJ L related risks when carrying out its
119, 4.5.2016, p. 1).
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.
_________
1. Regulation (EU) 2016/679 of the
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).
Recital 70
(70) Certain AI systems intended to (70) Certain AI systems intended to (70) Certain AI systems intended to (70) Certain AI systems intended to
interact with natural persons or to interact with natural persons or to interact with natural persons or to interact with natural persons or to
generate content may pose specific generate content may pose specific generate content may pose specific generate content may pose specific
risks of impersonation or deception risks of impersonation or deception risks of impersonation or deception risks of impersonation or deception
G 80 irrespective of whether they qualify irrespective of whether they qualify irrespective of whether they qualify irrespective of whether they qualify G
as high-risk or not. In certain as high-risk or not. In certain as high-risk or not. In certain as high-risk or not. In certain
circumstances, the use of these circumstances, the use of these circumstances, the use of these circumstances, the use of these
systems should therefore be subject systems should therefore be subject systems should therefore be subject systems should therefore be subject
to specific transparency obligations to specific transparency obligations to specific transparency obligations to specific transparency obligations
without prejudice to the without prejudice to the without prejudice to the without prejudice to the
requirements and obligations for requirements and obligations for requirements and obligations for requirements and obligations for
high-risk AI systems. In particular, high-risk AI systems. In particular, high-risk AI systems. In particular, high-risk AI systems and subject to
natural persons should be notified natural persons should be notified natural persons should be notified targeted exceptions to take into
that they are interacting with an AI that they are interacting with an AI that they are interacting with an AI account the special need of law
system, unless this is obvious from system, unless this is obvious from system, unless this is obvious from enforcement. In particular, natural
the circumstances and the context of the circumstances and the context of the point of view of a natural persons should be notified that they
use. Moreover, natural persons use. Moreover, natural persons person who is reasonably well- are interacting with an AI system,
should be notified when they are should be notified when they are informed, observant and unless this is obvious from the point
exposed to an emotion recognition exposed to an emotion recognition circumspect taking into account of view of a natural person who is
system or a biometric categorisation system or a biometric categorisation the circumstances and the context of reasonably well-informed,
system. Such information and system. Such information and use. When implementing such observant and circumspect taking
notifications should be provided in notifications should be provided in obligation, the characteristics of into account the circumstances and
accessible formats for persons with accessible formats for persons with individuals belonging to vulnerable the context of use. Moreover,
disabilities. Further, users, who use disabilities. Further, users, who use groups due to their age or disability natural persons should be notified
an AI system to generate or an AI system to generate or should be taken into account to the when they are exposed to an emotion
manipulate image, audio or video manipulate image, audio or video extent the AI system is intended to recognition system or a biometric
content that appreciably resembles content that appreciably resembles interact with those groups as well. categorisation system. Such
existing persons, places or events existing persons, places or events Moreover, natural persons should be information and notifications should
and would falsely appear to a person and would falsely appear to a person notified when they are exposed to an be provided in accessible formats for
to be authentic, should disclose that to be authentic, should disclose that emotion recognition system or a persons with disabilities. Further,
the content has been artificially the content has been artificially biometric categorisation users, who use an AI system to
created or manipulated by labelling created or manipulated by labelling systemsystems that, by processing generate or manipulate image, audio
the artificial intelligence output the artificial intelligence output their biometric data, can identify or or video content that appreciably
accordingly and disclosing its accordingly and disclosing its infer the emotions or intentions of resembles existingWhen
artificial origin. artificial origin. those persons or assign them to implementing such obligation, the
specific categories. Such specific characteristics of individuals
categories can relate to aspects belonging to vulnerable groups due
such as sex, age, hair colour, eye to their age or disability should be
colour, tatoos, personal traits, taken into account to the extent the
ethnic origin, personal preferences AI system is intended to interact
and interests or to other aspects with those groups as well.
such as sexual or political Moreover, natural persons should
orientation. Such information and be notified when they are exposed
notifications should be provided in to systems that, by processing their
accessible formats for persons with biometric data, can identify or infer
disabilities. Further, users, who use the emotions or intentions of those
an AI system to generate or persons, places or events and would
manipulate image, audio or video falsely appear to a person to be
content that appreciably resembles authentic, should disclose that the
existing persons, places or events content has been artificially created
and would falsely appear to a person or manipulated by labelling the
to be authentic, should disclose that artificial intelligence output
the content has been artificially accordingly and disclosing its
created or manipulated by labelling artificial origin or assign them to
the artificial intelligence output specific categories. Such specific
accordingly and disclosing its categories can relate to aspects
artificial origin. The compliance such as sex, age, hair colour, eye
with the information obligations colour, tattoos, personal traits,
referred to above should not be ethnic origin, personal preferences
interpreted as indicating that the and interests. Such information and
use of the system or its output is notifications should be provided in
lawful under this Regulation or accessible formats for persons with
other Union and Member State law disabilities.
and should be without prejudice to
other transparency obligations for
users of AI systems laid down in
Union or national law.
Furthermore it should also not be
interpreted 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 Funadamental
Rights of the EU, in particular
where the content is part of an
evidently creative, satirical, artistic
or fictional work or programme,
subject to appropriate safeguards
for the rights and freedoms of third
parties.
Recital 70a
(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
G 80a trace origin of information, it is G
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
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.
Recital 70b
(70b) Further to the technical

solutions employed by the providers
G 80b of the system, deployers , who use G
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.
Recital 70c
(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
G 80c G
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.
Recital 70d
(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
online search engines to identify
G 80d G
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.
Recital 70e
(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
G 80e G
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.
Recital 71
(71) Artificial intelligence is a (71) Artificial intelligence is a (71) Artificial intelligence is a (71) Artificial intelligence is a
rapidly developing family of rapidly developing family of rapidly developing family of rapidly developing family of
technologies that requires novel technologies that requires novel technologies that requires novel technologies that requires novel
G 81 forms of regulatory oversight and a forms of regulatory oversight and a forms of regulatory oversight and a forms of regulatory oversight and a G
safe space for experimentation, safe and controlled space for safe space for experimentation, safe and controlled space for
while ensuring responsible experimentation, while ensuring while ensuring responsible experimentation, while ensuring
innovation and integration of responsible innovation and innovation and integration of responsible innovation and
appropriate safeguards and risk integration of appropriate safeguards appropriate safeguards and risk integration of appropriate safeguards
mitigation measures. To ensure a and risk mitigation measures. To mitigation measures. To ensure a and risk mitigation measures. To
legal framework that is innovation- ensure a legal framework that is legal framework that is innovation- ensure a legal framework that is
friendly, future-proof and resilient to innovation-friendlypromotes friendly, future-proof and resilient to innovation-friendly, promotes
disruption, national competent innovation, is future-proof, and disruption, national competent innovation, is future-proof and
authorities from one or more resilient to disruption, national authorities from one or more resilient to disruption, national
Member States should be competent authorities from one or Member States should be competent authorities from one or
encouraged to establish artificial more Member States should be encouraged to establish artificial more Member States should be
intelligence regulatory sandboxes to encouraged to establishestablish at intelligence regulatory sandboxes to encouraged to establishMember
facilitate the development and least one artificial intelligence facilitate the development and States should ensure that their
testing of innovative AI systems regulatory sandboxessandbox to testing of innovative AI systems national competent authorities
under strict regulatory oversight facilitate the development and under strict regulatory oversight establish at least one artificial
before these systems are placed on testing of innovative AI systems before these systems are placed on intelligence regulatory sandboxes at
the market or otherwise put into under strict regulatory oversight the market or otherwise put into national level to facilitate the
service. before these systems are placed on service. development and testing of
the market or otherwise put into innovative AI systems under strict
service. It is indeed desirable for the regulatory oversight before these
establishment of regulatory systems are placed on the market or
sandboxes, whose establishment is otherwise put into service. Member
currently left at the discretion of States could also fulfill this
Member States, as a next step to be obligation through participating in
made mandatory with established already existing regulatory
criteria. That mandatory sandbox sandboxes or establishing jointly a
could also be established jointly sandbox with one or several
with one or several other Member Member States’ competent
States, as long as that sandbox authorities, insofar as this
would cover the respective national participation provides equivalent
level of the involved Member States. level of national coverage for the
Additional sandboxes may also be participating Member States.
established at different levels, Regulatory sandboxes could be
including cross Member States, in established in physical, digital or
order to facilitate cross-border hybrid form and may accommodate
cooperation and synergies. With the physical as well as digital products.
exception of the mandatory Establishing authorities should also
sandbox at national level, Member ensure that the regulatory
States should also be able to sandboxes have the adequate
establish virtual or hybrid resources for their functioning,
sandboxes. All regulatory including financial and human
sandboxes should be able to resources.
accommodate both physical and
virtual products. Establishing
authorities should also ensure that
the regulatory sandboxes have the
adequate financial and human
resources for their functioning.
Recital 72
(72) The objectives of the (72) The objectives of the (72) The objectives of the AI (72) The objectives of the AI
regulatory sandboxes should be to regulatory sandboxes should be to regulatory sandboxes should be to regulatory sandboxes should be to
foster AI innovation by establishing foster AI innovation by establishing foster AI innovation by establishing foster AI innovation by establishing
a controlled experimentation and a controlled experimentation and a controlled experimentation and a controlled experimentation and
testing environment in the testing environment in the testing environment in the testing environment in the
development and pre-marketing development and pre-marketing development and pre-marketing development and pre-marketing
phase with a view to ensuring phase with a view to ensuring phase with a view to ensuring phase with a view to ensuring
compliance of the innovative AI compliance of the innovative AI compliance of the innovative AI compliance of the innovative AI
systems with this Regulation and systems : for the establishing systems with this Regulation and systems with this Regulation and
other relevant Union and Member authorities to increase their other relevant Union and Member other relevant Union and Member
States legislation; to enhance legal understanding of technical States legislation; to enhance legal States legislation;, to enhance legal
certainty for innovators and the developments, improve supervisory certainty for innovators and the certainty for innovators and the
G 82 competent authorities’ oversight and methods and provide guidance to competent authorities’ oversight and competent authorities’ oversight and G
understanding of the opportunities, AI systems developers and providers understanding of the opportunities, understanding of the opportunities,
emerging risks and the impacts of AI to achieve regulatory compliance emerging risks and the impacts of AI emerging risks and the impacts of AI
use, and to accelerate access to with this Regulation and otheror use, and to accelerate access to use, to facilitate regulatory learning
markets, including by removing where relevant, other applicable markets, including by removing for authorities and companies,
barriers for small and medium Union and Member States barriers for small and medium including with a view to future
enterprises (SMEs) and start-ups. To legislation; to enhance legal enterprises (SMEs), including and adaptions of the legal framework,
ensure uniform implementation certainty for innovators and the start-ups. The participation in the to support cooperation and the
across the Union and economies of competent authorities’ oversight and AI regulatory sandbox should focus sharing of best practices with the
scale, it is appropriate to establish understanding of the opportunities, on issues that raise legal authorities involved in the AI
common rules for the regulatory emerging risks and the impacts of AI uncertainty for providers and regulatory sandbox, and to
sandboxes’ implementation and a use, and to accelerate access to prospective providers to innovate, accelerate access to markets,
framework for cooperation between markets, including by removing experiment with AI inTo ensure including by removing barriers for
the relevant authorities involved in barriers for small and medium uniform implementation across the small and medium enterprises
the supervision of the sandboxes. enterprises (SMEs) and start-ups. To Union and economies of scale, it is (SMEs), including and start-ups. To
This Regulation should provide the ensure uniform implementation appropriate to establish common ensure uniform implementation
legal basis for the use of personal across the Union and economies of rules for the contribute to evidence- acrossRegulatory sandboxes should
data collected for other purposes for scale, it is appropriate to establish based regulatory learning. The be widely available throughout the
developing certain AI systems in the common rules for the regulatory supervision of the AI systems in the Union, and particular attention
public interest within the AI sandboxes’ implementation and a AI regulatory sandboxes’ should be given to their accessibility
regulatory sandbox, in line with framework for cooperation between implementation and a framework for for SMEs, including startups. The
Article 6(4) of Regulation (EU) the relevant authorities involved in cooperation between the relevant participation in the AI and
2016/679, and Article 6 of the supervision of the sandboxes. authorities involved in the economies of scale, it is appropriate
Regulation (EU) 2018/1725, and This Regulation should provide the supervision of the sandboxes. This to establish common rules for the
without prejudice to Article 4(2) of legal basis for the use of personal Regulation should provide the legal regulatory sandboxes’
Directive (EU) 2016/680. data collected for other purposes for basis for the use of personal data implementation and a framework for
Participants in the sandbox should developing certain AI systems in the collected forsandbox should cooperation between the relevant
ensure appropriate safeguards and public interest within the AI therefore cover their development, authorities involved insandbox
cooperate with the competent regulatory sandbox, in line with training, testing and validation should focus on issues that raise
authorities, including by following Article 6(4) of Regulation (EU) before the systems are placed on the legal uncertainty for providers and
their guidance and acting 2016/679, and Article 6 of market or put into service, as well prospective providers to innovate,
expeditiously and in good faith to Regulation (EU) 2018/1725, and as the notion and occurrence of experiment with AI in the Union
mitigate any high-risks to safety and without prejudice to Article 4(2) of substantial modification that may and contribute to evidence-based
fundamental rights that may arise Directive (EU) 2016/680. require a new conformity regulatory learning. The
during the development and Participants in the sandbox, as well assessment procedure. Where supervision of the sandboxes. This
experimentation in the sandbox. The as with the Charter of Fundamental appropriate, national competent RegulationAI systems in the AI
conduct of the participants in the Rights; for the prospective authorities establishing AI regulatory sandbox should provide
sandbox should be taken into providers to allow and facilitate the regulatory sandboxes should the legal basis for the use of
account when competent authorities testing and development of cooperate with other purposes for personal data collected for other
decide whether to impose an innovative solutions related to AI developing certain AI systems in the purposes for developing
administrative fine under Article systems in the pre-marketing phase public interestrelevant authorities, certaintherefore cover their
83(2) of Regulation 2016/679 and to enhance legal certainty, to allow including those supervising the development, training, testing and
Article 57 of Directive 2016/680. for more regulatory learning by protection of fundamental rights, validation before the systems are
establishing authorities in a and could allow for the involvement placed on the market or put into
controlled environment to develop of other actors within the AI service, as well as the notion and
better guidance and to identify regulatory sandbox, in line with occurrence of substantial
possible future improvements of the Article 6(4) of Regulation (EU) modification that may require a
legal framework through the 2016/679ecosystem such as new conformity assessment
ordinary legislative procedure. Any national or European procedure. Any significant risks
significant risks identified during standardisation organisations, identified during the development
the development and testing of such notified bodies, testing and and testing of such AI systems
AI systems should result in experimentation facilities, research should result in adequate mitigation
immediate mitigation and, failing and experimentation labs, and, failing that, in the public
that, in the suspension of the innovation hubs and relevant interest within the suspension of the
development and testing process stakeholder and civil society development and testing process
until such mitigation takes place. organisations. To ensure uniform Where appropriate, national
To ensure uniform implementation implementation across the Union competent authorities establishing
across the Union and economies of and economies of scale, it is and AI regulatory sandbox, in line with
scale, it is appropriate to establish Article 6 of Regulation (EU) Article 6(4) of Regulation (EU)
common rules for the regulatory 2018/1725, and without prejudice to 2016/679, and Article 6 of
sandboxes’ implementation and a Article 4(2) of Directive (EU) Regulation (EU) 2018/1725, and
framework for cooperation between 2016/680. Participants in the without prejudice to Article 4(2) of
the relevant authorities involved in sandbox should ensure appropriate Directive (EU) 2016/680.
the supervision of the sandboxes. safeguards and cooperate with the Participants in the sandbox should
Member States should ensure competentto establish common rules ensuresandboxes should cooperate
appropriate safeguards and for the regulatory sandboxes’ with other relevant authorities,
cooperate with the competent implementation and a framework including those supervising the
authorities, including by following for cooperation between the protection of fundamental rights,,
their guidance and acting relevant authorities, including by and could allow for the involvement
expeditiously and in good faith to following their guidance and acting of other actors within the AI
mitigate any high-risks to safety and expeditiously and in good faith to ecosystem such as national or
fundamental rights that may arise mitigate any high-risks to safety and European standardisation
during the development and fundamental rights that may arise organisations, notified bodies,
experimentationthat regulatory during the development and testing and experimentation
sandboxes are widely available experimentation in the sandbox. The facilities, research and
throughout the Union, while the conduct of the participants in the experimentation labs, European
participation should remain sandbox should be taken into Digital innovation hubs and
voluntary. It is especially important account when involved in the relevant stakeholder and civil
to ensure that SMEs and startups supervision of the sandboxes. AI society organisations. To ensure
can easily access these sandboxes, regulatory sandboxes established uniform implementation across the
are actively involved and participate under this Regulation should be Union and economies of scale, it is
in the sandbox. The conduct of the without prejudice to other appropriate safeguards and
participants in the sandbox should legislation allowing for the cooperate with the competentto
be taken into account when establishment of other sandboxes establish common rules for the
competent authorities decide aiming at ensuring compliance with regulatory sandboxes’
whether to impose an administrative legislation other that this implementation and a framework
fine under Article 83(2) of Regulation. Where appropriate, for cooperation between the
Regulation 2016/679 and Article 57 relevant competent authorities in relevant authorities, including by
of Directive 2016/680development charge of those other regulatory following their guidance and acting
and testing of innovative AI sandboxes should consider the expeditiously and in good faith to
systems, in order to be able to benefits of using those sandboxes mitigate any high-risks to safety and
contribute with their knowhow and also for the purpose of ensuring fundamental rights that may arise
experience. compliance of AI systems with this during the development and
Regulation. Upon agreement experimentation in the sandbox. The
between the national competent conduct of the participants in the
authorities decide whether to impose sandbox should be taken into
an administrative fine under Article account when involved in the
83(2) of Regulation 2016/679 and supervision of the sandboxes. AI
Article 57 of Directive 2016/680and regulatory sandboxes established
the participants in the AI regulatory under this Regulation should be
sandbox, testing in real world without prejudice to other
conditions may also be operated legislation allowing for the
and supervised in the framework of establishment of other sandboxes
the AI regulatory sandbox. aiming at ensuring compliance with
legislation other that this
Regulation. Where appropriate,
relevant competent authorities in
charge of those other regulatory
sandboxes should consider the
benefits of using those sandboxes
also for the purpose of ensuring
compliance of AI systems with this
Regulation. Upon agreement
between the national competent
authorities decide whether to impose
an administrative fine under Article
83(2) of Regulation 2016/679 and
Article 57 of Directive 2016/680and
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.
Recital 72a
(72a) This Regulation should (72a) This Regulation should

provide the legal basis for the provide the legal basis for the
participants in the AI regulatory providers and prospective providers
sandbox to use personal data in the AI regulatory sandbox to use
collected for other purposes for personal data collected for other
developing certain AI systems in the purposes for developing certain AI
public interest within the AI systems in the public interest within
regulatory sandbox, in line with the AI regulatory sandbox, only
Article 6(4) and 9(2)(g) of under specified conditions, in line
Regulation (EU) 2016/679, and with Article 6(4) and 9(2)(g) of
Article 5 and 10 of Regulation (EU) Regulation (EU) 2016/679, and
2018/1725, and without prejudice to Article 5, 6 and 10 of Regulation
Articles 4(2) and 10 of Directive (EU) 2018/1725, and without
(EU) 2016/680. All other prejudice to Articles 4(2) and 10 of
obligations of data controllers and Directive (EU) 2016/680. All other
rights of data subjects under obligations of data controllers and
Regulation (EU) 2016/679, rights of data subjects under
G 82a Regulation (EU) 2018/1725 and Regulation (EU) 2016/679, G
Directive (EU) 2016/680 remain Regulation (EU) 2018/1725 and

applicable. In particular, this Directive (EU) 2016/680 remain
Regulation should not provide a applicable. In particular, this
legal basis in the meaning of Article Regulation should not provide a
22(2)(b) of Regulation (EU) legal basis in the meaning of Article
2016/679 and Article 24(2)(b) of 22(2)(b) of Regulation (EU)
Regulation (EU) 2018/1725. 2016/679 and Article 24(2)(b) of
Participants in the sandbox should Regulation (EU) 2018/1725.
ensure appropriate safeguards and Providers and prospective providers
cooperate with the competent in the sandbox should ensure
authorities, including by following appropriate safeguards and
their guidance and acting cooperate with the competent
expeditiously and in good faith to authorities, including by following
mitigate any high-risks to safety their guidance and acting
and fundamental rights that may expeditiously and in good faith to
arise during the development and adequately mitigate any identified -
experimentation in the sandbox. significant risks to safety, health,
The conduct of the participants in and fundamental rights that may
the sandbox should be taken into arise during the development,
account when competent testing and experimentation in the
authorities decide whether to sandbox.
impose an administrative fine under
Article 83(2) of Regulation
2016/679 and Article 57 of
Directive 2016/680.
Recital 72a
(72a) This Regulation should

provide the legal basis for the use of
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) of Regulation
(EU) 2016/679, and Article 6 of
Regulation (EU) 2018/1725, and
without prejudice to Article 4(2) of
Directive (EU) 2016/680.
G 82b Prospective providers in the G
sandbox should ensure appropriate

safeguards and cooperate with the
competent authorities, including by
following their guidance and acting
expeditiously and in good faith to
mitigate any high-risks to safety,
health and the environment and
fundamental rights that may arise
during the development and
experimentation in the sandbox.
The conduct of the prospective
providers in the sandbox should be
taken into account when competent
authorities decide over the
temporary or permanent suspension
of their participation in the sandbox
whether to impose an
administrative fine under Article
83(2) of Regulation 2016/679 and
Article 57 of Directive 2016/680.
Recital 72b
(72b) In order to accelerate the (72b) In order to accelerate the

process of development and placing process of development and placing
on the market of high-risk AI on the market of high-risk AI
systems listed in Annex III, it is systems listed in Annex III, it is
important that providers or important that providers or
prospective providers of such prospective providers of such
systems may also benefit from a systems may also benefit from a
specific regime for testing those specific regime for testing those
systems in real world conditions, systems in real world conditions,
without participating in an AI without participating in an AI
regulatory sandbox. However, in regulatory sandbox. However, in
such cases and taking into account such cases and taking into account
G 82c the possible consequences of such the possible consequences of such G
testing on individuals, it should be testing on individuals, it should be

ensured that appropriate and ensured that appropriate and
sufficient guarantees and sufficient guarantees and
conditions are introduced by the conditions are introduced by the
Regulation for providers or Regulation for providers or
prospective providers. Such prospective providers. Such
guarantees should include, among guarantees should include, among
others, requesting informed consent others, requesting informed consent
of natural persons to participate in of natural persons to participate in
testing in real world conditions, testing in real world conditions,
with the exception of law with the exception of law
enforcement in cases where the enforcement in cases where the
seeking of informed consent would seeking of informed consent would
prevent the AI system from being prevent the AI system from being
tested. Consent of subjects to tested. Consent of subjects to
participate in such testing under participate in such testing under
this Regulation is distinct from and this Regulation is distinct from and
without prejudice to consent of data without prejudice to consent of data
subjects for the processing of their subjects for the processing of their
personal data under the relevant personal data under the relevant
data protection law. data protection 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.
Recital 72c
(72b) To ensure that Artificial (72c) To ensure that Artificial

Intelligence leads to socially and Intelligence leads to socially and
environmentally beneficial environmentally beneficial
outcomes, Member States should outcomes, Member States are
support and promote research and encouraged to support and promote
development of AI in support of research and development of AI
G 82d socially and environmentally solutions in support of socially and G
beneficial outcomes by allocating environmentally beneficial

sufficient resources, including outcomes, such as AI-based
public and Union funding, and solutions to increase accessibility
giving priority access to regulatory for persons with disabilities, tackle
sandboxes to projects led by civil socio-economic inequalities, or
society. Such projects should be meet environmental targets, by
based on the principle of allocating sufficient resources,
interdisciplinary cooperation including public and Union
between AI developers, experts on funding, and, where appropriate
inequality and non-discrimination, and provided that the eligibility and
accessibility, consumer, selection criteria are fulfilled,
environmental, and digital rights, considering in particular projects
as well as academics. 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.
Recital 73
(73) In order to promote and protect (73) In order to promote and protect (73) In order to promote and protect (73) In order to promote and protect
innovation, it is important that the innovation, it is important that the innovation, it is important that the innovation, it is important that the
interests of small-scale providers and interests of small-scale providers and interests of small-scaleSME interests of small-scale providers
users of AI systems are taken into users of AI systems are taken into providers and users of AI systems and usersSMEs, including start-
particular account. To this objective, particular account. To this objective, are taken into particular account. To ups, that are providers or
Member States should develop Member States should develop this objective, Member States should deployers of AI systems are taken
initiatives, which are targeted at initiatives, which are targeted at develop initiatives, which are into particular account. To this
those operators, including on those operators, including on AI targeted at those operators, including objective, Member States should
awareness raising and information literacy, awareness raising and on awareness raising and develop initiatives, which are
G 83 communication. Moreover, the information communication. information communication. targeted at those operators, including G
specific interests and needs of small- Member States shall utilise existing Moreover, the specific interests and on , awareness raising and
scale providers shall be taken into channels and where appropriate, needs of small-scaleSME providers information communication.
account when Notified Bodies set establish new dedicated channels shall be taken into account when Member States shall provide
conformity assessment fees. for communication with SMEs, notified bodies set conformity SME’s, including start-ups, having
Translation costs related to start-ups, user and other innovators assessment fees. Translation costs a registered office or a branch in
mandatory documentation and to provide guidance and respond to related to mandatory documentation the Union, with priority access to
communication with authorities may queries about the implementation of and communication with authorities the AI regulatory sandboxes
constitute a significant cost for this Regulation. Such existing may constitute a significant cost for provided that they fulfil the
providers and other operators, channels could include but are not providers and other operators, eligibility conditions and selection
notably those of a smaller scale. limited to ENISA’s Computer notably those of a smaller scale. criteria and without precluding
Member States should possibly Security Incident Response Teams, Member States should possibly other providers and prospective
ensure that one of the languages National Data Protection Agencies, ensure that one of the languages providers to access the sandboxes
determined and accepted by them for the AI-on demand platform, the determined and accepted by them for provided the same conditions and
relevant providers’ documentation European Digital Innovation Hubs relevant providers’ documentation criteria are fulfilled.
and for communication with and other relevant instruments and for communication with Member States shall utilise existing
operators is one which is broadly funded by EU programmes as well operators is one which is broadly channels and where appropriate,
understood by the largest possible as the Testing and Experimentation understood by the largest possible establish new dedicated channels
number of cross-border users. Facilities established by the number of cross-border users. for communication with SMEs,
Commission and the Member States start-ups, deployers other
at national or Union level. Where innovators and, as appropriate,
appropriate, these channels shall local public authorities, to support
work together to create synergies SMEs throughout their
and ensure homogeneity in their development path by providing
guidance to start-ups, SMEs and guidance and responding to queries
users. Moreover, the specific about the implementation of this
interests and needs of small-scale Regulation. Where appropriate,
providers shall be taken into account these channels shall work together
when Notified Bodies set conformity to create synergies and ensure
assessment fees. The Commission homogeneity in their guidance to
shall regularly assess the SMEs including start-ups and
certification and compliance costs deployers. Additionally, Member
for SMEs and start-ups, including States should facilitate the
through transparent consultations participation of SMEs and other
with SMEs, start-ups and users and relevant stakeholders in the
shall work with Member States to standardisation development
lower such costs. For example, processes. Moreover, the specific
translation costs related to interests and needs of small-scale
mandatory documentation and SMEs including start-up providers
communication with authorities may shallshould be taken into account
constitute a significant cost for when Notified Bodies set conformity
providers and other operators, assessment fees. The Commission
notably those of a smaller scale. should regularly assess the
Member States should possibly certification and compliance costs
ensure that one of the languages for SMEs including start-ups,
determined and accepted by them for through transparent consultations
relevant providers’ documentation deployers and should work with
and for communication with Member States to lower such costs.
operators is one which is broadly For example, translation costs
understood by the largest possible related to mandatory documentation
number of cross-border users. and communication with authorities
Medium-sized enterprises which may constitute a significant cost for
recently changed from the small to providers and other operators,
medium-size category within the notably those of a smaller scale.
meaning of the Annex to Member States should possibly
Recommendation 2003/361/EC ensure that one of the languages
(Article 16) shall have access to determined and accepted by them for
these initiatives and guidance for a relevant providers’ documentation
period of time deemed appropriate and for communication with
by the Member States, as these new operators is one which is broadly
medium-sized enterprises may understood by the largest possible
sometimes lack the legal resources number of cross-border
and training necessary to ensure usersdeployers. In order to address
proper understanding and the specific needs of SMEs
compliance with provisions. 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.
Recital 73a
(73a) In order to promote and (73a) In order to promote and

protect innovation, the AI-on protect innovation, the AI-on
demand platform, all relevant EU demand platform, all relevant EU
funding programmes and projects, funding programmes and projects,
such as Digital Europe Programme, such as Digital Europe Programme,
G 83a Horizon Europe, implemented by Horizon Europe, implemented by G
the Commission and the Member the Commission and the Member
States at national or EU level States at national or Union level
should contribute to the should, as appropriate, contribute
achievement of the objectives of this to the achievement of the objectives
Regulation. of this Regulation.
Recital 74
(74) In order to minimise the risks (74) In order to minimise the risks (74) In particular, in order to (74) In particular, in order to
to implementation resulting from to implementation resulting from minimise the risks to implementation minimise the risks to implementation
lack of knowledge and expertise in lack of knowledge and expertise in resulting from lack of knowledge resulting from lack of knowledge
G 84 the market as well as to facilitate the market as well as to facilitate and expertise in the market as well and expertise in the market as well G
compliance of providers and notified compliance of providers and notified as to facilitate compliance of as to facilitate compliance of
bodies with their obligations under bodies with their obligations under providers, notably SMEs, and providers, notably SMEs, including
this Regulation, the AI-on demand this Regulation, the AI-on demand notified bodies with their obligations start-ups, and notified bodies with
platform, the European Digital platform, the European Digital under this Regulation, the AI-on their obligations under this
Innovation Hubs and the Testing and Innovation Hubs and the Testing and demand platform, the European Regulation, the AI-on demand
Experimentation Facilities Experimentation Facilities Digital Innovation Hubs and the platform, the European Digital
established by the Commission and established by the Commission and Testing and Experimentation Innovation Hubs and the Testing and
the Member States at national or EU the Member States at national or EU Facilities established by the Experimentation Facilities
level should possibly contribute to level should possibly contribute to Commission and the Member States established by the Commission and
the implementation of this the implementation of this at national or EU level should the Member States at national or EU
Regulation. Within their respective Regulation. Within their respective possibly contribute to the level should possibly contribute to
mission and fields of competence, mission and fields of competence, implementation of this Regulation. the implementation of this
they may provide in particular they may provide in particular Within their respective mission and Regulation. Within their respective
technical and scientific support to technical and scientific support to fields of competence, they may mission and fields of competence,
providers and notified bodies. providers and notified bodies. provide in particular technical and they may provide in particular
scientific support to providers and technical and scientific support to
notified bodies. providers and notified bodies.
Recital 74a
(74a) Moreover, in order to ensure (74a) Moreover, in order to ensure

proportionality considering the very proportionality considering the very
small size of some operators small size of some operators
regarding costs of innovation, it is regarding costs of innovation, it is
appropriate to exempt appropriate to allow
microenterprises from the most microenterprises to fulfill one of
costly obligations, such as to the most costly obligations, namely
establish a quality management to establish a quality management
system which would reduce the system, in a simplified manner
G 84a administrative burden and the costs which would reduce the G
for those enterprises without administrative burden and the costs

affecting the level of protection and for those enterprises without
the need for compliance with the affecting the level of protection and
requirements for high-risk AI the need for compliance with the
systems. 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
microentreprises.
Recital 75
(75) It is appropriate that the (75) It is appropriate that the (75) It is appropriate that the (75) It is appropriate that the
Commission facilitates, to the extent Commission facilitates, to the extent Commission facilitates, to the extent Commission facilitates, to the extent
possible, access to Testing and possible, access to Testing and possible, access to Testing and possible, access to Testing and
Experimentation Facilities to bodies, Experimentation Facilities to bodies, Experimentation Facilities to bodies, Experimentation Facilities to bodies,
groups or laboratories established or groups or laboratories established or groups or laboratories established or groups or laboratories established or
accredited pursuant to any relevant accredited pursuant to any relevant accredited pursuant to any relevant accredited pursuant to any relevant
Union harmonisation legislation and Union harmonisation legislation and Union harmonisation legislation and Union harmonisation legislation and
which fulfil tasks in the context of which fulfil tasks in the context of which fulfil tasks in the context of which fulfil tasks in the context of
conformity assessment of products conformity assessment of products conformity assessment of products conformity assessment of products
G 85 or devices covered by that Union or devices covered by that Union or devices covered by that Union or devices covered by that Union G
harmonisation legislation. This is harmonisation legislation. This is harmonisation legislation. This is harmonisation legislation. This is
notably the case for expert panels, notably the case for expert panels, notably the case for expert panels, notably the case for expert panels,
expert laboratories and reference expert laboratories and reference expert laboratories and reference expert laboratories and reference
laboratories in the field of medical laboratories in the field of medical laboratories in the field of medical laboratories in the field of medical
devices pursuant to Regulation (EU) devices pursuant to Regulation (EU) devices pursuant to Regulation (EU) devices pursuant to Regulation (EU)
2017/745 and Regulation (EU) 2017/745 and Regulation (EU) 2017/745 and Regulation (EU) 2017/745 and Regulation (EU)
2017/746. 2017/746. 2017/746. 2017/746.
Proposal
Recital 75a
(75a) This Regulation should

establish a governance framework
that both allows to coordinate and
G 85a support the application of this G
Regulation at national level, as well

as build capabilities at Union level
and integrate stakeholders in the
field of artificial intelligence. The
enforcement of this Regulation
require a governance framework
that allows to coordinate and build
up central expertise at Union level.
The Commission has 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.
Recital 76
(76) In order to facilitate a smooth, (76) In order to facilitate a smooth, (76) In order to facilitate a smooth, (76) In order to facilitate a smooth,
effective and harmonised avoid fragmentation, to ensure the effective and harmonised effective and harmonised
implementation of this Regulation a optimal functioning of the Single implementation of this Regulation a implementation of this Regulation a
European Artificial Intelligence market, to ensure effective and European Artificial Intelligence European Artificial Intelligence
Board should be established. The harmonised implementation of this Board should be established. The Board should be established. The
Board should be responsible for a Regulation, to achieve a high level Board should reflect the various Board should reflect the various
number of advisory tasks, including of trustworthiness and of protection interests of the AI eco-system and interests of the AI eco-system and
issuing opinions, recommendations, of health and safety, fundamental be composed of representatives of be composed of representatives of
advice or guidance on matters rights, the environment, democracy the Member States. In order to the Member States. The Board
related to the implementation of this and the rule of law across the ensure the involvement of relevant should be responsible for a number
Regulation, including on technical Union with regards to AI systems, stakeholders, a standing subgroup of advisory tasks, including issuing
specifications or existing standards to actively support national of the Board should be created. The opinions, recommendations, advice
regarding the requirements supervisory authorities, Union Board should be responsible for a or contributing to guidance on
G 86 established in this Regulation and institutions, bodies, offices and number of advisory tasks, including matters related to the G
providing advice to and assisting the agencies in matters pertaining to issuing opinions, recommendations, implementation of this Regulation,
Commission on specific questions this Regulation, and to increase the advice or contributing to guidance including on enforcement matters,
related to artificial intelligence. uptake of artificial intelligence on matters related to the technical specifications or existing
throughout the Union, an a implementation of this Regulation, standards regarding the requirements
European Union Artificial including on enforcement matters, established in this Regulation and
Intelligence BoardOffice should be technical specifications or existing providing advice to the Commission
established. The BoardAI Office standards regarding the requirements and the Member States and their
should have legal personality, established in this Regulation and national competent authoritiesand
should act in full independence, providing advice to and assisting the assisting the Commission on specific
should be responsible for a number Commissionthe Commission and questions related to artificial
of advisory and coordination tasks, the Member States and their intelligence. In order to give some
including issuing opinions, national competent authorities on flexibility to Member States in the
recommendations, advice or specific questions related to artificial designation of their representatives
guidance on matters related to the intelligence. In order to give some in the AI Board, such
implementation of this Regulation flexibility to Member States in the representatives may be any persons
and should be adequately funded designation of their representatives belonging to public entities who
and staffed. Member States should in the AI Board, such should have the relevant
provide the strategic direction and representatives may be any persons competences and powers to
control of the AI Office through the belonging to public entities who facilitate coordination at national
management board of the AI should have the relevant level and contribute to the
Office, alongside the Commission, competences and powers to achievement of the Board's tasks.
the EDPS, the FRA, and ENISA. facilitate coordination at national The Board should establish two
An executive director should be level and contribute to the standing sub-groups to provide a
responsible for managing the achievement of the Board's tasks. platform for cooperation and
activities of the secretariat of the AI The Board should establish two exchange among market
office and for representing the AI standing sub-groups to provide a surveillance authorities and
office. Stakeholders should platform for cooperation and notifying authorities on issues
formally participate in the work of exchange among market related respectively to market
the AI Office through an advisory surveillance authorities and surveillance and notified bodies.
forum that should ensure varied notifying authorities on issues The standing subgroup for market
and balanced stakeholder related respectively to market surveillance should act as the
representation and should advise surveillance and notified bodies. Administrative Cooperation Group
the AI Office on matters pertaining The standing subgroup for market (ADCO) for this Regulation in the
to this Regulation. In case the surveillance should act as the meaning of Article 30 of Regulation
establishment of the AI Office Administrative Cooperation Group (EU) 2019/1020. In line with the
prove not to be sufficient to ensure (ADCO) for this Regulation in the role and tasks of the Commission
a fully consistent application of this meaning of Article 30 of Regulation pursuant to Article 33 of
Regulation at Union level as well as (EU) 2019/1020. In line with the Regulation (EU) 2019/1020, the
efficient cross-border enforcement role and tasks of the Commission Commission should support the
measures, the creation of an AI pursuant to Article 33 of activities of the standing subgroup
agency should be considered, Regulation (EU) 2019/1020, the for market surveillance by
including on technical specifications Commission should support the undertaking market evaluations or
or existing standards regarding the activities of the standing subgroup studies, notably with a view to
requirements established in this for market surveillance by identifying aspects of this
Regulation and providing advice to undertaking market evaluations or Regulation requiring specific and
and assisting the Commission on studies, notably with a view to urgent coordination among market
specific questions related to identifying aspects of this surveillance authorities. The Board
artificial intelligence. Regulation requiring specific and may establish other standing or
urgent coordination among market temporary sub-groups as
surveillance authorities. The Board appropriate for the purpose of
may establish other standing or examining specific issues. The
temporary sub-groups as Board should also cooperate, as
appropriate for the purpose of appropriate, with relevant EU
examining specific issues. The bodies, experts groups and
Board should also cooperate, as networks active in the context of
appropriate, with relevant EU relevant EU legislation, including
bodies, experts groups and in particular those active under
networks active in the context of relevant EU regulation on data,
relevant EU legislation, including digital products and services.
in particular those active under
relevant EU regulation on data, (76x) With a view to ensure the
digital products and services. 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.
Recital 76a
(76a) The Commission should (76a) In order to support adequate

actively support the Member States enforcement as regards AI systems
and operators in the and reinforce the capacities of the
G 86a implementation and enforcement of Member States, EU AI testing G
this Regulation. In this regard it support structures should be

should develop guidelines on established and made available to
particular topics aiming at the Member States.
facilitating the application of this
Regulation, while paying particular
attention to the needs of SMEs and
start-us in sectors most likely to be
affected. In order to support
adequate enforcement and the
capacities of the Member States,
Union testing facilities on AI and a
pool of relevant experts should be
established and made available to
the Member States.
Recital 77
(77) Member States hold a key role (77) Each Member States hold a (77) Member States hold a key role (77) Member States hold a key role
in the application and enforcement key role inState should designate a in the application and enforcement in the application and enforcement
of this Regulation. In this respect, national supervisory authority for of this Regulation. In this respect, of this Regulation. In this respect,
each Member State should designate the purpose of supervising the each Member State should designate each Member State should designate
one or more national competent application and one or more national competent at least one notifying authority and
authorities for the purpose of enforcementimplementation of this authorities for the purpose of at least one market surveillance
supervising the application and Regulation. In this respect, each supervising the application and authority asone or more national
implementation of this Regulation. Member StateIt should designate implementation of this Regulation. competent authorities for the
In order to increase organisation one or more national competent In order to increase organisation purpose of supervising the
efficiency on the side of Member authorities for the purpose of efficiency on the side of Member application and implementation of
States and to set an official point of supervising the application and States and to set an official point of this Regulation. Member States may
G 87 G
contact vis-à-vis the public and other implementation of this contact vis-à-vis the public and decide to appoint any kind of public
counterparts at Member State and Regulationalso represent its other counterparts at Member State entity to perform the tasks of the
Union levels, in each Member State Member State at the management and Union levels, in each Member national competent authorities
one national authority should be board of the AI Office. In order to State oneMember States may decide within the meaning of this
designated as national supervisory increase organisation efficiency on to appoint any kind of public entity Regulation, in accordance with
authority. the side of Member States and to set to perform the tasks of the national their specific national
an official point of contact vis-à-vis competent authorities within the organisational characteristics and
the public and other counterparts at meaning of this Regulation, in needs. In order to increase
Member State and Union levels, in accordance with their specific organisation efficiency on the side of
each Member State one national national authority should be Member States and to set an
authority should be designated as designated as national supervisory officiala single point of contact vis-
national supervisory authority. Each authorityorganisational à-vis the public and other
national supervisory authority characteristics and needs. counterparts at Member State and
should act with complete Union levels, in each Member State
independence in performing its one national authority should be
tasks and exercising its powers in designated as national supervisory
accordance with this Regulation. authorityshould designate a market
surveillance authority to act as
single point of contact.
Recital 77a
(77a) The national supervisory

authorities should monitor the
application of the provisions
pursuant to this Regulation and
contribute to its consistent
application throughout the Union.
G 87a G
For that purpose, the national
supervisory authorities should
cooperate with each other, with the
relevant national competent
authorities, the Commission, and
with the AI Office.
Recital 77a
(77b) The member or the staff of (77a) The national competent

each national supervisory authority authorities should exercise their
should, in accordance with Union powers independently, impartially
or national law, be subject to a duty and without bias, so as to safeguard
G 87b of professional secrecy both during the principles of objectivity of their G
and after their term of office, with activities and tasks and to ensure
regard to any confidential the application and implementation
information which has come to of this Regulation. The members of
their knowledge in the course of the these authorities should refrain
performance of their tasks or from any action incompatible with
exercise of their powers. During their duties and should be subject to
their term of office, that duty of confidentiality rules under this
professional secrecy should in Regulation.
particular apply to trade secrets and
to reporting by natural persons of
infringements of this Regulation.
Recital 78
(78) In order to ensure that (78) In order to ensure that (78) In order to ensure that (78) In order to ensure that
providers of high-risk AI systems providers of high-risk AI systems providers of high-risk AI systems providers of high-risk AI systems
can take into account the experience can take into account the experience can take into account the experience can take into account the experience
on the use of high-risk AI systems on the use of high-risk AI systems on the use of high-risk AI systems on the use of high-risk AI systems
for improving their systems and the for improving their systems and the for improving their systems and the for improving their systems and the
design and development process or design and development process or design and development process or design and development process or
can take any possible corrective can take any possible corrective can take any possible corrective can take any possible corrective
action in a timely manner, all action in a timely manner, all action in a timely manner, all action in a timely manner, all
providers should have a post-market providers should have a post-market providers should have a post-market providers should have a post-market
monitoring system in place. This monitoring system in place. This monitoring system in place. This monitoring system in place. Where
system is also key to ensure that the system is also key to ensure that the system is also key to ensure that the relevant, post-market monitoring
possible risks emerging from AI possible risks emerging from AI possible risks emerging from AI should include an analysis of the
systems which continue to ‘learn’ systems which continue to ‘learn’ or systems which continue to ‘learn’ interaction with other AI systems
G 88 G
after being placed on the market or evolve after being placed on the after being placed on the market or including other devices and
put into service can be more market or put into service can be put into service can be more software. Post-market monitoring
efficiently and timely addressed. In more efficiently and timely efficiently and timely addressed. In should not cover sensitive
this context, providers should also be addressed. In this context, providers this context, providers should also be operational data of deployers which
required to have a system in place to should also be required to have a required to have a system in place to are law enforcement authorities.
report to the relevant authorities any system in place to report to the report to the relevant authorities any This system is also key to ensure
serious incidents or any breaches to relevant authorities any serious serious incidents or any breaches to that the possible risks emerging from
national and Union law protecting incidents or any breaches to national national and Union law protecting AI systems which continue to ‘learn’
fundamental rights resulting from and Union law, including those fundamental rights resulting from after being placed on the market or
the use of their AI systems. protecting fundamental rights and the use of their AI systems. put into service can be more
consumer rights resulting from the efficiently and timely addressed. In
use of their AI systems and take this context, providers should also be
appropriate corrective actions. required to have a system in place to
Deployers should also report to the report to the relevant authorities any
relevant authorities, any serious serious incidents resulting from the
incidents or breaches to national use of their AI systems, meaning
and Union law resulting from the incident or malfunctioning leading
use of their AI system when they to death or serious damage to
become aware of such serious health, serious and irreversible
incidents or breaches. disruption of the management and
operation of critical infrastructure,
breaches of obligations under or
any breaches to national and Union
law protectingintended to protect
fundamental rights resulting from
the use of their AI systemsor serious
damage to property or the
environment.
Recital 79
(79) In order to ensure an (79) In order to ensure an (79) In order to ensure an (79) In order to ensure an
appropriate and effective appropriate and effective appropriate and effective appropriate and effective
enforcement of the requirements and enforcement of the requirements and enforcement of the requirements and enforcement of the requirements and
obligations set out by this obligations set out by this obligations set out by this obligations set out by this
Regulation, which is Union Regulation, which is Union Regulation, which is Union Regulation, which is Union
harmonisation legislation, the system harmonisation legislation, the system harmonisation legislation, the system harmonisation legislation, the system
of market surveillance and of market surveillance and of market surveillance and of market surveillance and
compliance of products established compliance of products established compliance of products established compliance of products established
by Regulation (EU) 2019/1020 by Regulation (EU) 2019/1020 by Regulation (EU) 2019/1020 by Regulation (EU) 2019/1020
G 89 G
should apply in its entirety. Where should apply in its entirety. For the should apply in its entirety. Where should apply in its entirety.
necessary for their mandate, national purpose of this Regulation, national necessary forMarket surveillance Market surveillance authorities
public authorities or bodies, which supervisory authorities should act authorities designated pursuant to designated pursuant to this
supervise the application of Union as market surveillance authorities this Regulation should have all Regulation should have all
law protecting fundamental rights, for AI systems covered by this enforcement powers under this enforcement powers under this
including equality bodies, should Regulation except for AI systems Regulation and Regulation (EU) Regulation and Regulation (EU)
also have access to any covered by Annex II of this 2019/1020 and should exercise their 2019/1020 and should exercise
documentation created under this Regulation. For AI systems covered mandate, national publicpowers and Where necessary for their mandate,
Regulation. by legal acts listed in the Annex II, carry out their duties national publicpowers and carry out
the competent authorites under independently, impartially and their duties independently,
those legal acts should remain the without bias. Although the majority impartially and without bias.
lead authority. National supervisory of AI systems are not subject to Although the majority of AI systems
authorities and competent specific requirements and are not subject to specific
authorities in the legal acts listed in obligations under this Regualtion, requirements and obligations under
Annex II should work together market surveillance authorities this Regulation, market
whenever necessary. When ormay take measures in relation to surveillance authorities ormay take
appropriate, the competent all AI systems when they present a measures in relation to all AI
authorities in the legal acts listed in risk in accordance with this systems when they present a risk in
Annex II should send competent Regulation. Due to the specific accordance with this Regulation.
staff to the national supervisory nature of Union institutions, Due to the specific nature of Union
authority in order to assist in the agencies and bodies falling within institutions, agencies and bodies
performance of its tasks. For the the scope of this Regulation, it is falling within the scope of this
purpose of this Regulation, national appropriate to designate the Regulation, it is appropriate to
supervisory authorities should have European Data Protection designate the European Data
the same powers and obligations as Supervisor as a competent market Protection Supervisor as a
market surveillance authorities surveillance authority for them. competent market surveillance
under Regulation (EU) 2019/1020. This should be without prejudice to authority for them. This should be
Where necessary for their mandate, the designation of national without prejudice to the designation
national public authorities or bodies, competent authorities by the of national competent authorities by
which supervise the application of Member States. Market surveillance the Member States. Market
Union law protecting fundamental activities, which supervise the surveillance activities, which
rights, including equality bodies, application of Union law protecting supervise the application of Union
should also have access to any fundamental rights, including law protecting fundamental rights,
documentation created under this equality bodies, should also have including equality bodies, should
Regulation. After having exhausted access to any documentation created also have access to any
all other reasonable ways to under this Regulationnot affect the documentation created under this
assess/verify the conformity and ability of the supervised entities to Regulationnot affect the ability of
upon a reasoned request, the carry out their tasks independently, the supervised entities to carry out
national supervisory authority when such independence is their tasks independently, when
should be granted access to the required by Union law. such independence is required by
training, validation and testing Union law.
datasets, the trained and training
model of the high-risk AI system,
including its relevant model
parameters and their execution /run
environment. In cases of simpler
software systems falling under this
Regulation that are not based on
trained models, and where all other
ways to verify conformity have been
exhausted, the national supervisory
authority may exceptionally have
access to the source code, upon a
reasoned request. Where the
national supervisory authority has
been granted access to the training,
validation and testing datasets in
accordance with this Regulation,
such access should be achieved
through appropriate technical
means and tools, including on site
access and in exceptional
circumstances, remote access. The
national supervisory authority
should treat any information,
including source code, software,
and data as applicable, obtained as
confidential information and
respect relevant Union law on the
protection of intellectual property
and trade secrets. The national
supervisory authority should delete
any information obtained upon the
completion of the investigation.
Recital 79a
(79a) This Regulation is without (79a) This Regulation is without

prejudice to the competences, tasks, prejudice to the competences, tasks,
G 89a powers and independence of powers and independence of G
relevant national public authorities relevant national public authorities

or bodies which supervise the or bodies which supervise the
application of Union law protecting application of Union law protecting
fundamental rights, including fundamental rights, including
equality bodies and data protection equality bodies and data protection
authorities. Where necessary for authorities. Where necessary for
their mandate, those national their mandate, those national
public authorities or bodies should public authorities or bodies should
also have access to any also have access to any
documentation created under this documentation created under this
Regulation. A specific safeguard Regulation. A specific safeguard
procedure should be set for procedure should be set for
ensuring adequate and timely ensuring adequate and timely
enforcement against AI systems enforcement against AI systems
presenting a risk to health, safety presenting a risk to health, safety
and fundamental rights. The and fundamental rights.
procedure for such AI systems The procedure for such AI systems
presenting a risk should be applied presenting a risk should be applied
to high-risk AI systems presenting a to high-risk AI systems presenting a
risk, prohibited systems which have risk, prohibited systems which have
been placed on the market, put into been placed on the market, put into
service or used in violation of the service or used in violation of the
prohibited practices laid down in prohibited practices laid down in
this Regulation and AI systems this Regulation and AI systems
which have been made available in which have been made available in
violation of the transparency violation of the transparency
requirements laid down in this requirements laid down in this
Regulation and present a risk. Regulation and present a risk.
Recital 80
(80) Union legislation on financial (80) Union legislationlaw on (80) Union legislation on financial (80) Union legislation on financial
services includes internal financial services includes internal services includes internal services includes internal
governance and risk management governance and risk management governance and risk management governance and risk management
G 90 rules and requirements which are rules and requirements which are rules and requirements which are rules and requirements which are G
applicable to regulated financial applicable to regulated financial applicable to regulated financial applicable to regulated financial
institutions in the course of institutions in the course of institutions in the course of institutions in the course of
provision of those services, provision of those services, provision of those services, provision of those services,
including when they make use of AI including when they make use of AI including when they make use of AI including when they make use of AI
systems. In order to ensure coherent systems. In order to ensure coherent systems. In order to ensure coherent systems. In order to ensure coherent
application and enforcement of the application and enforcement of the application and enforcement of the application and enforcement of the
obligations under this Regulation obligations under this Regulation obligations under this Regulation obligations under this Regulation
and relevant rules and requirements and relevant rules and requirements and relevant rules and requirements and relevant rules and requirements
of the Union financial services of the Union financial services of the Union financial services of the Union financial services
legislation, the authorities legislation, the law, the competent legislation, the authorities legislation, the authorities
responsible for the supervision and authorities responsible for the responsible for the supervision and responsiblecompetent authorities
enforcement of the financial services supervision and enforcement of the enforcement of the financial services for the supervision and enforcement
legislation, including where financial services legislationlaw, legislation, including where of the financial services legislation,
applicable the European Central including where applicable the applicable the European Central including where applicablenotably
Bank, should be designated as European Central Bank, should be Bank, should be designated as competent authorities as defined in
competent authorities for the designated as competent authorities competent authorities for the Directive 2009/138/EC, Directive
purpose of supervising the for the purpose of supervising the purpose of supervising the (EU) 2016/97, Directive
implementation of this Regulation, implementation of this Regulation, implementation of this Regulation, 2013/36/EU Regulation (EU) No
including for market surveillance including for market surveillance including for market surveillance 575/2013, Directive 2008/48/EC
activities, as regards AI systems activities, as regards AI systems activities, as regards AI systems and Directive 2014/17/EU of the
provided or used by regulated and provided or used by regulated and provided or used by regulated and European Central BankParliament
supervised financial institutions. To supervised financial institutions. To supervised financial institutions and of the Council, should be
further enhance the consistency further enhance the consistency unless Member States decide to designated, within their respective
between this Regulation and the between this Regulation and the designate another authority to competences, as competent
rules applicable to credit institutions rules applicable to credit institutions fulfill these market surveillance authorities for the purpose of
regulated under Directive regulated under Directive tasks. Those competent authorities supervising the implementation of
2013/36/EU of the European 2013/36/EU of the European should have all powers under this this Regulation, including for market
Parliament and of the Council1, it is Parliament and of the Council1, it is Regulation and Regulation (EU) surveillance activities, as regards AI
also appropriate to integrate the also appropriate to integrate the 2019/1020 on market surveillance systems provided or used by
conformity assessment procedure conformity assessment procedure to enforce the requirements and regulated and supervised financial
and some of the providers’ and some of the providers’ obligations of this Regulation, institutions unless Member States
procedural obligations in relation to procedural obligations in relation to including powers to carry our ex decide to designate another
risk management, post marketing risk management, post marketing post market surveillance activities authority to fulfil these market
monitoring and documentation into monitoring and documentation into that can be integrated, as surveillance tasks. Those competent
the existing obligations and the existing obligations and appropriate, into their existing authorities should have all powers
procedures under Directive procedures under Directive supervisory mechanisms and under this Regulation and
2013/36/EU. In order to avoid 2013/36/EU. In order to avoid procedures under the relevant Regulation (EU) 2019/1020 on
overlaps, limited derogations should overlaps, limited derogations should Union financial services legislation. market surveillance to enforce the
also be envisaged in relation to the also be envisaged in relation to the It is appropriate to envisage that, requirements and obligations of this
quality management system of quality management system of when acting as market surveillance Regulation, including powers to
providers and the monitoring providers and the monitoring authorities under this Regulation, carry our ex post market
obligation placed on users of high- obligation placed on usersdeployers the national authorities responsible surveillance activities that can be
risk AI systems to the extent that of high-risk AI systems to the extent for the supervision of credit integrated, as appropriate, into their
these apply to credit institutions that these apply to credit institutions institutions regulated under existing supervisory mechanisms
regulated by Directive 2013/36/EU. regulated by Directive 2013/36/EU. Directive 2013/36/EU, which are and procedures under the relevant
_________ _________ participating in the Single Union financial services legislation.
1. Directive 2013/36/EU of the European 1. Directive 2013/36/EU of the European Supervisory Mechanism (SSM) It is appropriate to envisage that,
Parliament and of the Council of 26 June Parliament and of the Council of 26 June established by Council Regulation when acting as market surveillance
2013 on access to the activity of credit 2013 on access to the activity of credit
institutions and the prudential supervision of institutions and the prudential supervision of No 1024/2013, should report, authorities under this Regulation,
credit institutions and investment firms, credit institutions and investment firms, without delay, to the European the national authorities responsible
amending Directive 2002/87/EC and amending Directive 2002/87/EC and Central Bank any information for the supervision of credit
repealing Directives 2006/48/EC and repealing Directives 2006/48/EC and identified in the course of their institutions regulated under
2006/49/EC (OJ L 176, 27.6.2013, p. 338). 2006/49/EC (OJ L 176, 27.6.2013, p. 338).
market surveillance activities that Directive 2013/36/EU, which are
may be of potential interest for the participating in the Single
European Central Bank’s Supervisory Mechanism (SSM)
prudential supervisory tasks as established by Council Regulation
specified in that Regulation. To No 1024/2013, should report,
further enhance the consistency without delay, to the European
between this Regulation and the Central Bank any information
rules applicable to credit institutions identified in the course of their
regulated under Directive market surveillance activities that
2013/36/EU of the European may be of potential interest for the
Parliament and of the Council1, it is European Central Bank’s
also appropriate to integrate the prudential supervisory tasks as
conformity assessment procedure specified in that Regulation. To
and some of the providers’ further enhance the consistency
procedural obligations in relation to between this Regulation and the
risk management, post marketing rules applicable to credit institutions
monitoring and documentation into regulated under Directive
the existing obligations and 2013/36/EU of the European
procedures under Directive Parliament and of the Council1, it is
2013/36/EU. In order to avoid also appropriate to integrate the
overlaps, limited derogations should conformity assessment procedure
also be envisaged in relation to the and some of the providers’
quality management system of procedural obligations in relation to
providers and the monitoring risk management, post marketing
obligation placed on users of high- monitoring and documentation into
risk AI systems to the extent that the existing obligations and
these apply to credit institutions procedures under Directive
regulated by Directive 2013/36/EU. 2013/36/EU. In order to avoid
The same regime should apply to overlaps, limited derogations should
insurance and re-insurance also be envisaged in relation to the
undertakings and insurance quality management system of
holding companies under Directive providers and the monitoring
2009/138/EU (Solvency II) and the obligation placed on usersdeployers
insurance intermediaries under of high-risk AI systems to the extent
Directive 2016/97/EU and other that these apply to credit institutions
types of financial institutions regulated by Directive 2013/36/EU.
subject to requirements regarding The same regime should apply to
internal governance, arrangements insurance and re-insurance
or processes established pursuant to undertakings and insurance
the relevant Union financial holding companies under Directive
services legislation to ensure 2009/138/EU (Solvency II) and the
consistency and equal treatment in insurance intermediaries under
the financial sector. Directive 2016/97/EU and other
_________ types of financial institutions
1. [1] Directive 2013/36/EU of the subject to requirements regarding
European Parliament and of the Council of internal governance, arrangements
26 June 2013 on access to the activity of
credit institutions and the prudential or processes established pursuant to
supervision of credit institutions and the relevant Union financial
investment firms, amending Directive services legislation to ensure
2002/87/EC and repealing Directives consistency and equal treatment in
2006/48/EC and 2006/49/EC (OJ L 176,
27.6.2013, p. 338).
the financial sector.
(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
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
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
systems.
(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
models. In the conduct of
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.
_________
1. 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).
Text Origin: GSC
Recital 80a
(80a) Given the objectives of this

Regulation, namely to ensure an
equivalent level of protection of
rights of natural persons, to ensure
the protection of the rule of law and
G 90a democracy, and taking into account G
that the mitigation of the risks of AI

system against such rights may not
be sufficiently achieved at national
level or may be subject to diverging
interpretation which could
ultimately lead to an uneven level of
protection of natural persons and
create market fragmentation, the
national supervisory authorities
should be empowered to conduct
joint investigations or rely on the
union safeguard procedure
provided for in this Regulation for
effective enforcement. Joint
investigations should be initiated
where the national supervisory
authority have sufficient reasons to
believe that an infringement of this
Regulation amount to a widespread
infringement or a widespread
infringement with a Union
dimension, or where the AI system
or foundation model presents a risk
which affects or is likely to affect at
least 45 million individuals in more
than one Member State.
Recital 80a
G 90b G
Recital 81
(81) The development of AI (81) The development of AI (81) The development of AI (81) The development of AI
systems other than high-risk AI systems other than high-risk AI systems other than high-risk AI systems other than high-risk AI
systems in accordance with the systems in accordance with the systems in accordance with the systems in accordance with the
requirements of this Regulation may requirements of this Regulation may requirements of this Regulation may requirements of this Regulation may
G 91 lead to a larger uptake of trustworthy lead to a larger uptake of trustworthy lead to a larger uptake of trustworthy lead to a larger uptake of ethical and G
artificial intelligence in the Union. artificial intelligence in the Union. artificial intelligence in the Union. trustworthy artificial intelligence in
Providers of non-high-risk AI Providers of non-high-risk AI Providers of non-high-risk AI the Union. Providers of non-high-
systems should be encouraged to systems should be encouraged to systems should be encouraged to risk AI systems should be
create codes of conduct intended to create codes of conduct intended to create codes of conduct intended to encouraged to create codes of
foster the voluntary application of foster the voluntary application of foster the voluntary application of conduct, including related
the mandatory requirements the mandatory requirements the mandatory requirements governance mechanisms, intended
applicable to high-risk AI systems. applicable to high-risk AI systems. applicable to high-risk AI systems, to foster the voluntary application of
Providers should also be encouraged Providers should also be encouraged adapted in light of the intended some or all of the mandatory
to apply on a voluntary basis to apply on a voluntary basis purpose of the systems and the requirements applicable to high-risk
additional requirements related, for additional requirements related, for lower risk involved. Providers AI systems, adapted in light of the
example, to environmental example, to environmental should also be encouraged to apply intended purpose of the systems and
sustainability, accessibility to sustainability, accessibility to on a voluntary basis additional the lower risk involved and taking
persons with disability, stakeholders’ persons with disability, stakeholders’ requirements related, for example, to into account the available technical
participation in the design and participation in the design and environmental sustainability, solutions and industry best
development of AI systems, and development of AI systems, and accessibility to persons with practices such as model and data
diversity of the development teams. diversity of the development teams. disability, stakeholders’ participation cards. Providers and, as
The Commission may develop The Commission may develop in the design and development of AI appropriate, deployers of all AI
initiatives, including of a sectorial initiatives, including of a sectorial systems, and diversity of the systems, high-risk or not, and
nature, to facilitate the lowering of nature, to facilitate the lowering of development teams. The models should also be encouraged to
technical barriers hindering cross- technical barriers hindering cross- Commission may develop initiatives, apply on a voluntary basis additional
border exchange of data for AI border exchange of data for AI including of a sectorial nature, to requirements related, for example, to
development, including on data development, including on data facilitate the lowering of technical the elements of the European ethic
access infrastructure, semantic and access infrastructure, semantic and barriers hindering cross-border guidelines for trustworthy AI,
technical interoperability of different technical interoperability of different exchange of data for AI environmental sustainability, AI
types of data. types of data. development, including on data literacy measures, inclusive and
access infrastructure, semantic and diverse design and development of
technical interoperability of different AI systems, including attention to
types of data. 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.
Recital 82
(82) It is important that AI systems (82) It is important that AI systems (82) It is important that AI systems (82) It is important that AI systems
related to products that are not high- related to products that are not high- related to products that are not high- related to products that are not high-
risk in accordance with this risk in accordance with this risk in accordance with this risk in accordance with this
Regulation and thus are not required Regulation and thus are not required Regulation and thus are not required Regulation and thus are not required
to comply with the requirements set to comply with the requirements set to comply with the requirements set to comply with the requirements set
out herein are nevertheless safe out hereinfor high-risk AI systems out herein are nevertheless safe out hereinfor high-risk AI systems
G 92 G
when placed on the market or put are nevertheless safe when placed on when placed on the market or put are nevertheless safe when placed on
into service. To contribute to this the market or put into service. To into service. To contribute to this the market or put into service. To
objective, the Directive 2001/95/EC contribute to this objective, the objective, the Directive 2001/95/EC contribute to this objective, the
of the European Parliament and of Directive 2001/95/EC of the of the European Parliament and of Directive 2001/95/EC Regulation
the Council1 would apply as a safety European Parliament and of the the Council1 would apply as a (EU) 2023/988 of the European
net. Council1 would apply as a safety safety net. Parliament and of the Council1
_________ net. _________ would apply as a safety net.
1. Directive 2001/95/EC of the European _________ 1. Directive 2001/95/EC of the European _________
Parliament and of the Council of 3 December 1. Directive 2001/95/EC of the European Parliament and of the Council of 3 December 1. Regulation (EU) 2023/988 Directive
2001 on general product safety (OJ L 11, Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 2001/95/EC of the European Parliament and
15.1.2002, p. 4). 2001 on general product safety (OJ L 11, 15.1.2002, p. 4). of the Council of 3 December 2001of 10
15.1.2002, p. 4). May 2023 on general product safety,
amending Regulation (EU) No 1025/2012
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) (OJ L 11, 15.1.2002, p. 4).
Recital 83
(83) In order to ensure trustful and (83) In order to ensure trustful and (83) In order to ensure trustful and (83) In order to ensure trustful and
constructive cooperation of constructive cooperation of constructive cooperation of constructive cooperation of
competent authorities on Union and competent authorities on Union and competent authorities on Union and competent authorities on Union and
national level, all parties involved in national level, all parties involved in national level, all parties involved in national level, all parties involved in
the application of this Regulation the application of this Regulation the application of this Regulation the application of this Regulation
should respect the confidentiality of should respectaim for transparency should respect the confidentiality of should respect the confidentiality of
information and data obtained in and openness while respecting the information and data obtained in information and data obtained in
carrying out their tasks. confidentiality of information and carrying out their tasks, in carrying out their tasks, in
data obtained in carrying out their accordance with Union or national accordance with Union or national
tasks by putting in place technical law. law. They should carry out their
G 93 G
and organisational measures to tasks and activities in such a
protect the security and manner as to protect, in particular,
confidentiality of the information intellectual property rights,
obtained carrying out their confidential business information
activities including for intellectual and trade secrets, the effective
property rights and public and implementation of this Regulation,
national security interests. Where public and national security
the activities of the Commission, interests, the integrity of criminal or
national competent authorities and administrative proceedings, and the
notified bodies pursuant to this integrity of classified information.
Regulation results in a breach of
intellectual property rights, Member
States should provide for adequate
measures and remedies to ensure
the enforcement of intellectual
property rights in application of
Directive 2004/48/EC.
Recital 84
(84) Member States should take all (84) Compliance with this (84) Member States should take all (84) Compliance with this
necessary measures to ensure that Regulation should be enforceable necessary measures to ensure that Regulation should be enforceable
the provisions of this Regulation are by means of the imposition of fines the provisions of this Regulation are by means of the imposition of
implemented, including by laying by the national supervisory implemented, including by laying penalties and other enforcement
down effective, proportionate and authority when carrying out down effective, proportionate and measures. Member States should
dissuasive penalties for their proceedings under the procedure dissuasive penalties for their take all necessary measures to
infringement. For certain specific laid down in this Regulation. infringement, and in respect of the ensure that the provisions of this
infringements, Member States Member States should take all ne bis in idem principle. For certain Regulation are implemented,
should take into account the margins necessary measures to ensure that specific infringements, Member including by laying down effective,
and criteria set out in this the provisions of this Regulation are States should take into account the proportionate and dissuasive
Regulation. The European Data implemented, including by laying margins and criteria set out in this penalties for their infringement, and
Protection Supervisor should have down effective, proportionate and Regulation. The European Data in respect of the ne bis in idem
the power to impose fines on Union dissuasive penalties for their Protection Supervisor should have principle. In order to strengthen
G 94 G
institutions, agencies and bodies infringement. In order to strengthen the power to impose fines on Union and harmonise administrative
falling within the scope of this and harmonise administrative institutions, agencies and bodies penalties for infringement of this
Regulation. penalties for infringement of this falling within the scope of this Regulation, the upper limits for
Regulation, the upper limits for Regulation. setting the administrative fines . for
setting the administrative fines for certain specific infringements
certain specific infringements should be laid down. When
should be laid down. When assessing the amount of the fines,
assessing the amount of the fines, Member States should, in each
national competent authorities, individual case, take into account all
Member States should, in each relevant circumstances of the
individual case, take into account all specific situation, with due regard
relevant circumstances of the in particular to the nature, gravity
specific situation, with due regard and duration of the infringement
in particular to the nature, gravity and of its consequences and to the
and duration of the infringement provider’s size, in particular if the
and of its consequences and to the provider is an SME including a
provider’s size, in particular if the start-upthe margins and criteria set
provider is a SME or a start-upthe out in this Regulation. The European
margins and criteria set out in this Data Protection Supervisor should
Regulation. The European Data have the power to impose fines on
Protection Supervisor should have Union institutions, agencies and
the power to impose fines on Union bodies falling within the scope of
institutions, agencies and bodies this Regulation.
falling within the scope of this
Regulation. The penalties and (84a) Compliance with the
litigation costs under this obligations on providers of general-
Regulation should not be subject to purpose AI models imposed under
contractual clauses or any other this Regulation should be
arrangements. enforceable among others by means
of fines. To that end, appropriate
levels of fines should also be laid
down for infringement of those
obligations, including the failure to
comply with measures requested by
the Commission in 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.
Recital 84a
(84a) As the rights and freedoms of (84aa) Union and national law
G 94a G
natural and legal persons and already provides effective remedies
groups of natural persons can be to natural and legal persons whose
seriously undermined by AI rights and freedoms are adversely
systems, it is essential that natural affected by the use of AI systems.
and legal persons or groups of Without prejudice to those
natural persons have meaningful remedies, any natural or legal
access to reporting and redress person having grounds to consider
mechanisms and to be entitled to that there has been an infringement
access proportionate and effective of the provisions of this Regulation
remedies. They should be able to should be entitled to lodge a
report infringments of this complaint to the relevant market
Regulation to their national surveillance authority.
supervisory authority and have the
right to lodge a complaint against
the providers or deployers of AI
systems. Where applicable,
deployers should provide internal
complaints mechanisms to be used
by natural and legal persons or
groups of natural persons. Without
prejudice to any other
administrative or non-judicial
remedy, natural and legal persons
and groups of natural persons
should also have the right to an
effective judicial remedy with
regard to a legally binding decision
of a national supervisory authority
concerning them or, where the
national supervisory authority does
not handle a complaint, does not
inform the complainant of the
progress or preliminary outcome of
the complaint lodged or does not
comply with its obligation to reach
a final decision, with regard to the
complaint.
Recital 84b
(84b) Affected persons should (84b) Affected persons should have

always be informed that they are the right to request an explanation
subject to the use of a high-risk AI when a decision is taken by the
system, when deployers use a high- deployer with the output from
risk AI system to assist in decision- certain high-risk systems as
making or make decisions related to provided for in this Regulation as
natural persons. This information the main basis and which produces
can provide a basis for affected legal effects or similarly
persons to exercise their right to an significantly affects him or her in a
explanation under this way that they consider to adversely
Regulation.When deployers provide impact their health, safety or
G 94b G
an explanation to affected persons fundamental rights. This
under this Regulation, they should explanation should be a clear and
take into account the level of meaningful and should provide a
expertise and knowledge of the basis for affected persons to
average consumer or individual. 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.
Recital 84c
(84c) Union law on the protection (84c) Persons acting as

of whistleblowers (Directive (EU) ‘whisteblowers’ on the breaches of
2019/1937) has full application to this Regulation should be afforded
academics, designers, developers, the protection guaranteed by Union
G 94c project contributors, auditors, legislation on the protection of G
product managers, engineers and persons who report breaches of law.

economic operators acquiring Therefore, Directive (EU)
information on breaches of Union 2019/1937 should apply to the
law by a provider of AI system or its reporting of breaches of this
AI system. Regulation and the protection of
persons reporting such breaches.
Recital 85
(85) In order to ensure that the (85) In order to ensure that the (85) In order to ensure that the (85) In order to ensure that the
regulatory framework can be regulatory framework can be regulatory framework can be regulatory framework can be
adapted where necessary, the power adapted where necessary, the power adapted where necessary, the power adapted where necessary, the power
to adopt acts in accordance with to adopt acts in accordance with to adopt acts in accordance with to adopt acts in accordance with
Article 290 TFEU should be Article 290 TFEU should be Article 290 TFEU should be Article 290 TFEU should be
delegated to the Commission to delegated to the Commission to delegated to the Commission to delegated to the Commission to
amend the techniques and amend the techniques and amend the techniques and amend the techniques and
approaches referred to in Annex I to approaches referred to in Annex I to approaches referred to in Annex I to approaches referred to in Annex I to
define AI systems, the Union define AI systems, the Union define AI systems, the Union define AI systems, the Union
harmonisation legislation listed in harmonisation legislation listed in harmonisation legislation listed in harmonisation legislation listed in
Annex II, the high-risk AI systems Annex II, the high-risk AI systems Annex II, the high-risk AI systems Annex II, the high-risk AI systems
listed in Annex III, the provisions listed in Annex III, the provisions listed in Annex III, the provisions listed in Annex III, the provisions
regarding technical documentation regarding technical documentation regarding technical documentation regarding technical documentation
listed in Annex IV, the content of the listed in Annex IV, the content of the listed in Annex IV, the content of the listed in Annex IV, the content of the
EU declaration of conformity in EU declaration of conformity in EU declaration of conformity in EU declaration of conformity in
G 95 Annex V, the provisions regarding Annex V, the provisions regarding Annex V, the provisions regarding Annex V, the provisions regarding G
the conformity assessment the conformity assessment the conformity assessment the conformity assessment
procedures in Annex VI and VII and procedures in Annex VI and VII and procedures in Annex VI and VII and procedures in Annex VI and VII
the provisions establishing the high- the provisions establishing the high- the provisions establishing the high- and, the provisions establishing the
risk AI systems to which the risk AI systems to which the risk AI systems to which the high-risk AI systems to which the
conformity assessment procedure conformity assessment procedure conformity assessment procedure conformity assessment procedure
based on assessment of the quality based on assessment of the quality based on assessment of the quality based on assessment of the quality
management system and assessment management system and assessment management system and assessment management system and assessment
of the technical documentation of the technical documentation of the technical documentation of the technical documentation
should apply. It is of particular should apply. It is of particular should apply. It is of particular should apply, the threshold as well
importance that the Commission importance that the Commission importance that the Commission as to supplement benchmarks and
carry out appropriate consultations carry out appropriate consultations carry out appropriate consultations indicators in the rules for
during its preparatory work, during its preparatory work, during its preparatory work, classification of general-purpose AI
including at expert level, and that including at expert level, and that including at expert level, and that models with systemic risk, the
those consultations be conducted in those consultations be conducted in those consultations be conducted in criteria for the designation of
accordance with the principles laid accordance with the principles laid accordance with the principles laid general-purpose AI models with
down in the Interinstitutional down in the Interinstitutional down in the Interinstitutional systemic risk in Annex YY, the
Agreement of 13 April 2016 on Agreement of 13 April 2016 on Agreement of 13 April 2016 on technical documentation for
Better Law-Making1. In particular, Better Law-Making1. These Better Law-Making1. In particular, providers of general-purpose AI
to ensure equal participation in the consultations should involve the to ensure equal participation in the models in Annex VIIIb and the
preparation of delegated acts, the participation of a balanced preparation of delegated acts, the transparency information for
European Parliament and the selection of stakeholders, including European Parliament and the providers of general-purpose AI
Council receive all documents at the consumer organisations, civil Council receive all documents at the models in Annex VIIIc. It is of
same time as Member States’ society, associations representing same time as Member States’ particular importance that the
experts, and their experts affected persons, businesses experts, and their experts Commission carry out appropriate
systematically have access to representatives from different systematically have access to consultations during its preparatory
meetings of Commission expert sectors and sizes, as well as meetings of Commission expert work, including at expert level, and
groups dealing with the preparation researchers and scientists. In groups dealing with the preparation that those consultations be
of delegated acts. particular, to ensure equal of delegated acts. Such conducted in accordance with the
_________ participation in the preparation of consultations and advisory support principles laid down in the
1. OJ L 123, 12.5.2016, p. 1. delegated acts, the European should also be carried out in the Interinstitutional Agreement of 13
Parliament and the Council receive framework of the activities of the AI April 2016 on Better Law-Making11.
all documents at the same time as Board and its subgroups. In particular, to ensure equal
Member States’ experts, and their _________ participation in the preparation of
experts systematically have access to 1. [1] OJ L 123, 12.5.2016, p. 1. delegated acts, the European
meetings of Commission expert Parliament and the Council receive
groups dealing with the preparation all documents at the same time as
of delegated acts. Member States’ experts, and their
_________ experts systematically have access to
1. OJ L 123, 12.5.2016, p. 1. meetings of Commission expert
groups dealing with the preparation
of delegated acts.
_________
1. OJ L 123, 12.5.2016, p. 1.
Recital 85a
(85a) Given the rapid technological (85a) Given the rapid technological
developments and the required developments and the required
G 95a technical expertise in conducting technical expertise in the effective G
the assessment of high-risk AI application of this Regulation, the

systems, the Commission should Commission should evaluate and
regularly review the review this Regulation by three
implementation of this Regulation, years after the date of entry into
in particular the prohibited AI application and every four years
systems, the transparency thereafter and report to the
obligations and the list of high-risk European Parliament and the
areas and use cases, at least every Council. In addition, taking into
year, while consulting the AI office account the implications for the
and the relevant stakeholders. 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.
Recital 86
(86) In order to ensure uniform (86) In order to ensure uniform (86) In order to ensure uniform (86) In order to ensure uniform
conditions for the implementation of conditions for the implementation of conditions for the implementation of conditions for the implementation of
this Regulation, implementing this Regulation, implementing this Regulation, implementing this Regulation, implementing
powers should be conferred on the powers should be conferred on the powers should be conferred on the powers should be conferred on the
Commission. Those powers should Commission. Those powers should Commission. Those powers should Commission. Those powers should
be exercised in accordance with be exercised in accordance with be exercised in accordance with be exercised in accordance with
Regulation (EU) No 182/2011 of the Regulation (EU) No 182/2011 of the Regulation (EU) No 182/2011 of the Regulation (EU) No 182/2011 of the
Council1. Council1. Council1. It is of particular Council11.
_________ _________ importance that, in accordance with _________
1. Regulation (EU) No 182/2011 of the 1. Regulation (EU) No 182/2011 of the the principles laid down in the 1. Regulation (EU) No 182/2011 of the
European Parliament and of the Council of European Parliament and of the Council of Interinstitutional Agreement of 13 European Parliament and of the Council of
16 February 2011 laying down the rules and 16 February 2011 laying down the rules and 16 February 2011 laying down the rules and
general principles concerning mechanisms general principles concerning mechanisms April 2016 on Better Law-Making, general principles concerning mechanisms
for control by the Member States of the for control by the Member States of the whenever broader expertise is for control by the Member States of the
G 96 Commission's exercise of implementing Commission's exercise of implementing needed in the early preparation of Commission's exercise of implementing G
powers (OJ L 55, 28.2.2011, p.13). powers (OJ L 55, 28.2.2011, p.13). draft implementing acts, the powers (OJ L 55, 28.2.2011, p.13).
Commission makes use of expert
groups, consults targeted
stakeholders or carries out public
consultations, as appropriate. Such
consultations and advisory support
should also be carried out in the
framework of the activities of the AI
Board and its subgroups, including
the preparation of implementing
acts in relation to Articles 4, 4b and
6.
_________
1. [1] Regulation (EU) No 182/2011
Council of 16 February 2011 laying down
the rules and general principles concerning
mechanisms for control by the Member
States of the Commission's exercise of
implementing powers (OJ L 55, 28.2.2011,
p.13).
Recital 87
(87) Since the objective of this (87) Since the objective of this (87) Since the objective of this (87) Since the objective of this
Regulation cannot be sufficiently Regulation cannot be sufficiently Regulation cannot be sufficiently Regulation cannot be sufficiently
achieved by the Member States and achieved by the Member States and achieved by the Member States and achieved by the Member States and
can rather, by reason of the scale or can rather, by reason of the scale or can rather, by reason of the scale or can rather, by reason of the scale or
effects of the action, be better effects of the action, be better effects of the action, be better effects of the action, be better
achieved at Union level, the Union achieved at Union level, the Union achieved at Union level, the Union achieved at Union level, the Union
may adopt measures in accordance may adopt measures in accordance may adopt measures in accordance may adopt measures in accordance
with the principle of subsidiarity as with the principle of subsidiarity as with the principle of subsidiarity as with the principle of subsidiarity as
G 97 set out in Article 5 TEU. In set out in Article 5 TEU. In set out in Article 5 TEU. In set out in Article 5 TEU. In
G
accordance with the principle of accordance with the principle of accordance with the principle of accordance with the principle of
proportionality as set out in that proportionality as set out in that proportionality as set out in that proportionality as set out in that
Article, this Regulation does not go Article, this Regulation does not go Article, this Regulation does not go Article, this Regulation does not go
beyond what is necessary in order to beyond what is necessary in order to beyond what is necessary in order to beyond what is necessary in order to
achieve that objective. achieve that objective. achieve that objective. achieve that objective.
Proposal
Recital 87a
(87a) In order to ensure legal (87a) In order to ensure legal

certainty, ensure an appropriate certainty, ensure an appropriate
adaptation period for operators and adaptation period for operators and
G 97a G
avoid disruption to the market, avoid disruption to the market,
including by ensuring continuity of including by ensuring continuity of
the use of AI systems, it is the use of AI systems, it is
appropriate that this Regulation appropriate that this Regulation
applies to the high-risk AI systems applies to the high-risk AI systems
that have been placed on the market that have been placed on the market
or put into service before the or put into service before the
general date of application thereof, general date of application thereof,
only if, from that date, those only if, from that date, those
systems are subject to significant systems are subject to significant
changes in their design or intended changes in their design or intended
purpose. It is appropriate to clarify purpose. It is appropriate to clarify
that, in this respect, the concept of that, in this respect, the concept of
significant change should be significant change should be
understood as equivalent in understood as equivalent in
substance to the notion of substance to the notion of
substantial modification, which is substantial modification, which is
used with regard only to high-risk used with regard only to high-risk
AI systems as defined in this AI systems as defined in this
Regulation. 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.
Recital 87a
(87a) As reliable information on

G 97b the resource and energy use, waste G
production and other

environmental impact of AI systems
and related ICT technology,
including software, hardware and
in particular data centres, is
limited, the Commission should
introduce of an adequate
methodology to measure the
environmental impact and
effectiveness of this Regulation in
light of the Union environmental
and climate objectives.
Recital 87b
(87b) Providers of high-risk AI

systems are encouraged to start to
comply, on voluntary basis, with the
G 97c G
relevant obligations foreseen under
this Regulation already during the
transitional period.
Recital 88
(88) This Regulation should apply (88) This Regulation should apply (88) This Regulation should apply (88) This Regulation should apply
from … [OP – please insert the date from … [OP – please insert the date from … [OP – please insert the date from … [OP – please insert the date
established in Art. 85]. However, the established in Art. 85]. However, the established in Art. 85OP – please established in Art. 85]. However,
infrastructure related to the infrastructure related to the insert the date established in Art. taking into account the
governance and the conformity governance and the conformity 85]. However, the infrastructure unacceptable risk associated with
assessment system should be assessment system should be related to the governance and the the use of AI in certain ways, the
G 98 G
operational before that date, operational before that date, conformity assessment system prohibitions should apply already
therefore the provisions on notified therefore the provisions on notified should be operational before that from … [OP – please insert the date
bodies and governance structure bodies and governance structure date, therefore the provisions on – 6 months after entry into force of
should apply from … [OP – please should apply from … [OP – please notified bodies and governance this Regulation]. While the full
insert the date – three months insert the date – three months structure should apply from … [OP effect of these prohibitions follows
following the entry into force of this following the entry into force of this – please insert the date – three with the establishment of the
Regulation]. In addition, Member Regulation]. In addition, Member months following the entry into governance and enforcement of this
States should lay down and notify to States should lay down and notify to force of this RegulationOP – please Regulation, anticipating the
the Commission the rules on the Commission the rules on insert the date – three months application of the prohibitions is
penalties, including administrative penalties, including administrative following the entry into force of this important to take account of
fines, and ensure that they are fines, and ensure that they are Regulation]. In addition, Member unacceptable risk and has effect on
properly and effectively properly and effectively States should lay down and notify to other procedures, such as in civil
implemented by the date of implemented by the date of the Commission the rules on law. Moreover, the infrastructure
application of this Regulation. application of this Regulation. penalties, including administrative related to the governance and the
Therefore the provisions on penalties Therefore the provisions on penalties fines, and ensure that they are conformity assessment system
should apply from [OP – please should apply from [OP – please properly and effectively should be operational before that
insert the date – twelve months insert the date – twelve months implemented by the date of date, therefore the provisions on
following the entry into force of this following the entry into force of this application of this Regulation. notified bodies and governance
Regulation]. Regulation]. Therefore the provisions on penalties structure should apply from … [OP
should apply from [OP – please – please insert the date – three
insert the date – twelve months twelve months following the entry
following the entry into force of this into force of this Regulation]. Given
RegulationOP – please insert the the rapid pace of technological
date – twelve months following the advancements and adoption of
entry into force of this Regulation]. 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].
Recital 89
(89) The European Data Protection (89) The European Data Protection (89) The European Data Protection (89) The European Data Protection
Supervisor and the European Data Supervisor and the European Data Supervisor and the European Data Supervisor and the European Data
Protection Board were consulted in Protection Board were consulted in Protection Board were consulted in Protection Board were consulted in
G 99 accordance with Article 42(2) of accordance with Article 42(2) of accordance with Article 42(2) of accordance with Article 42(2) of G
Regulation (EU) 2018/1725 and Regulation (EU) 2018/1725 and Regulation (EU) 2018/1725 and Regulation (EU) 2018/1725 and
delivered an opinion on […]”. delivered an opinion on […]”18 delivered an opinion on […]”. delivered an opinion on […]”18
June 2021. June 2021.
Formula
HAVE ADOPTED THIS HAVE ADOPTED THIS HAVE ADOPTED THIS

G 100 G
REGULATION: REGULATION: REGULATION:
TITLE I
TITLE I TITLE I TITLE I TITLE I

GENERAL PROVISIONS GENERAL PROVISIONS GENERAL PROVISIONS GENERAL PROVISIONS
G 101 G

Proposal
Article 1
G 102 G
Article 1 Article 1 Article 1 Article 1
Subject matter Subject matter Subject matter Subject matter
Proposal
Article 1, first paragraph -a
The purpose of this Regulation is to (1) The purpose of this Regulation

promote the uptake of human- is to improve the functioning of the
centric and trustworthy artificial internal market and promoting the
intelligence and to ensure a high uptake of human centric and
level of protection of health, safety, trustworthy artificial intelligence,
fundamental rights, democracy and while ensuring a high level of
the rule of law, and the protection of health, safety,
G 102a G
environment from harmful effects fundamental rights enshrined in the
of artificial intelligence systems in Charter, including democracy, rule
the Union while supporting of law and environmental
innovation; protection against harmful effects
of artificial intelligence systems in
the Union and supporting
innovation.
Article 1, first paragraph
This Regulation lays down: This Regulation lays down: This Regulation lays down: This Regulation lays down:
G
Proposal
Article 1, first paragraph, point (a)
(a) harmonised rules for the placing (a) harmonised rules for the placing (a) harmonised rules for the placing (a) harmonised rules for the placing
G 104 on the market, the putting into on the market, the putting into on the market, the putting into on the market, the putting into G
service and the use of artificial service and the use of artificial service and the use of artificial service and the use of artificial
intelligence systems (‘AI systems’) intelligence systems (‘AI systems’) intelligence systems (‘AI systems’) intelligence systems (‘AI systems’)
in the Union; in the Union; in the Union; in the Union;
Proposal
Article 1, first paragraph, point (b)
(b) prohibitions of certain artificial (b) prohibitions of certain artificial (b) prohibitions of certain artificial (b) prohibitions of certain artificial
intelligence practices; intelligence practices; intelligence practices; intelligence practices;
G 105 G

Proposal
Article 1, first paragraph, point (c)
(c) specific requirements for high- (c) specific requirements for high- (c) specific requirements for high- (c) specific requirements for high-
risk AI systems and obligations for risk AI systems and obligations for risk AI systems and obligations for risk AI systems and obligations for
G 106 operators of such systems; operators of such systems; operators of such systems; operators of such systems; G

Proposal
Article 1, first paragraph, point (d)
(d) harmonised transparency rules (d) harmonised transparency rules (d) harmonised transparency rules (d) harmonised transparency rules
for AI systems intended to interact for AI systems intended to interact for AI systems intended to interact for certain AI systems;
with natural persons, emotion with natural persons, emotion with natural persons, emotion
recognition systems and biometric recognition systems and biometric recognition systems and biometric (da) harmonised rules for the
categorisation systems, and AI categorisation systems, andcertain categorisation systems, andcertain placing on the market of general-
G 107 systems used to generate or AI systems used to generate or AI systems used to generate or purpose AI models intended to G
manipulate image, audio or video manipulate image, audio or video manipulate image, audio or video interact with natural persons,
content; content; content; emotion recognition systems and
biometric categorisation systems,
and AI systems used to generate or
manipulate image, audio or video
content;
Article 1, first paragraph, point (e)
(e) rules on market monitoring and (e) rules on market monitoring, (e) rules on market monitoring, (e) rules on market monitoring,
surveillance. market surveillance governance market surveillance and market surveillance governance
G 108 and enforcement; and surveillance. governance; and surveillance. and enforcement; and surveillance. G
Article 1, first paragraph, point (ea)
(ea) measures in support of

G 108a G
innovation.
(ea) measures to support (ea) measures to support

innovation, with a particular focus innovation, with a particular focus
on SMEs and start-ups, including on SMEs, including start-ups;
G 108b on setting up regulatory sandboxes G
and targeted measures to reduce the
regulatory burden on SMEs’s and
start-ups;
Article 1, first paragraph a, point (eb new)
(eb) rules for the establishment and

functioning of the Union’s
G 108c G
Artificial Intelligence Office (AI
Office).
Article 2

Scope Scope Scope Scope
G 109 G

Proposal
Article 2(1)
1. This Regulation applies to: 1. This Regulation applies to: 1. This Regulation applies to: 1. This Regulation applies to:
G
Proposal
Article 2(1), point (a)
(a) providers placing on the market (a) providers placing on the market (a) providers placing on the market (a) providers placing on the market
or putting into service AI systems in or putting into service AI systems in or putting into service AI systems in or putting into service AI systems or
the Union, irrespective of whether the Union, irrespective of whether the Union, irrespective of whether placing on the market general-
those providers are established those providers are established those providers are physically purpose AI models in the Union,
G 111 within the Union or in a third within the Union or in a third present or established within the irrespective of whether those G
country; country; Union or in a third country; providers are established or who are
located within the Union or in a
third country;
Text Origin: Council Mandate
Article 2(1), point (b)
(b) users of AI systems located (b) usersdeployers of AI systems (b) users of AI systems locatedwho (b) usersdeployers of AI systems
within the Union; that have their place of are physically present or established that have their place of
G 112 establishment or who are located within the Union; establishment or who are located G
within the Union; within the Union;

Article 2(1), point (c)
(c) providers and users of AI (c) providers and usersdeployers of (c) providers and users of AI (c) providers and usersdeployers of
systems that are located in a third AI systems that have their place of systems that are locatedwho are AI systems that have their place of
country, where the output produced establishment or who are located in physically present or established in establishment or who are located in
by the system is used in the Union; a third country, where either a third country, where the output a third country, where the output
G 113 G
Member State law applies by virtue produced by the system is used in produced by the system is used in
of a public international law or the the Union; the Union;
output produced by the system is
intended to be used in the Union;
Article 2(1), point (ca)
(ca) importers and distributors of (ca) importers and distributors of

G 113a AI systems; AI systems; G
Article 2(1), point (ca new)
(ca) providers placing on the

market or putting into service AI
systems referred to in Article 5
G 113b G
outside the Union where the
provider or distributor of such
systems is located within the Union;
Article 2(1), point (cb)
(cb) product manufacturers (cb) product manufacturers

placing on the market or putting placing on the market or putting
G 113c G
into service an AI system together into service an AI system together
with their product and under their with their product and under their
own name or trademark; own name or trademark;
Article 2(1), point (cb new)
(cb) importers and distributors of

AI systems as well as authorised
representatives of providers of AI
systems, where such importers,
G 113d G
distributors or authorised
representatives have their
establishment or are located in the
Union;
Article 2(1), point (cc)
(cc) authorised representatives of (cc) authorised representatives of

providers, which are established in providers, which are not established
G 113e the Union. in the Union. G
Article 2(1), point (cd)
(cc) affected persons as defined in (cc) affected persons that are

Article 3(8a) that are located in the located in the Union.
Union and whose health, safety or
G 113f fundamental rights are adversely G
impacted by the use of an AI system

that is placed on the market or put
into service within the Union.
Article 2(2)
G 114 G
2. For high-risk AI systems that are 2. For high-risk AI systems that are 2. For high-risk AI systems that are 2. 2. For high-risk AI systems that
safety components of products or safety components of products or safety components of products or are safety components of products or
systems, or which are themselves systems, or which are themselves systems, or which are systems, or which are
products or systems, falling within products or systems, falling and that themselvesclassified as high-risk AI themselvesclassified as high-risk AI
the scope of the following acts, only fall, within the scope of the systems in accordance with Articles systems in accordance with Articles
Article 84 of this Regulation shall following actsharmonisation 6(1) and 6(2) related to products or 6(1) and 6(2) related to products or
apply: legislation listed in Annex II - systems, falling within the scope of systems, falling within the scope of
Section B, only Article 84 of this the following acts,covered by Union the following acts, covered by Union
Regulation shall apply:; harmonisation legislation listed in harmonisation legislation listed in
Annex II, section B only Article 84 Annex II, section B only Article 84
of this Regulation shall apply:. of this Regulation shall apply:.
Article 53 shall apply only insofar Article 53 shall apply only insofar
as the requirements for high-risk as the requirements for high-risk
AI systems under this Regulation AI systems under this Regulation
have been integrated under that have been integrated under that
Union harmonisation legislation. Union harmonisation legislation.
(a) Regulation (EC) 300/2008;

G 115 G
deleted deleted
(b) Regulation (EU) No 167/2013;

G 116 G
deleted deleted
(c) Regulation (EU) No 168/2013;

G 117 G
deleted deleted
Article 2(2), point (d)
(d) Directive 2014/90/EU; (d) Directive 2014/90/EU;deleted

G 118 G
deleted deleted
Article 2(2), point (e)
(e) Directive (EU) 2016/797; (e) Directive (EU) 2016/797;deleted

G 119 G
deleted deleted
Article 2(2), point (f)
(f) Regulation (EU) 2018/858; (f) Regulation (EU)

G 120 G
deleted deleted 2018/858;deleted
Article 2(2), point (g)
(g) Regulation (EU) 2018/1139; (g) Regulation (EU)

G 121 G
deleted deleted 2018/1139;deleted
Article 2(2), point (h)
(h) Regulation (EU) 2019/2144. (h) Regulation (EU)

G 122 G
deleted deleted 2019/2144.deleted
Article 2(3)
3. This Regulation shall not apply to 3. This Regulation shall not apply to 3. This Regulation shall not apply
AI systems developed or used AI systems developedif and insofar to areas outside the scope of EU
G 123 exclusively for military purposes. placed on the market, put into law and in any event shall not G
service, or used exclusively for with affect the competences of the

or without modification of such Member States concerning national
systems for the purpose of activities security, regardless of the type of
which fall outside the scope of entity entrusted by the Member
Union law, and in any event States to carry out the tasks in
activities concerning military, relation to those competences.
defence or national security,
regardless of the type of entity This Regulation shall not apply to AI
carrying out those activities. systems developed or used if and
In addition, this Regulation insofar placed on the market, put
shall not apply to AI systems which into service, or used with or without
are not placed on the market or put modification of such systems
into service in the Union, where the exclusively for military, defence or
output is used in the Union for the national security purposes,
purpose of activities which fall regardless of the type of entity
outside the scope of Union law, and carrying out those activities.
in any event activities concerning
military, defence or national This Regulation shall not apply to
security, regardless of the type of AI systems which are not placed on
entity carrying out those activities the market or put into service in the
purposes. 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.
Article 2(4)
4. This Regulation shall not apply to 4. This Regulation shall not apply to 4. This Regulation shall not apply to 4. This Regulation shall not apply to
public authorities in a third country public authorities in a third country public authorities in a third country public authorities in a third country
nor to international organisations nor to international organisations nor to international organisations nor to international organisations
falling within the scope of this falling within the scope of this falling within the scope of this falling within the scope of this
Regulation pursuant to paragraph 1, Regulation pursuant to paragraph 1, Regulation pursuant to paragraph 1, Regulation pursuant to paragraph 1,
G 124 G
where those authorities or where those authorities or where those authorities or where those authorities or
organisations use AI systems in the organisations use AI systems in the organisations use AI systems in the organisations use AI systems in the
framework of international framework of international framework of international framework of international
agreements for law enforcement and cooperation or agreements for law agreements for law enforcement and cooperation or agreements for law
judicial cooperation with the Union enforcement and judicial judicial cooperation with the Union enforcement and judicial
or with one or more Member States. cooperation with the Union or with or with one or more Member States. cooperation with the Union or with
one or more Member States. and are one or more Member States., under
subject of a decision of the the condition that this third
Commission adopted in accordance country or international
with Article 36 of Directive (EU) organisations provide adequate
2016/680 or Article 45 of safeguards with respect to the
Regulation 2016/679 (adequacy protection of fundamental rights
decision) or are part of an and freedoms of individuals;
international agreement concluded
between the Union and that third
country or international
organisation pursuant to Article
218 TFUE providing adequate
safeguards with respect to the
protection of privacy and
fundamental rights and freedoms of
individuals;
Article 2(5)
5. This Regulation shall not affect 5. This Regulation shall not affect 5. This Regulation shall not affect 5. This Regulation shall not affect
the application of the provisions on the application of the provisions on the application of the provisions on the application of the provisions on
the liability of intermediary service the liability of intermediary service the liability of intermediary service the liability of intermediary service
providers set out in Chapter II, providers set out in Chapter II, providers set out in Chapter II, providers set out in Chapter II,
Section IV of Directive 2000/31/EC Section IV of Directive 2000/31/EC Section IV4 of Directive 2000/31/EC Section IV4 of Directive 2000/31/EC
the Council1 [as to be replaced by the Council1 [as to be replaced by the Council1 [as to be replaced by the Council1 [as to be replaced by
the corresponding provisions of the the corresponding provisions of the the corresponding provisions of the the corresponding provisions of the
G 125 G
Digital Services Act]. Digital Services Act]. Digital Services Actas to be Digital Services Actas to be
_________ _________ replaced by the corresponding replaced by the corresponding
1. Directive 2000/31/EC of the European 1. Directive 2000/31/EC of the European provisions of the Digital Services provisions of the Digital Services
Parliament and of the Council of 8 June 2000 Parliament and of the Council of 8 June 2000 Act]. Act].
on certain legal aspects of information on certain legal aspects of information
society services, in particular electronic society services, in particular electronic _________ _________
commerce, in the Internal Market ('Directive commerce, in the Internal Market ('Directive 1. [1] Directive 2000/31/EC of the 1. [1] Directive 2000/31/EC of the
on electronic commerce') (OJ L 178, on electronic commerce') (OJ L 178, European Parliament and of the Council of 8 European Parliament and of the Council of 8
17.7.2000, p. 1). 17.7.2000, p. 1). June 2000 on certain legal aspects of June 2000 on certain legal aspects of
information society services, in particular information society services, in particular
electronic commerce, in the Internal Market electronic commerce, in the Internal Market
('Directive on electronic commerce') (OJ L ('Directive on electronic commerce') (OJ L
178, 17.7.2000, p. 1). 178, 17.7.2000, p. 1).
Article 2(5a)
5a. This Regulation shall not apply 5a. This Regulation shall not apply
to AI systems, including their to AI systems and models, including
output, specifically developed and their output, specifically developed
G 125a put into service for the sole purpose and put into service for the sole G
of scientific research and purpose of scientific research and

development. development.
Article 2(5b)
5a. Union law on the protection of 5a. Union law on the protection of
personal data, privacy and the personal data, privacy and the
confidentiality of communications confidentiality of communications
applies to personal data processes applies to personal data processed
in connection with the rights and in connection with the rights and
obligations laid down in this obligations laid down in this
Regulation. This Regulation shall Regulation. This Regulation shall
G 125b not affect Regulations (EU) not affect Regulations (EU) G
2016/679 and (EU) 2018/1725 and 2016/679 and (EU) 2018/1725 and
Directives 2002/58/EC and (EU) Directives 2002/58/EC and (EU)
2016/680, without prejudice to 2016/680, without prejudice to
arrangements provided for in arrangements provided for in
Article 10(5) and Article 54 of this Article 10(5) and Article 54 of this
Regulation.; Regulation;
Article 2(5c)
5b. This Regulation shall not apply 5b. This Regulation shall not apply
to any research and development to any research, testing and
activity regarding AI systems. development activity regarding AI
systems or models prior to being
G 125c service; those activities shall be G
conducted respecting applicable

Union law. The testing in real
world conditions shall not be
covered by this exemption.
Article 2(5d)
5b. This Regulation is without 5b. This Regulation is without

prejudice to the rules laid down by prejudice to the rules laid down by
other Union legal acts related to other Union legal acts related to
G 125d consumer protection and product consumer protection and product G
safety; safety.
Article 2(5e)
5c. This Regulation shall not apply 5c. This Regulation shall not apply
to obligations of users who are to obligations of deployers who are
natural persons using AI systems in natural persons using AI systems in
G 125e the course of a purely personal the course of a purely personal G
non-professional activity, except non-professional activity.

Article 52.
Article 2(5f)
5c. This regulation shall not 5e. This Regulation shall not
preclude Member States or the preclude Member States or the
Union from maintaining or Union from maintaining or
introducing laws, regulations or introducing laws, regulations or
administrative provisions which are administrative provisions which are
more favourable to workers in more favourable to workers in
G 125f terms of protecting their rights in terms of protecting their rights in G
respect of the use of AI systems by respect of the use of AI systems by

employers, or to encourage or allow employers, or to encourage or allow
the application of collective the application of collective
agreements which are more agreements which are more
favourable to workers. favourable to workers.
Text Origin: Presidency2
Article 2(5d) new
5d. This Regulation shall not apply

to research, testing and
development activities regarding an
AI system prior to this system being
service, provided that these
activities are conducted respecting
fundamental rights and the
G 125g applicable Union law. The testing G
in real world conditions shall not be

covered by this exemption.The
Commission is empowered to may
adopt delegated acts in accordance
with Article 73 that clarify the
application of this paragraph to
specify this exemption to prevent its
existing and potential abuse. The
AI Office shall provide guidance on
the governance of research and
development pursuant to Article 56,
also aiming to coordinate its
application by the national
supervisory authorities;
Article 2(5g)
5g. The obligations laid down in

this Regulation shall not apply to
AI systems released under free and
open source licences unless they
G 125h G
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 2(5h)
5e. This Regulation shall not apply 5f.

to AI components provided under
free and open-source licences
except to the extent they are placed
on the market or put into service by
G 125i a provider as part of a high-risk AI G
system or of an AI system that falls

under Title II or IV. This
exemption shall not apply to
foundation models as defined in Art
3.
Article 3
G 126 G
Article 3 Article 3 Article 3
Definitions Definitions Definitions
For the purpose of this Regulation, For the purpose of this Regulation, For the purpose of this Regulation,
G 127 G
the following definitions apply: the following definitions apply: the following definitions apply:
Article 3, first paragraph, point (1)
(1) ‘artificial intelligence system’ (1) ‘artificial intelligence system’ (1) ‘artificial intelligence system’ (1) ‘artificial intelligenceAn AI
(AI system) means software that is (AI system) means softwarea (AI system) means softwarea system system’ (AI system) means software
developed with one or more of the machine-based system that is that is developed with one or more of that is developed with one or more
techniques and approaches listed in developed with one or more of the the techniques and approaches listed of the techniques and approaches
Annex I and can, for a given set of techniques and approaches listed in in Annex I and can, fordesigned to listed in Annex I and can, for a given
human-defined objectives, generate Annex I and can, for a given set of operate with elements of autonomy set of human-defined objectives is a
outputs such as content, predictions, human-defineddesigned to operate and that, based on machine and/or machine-based system designed to
recommendations, or decisions with varying levels of autonomy human-provided data and inputs, operate with varying levels of
influencing the environments they and that can, for explicit or implicit infers how to achieve a given set of autonomy and that may exhibit
interact with; objectives, generate outputs such as human-defined objectives, adaptiveness after deployment and
G 128 G
content, predictions, generateobjectives using machine that, for explicit or implicit
recommendations, or decisions, that learning and/or logic- and objectives, infers, from the input it
influence physical or virtual knowledge based approaches, and receives, how to generate outputs
environments influencing the produces system-generated outputs such as content,
environments they interact with; such as content (generative AI predictionspredictions, content,
systems), predictions, recommendations, or decisions
recommendations, or decisions, influencing thethat can influence
influencing the environments they physical or virtual environments. .
interact withwith which the AI they interact with;
system interacts;
Article 3, first paragraph, point (1a)
G 128a (1a) ‘life cycle of an AI system’ G
means the duration of an AI

system, from design through
retirement. Without prejudice to the
powers of the market surveillance
authorities, such retirement may
happen at any point in time during
the post-market monitoring phase
upon the decision of the provider
and implies that the system may not
be used further. An AI system
lifecycle is also ended by a
substantial modification to the AI
system made by the provider or any
other natural or legal person, in
which case the substantially
modified AI system shall be
considered as a new AI system.
(1a) ‘risk’ means the combination (1a) ‘risk’ means the combination
of the probability of an occurrence of the probability of an occurrence
G 128b G
of harm and the severity of that of harm and the severity of that
harm; harm;
Article 3, first paragraph, point (1b)
(1b) ‘general purpose AI system’

means an AI system that -
irrespective of how it is placed on
the market or put into service,
G 128c G
including as open source software -
is intended by the provider to
perform generally applicable
functions such as image and speech
recognition, audio and video
generation, pattern detection,
question answering, translation and
others; a general purpose AI system
may be used in a plurality of
contexts and be integrated in a
plurality of other AI systems;
Article 3, first paragraph, point (1b new)
(1b) ‘significant risk’ means a risk

that is significant as a result of the
combination of its severity,
intensity, probability of occurrence,
G 128d G
and duration of its effects, and its
the ability to affect an individual, a
plurality of persons or to affect a
particular group of persons;
Article 3, first paragraph, point (1c new)
(1c) ‘foundation model’ means an

AI system model that is trained on
broad data at scale, is designed for
G 128e G
generality of output, and can be
adapted to a wide range of
distinctive tasks;
Article 3, first paragraph, point (1d new)
(1d) ‘general purpose AI system’

means an AI system that can be
G 128f G
used in and adapted to a wide range
of applications for which it was not
intentionally and specifically
designed;
Article 3, first paragraph, point (1e new)
(1e) ‘large training runs’ means

the production process of a
G 128g powerful AI model that require G
computing resources above a very

high threshold;
(2) ‘provider’ means a natural or (2) ‘provider’ means a natural or (2) ‘provider’ means a natural or (2) ‘provider’ means a natural or
legal person, public authority, legal person, public authority, legal person, public authority, legal person, public authority,
agency or other body that develops agency or other body that develops agency or other body that develops agency or other body that develops
an AI system or that has an AI an AI system or that has an AI an AI system or that has an AI an AI system or a general purpose
system developed with a view to system developed with a view to system developed with a view to AI model or that has an AI system
placing it on the market or putting it placing it on the market or putting it placing itand places that system on developed with a view to placing itor
G 129 into service under its own name or into service under its own name or the market or puttingputs it into a general purpose AI model G
trademark, whether for payment or trademark, whether for payment or service under its own name or developed and places them on the
free of charge; free of charge; trademark, whether for payment or market or putting itputs the system
free of charge; into service under its own name or
trademark, whether for payment or
free of charge;
(3) ‘small-scale provider’ means a

provider that is a micro or small deleted deleted
G 130 G
enterprise within the meaning of
Commission Recommendation
2003/361/EC1;
_________
1. Commission Recommendation of 6 May
2003 concerning the definition of micro,
small and medium-sized enterprises (OJ L
124, 20.5.2003, p. 36).
(3a) ‘small and medium-sized

enterprise’ (SMEs) means an
enterprise as defined in the Annex
G 130a of Commission Recommendation G
2003/361/EC concerning the

definition of micro, small and
medium-sized enterprises;
(4) ‘user’ means any natural or legal (4) ‘user’ deployer means any (4) ‘user’ means any natural or legal (4) ‘user’deployer means any
person, public authority, agency or natural or legal person, public person, including a public authority, natural or legal person, public
other body using an AI system under authority, agency or other body agency or other body using an AI authority, agency or other body
G 131 its authority, except where the AI using an AI system under its system, under itswhose authority, using an AI system under its G
system is used in the course of a authority, except where the AI except where the AI the system is authority, except where the AI
personal non-professional activity; system is used in the course of a used in the course of a personal non- system is used in the course of a
personal non-professional activity; professional activity; personal non-professional activity;
(5) ‘authorised representative’ (5) ‘authorised representative’ (5) ‘authorised representative’ (5) ‘authorised representative’
means any natural or legal person means any natural or legal person means any natural or legal person means any natural or legal person
established in the Union who has established in the Union who has physically present or established in located or established in the Union
G 132 G
received a written mandate from a received a written mandate from a the Union who has received and who has received and accepted a
provider of an AI system to, provider of an AI system to, accepted a written mandate from a written mandate from a provider of
respectively, perform and carry out respectively, perform and carry out provider of an AI system to, an AI system or a general-purpose
on its behalf the obligations and on its behalf the obligations and respectively, perform and carry out AI model to, respectively, perform
procedures established by this procedures established by this on its behalf the obligations and and carry out on its behalf the
Regulation; Regulation; procedures established by this obligations and procedures
Regulation; established by this Regulation;
(5a) ‘product manufacturer’ means

a manufacturer within the meaning
G 132a G
of any of the Union harmonisation
legislation listed in Annex II;
(6) ‘importer’ means any natural or (6) ‘importer’ means any natural or (6) ‘importer’ means any natural or (6) ‘importer’ means any natural or
legal person established in the Union legal person established in the Union legal person physically present or legal person located or established
that places on the market or puts into that places on the market or puts into established in the Union that places in the Union that places on the
service an AI system that bears the service an AI system that bears the on the market or puts into service an market or puts into service an AI
G 133 name or trademark of a natural or name or trademark of a natural or AI system that bears the name or system that bears the name or G
legal person established outside the legal person established outside the trademark of a natural or legal trademark of a natural or legal
Union; Union; person established outside the person established outside the
Union; Union;
(7) ‘distributor’ means any natural (7) ‘distributor’ means any natural (7) ‘distributor’ means any natural (7) ‘distributor’ means any natural
or legal person in the supply chain, or legal person in the supply chain, or legal person in the supply chain, or legal person in the supply chain,
other than the provider or the other than the provider or the other than the provider or the other than the provider or the
G 134 G
importer, that makes an AI system importer, that makes an AI system importer, that makes an AI system importer, that makes an AI system
available on the Union market available on the Union market available on the Union market available on the Union market
without affecting its properties; without affecting its properties; without affecting its properties; without affecting its properties;
(8) ‘operator’ means the provider, (8) ‘operator’ means the provider, (8) ‘operator’ means the provider, (8) ‘operator’ means the provider,
the user, the authorised the userdeployer, the authorised the product manufacturer, the user, the userproduct manufacturer, the
representative, the importer and the representative, the importer and the the authorised representative, the deployer, the authorised
G 135 distributor; distributor; importer andor the distributor; representative, the importer andor G
the distributor;
Article 3, first paragraph, point (8a new)
(8a) ‘affected person’ means any

natural person or group of persons
G 135a G
who are subject to or otherwise
affected by an AI system;
(9) ‘placing on the market’ means (9) ‘placing on the market’ means (9) ‘placing on the market’ means (9) ‘placing on the market’ means
the first making available of an AI the first making available of an AI the first making available of an AI the first making available of an AI
system on the Union market; system on the Union market; system on the Union market; system or a general purpose AI
G 136 model on the Union market;
G

Proposal
(10) ‘making available on the (10) ‘making available on the (10) ‘making available on the (10) ‘making available on the
G 137 G
market’ means any supply of an AI market’ means any supply of an AI market’ means any supply of an AI market’ means any supply of an AI
system for distribution or use on the system for distribution or use on the system for distribution or use on the system or a general purpose AI
Union market in the course of a Union market in the course of a Union market in the course of a model for distribution or use on the
commercial activity, whether in commercial activity, whether in commercial activity, whether in Union market in the course of a
return for payment or free of charge; return for payment or free of charge; return for payment or free of charge; commercial activity, whether in
return for payment or free of charge;
Proposal
(11) ‘putting into service’ means the (11) ‘putting into service’ means the (11) ‘putting into service’ means the (11) ‘putting into service’ means the
supply of an AI system for first use supply of an AI system for first use supply of an AI system for first use supply of an AI system for first use
directly to the user or for own use on directly to the userdeployer or for directly to the user or for own use directly to the userdeployer or for
G 138 the Union market for its intended own use on the Union market for its onin the Union market for its own use onin the Union market for G
purpose; intended purpose; intended purpose; its intended purpose;

(12) ‘intended purpose’ means the (12) ‘intended purpose’ means the (12) ‘intended purpose’ means the (12) ‘intended purpose’ means the
use for which an AI system is use for which an AI system is use for which an AI system is use for which an AI system is
intended by the provider, including intended by the provider, including intended by the provider, including intended by the provider, including
the specific context and conditions the specific context and conditions the specific context and conditions the specific context and conditions
of use, as specified in the of use, as specified in the of use, as specified in the of use, as specified in the
information supplied by the provider information supplied by the provider information supplied by the provider information supplied by the provider
G 139 in the instructions for use, in the instructions for use, in the instructions for use, in the instructions for use,
G
promotional or sales materials and promotional or sales materials and promotional or sales materials and promotional or sales materials and
statements, as well as in the statements, as well as in the statements, as well as in the statements, as well as in the
technical documentation; technical documentation; technical documentation; technical documentation;
Proposal
(13) ‘reasonably foreseeable (13) ‘reasonably foreseeable (13) ‘reasonably foreseeable (13) ‘reasonably foreseeable
misuse’ means the use of an AI misuse’ means the use of an AI misuse’ means the use of an AI misuse’ means the use of an AI
system in a way that is not in system in a way that is not in system in a way that is not in system in a way that is not in
accordance with its intended accordance with its intended purpose accordance with its intended accordance with its intended
purpose, but which may result from as indicated in instructions for use purpose, but which may result from purpose, but which may result from
G 140 reasonably foreseeable human established by the provider, but reasonably foreseeable human reasonably foreseeable human G
behaviour or interaction with other which may result from reasonably behaviour or interaction with other behaviour or interaction with other
systems; foreseeable human behaviour or systems; systems, including other AI
interaction with other systems, systems;
including other AI systems;
(14) ‘safety component of a product (14) ‘safety component of a product (14) ‘safety component of a product (14) ‘safety component of a product
or system’ means a component of a or system’ means, in line with or system’ means a component of a or system’ means a component of a
product or of a system which fulfils Union harmonisation law listed in product or of a system which fulfils product or of a system which fulfils
a safety function for that product or Annex II, a component of a product a safety function for that product or a safety function for that product or
G 141 system or the failure or or of a system which fulfils a safety system or the failure or system, or the failure or G
malfunctioning of which endangers function for that product or system, malfunctioning of which endangers malfunctioning of which endangers
the health and safety of persons or or the failure or malfunctioning of the health and safety of persons or the health and safety of persons or
property; which endangers the health and property; property;
safety of persons or property;
(15) ‘instructions for use’ means the (15) ‘instructions for use’ means the (15) ‘instructions for use’ means the (15) ‘instructions for use’ means the
information provided by the provider information provided by the provider information provided by the provider information provided by the provider
to inform the user of in particular an to inform the userdeployer of in to inform the user of in particular an to inform the user of in particular an
G 142 AI system’s intended purpose and particular an AI system’s intended AI system’s intended purpose and AI system’s intended purpose and G
proper use, inclusive of the specific purpose and proper use, as well as proper use, inclusive of the specific proper use, inclusive of the specific
geographical, behavioural or information on any precautions to geographical, behavioural or geographical, behavioural or
functional setting within which the be taken; inclusive of the specific functional setting within which the functional setting within which the
high-risk AI system is intended to be geographical, behavioural or high-risk AI system is intended to be high-risk AI system is intended to be
used; functional setting within which the used; used;
high-risk AI system is intended to be
used;
(16) ‘recall of an AI system’ means (16) ‘recall of an AI system’ means (16) ‘recall of an AI system’ means (16) ‘recall of an AI system’ means
any measure aimed at achieving the any measure aimed at achieving the any measure aimed at achieving the any measure aimed at achieving the
return to the provider of an AI return to the provider of an AI return to the provider or taking it return to the provider or taking it
G 143 system made available to users; system that has been made available out of service or disabling the use out of service or disabling the use G
to usersdeployers; of an AI system made available to of an AI system made available to

users; usersdeployers;
(17) ‘withdrawal of an AI system’ (17) ‘withdrawal of an AI system’ (17) ‘withdrawal of an AI system’ (17) ‘withdrawal of an AI system’
means any measure aimed at means any measure aimed at means any measure aimed at means any measure aimed at
preventing the distribution, display preventing the distribution, display preventing an AI system in the preventing an AI system in the
G 144 and offer of an AI system; and offer of an AI system; supply chain being made available supply chain being made available G
on the marketthe distribution, on the marketthe distribution,

display and offer of an AI system; display and offer of an AI system;
(18) ‘performance of an AI system’ (18) ‘performance of an AI system’ (18) ‘performance of an AI system’ (18) ‘performance of an AI system’
means the ability of an AI system to means the ability of an AI system to means the ability of an AI system to means the ability of an AI system to
G 145 achieve its intended purpose; achieve its intended purpose; achieve its intended purpose; achieve its intended purpose; G

Proposal
(19) ‘notifying authority’ means the (19) ‘notifying authority’ means the (19) ‘notifying authority’ means the (19) ‘notifying authority’ means the
national authority responsible for national authority responsible for national authority responsible for national authority responsible for
setting up and carrying out the setting up and carrying out the setting up and carrying out the setting up and carrying out the
necessary procedures for the necessary procedures for the necessary procedures for the necessary procedures for the
assessment, designation and assessment, designation and assessment, designation and assessment, designation and
G 146 notification of conformity notification of conformity notification of conformity notification of conformity
G
assessment bodies and for their assessment bodies and for their assessment bodies and for their assessment bodies and for their
monitoring; monitoring; monitoring; monitoring;
Proposal
(20) ‘conformity assessment’ means (20) ‘conformity assessment’ means (20) ‘conformity assessment’ means (20) ‘conformity assessment’ means
the process of verifying whether the the process of the process of verifying whether the the process of
requirements set out in Title III, verifyingdemonstrating whether the requirements set out in Title III, verifyingdemonstrating whether the
Chapter 2 of this Regulation relating requirements set out in Title III, Chapter 2 of this Regulation relating requirements set out in Title III,
G 147 to an AI system have been fulfilled; Chapter 2 of this Regulation relating to ana high-risk AI system have Chapter 2 of this Regulation relating G
to an AI system have been fulfilled; been fulfilled; to ana high-risk AI system have
been fulfilled;
(21) ‘conformity assessment body’ (21) ‘conformity assessment body’ (21) ‘conformity assessment body’ (21) ‘conformity assessment body’
means a body that performs third- means a body that performs third- means a body that performs third- means a body that performs third-
party conformity assessment party conformity assessment party conformity assessment party conformity assessment
G 148 activities, including testing, activities, including testing, activities, including testing, activities, including testing,
G
certification and inspection; certification and inspection; certification and inspection; certification and inspection;
Proposal
(22) ‘notified body’ means a (22) ‘notified body’ means a (22) ‘notified body’ means a (22) ‘notified body’ means a
conformity assessment body conformity assessment body conformity assessment body conformity assessment body
designated in accordance with this designatednotified in accordance designated in accordance with this designatednotified in accordance
G 149 Regulation and other relevant Union with this Regulation and other Regulation and other relevant Union with this Regulation and other G
harmonisation legislation; relevant Union harmonisation harmonisation legislation; relevant Union harmonisation
legislation; legislation;
(23) ‘substantial modification’ (23) ‘substantial modification’ (23) ‘substantial modification’ (23) ‘substantial modification’
means a change to the AI system means a change tomodification or a means a change to the AI system means a change to the AI system
following its placing on the market series of modifications of the AI following its placing on the market followingafter its placing on the
or putting into service which affects system followingafter its placing on or putting into service which affects market or putting into service which
the compliance of the AI system the market or putting into service the compliance of the AI system affectsis not foreseen or planned in
with the requirements set out in Title which affectsis not foreseen or with the requirements set out in Title the initial conformity assessment by
III, Chapter 2 of this Regulation or planned in the initial risk III, Chapter 2 of this Regulation, or the provider and as a result of
results in a modification to the assessment by the provider and as a results in a modification to the which the compliance of the AI
intended purpose for which the AI result of which the compliance of intended purpose for which the AI system with the requirements set out
system has been assessed; the AI system with the requirements system has been assessed. For high- in Title III, Chapter 2 of this
G 150 G
set out in Title III, Chapter 2 of this risk AI systems that continue to Regulation is affected or results in a
Regulation is affected or results in a learn after being placed on the modification to the intended purpose
modification to the intended purpose market or put into service, changes for which the AI system has been
for which the AI system has been to the high-risk AI system and its assessed;
assessed; performance that have been pre-
determined by the provider at the
moment of the initial conformity
assessment and are part of the
information contained in the
technical documentation referred to
in point 2(f) of Annex IV, shall not
constitute a substantial
modification;
(24) ‘CE marking of conformity’ (24) ‘CE marking of conformity’ (24) ‘CE marking of conformity’ (24) ‘CE marking of conformity’
(CE marking) means a marking by (CE marking) means a physical or (CE marking) means a marking by (CE marking) means a marking by
which a provider indicates that an AI digital marking by which a provider which a provider indicates that an AI which a provider indicates that an AI
system is in conformity with the indicates that an AI system or a system is in conformity with the system is in conformity with the
requirements set out in Title III, product with an embedded AI requirements set out in Title III, requirements set out in Title III,
Chapter 2 of this Regulation and system is in conformity with the Chapter 2 or in Article 4b of this Chapter 2 of this Regulation and
G 151 other applicable Union legislation requirements set out in Title III, Regulation and other applicable other applicable Union legislation G
harmonising the conditions for the Chapter 2 of this Regulation and Union legislationlegal act harmonising the conditions for the
marketing of products (‘Union other applicable Union legislation harmonising the conditions for the marketing of products (‘Union
harmonisation legislation’) harmonising the conditions for the marketing of products (‘Union harmonisation legislation’)
providing for its affixing; marketing of products (‘Union harmonisation legislation’) providing for its affixing;
harmonisation legislation’) providing for its affixing;
providing for its affixing; Proposal
(25) ‘post-market monitoring’ (25) ‘post-market monitoring’ (25) ‘post-market monitoring (25) ‘post-market monitoring
means all activities carried out by means all activities carried out by system’ means all activities carried system’ means all activities carried
providers of AI systems to providers of AI systems to out by providers of AI systems to out by providers of AI systems to
proactively collect and review proactively collect and review proactively collect and review proactively collect and review
experience gained from the use of AI experience gained from the use of AI experience gained from the use of AI experience gained from the use of AI
G 152 systems they place on the market or systems they place on the market or systems they place on the market or systems they place on the market or G
put into service for the purpose of put into service for the purpose of put into service for the purpose of put into service for the purpose of
identifying any need to immediately identifying any need to immediately identifying any need to immediately identifying any need to immediately
apply any necessary corrective or apply any necessary corrective or apply any necessary corrective or apply any necessary corrective or
preventive actions; preventive actions; preventive actions; preventive actions;

(26) ‘market surveillance authority’ (26) ‘market surveillance authority’ (26) ‘market surveillance authority’ (26) ‘market surveillance authority’
means the national authority means the national authority means the national authority means the national authority
carrying out the activities and taking carrying out the activities and taking carrying out the activities and taking carrying out the activities and taking
G 153 the measures pursuant to Regulation the measures pursuant to Regulation the measures pursuant to Regulation the measures pursuant to Regulation G
(EU) 2019/1020; (EU) 2019/1020; (EU) 2019/1020; (EU) 2019/1020;

Proposal
(27) ‘harmonised standard’ means a (27) ‘harmonised standard’ means a (27) ‘harmonised standard’ means a (27) ‘harmonised standard’ means a
European standard as defined in European standard as defined in European standard as defined in European standard as defined in
Article 2(1)(c) of Regulation (EU) Article 2(1)(c) of Regulation (EU) Article 2(1)(c) of Regulation (EU) Article 2(1)(c) of Regulation (EU)
G 154 No 1025/2012; No 1025/2012; No 1025/2012; No 1025/2012;
G

Proposal
(28) ‘common specifications’ means (28) ‘common specifications’ means (28) ‘common (28) ‘common
a document, other than a standard, a document, other than a standard, specificationsspecification’ means a specificationsspecification’ means a
containing technical solutions containing technical solutions document, other than a standard, document, other than a standard,
providing a means to, comply with providing a means to, comply with containing technical solutions containing technical solutions
certain requirements and obligations certain requirements and obligations providing aset of technical providing aset of technical
established under this Regulation; established under this Regulation; specifications, as defined in point 4 specifications, as defined in point 4
G 155 of Article 2 of Regulation (EU) No of Article 2 of Regulation (EU) No G
1025/2012 providing means to, 1025/2012 providing means to,

comply with certain requirements comply with certain requirements
and obligations established under and obligations established under
this Regulation; this Regulation;
(29) ‘training data’ means data used (29) ‘training data’ means data used (29) ‘training data’ means data used (29) ‘training data’ means data used
for training an AI system through for training an AI system through for training an AI system through for training an AI system through
fitting its learnable parameters, fitting its learnable parameters, fitting its learnable parameters, fitting its learnable parameters,
G 156 including the weights of a neural including the weights of a neural including the weights of a neural including the weights of a neural G
network; network; network; network;

(30) ‘validation data’ means data (30) ‘validation data’ means data (30) ‘validation data’ means data (30) ‘validation data’ means data
used for providing an evaluation of used for providing an evaluation of used for providing an evaluation of used for providing an evaluation of
the trained AI system and for tuning the trained AI system and for tuning the trained AI system and for tuning the trained AI system and for tuning
its non-learnable parameters and its its non-learnable parameters and its its non-learnable parameters and its its non-learnable parameters and its
learning process, among other learning process, among other learning process, among other learning process, among other
things, in order to prevent things, in order to prevent things, in order to prevent things, in order to prevent
G 157 overfitting; whereas the validation underfitting or overfitting; whereas overfitting; whereas the validation underfitting or overfitting; whereas G
dataset can be a separate dataset or the validation dataset can beis a dataset can be a separate dataset or the validation dataset can beis a
part of the training dataset, either as separate dataset or part of the part of the training dataset, either as separate dataset or part of the
a fixed or variable split; training dataset, either as a fixed or a fixed or variable split; training dataset, either as a fixed or
variable split; variable split;
(31) ‘testing data’ means data used (31) ‘testing data’ means data used (31) ‘testing data’ means data used (31) ‘testing data’ means data used
for providing an independent for providing an independent for providing an independent for providing an independent
evaluation of the trained and evaluation of the trained and evaluation of the trained and evaluation of the trained and
G 158 validated AI system in order to validated AI system in order to validated AI system in order to validated AI system in order to G
confirm the expected performance of confirm the expected performance of confirm the expected performance of confirm the expected performance of
that system before its placing on the that system before its placing on the that system before its placing on the that system before its placing on the
market or putting into service; market or putting into service; market or putting into service; market or putting into service;
Proposal
(32) ‘input data’ means data (32) ‘input data’ means data (32) ‘input data’ means data (32) ‘input data’ means data
provided to or directly acquired by provided to or directly acquired by provided to or directly acquired by provided to or directly acquired by
an AI system on the basis of which an AI system on the basis of which an AI system on the basis of which an AI system on the basis of which
G 159 the system produces an output; the system produces an output; the system produces an output; the system produces an output;
G

Proposal
(33) ‘biometric data’ means (33) ‘biometric data’ means (33) ‘biometric data’ means (33) ‘biometric data’ means
personal data resulting from specific personal data resulting from specific personal data resulting from specific personal data resulting from specific
technical processing relating to the technical processing relating to the technical processing relating to the technical processing relating to the
physical, physiological or physical, physiological or physical, physiological or physical, physiological or
behavioural characteristics of a behavioural characteristics of a behavioural characteristics of a behavioural characteristics of a
natural person, which allow or natural person, which allow or natural person, which allow or natural person, which allow or
G 160 G
confirm the unique identification of confirm the unique identification of confirm the unique identification of confirm the unique identification of
that natural person, such as facial that natural person, such as facial that natural person, such as facial that natural person, such as facial
images or dactyloscopic data; images or dactyloscopic images or dactyloscopic data; images or dactyloscopic data;
databiometric data as defined in
Article 4, point (14) of Regulation
(EU) 2016/679;
Article 3, first paragraph, point (33a new)
(33a) ‘biometric-based data’ means

data resulting from specific
G 160a G
technical processing relating to
physical, physiological or
behavioural signals of a natural
person;
(33b) ‘biometric identification’ (33a) ‘biometric identification’

means the automated recognition of means the automated recognition of
physical, physiological, physical, physiological,
behavioural, and psychological behavioural, and psychological
human features for the purpose of human features for the purpose of
G 160b G
establishing an individual’s identity establishing an individual’s identity
by comparing biometric data of that by comparing biometric data of that
individual to stored biometric data individual to stored biometric data
of individuals in a database (one-to- of individuals in a database;
many identification);
(33c) ‘biometric verification’ (33c) ‘biometric verification’

means the automated verification of means the automated verification of
the identity of natural persons by the identity of natural persons by
comparing biometric data of an comparing biometric data of an
G 160c individual to previously provided individual to previously provided G
biometric data (one-to-one biometric data (one-to-one

verification, including verification, including
authentication); authentication);
Article 3, first paragraph, point (33c)
(33d) ‘special categories of (33d) ‘special categories of

G 160d personal data’ means the categories personal data’ means the categories G
of personal data referred to in of personal data referred to in

Article 9(1) of Regulation (EU) Article 9(1) of Regulation (EU)
2016/679; 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.
(34) ‘emotion recognition system’ (34) ‘emotion recognition system’ (34) ‘emotion recognition system’ (34) ‘emotion recognition system’
means an AI system for the purpose means an AI system for the purpose means an AI system for the purpose means an AI system for the purpose
of identifying or inferring emotions of identifying or inferring emotions, of identifying or inferring of identifying or inferring emotions
or intentions of natural persons on thoughts, states of mind or psychological states, emotions or or intentions of natural persons on
G 161 G
the basis of their biometric data; intentions of natural intentions of natural persons on the the basis of their biometric data;
personsindividuals or groups on the basis of their biometric data;
basis of their biometric and Proposal
biometric-based data;
(35) ‘biometric categorisation (35) ‘biometric categorisation (35) ‘biometric categorisation (35) ‘biometric categorisation
system’ means an AI system for the system’ means an AI system for the system’ means an AI system for the system’ means an AI system for the
purpose of assigning natural persons purpose of assigning natural persons purpose of assigning natural persons purpose of assigning natural persons
G 162 G
to specific categories, such as sex, to specific categories, such as sex, to specific categories, such as sex, to specific categories, such as sex,
age, hair colour, eye colour, tattoos, age, hair colour, eye colour, tattoos, age, hair colour, eye colour, tattoos, age, hair colour, eye colour, tattoos,
ethnic origin or sexual or political ethnic origin or sexual or political ethnic origin or sexual or political ethnic origin or sexual or political
orientation, on the basis of their orientation, on the basis of their orientation, on the basis of their orientation, on the basis of their
biometric data; biometricor inferring their biometric data; biometric data on the basis of their
characteristics and attributes on the biometric data unless ancillary to
basis of their biometric or another commercial service and
biometric-based data, or which can strictly necessary for objective
be inferred from such data; technical reasons;
(36) ‘remote biometric (36) ‘remote biometric (36) ‘remote biometric (36) ‘remote biometric
identification system’ means an AI identification system’ means an AI identification system’ means an AI identification system’ means an AI
system for the purpose of identifying system for the purpose of identifying system for the purpose of identifying system for the purpose of identifying
natural persons at a distance through natural persons at a distance through natural persons typically at a natural persons, without their active
the comparison of a person’s the comparison of a person’s distance, without their active involvement, typically at a distance
biometric data with the biometric biometric data with the biometric involvement, through the through the comparison of a
data contained in a reference data contained in a reference comparison of a person’s biometric person’s biometric data with the
G 163 database, and without prior database, and without prior data with the biometric data biometric data contained in a
G
knowledge of the user of the AI knowledge of the userdeployer of contained in a reference database, reference database, and without
system whether the person will be the AI system whether the person and without prior knowledge of the prior knowledge of the user of the AI
present and can be identified ; will be present and can be identified, user of the AI system whether the system whether the person will be
excluding verification systems ; person will be present and can be present and can be identified ;
identified data repository;
Proposal
(37) ‘‘real-time’ remote biometric (37) ‘‘real-time’ remote biometric (37) ‘‘real-time’ remote biometric (37) ‘‘real-time’ remote biometric
identification system’ means a identification system’ means a identification system’ means a identification system’ means a
remote biometric identification remote biometric identification remote biometric identification remote biometric identification
G 164 system whereby the capturing of system whereby the capturing of system whereby the capturing of system whereby the capturing of G
biometric data, the comparison and biometric data, the comparison and biometric data, the comparison and biometric data, the comparison and
the identification all occur without a the identification all occur without a the identification all occur without a the identification all occur without a
significant delay. This comprises not significant delay. This comprises not significant delay. This comprises not significant delay. This comprises not
only instant identification, but also only instant identification, but also only instant identification, but also only instant identification, but also
limited short delays in order to avoid limited short delays in order to avoid limited short delays in order to avoid limited short delays in order to avoid
circumvention. circumvention.; circumvention.instantaneously or circumvention.
near instantaneously;
Proposal
(38) ‘‘post’ remote biometric (38) ‘‘post’ remote biometric (38) ‘‘post’ remote biometric
identification system’ means a identification system’ means a deleted identification system’ means a
G 165 system other than a ‘real-time’ system other than a ‘real-time’ system other than a ‘real-time’ G

system; system; system;
(39) ‘publicly accessible space’ (39) ‘publicly accessible space’ (39) ‘publicly accessible space’ (39) ‘publicly accessible space’
means any physical place accessible means any publicly or privately means any publicly or privately means any publicly or privately
to the public, regardless of whether owned physical place accessible to owned physical place accessible to owned physical place accessible to
certain conditions for access may the public, regardless of whether the public,an undetermined number the publican undetermined number
apply; certain conditions for access may of natural persons regardless of of natural persons, regardless of
G 166 apply, and regardless of the whether certain conditions or whether certain conditions for access
G
potential capacity restrictions; circumstances for access may may apply, and regardless of the
applyhave been predetermined, and potential capacity restrictions;
regardless of the potential capacity
restrictions; Proposal
G 167 (40) ‘law enforcement authority’ (40) ‘law enforcement authority’ (40) ‘law enforcement authority’ (40) ‘law enforcement authority’ G
means: means: means: means:
Proposal
Article 3, first paragraph, point (40)(a)
(a) any public authority competent (a) any public authority competent (a) any public authority competent (a) any public authority competent
for the prevention, investigation, for the prevention, investigation, for the prevention, investigation, for the prevention, investigation,
detection or prosecution of criminal detection or prosecution of criminal detection or prosecution of criminal detection or prosecution of criminal
offences or the execution of criminal offences or the execution of criminal offences or the execution of criminal offences or the execution of criminal
G 168 penalties, including the safeguarding penalties, including the safeguarding penalties, including the safeguarding penalties, including the safeguarding G
against and the prevention of threats against and the prevention of threats against and the prevention of threats against and the prevention of threats
to public security; or to public security; or to public security; or to public security; or
Proposal
Article 3, first paragraph, point (40)(b)
(b) any other body or entity (b) any other body or entity (b) any other body or entity (b) any other body or entity
entrusted by Member State law to entrusted by Member State law to entrusted by Member State law to entrusted by Member State law to
exercise public authority and public exercise public authority and public exercise public authority and public exercise public authority and public
powers for the purposes of the powers for the purposes of the powers for the purposes of the powers for the purposes of the
prevention, investigation, detection prevention, investigation, detection prevention, investigation, detection prevention, investigation, detection
or prosecution of criminal offences or prosecution of criminal offences or prosecution of criminal offences or prosecution of criminal offences
G 169 or the execution of criminal or the execution of criminal or the execution of criminal or the execution of criminal
G
penalties, including the safeguarding penalties, including the safeguarding penalties, including the safeguarding penalties, including the safeguarding
against and the prevention of threats against and the prevention of threats against and the prevention of threats against and the prevention of threats
to public security; to public security; to public security; to public security;
Proposal
G 170 G
(41) ‘law enforcement’ means (41) ‘law enforcement’ means (41) ‘law enforcement’ means (41) ‘law enforcement’ means
activities carried out by law activities carried out by law activities carried out by law activities carried out by law
enforcement authorities for the enforcement authorities or on their enforcement authorities or on their enforcement authorities or on their
prevention, investigation, detection behalf for the prevention, behalf for the prevention, behalf for the prevention,
or prosecution of criminal offences investigation, detection or investigation, detection or investigation, detection or
or the execution of criminal prosecution of criminal offences or prosecution of criminal offences or prosecution of criminal offences or
penalties, including the safeguarding the execution of criminal penalties, the execution of criminal penalties, the execution of criminal penalties,
against and the prevention of threats including the safeguarding against including the safeguarding against including the safeguarding against
to public security; and the prevention of threats to and the prevention of threats to and the prevention of threats to
public security; public security; public security;
(42) ‘national supervisory authority’ (42) ‘national supervisory authority’ (42) ‘national supervisory
means the authority to which a means thea public authority to deleted authority’Artificial Intelligence
Member State assigns the which a Member State assigns the office means the Commission’s
responsibility for the implementation responsibility for the implementation function of contributing to the
and application of this Regulation, and application of this Regulation, implementation, monitoring and
for coordinating the activities for coordinating the activities supervision of AI systems and AI
entrusted to that Member State, for entrusted to that Member State, for governance. References in this
acting as the single contact point for acting as the single contact point for Regulation to the Artificial
the Commission, and for the Commission, and for Intelligence office shall be
representing the Member State at the representing the Member State at the understood as references to the
G 171 European Artificial Intelligence European Artificial Intelligence Commission. means the authority G
Board; Boardin the management Board of to which a Member State assigns the
the AI Office; responsibility for the implementation
and application of this Regulation,
for coordinating the activities
entrusted to that Member State, for
acting as the single contact point for
the Commission, and for
representing the Member State at the
European Artificial Intelligence
Board;
(43) ‘national competent authority’ (43) ‘national competent authority’ (43) ‘national competent authority’ (43) ‘national competent authority’
means the national supervisory means any of the national means the national supervisory means the national supervisory
authority, the notifying authority and supervisory authority, the notifying authority,any of the following: the authority,any of the following: the
the market surveillance authority; authority and the market notifying authority and the market notifying authority and the market
surveillance authorityauthorities surveillance authority. As regards surveillance authority. As regards
which are responsible for the AI systems put into service or used AI systems put into service or used
enforcement of this Regulation; by EU institutions, agencies, offices by EU institutions, agencies, offices
and bodies, the European Data and bodies, any reference to
Protection Supervisor shall fulfil national competent authorities or
G 172 G
the responsibilities that in the market surveillance authorities in
Member States are entrusted to the this Regulation shall be understood
national competent authority and, as referring to the European Data
as relevant, any reference to Protection Supervisor;
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 (44) ‘serious incident’ means any (44) ‘serious incident’ means any (44) ‘serious incident’ means any
incident that directly or indirectly incident or malfunctioning of an AI incident that directly or indirectly incident that directly or indirectly
leads, might have led or might lead system that directly or indirectly leads, might have led or might leads, might have led or might
G 173 to any of the following: leads, might have led or might lead leador malfunctioning of an AI leador malfunctioning of an AI G
to any of the following: system that directly or indirectly system that directly or indirectly
leads to any of the following: leads to any of the following:
Article 3, first paragraph, point (44)(a)
G 174 G
(a) the death of a person or serious (a) the death of a person or serious (a) the death of a person or serious (a) the death of a person or serious
damage to a person’s health, to damage to a person’s health, to damage to a person’s health, to damage to a person’s health, to
property or the environment, property or the environment, property or the environment,; property or the environment,;
Article 3, first paragraph, point (44)(b)
(b) a serious and irreversible (b) a serious and irreversible (b) a serious and irreversible (b) a serious and irreversible
disruption of the management and disruption of the management and disruption of the management and disruption of the management and
G 175 operation of critical infrastructure. operation of critical infrastructure.; operation of critical infrastructure.; operation of critical infrastructure. G

Proposal
Article 3, first paragraph, point (44)(ba)
(ba) breach of obligations under (ba) breach of obligations under

Union law intended to protect Union law intended to protect
G 175a fundamental rights; fundamental rights; G
Article 3, first paragraph, point (44)(ba new)
(ba) a breach of fundamental

G 175b G
rights protected under Union law,
Article 3, first paragraph, point (44)(bb)
(bb) serious damage to property or (bb) serious damage to property or

G 175c the environment. the environment. G
Article 3, first paragraph, point (44)(bb new)

(bb) serious damage to property or

G 175d G
the environment.
Article 3, first paragraph, point (44)(bc)
(44a) 'personal data' means (44a) 'personal data' means

personal data as defined in Article personal data as defined in Article
G 175e 4, point (1) of Regulation (EU) 4, point (1) of Regulation (EU) G
2016/679; 2016/679 ;
Article 3, first paragraph, point (44)(bd)
(44a) ‘non-personal data’ means (44c) ‘non-personal data’ means

data other than personal data as data other than personal data as
G 175f defined in point (1) of Article 4 of defined in point (1) of Article 4 of G
Regulation (EU) 2016/679; Regulation (EU) 2016/679;

Article 3, first paragraph, point (44)(be)
(44b) ‘profiling’ means any form (be) ‘profiling’ means any form of
of automated processing of automated processing of personal
personal data as defined in point (4) data as defined in point (4) of
of Article 4 of Regulation (EU) Article 4 of Regulation (EU)
2016/679; or in the case of law 2016/679; or in the case of law
G 175g G
enforcement authorities – in point 4 enforcement authorities – in point 4
of Article 3 of Directive (EU) of Article 3 of Directive (EU)
2016/680 or, in the case of Union 2016/680 or, in the case of Union
institutions, bodies, offices or institutions, bodies, offices or
agencies, in point 5 Article 3 of agencies, in point 5 Article 3 of
Regulation (EU) 2018/1725; Regulation (EU) 2018/1725;
Article 3, first paragraph, point (44)(bf)
(44b) ‘real world testing plan’ (bf) ‘real world testing plan’ means
means a document that describes a document that describes the
the objectives, methodology, objectives, methodology,
geographical, population and geographical, population and
temporal scope, monitoring, temporal scope, monitoring,
organisation and conduct of testing organisation and conduct of testing
in real world conditions; in real world conditions;
G 175h G
(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.
Article 3, first paragraph, point (44)(bg)
(44c) ‘AI regulatory sandbox’ (bg) 'AI regulatory sandbox’

means a concrete framework set up means a concrete and controlled
by a national competent authority framework set up by a competent
which offers providers or authority which offers providers or
prospective providers of AI systems prospective providers of AI systems
G 175i the possibility to develop, train, the possibility to develop, train, G
validate and test, where appropriate validate and test, where appropriate
in real world conditions, an in real world conditions, an
innovative AI system, pursuant to a innovative AI system, pursuant to a
specific plan for a limited time sandbox plan for a limited time
under regulatory supervision. under regulatory supervision.
Article 3, first paragraph, point (44)(bh)

(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
G 175j the context of this Regulation, to G
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.
Article 3, first paragraph, point (44)(bi)
(44e) ‘testing in real world ‘testing in real world conditions’

conditions’ means the temporary means the temporary testing of an
testing of an AI system for its AI system for its intended purpose
intended purpose in real world in real world conditions outside of a
conditions outside of a laboratory laboratory or otherwise simulated
or otherwise simulated environment environment with a view to
with a view to gathering reliable gathering reliable and robust data
and robust data and to assessing and to assessing and verifying the
and verifying the conformity of the conformity of the AI system with
G 175k G
AI system with the requirements of the requirements of this
this Regulation; testing in real Regulation; testing in real world
world conditions shall not be conditions shall not be considered
considered as placing the AI system as placing the AI system on the
on the market or putting it into market or putting it into service
service within the meaning of this within the meaning of this
Regulation, provided that all Regulation, provided that all
conditions under Article 53 or conditions under Article 53 or
Article 54a are fulfilled; Article 54a are fulfilled;
Article 3, first paragraph, point (44)(bj)
(44f) ‘subject’ for the purpose of (bj) ‘subject’ for the purpose of
real world testing means a natural real world testing means a natural
G 175l G
person who participates in testing person who participates in testing
Article 3, first paragraph, point (44)(bk)
(44g) ‘informed consent’ means a (bk) ‘informed consent’ means a

subject's free and voluntary subject's freely given, specific,
expression of his or her willingness unambiguous and voluntary
to participate in a particular testing expression of his or her willingness
in real world conditions, after to participate in a particular testing
having been informed of all aspects in real world conditions, after
G 175m G
of the testing that are relevant to having been informed of all aspects
the subject's decision to participate; of the testing that are relevant to
in the case of minors and of the subject's decision to participate;
incapacitated subjects, the informed
consent shall be given by their
legally designated representative;
Article 3, first paragraph, point (44)(bl)
(44c) "deep fake" means (bl) "deep fake" means AI

manipulated or synthetic audio, generated or manipulated image,
image or video content that would audio or video content that
falsely appear to be authentic or resembles existing persons, objects,
truthful, and which features places or other entities or events
G 175n G
depictions of persons appearing to and would falsely appear to a
say or do things they did not say or person to be authentic or truthful
do, produced using AI techniques,
including machine learning and
deep learning;
Article 3, first paragraph, point (44)(bm)

(44d) ‘widespread infringement’ (44e) ‘widespread infringement’

means any act or omission contrary means any act or omission contrary
G 175o to Union law that protects the to Union law that protects the G
interest of individuals: interest of individuals:

Article 3, first paragraph, point (44)(bn)
(a) which has harmed or is likely to (a) which has harmed or is likely to
harm the collective interests of harm the collective interests of
individuals residing in at least two individuals residing in at least two
G 175p Member States other than the Member States other than the G
Member State, in which: Member State, in which:

Article 3, first paragraph, point (44e)(a)(i new)
(i) the act or omission originated or (i) the act or omission originated or
G 175q took place; took place; G
(ii) the provider concerned, or, (ii) the provider concerned, or,
where applicable, its authorised where applicable, its authorised
G 175r representative is established; or, representative is established; or, G
(iii) the deployer is established, (iii) the deployer is established,

when the infringement is committed when the infringement is committed
G 175s by the deployer; by the deployer; G
(b) which protects the interests of (b) which protects the interests of
individuals, that have caused, cause individuals, that have caused, cause
or are likely to cause harm to the or are likely to cause harm to the
collective interests of individuals collective interests of individuals
and that have common features, and that have common features,
including the same unlawful including the same unlawful
G 175t practice, the same interest being practice, the same interest being G
infringed and that are occurring infringed and that are occurring
concurrently, committed by the concurrently, committed by the
same operator, in at least three same operator, in at least three
Member States; Member States;
Article 3, first paragraph, point (44h)
(44h) ‘critical infrastructure’

means an asset, system or part
thereof which is necessary for the
delivery of a service that is essential
G 175u for the maintenance of vital societal G
functions or economic activities

within the meaning of Article 2(4)
and (5) of Directive …../….. on the
resilience of critical entities;
Article 3, first paragraph, point (44i)
(44i) ‘personal data’ means data as

G 175v defined in point (1) of Article 4 of G
Article 3, first paragraph, point (44b new)
(44e) ‘non-personal data’ means

G 175w G
data other than personal data;
Article 3, first paragraph, point (44f new)
(44f) ‘widespread infringement

with a Union dimension’ means a
widespread infringement that has
harmed or is likely to harm the
G 175x collective interests of individuals in G
at least two-thirds of the Member

States, accounting, together, for at
least two-thirds of the population of
the Union;
Article 3, first paragraph, point (44g new)
(44g) ‘regulatory sandbox’ means

a controlled environment
established by a public authority
that facilitates the safe
G 175y G
development, testing and validation
of innovative AI systems for a
limited time before their placement
on the market or putting into
service pursuant to a specific plan
under regulatory supervision;
(44h) ‘critical infrastructure’ (44h) ‘critical infrastructure’

means an asset, a facility, means an asset, a facility,
equipment, a network or a system, equipment, a network or a system,
or a part of an asset, a facility, or a part of thereof, which is
G 175z equipment, a network or a system, necessary for the provision of an G
which is necessary for the provision essential service within the meaning
of an essential service within the of Article 2(4) of Directive (EU)
meaning of Article 2(4) of Directive 2022/2557;
(EU) 2022/2557;
Article 3, first paragraph, point (44k new)
(44k) ‘social scoring’ means

evaluating or classifying natural
persons based on their social
G 175aa G
behaviour, socio-economic status or
known or predicted personal or
personality characteristics;
Article 3, first paragraph, point (44l new)
(44l) ‘social behaviour’ means the

way a natural person interacts with
G 175ab G
and influences other natural
persons or society;
Article 3, first paragraph, point (44m new)

G 175ac G
(44m) ‘state of the art’ means the
developed stage of technical
capability at a given time as regards
products, processes and services,
based on the relevant consolidated
findings of science, technology and
experience;
Article 3, first paragraph, point (44n new)
(44n) ‘testing in real world

conditions’ means the temporary
testing of an AI system for its
G 175ad intended purpose in real world G
conditions outside of a laboratory

or otherwise simulated
environment;
(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
G 175ae G
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
prototyping activities.
Article 3, first paragraph, point (44c)
(44c) ‘high-impact capabilities’ in

general purpose AI models means
capabilities that match or exceed
G 175af G
the capabilities recorded in the most
advanced general purpose AI
models.
Article 3, first paragraph, point (44d)
(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
G 175ag G
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.
Article 3, first paragraph, point (44e)
(44e) ‘general-purpose AI system’

means an AI system which is based
G 175ah on a general-purpose AI model , G
that has the capability to serve a

variety of purposes, both for direct
use as well as for integration in
other AI systems;
Article 3, first paragraph, point (44f)
(44f) ’floating-point operation’

means any mathematical operation
or assignment involving floating-
point numbers, which are a subset
G 175ai G
of the real numbers typically
represented on computers by an
integer of fixed precision scaled by
an integer exponent of a fixed base.
Article 3, first paragraph, point (44g)
(44g) ‘downstream provider’

means a provider of an AI system,
including a general-purpose AI
system, which integrates an AI
G 175aj model, regardless of whether the G
model is provided by themselves

and vertically integrated or
provided by another entity based on
contractual relations.
Article 4
Article 4 Article 4
G 176 Amendments to Annex I deleted Amendments to Annex I G
Implementing acts

G 177 G
The Commission is empowered to The Commission is empowered to
adopt delegated acts in accordance deleted adopt delegated acts in accordance
with Article 73 to amend the list of with Article 73 to amend the list of
techniques and approaches listed in techniques and In order to ensure
Annex I, in order to update that list uniform conditions for the
to market and technological implementation of this Regulation
developments on the basis of as regards machine learning
characteristics that are similar to the approaches and logic- and
techniques and approaches listed knowledged based approaches listed
therein. in Annex I, in order to update that
list toreferred to in Article 3(1), the
Commission may adopt
implementing acts to specify the
technical elements of those
approaches, taking into account
market and technological
developments. Those implementing
acts shall be adopted in accordance
with the examination procedure
referred to in Article 74(2) on the
basis of characteristics that are
similar to the techniques and
approaches listed therein.
Title Ia
Title Ia
G 177a GENERAL PURPOSE AI G
SYSTEMS
Article 4a new
Article 4a
G 177b G
General principles applicable to all
AI systems
Article 4a, first paragraph new
1. All operators falling under this

Regulation shall make their best
efforts to develop and use AI
systems or foundation models in
accordance with the following
general principles establishing a
G 177c high-level framework that promotes G
a coherent human-centric
European approach to ethical and
trustworthy Artificial Intelligence,
which is fully in line with the
Charter as well as the values on
which the Union is founded:
Article 4a, first paragraph, point (a new)
(a) ‘human agency and oversight’

means that AI systems shall be
developed and used as a tool that
serves people, respects human
G 177d G
dignity and personal autonomy, and
that is functioning in a way that
can be appropriately controlled and
overseen by humans;
Article 4a, first paragraph, point (b new)
(b) ‘technical robustness and

G 177e safety’ means that AI systems shall G
be developed and used in a way to

minimize unintended and
unexpected harm as well as being
robust in case of unintended
problems and being resilient
against attempts to alter the use or
performance of the AI system so as
to allow unlawful use by malicious
third parties;
Article 4a, first paragraph, point (c new)
(c) ‘privacy and data governance’

means that AI systems shall be
developed and used in compliance
G 177f with existing privacy and data G
protection rules, while processing

data that meets high standards in
terms of quality and integrity;
Article 4a, first paragraph, point (d new)
(d) ‘transparency’ means that AI

systems shall be developed and used
in a way that allows appropriate
traceability and explainability,
while making humans aware that
G 177g they communicate or interact with G
an AI system as well as duly

informing users of the capabilities
and limitations of that AI system
and affected persons about their
rights;
Article 4a, first paragraph, point (e new)

G 177h G
(e) ‘diversity, non-discrimination
and fairness’ means that AI systems
shall be 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;
Article 4a, first paragraph, point (f new)
(f) ‘social and environmental well-

being’ means that AI systems shall
be developed and used in a
sustainable and environmentally
G 177i friendly manner as well as in a way G
to benefit all human beings, while

monitoring and assessing the long-
term impacts on the individual,
society and democracy.
Article 4a, second paragraph new
2. Paragraph 1 is without prejudice

to obligations set up by existing
Union and national law. For high-
risk AI systems, the general
G 177j principles are translated into and G
complied with by providers or

deployers by means of the
requirements set out in Articles 8 to
15, and the relevant obligations laid
down in Chapter 3 of Title III of
this Regulation. For foundation
models, the general principles are
translated into and complied with
by providers by means of the
requirements set out in Articles 28
to 28b. For all AI systems, the
application of the principles
referred to in paragraph 1 can be
achieved, as applicable, through the
provisions of Article 28, Article 52,
or the application of harmonised
standards, technical specifications,
and codes of conduct as referred to
in Article 69,without creating new
Article 4a, third paragraph new
3. The Commission and the AI

Office shall incorporate these
guiding principles in
standardisation requests as well as
recommendations consisting in
technical guidance to assist
providers and deployers on how to
develop and use AI systems.
G 177k European Standardisation G
Organisations shall take the

general principles referred to in
paragraph 1 of this Article into
account as outcome-based
objectives when developing the
appropriate harmonised standards
for high risk AI systems as referred
to in Article 40(2b).
Article 4, first paragraph a
Article 4b Article 4b AI literacy

G 177l AI literacy G
Article 4, third paragraph
1. When implementing this

Regulation, the Union and the
Member States shall promote
measures for the development of a
sufficient level of AI literacy, across
sectors and taking into account the
different needs of groups of
G 177m providers, deployers and affected G
persons concerned, including

through education and training,
skilling and reskilling programmes
and while ensuring proper gender
and age balance, in view of
allowing a democratic control of AI
systems.
Article 4, fourth paragraph
2. Providers and deployers of AI 2. Providers and deployers of AI

systems shall take measures to systems shall take measures to
ensure a sufficient level of AI ensure, to their best extent, a
literacy of their staff and other sufficient level of AI literacy of
G 177n G
persons dealing with the operation their staff and other persons
and use of AI systems on their dealing with the operation and use
behalf, taking into account their of AI systems on their behalf,
technical knowledge, experience, taking into account their technical
education and training and the knowledge, experience, education
context the AI systems are to be and training and the context the AI
used in, and considering the systems are to be used in, and
persons or groups of persons on considering the persons or groups
which the AI systems are to be used. of persons on which the AI systems
are to be used.
Article 4b, third paragraph new
3. Such literacy measures shall

consist, in particular, of the
teaching of basic notions and skills
G 177o about AI systems and their G
functioning, including the different

types of products and uses, their
risks and benefits.
Article 4b, fourth paragraph new
4. A sufficient level of AI literacy is

one that contributes, as necessary,
G 177p to the ability of providers and G
deployers to ensure compliance and

enforcement of this Regulation.
Article 4a
Article 4a
G 177q Compliance of general purpose AI G
systems with this Regulation
Article 4a(1)
G 177r G
1. Without prejudice to Articles 5,
52, 53 and 69 of this Regulation,
general purpose AI systems shall
only comply with the requirements
and obligations set out in Article
4b.
Article 4a(2)
2. Such requirements and

obligations shall apply irrespective
of whether the general purpose AI
system is placed on the market or
G 177s put into service as a pre-trained G
model and whether further fine-

tuning of the model is to be
performed by the user of the
general purpose AI system.
Article 4b
Article 4b
Requirements for general purpose
G 177t G
AI systems and obligations for
providers of such systems
Article 4b(1)
1. General purpose AI systems

which may be used as high risk AI
systems or as components of high
G 177u G
risk AI systems in the meaning of
Article 6, shall comply with the
requirements established in Title
III, Chapter 2 of this Regulation as
from the date of application of the
implementing acts adopted by the
Commission in accordance with the
examination procedure referred to
in Article 74(2) no later than 18
months after the entry into force of
this Regulation. Those
implementing acts shall specify and
adapt the application of the
requirements established in Title
III, Chapter 2 to general purpose
AI systems in the light of their
characteristics, technical feasibility,
specificities of the AI value chain
and of market and technological
developments. When fulfilling those
requirements, the generally
acknowledged state of the art shall
be taken into account.
Article 4b(2)
2. Providers of general purpose AI

systems referred to in paragraph 1
shall comply, as from the date of
application of the implementing
G 177v G
acts referred to in paragraph 1,
with the obligations set out in
Articles 16aa, 16e, 16f, 16g, 16i,
16j, 25, 48 and 61.
Article 4b(3)
G 177w 3. For the purpose of complying G
with the obligations set out in

Article 16e, providers shall follow
the conformity assessment
procedure based on internal control
set out in Annex VI, points 3 and 4.
Article 4b(4)
4. Providers of such systems shall

also keep the technical
documentation referred to in Article
11 at the disposal of the national
G 177x competent authorities for a period G
ending ten years after the general

purpose AI system is placed on the
Union market or put into service in
the Union.
Article 4b(5)

systems shall cooperate with and
provide the necessary information
to other providers intending to put
into service or place such systems
on the Union market as high-risk
AI systems or as components of
G 177y high-risk AI systems, with a view to G
enabling the latter to comply with

their obligations under this
Regulation. Such cooperation
between providers shall preserve, as
appropriate, intellectual property
rights, and confidential business
information or trade secrets in
accordance with Article 70. In
order to ensure uniform conditions
for the implementation of this
Regulation as regards the
information to be shared by the
systems, the Commission may adopt
implementing acts in accordance
with the examination procedure
referred to in Article 74(2).
Article 4b(6)
6. In complying with the

requirements and obligations
referred to in paragraphs 1, 2 and
3:
- any reference to the intended
purpose shall be understood as
referring to possible use of the
general purpose AI systems as high
G 177z G
risk AI systems or as components of
AI high risk systems in the meaning
of Article 6;
- any reference to the requirements
for high-risk AI systems in Chapter
II, Title III shall be understood as
referring only to the requirements
set out in the present Article.
Article 4c
Article 4c
G 177aa G
Exceptions to Article 4b
Article 4c(1)
1. Article 4b shall not apply when

the provider has explicitly excluded
all high-risk uses in the instructions
G 177ab G
of use or information
accompanying the general purpose
AI system.
Article 4c(2)
2. Such exclusion shall be made in

good faith and shall not be deemed
G 177ac justified if the provider has G
sufficient reasons to consider that

the system may be misused.
Article 4c(3)
3. When the provider detects or is

informed about market misuse they
shall take all necessary and
proportionate measures to prevent
G 177ad G
such further misuse, in particular
taking into account the scale of the
misuse and the seriousness of the
associated risks.
TITLE II
TITLE II TITLE II TITLE II TITLE II

G 178 PROHIBITED ARTIFICIAL PROHIBITED ARTIFICIAL PROHIBITED ARTIFICIAL PROHIBITED ARTIFICIAL G
INTELLIGENCE PRACTICES INTELLIGENCE PRACTICES INTELLIGENCE PRACTICES INTELLIGENCE PRACTICES

Proposal
Article 5

Prohibited Artificial Intelligence
G 179 Practices G

Proposal
Article 5(1)
1. The following artificial 1. The following artificial 1. The following artificial 1. The following artificial
intelligence practices shall be intelligence practices shall be intelligence practices shall be intelligence practices shall be
G 180 prohibited: prohibited: prohibited: prohibited: G

Proposal
Article 5(1), point (-a)(a)
(a) the placing on the market, (a) the placing on the market, (a) the placing on the market, (a) the placing on the market,
putting into service or use of an AI putting into service or use of an AI putting into service or use of an AI putting into service or use of an AI
system that deploys subliminal system that deploys subliminal system that deploys subliminal system that deploys subliminal
techniques beyond a person’s techniques beyond a person’s techniques beyond a person’s techniques beyond a person’s
consciousness in order to materially consciousness in order to or consciousness in order to with the consciousness in order to or
distort a person’s behaviour in a purposefully manipulative or objective to or the effect of purposefully manipulative or
G 181 G
manner that causes or is likely to deceptive techniques, with the materially distortdistorting a deceptive techniques, with the
cause that person or another person objective to or the effect of person’s behaviour in a manner that objective to or the effect of
physical or psychological harm; materially distortdistorting a causes or is reasonably likely to materially distortdistorting a
person’s or a group of persons’ cause that person or another person person’s or a group of persons’
behaviour by appreciably impairing physical or psychological harm; behaviour by appreciably impairing
the person’s ability to make an the person’s ability to make an
informed decision, thereby causing informed decision, thereby causing
the person to take a decision that the person to take a decision that
that person would not have that person would not have
otherwise taken in a manner that otherwise taken in a manner that
causes or is likely to cause that causes or is likely to cause that
person or, another person physical person or, another person physical
or psychologicalor group of persons or psychologicalor group of persons
significant harm; significant harm;
Article 5(1), point (-a)(a) a
The prohibition of AI system that

deploys subliminal techniques
referred to in the first sub-
paragraph shall not apply to AI
systems intended to be used for
G 181a G
approved therapeutical purposes on
the basis of specific informed
consent of the individuals that are
exposed to them or, where
applicable, of their legal guardian;
(b) the placing on the market, (b) the placing on the market, (b) the placing on the market, (b) the placing on the market,
putting into service or use of an AI putting into service or use of an AI putting into service or use of an AI putting into service or use of an AI
system that exploits any of the system that exploits any of the system that exploits any of the system that exploits any of the
vulnerabilities of a specific group of vulnerabilities of a person or a vulnerabilities of a specific group of vulnerabilities of a person or a
G 182 persons due to their age, physical or specific group of persons, including persons due to their age, physical or specific group of persons due to their G
mental disability, in order to characteristics of such person’s or mental disability, in order to age, physical or mental disability, in
materially distort the behaviour of a a such group’s known or predicted disability or a specific social or order to disability or a specific
person pertaining to that group in a personality traits or social or economic situation, with the social or economic situation, with
manner that causes or is likely to economic situation due to their age, objective to or the effect of the objective to or the effect of
cause that person or another person physical or mental disability, in materially distortdistorting the materially distortdistorting the
physical or psychological harm; order to ability with the objective or behaviour of a person pertaining to behaviour of that person or a person
to the effect of materially that group in a manner that causes or pertaining to that group in a manner
distortdistorting the behaviour of is reasonably likely to cause that that causes or is reasonably likely to
that person or a person pertaining to person or another person physical or cause that person or another person
that group in a manner that causes or psychological harm; physical or psychological
is likely to cause that person or harm;significant harm
another person physical or
psychologicalsignificant harm;
Article 5(1), point (ba)
(ba) the placing on the market, (ba) the placing on the market or
putting into service or use of putting into service for this specific
biometric categorisation systems purpose, or use of biometric
that categorise natural persons categorisation systems that
according to sensitive or protected categorise individually natural
attributes or characteristics or persons based on their biometric
based on the inference of those data to deduce or infer their race,
attributes or characteristics. This political opinions, trade union
prohibition shall not apply to AI membership, religious or
G 182a G
systems intended to be used for philosophical beliefs, sex life or
approved therapeutical purposes on sexual orientation.
the basis of specific informed
consent of the individuals that are This prohibition does not cover any
exposed to them or, where labelling or filtering of lawfully
applicable, of their legal guardian. 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, (c) the placing on the market, (c) the placing on the market, (c) the placing on the market,
G 183 G
putting into service or use of AI putting into service or use of AI putting into service or use of AI putting into service or use of AI
systems by public authorities or on systems by public authorities or on systems by public authorities or on systems by public authorities or on
their behalf for the evaluation or their behalf for thefor the social their behalf for the evaluation or their behalf for the evaluation or
classification of the trustworthiness scoring evaluation or classification classification of the trustworthiness classification of the trustworthiness
of natural persons over a certain of the trustworthiness of natural of natural persons over a certain of natural personsnatural persons
period of time based on their social personsnatural persons or groups period of time based on their social or groups thereof over a certain
behaviour or known or predicted thereof over a certain period of time behaviour or known or predicted period of time based on their social
personal or personality based on their social behaviour or personal or personality behaviour or known, inferred or
characteristics, with the social score known, inferred or predicted characteristics, with the social score predicted personal or personality
leading to either or both of the personal or personality leading to either or both of the characteristics, with the social score
following: characteristics, with the social score following: leading to either or both of the
leading to either or both of the following:
following:
Article 5(1), point (c)(i)
(i) detrimental or unfavourable (i) detrimental or unfavourable (i) detrimental or unfavourable (i) detrimental or unfavourable
treatment of certain natural persons treatment of certain natural persons treatment of certain natural persons treatment of certain natural persons
or whole groups thereof in social or whole groups thereof in social or whole groups thereof in social or whole groups thereof in social
G 184 contexts which are unrelated to the contexts whichthat are unrelated to contexts which are unrelated to the contexts whichthat are unrelated to G
contexts in which the data was the contexts in which the data was contexts in which the data was the contexts in which the data was
originally generated or collected; originally generated or collected; originally generated or collected; originally generated or collected;
Article 5(1), point (c)(ii)
(ii) detrimental or unfavourable (ii) detrimental or unfavourable (ii) detrimental or unfavourable (ii) detrimental or unfavourable
treatment of certain natural persons treatment of certain natural persons treatment of certain natural persons treatment of certain natural persons
or whole groups thereof that is or whole groups thereof that is or whole groups thereof that is or whole groups thereof that is
G 185 unjustified or disproportionate to unjustified or disproportionate to unjustified or disproportionate to unjustified or disproportionate to G
their social behaviour or its gravity; their social behaviour or its gravity; their social behaviour or its gravity; their social behaviour or its gravity;
(d) the use of ‘real-time’ remote (d) the use of ‘real-time’ remote (d) the use of ‘real-time’ remote (d) the use of ‘real-time’ remote
biometric identification systems in biometric identification systems in biometric identification systems in biometric identification systems in
publicly accessible spaces for the publicly accessible spaces for the publicly accessible spaces by law publicly accessible spaces for the
purpose of law enforcement, unless purpose of law enforcement, unless enforcement authorities or on their purpose of law enforcement, unless
G 186 G
and in as far as such use is strictly and in as far as such use is strictly behalf for the purpose of law and in as far as such use is strictly
necessary for one of the following necessary for one of the following enforcement, unless and in as far as necessary for one of the following
objectives: objectives:; such use is strictly necessary for one objectives:
of the following objectives:
Article 5(1), point (d)(i)
(i) the targeted search for specific (i) the targeted search for specific (i) the targeted search for specific
potential victims of crime, including deleted potential victims of crime, including potential victims of crime,
missing children; missing children; includingabduction, trafficking in
G 187 human beings and sexual G
exploitation of human beings as

well as search for missing
children;persons
Article 5(1), point (d)(ii)
(ii) the prevention of a specific, (ii) the prevention of a specific, (ii) the prevention of a specific,
substantial and imminent threat to deleted substantial and imminent and substantial and imminent threat to
the life or physical safety of natural substantial threat to the critical the life or physical safety of natural
G 188 persons or of a terrorist attack; infrastructure, life, healthlife or persons or a genuine and present or G
physical safety of natural persons or genuine and foreseeable threat of a

of athe prevention of terrorist terrorist attack;
attackattacks;
Article 5(1), point (d)(iii)
G 189 (iii) the detection, localisation, (iii) the detection, localisation, (iii) the detection, localisation, or G
identification or prosecution of a deleted identification or prosecution of a identification or prosecution of a

perpetrator or suspect of a criminal perpetrator or suspect of or perpetrator or suspect of of a person
offence referred to in Article 2(2) of identification of a natural person suspected of having committed a
Council Framework Decision for the purposes of conducting a criminal offence, for the purposes
2002/584/JHA1 and punishable in criminal offenceinvestigation, of conducting a criminal offence
the Member State concerned by a prosecution or executing a criminal referred to in Article 2(2) of Council
custodial sentence or a detention penalty for offences, referred to in Framework Decision
order for a maximum period of at Article 2(2) of Council Framework 2002/584/JHA1investigation,
least three years, as determined by Decision 2002/584/JHA1 and prosecution or executing a criminal
the law of that Member State. punishable in the Member State penalty for offences, referred to in
_________ concerned by a custodial sentence or Annex IIa and punishable in the
1. Council Framework Decision a detention order for a maximum Member State concerned by a
2002/584/JHA of 13 June 2002 on the period of at least three years, or custodial sentence or a detention
procedures between Member States (OJ L other specific offences punishable order for a maximum period of at
190, 18.7.2002, p. 1). in the Member State concerned by a least threefour years, as determined
custodial sentence or a detention by the law of that Member State.
order for a maximum period of at
least five years, as determined by the This paragraph is without prejudice
law of that Member State. to the provisions in Article 9 of the
_________ GDPR for the processing of
1. [1] Council Framework Decision biometric data for purposes other
2002/584/JHA of 13 June 2002 on the than law enforcement.
procedures between Member States (OJ L _________
190, 18.7.2002, p. 1). 1. Council Framework Decision
2002/584/JHA of 13 June 2002 on the
procedures between Member States (OJ L
190, 18.7.2002, p. 1).
Article 5(1), point (d)(iiia)
(da) the placing on the market, (da) the placing on the market,
putting into service or use of an AI putting into service for this specific
system for making risk assessments purpose, or use of an AI system for
G 189a G
of natural persons or groups making risk assessments of natural
thereof in order to assess the risk of persons in order to assess or predict
a natural person for offending or the risk of a natural person to
reoffending or for predicting the commit a criminal offence, based
occurrence or reoccurrence of an solely on the profiling of a natural
actual or potential criminal or person or on assessing their
administrative offence based on personality traits and
profiling of a natural person or on characteristics;
assessing personality traits and
characteristics, including the This prohibition shall not apply to
person’s location, or past criminal AI systems used to support the
behaviour of natural persons or human assessment of the
groups of natural persons; involvement of a person in a
criminal activity, which is already
based on objective and verifiable
facts directly linked to a criminal
activity.
Article 5(1), point (d)(iiib)
(db) The placing on the market, (db) the placing on the market,
putting into service or use of AI putting into service for this specific
systems that create or expand facial purpose, or use of AI systems that
G 189b recognition databases through the create or expand facial recognition G
untargeted scraping of facial databases through the untargeted

images from the internet or CCTV scraping of facial images from the
footage; internet or CCTV footage;
Article 5(1), point (d)(iiic)
(dc) the placing on the market, dc) the placing on the market,
putting into service or use of AI putting into service for this specific
systems to infer emotions of a purpose, or use of AI systems to
natural person in the areas of law infer emotions of a natural person
G 189c G
enforcement, border management, in the areas of workplace and
in workplace and education education institutions except in
institutions. cases where the use of the AI
system is intended to be put in place
or into the market for medical or
safety reasons;
Article 5(1), point (d)(iiid)
(dd) the putting into service or use (iiid) deleted

of AI systems for the analysis of
recorded footage of publicly
accessible spaces through ‘post’
systems, unless they are subject to a
pre-judicial authorisation in
G 189d G
accordance with Union law and
strictly necessary for the targeted
search connected to a specific
serious criminal offense as defined
in Article 83(1) of TFEU that
already took place for the purpose
of law enforcement.
Article 5(1), point (d)(iiie)
1a. This Article shall not affect the 1a. This Article shall not affect the
prohibitions that apply where an prohibitions that apply where an
artificial intelligence practice artificial intelligence practice
infringes another Union law, infringes other Union law.
G 189e G
including Union law on data
protection, non discrimination,
consumer protection or
competition;
Article 5(2), first subparagraph
G 190 2. The use of ‘real-time’ remote 2. The use of ‘real-time’ remote 2. The use of ‘real-time’ remote G
biometric identification systems in deleted biometric identification systems in biometric identification systems in
publicly accessible spaces for the publicly accessible spaces for the publicly accessible spaces for the
purpose of law enforcement for any purpose of law enforcement for any purpose of law enforcement for any
of the objectives referred to in of the objectives referred to in of the objectives referred to in
paragraph 1 point d) shall take into paragraph 1 point d) shall take into paragraph 1 point d) shall only be
account the following elements: account the following elements: 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:
Article 5(2), first subparagraph, point (a)
(a) the nature of the situation giving (a) the nature of the situation giving (a) the nature of the situation giving
rise to the possible use, in particular deleted rise to the possible use, in particular rise to the possible use, in particular
G 191 the seriousness, probability and scale the seriousness, probability and scale the seriousness, probability and scale G
of the harm caused in the absence of of the harm caused in the absence of of the harm caused in the absence of
the use of the system; the use of the system; the use of the system;
Article 5(2), first subparagraph, point (b)
(b) the consequences of the use of (b) the consequences of the use of (b) the consequences of the use of
the system for the rights and deleted the system for the rights and the system for the rights and
freedoms of all persons concerned, freedoms of all persons concerned, freedoms of all persons concerned,
G 192 G
in particular the seriousness, in particular the seriousness, in particular the seriousness,
probability and scale of those probability and scale of those probability and scale of those
consequences. consequences. consequences.
Article 5(2), second subparagraph
In addition, the use of ‘real-time’ In addition, the use of ‘real-time’ In addition, the use of ‘real-time’
remote biometric identification deleted remote biometric identification remote biometric identification
G 193 G
systems in publicly accessible spaces systems in publicly accessible spaces systems in publicly accessible spaces
for the purpose of law enforcement for the purpose of law enforcement for the purpose of law enforcement
for any of the objectives referred to for any of the objectives referred to for any of the objectives referred to
in paragraph 1 point d) shall comply in paragraph 1 point d) shall comply in paragraph 1 point d) shall comply
with necessary and proportionate with necessary and proportionate with necessary and proportionate
safeguards and conditions in relation safeguards and conditions in relation safeguards and conditions in relation
to the use, in particular as regards to the use, in particular as regards to the use in accordance with
the temporal, geographic and the temporal, geographic and national legislations authorizing
personal limitations. personal limitations. the use thereof, in particular as
regards the temporal, geographic and
personal limitations.
The use of the ‘real-time’ remote
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 may be
commenced without the
registration, provided that the
registration is completed without
undue delay.
3. As regards paragraphs 1, point 3. As regards paragraphs 1, point 3. As regards paragraphs 1, point

(d) and 2, each individual use for the deleted (d) and 2, each individual use for the (d) and 2, each individual use for the
purpose of law enforcement of a purpose of law enforcement of a purpose of law enforcement of a
‘real-time’ remote biometric ‘real-time’ remote biometric ‘real-time’ remote biometric
G 194 G
identification system in publicly identification system in publicly identification system in publicly
accessible spaces shall be subject to accessible spaces shall be subject to accessible spaces shall be subject to
a prior authorisation granted by a a prior authorisation granted by a a prior authorisation granted by a
judicial authority or by an judicial authority or by an judicial authority or by an
independent administrative authority independent administrative authority independent administrative authority
of the Member State in which the of the Member State in which the whose decision is binding of the
use is to take place, issued upon a use is to take place, issued upon a Member State in which the use is to
reasoned request and in accordance reasoned request and in accordance take place, issued upon a reasoned
with the detailed rules of national with the detailed rules of national request and in accordance with the
law referred to in paragraph 4. law referred to in paragraph 4. detailed rules of national law
However, in a duly justified situation However, in a duly justified situation referred to in paragraph 4. However,
of urgency, the use of the system of urgency, the use of the system in a duly justified situation of
may be commenced without an may be commenced without an urgency, the use of the system may
authorisation and the authorisation authorisation and theprovided that, be commenced without an
may be requested only during or such authorisation mayshall be authorisation and theprovided that,
after the use. requested onlywithout undue delay such authorisation mayshall be
during or after the useuse of the AI requested only during or after the
system, and if such authorisation is usewithout undue delay, at the
rejected, its use shall be stopped latest within 24 hours. If such
with immediate effect. 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 or The competent judicial or The competent judicial authority or
administrative authority shall only deleted administrative authority shall only an independent or administrative
grant the authorisation where it is grant the authorisation where it is authority whose decision is binding
satisfied, based on objective satisfied, based on objective shall only grant the authorisation
evidence or clear indications evidence or clear indications where it is satisfied, based on
presented to it, that the use of the presented to it, that the use of the objective evidence or clear
G 195 G
‘real-time’ remote biometric ‘real-time’ remote biometric indications presented to it, that the
identification system at issue is identification system at issue is use of the ‘real-time’ remote
necessary for and proportionate to necessary for and proportionate to biometric identification system at
achieving one of the objectives achieving one of the objectives issue is necessary for and
specified in paragraph 1, point (d), specified in paragraph 1, point (d), proportionate to achieving one of the
as identified in the request. In as identified in the request. In objectives specified in paragraph 1,
deciding on the request, the deciding on the request, the point (d), as identified in the request
competent judicial or administrative competent judicial or administrative and, in particular, remains limited
authority shall take into account the authority shall take into account the to what is strictly necessary
elements referred to in paragraph 2. elements referred to in paragraph 2. concerning the period of time as
well as geographic and personal
scope. . In deciding on the request,
the competent judicial authority or
an independent or 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
solely based on the output of the
system . .
Article 5(3a)
3a. Without prejudice to paragraph

3, each use of a ‘real-time’ remote
publicly accessible spaces for law
enforcement purposes shall be
notified to the relevant market
G 195a surveillance authority and the G

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.
Article 5(4)
4. A Member State may decide to 4. A Member State may decide to 4. A Member State may decide to
provide for the possibility to fully or deleted provide for the possibility to fully or provide for the possibility to fully or
partially authorise the use of ‘real- partially authorise the use of ‘real- partially authorise the use of ‘real-
time’ remote biometric identification time’ remote biometric identification time’ remote biometric identification
systems in publicly accessible spaces systems in publicly accessible spaces systems in publicly accessible spaces
for the purpose of law enforcement for the purpose of law enforcement for the purpose of law enforcement
within the limits and under the within the limits and under the within the limits and under the
conditions listed in paragraphs 1, conditions listed in paragraphs 1, conditions listed in paragraphs 1,
point (d), 2 and 3. That Member point (d), 2 and 3. That Member point (d), 2 and 3. That Member
State shall lay down in its national State shall lay down in its national StateStates concerned shall lay
law the necessary detailed rules for law the necessary detailed rules for down in itstheir national law the
the request, issuance and exercise of, the request, issuance and exercise of, necessary detailed rules for the
as well as supervision relating to, the as well as supervision and reporting request, issuance and exercise of, as
authorisations referred to in relating to, the authorisations well as supervision and reporting
paragraph 3. Those rules shall also referred to in paragraph 3. Those relating to, the authorisations
G 196 specify in respect of which of the rules shall also specify in respect of referred to in paragraph 3. Those G
objectives listed in paragraph 1, which of the objectives listed in rules shall also specify in respect of
point (d), including which of the paragraph 1, point (d), including which of the objectives listed in
criminal offences referred to in point which of the criminal offences paragraph 1, point (d), including
(iii) thereof, the competent referred to in point (iii) thereof, the which of the criminal offences
authorities may be authorised to use competent authorities may be referred to in point (iii) thereof, the
those systems for the purpose of law authorised to use those systems for competent authorities may be
enforcement. the purpose of law enforcement. 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.
Article 5(5)
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
G 196a Commission shall provide Member G
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
upon requests for authorisations in
accordance with paragraph 3 and
their result;
Article 5(6)
6. The Commission shall publish

annual reports on the use of ‘real-
G 196b G
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.
TITLE III
TITLE III TITLE III TITLE III TITLE III

HIGH-RISK AI SYSTEMS HIGH-RISK AI SYSTEMS HIGH-RISK AI SYSTEMS HIGH-RISK AI SYSTEMS
G 197 G

Proposal
Chapter 1
Chapter 1 Chapter 1 Chapter 1

G 198 CLASSIFICATION OF AI CLASSIFICATION OF AI CLASSIFICATION OF AI G
SYSTEMS AS HIGH-RISK SYSTEMS AS HIGH-RISK SYSTEMS AS HIGH-RISK
Article 6

Classification rules for high-risk AI Classification rules for high-risk AI Classification rules for high-risk AI Classification rules for high-risk AI
G 199 systems systems systems systems G

Proposal
Article 6(1)
G 200 G
1. Irrespective of whether an AI 1. Irrespective of whether an AI 1. Irrespective of whether An AI 1. Irrespective of whether an AI
system is placed on the market or system is placed on the market or system that is itself a product system is placed on the market or
put into service independently from put into service independently from covered by the Union put into service independently from
the products referred to in points (a) the products referred to in points (a) harmonisation legislation listed in the products referred to in points (a)
and (b), that AI system shall be and (b), that AI system shall be Annex II shall be considered as and (b), that AI system shall be
considered high-risk where both of considered high-risk where both of high risk if it is required to undergo considered high-risk where both of
the following conditions are the following conditions are a third-party conformity assessment the following conditions are
fulfilled: fulfilled: with a view to the placing on the fulfilled:
market or putting into service of
that product pursuant to the above Proposal
mentioned legislation.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 (a) the AI system is intended to be (a) the AI system is intended to be
used as a safety component of a used as a safety component of a deleted used as a safety component of a
product, or is itself a product, product, or the AI system is itself a product, or the AI system is itself a
G 201 covered by the Union harmonisation product, covered by the Union product, covered by the Union G
legislation listed in Annex II; harmonisation legislationlaw listed harmonisation legislation listed in
in Annex II; Annex II;
(b) the product whose safety (b) the product whose safety (b) the product whose safety
component is the AI system, or the component pursuant to point (a) is deleted component pursuant to point (a) is
G 202 G
AI system itself as a product, is the AI system, or the AI system the AI system, or the AI system
required to undergo a third-party itself as a product, is required to itself as a product, is required to
conformity assessment with a view undergo a third-party conformity undergo a third-party conformity
to the placing on the market or assessment related to risks for assessment, with a view to the
putting into service of that product health and safety, with a view to the placing on the market or putting into
pursuant to the Union harmonisation placing on the market or putting into service of that product pursuant to
legislation listed in Annex II. service of that product pursuant to the Union harmonisation legislation
the Union harmonisation listed in Annex II.;
legislationlaw listed in Annex II.;
Article 6(2)
2. In addition to the high-risk AI 21a. In addition to the high-risk AI 2. In addition to the high-risk AI 2. In addition to the high-risk AI
systems referred to in paragraph 1, systems referred to in paragraph 1, systemsAn AI system intended to be systems referred to in paragraph 1,
AI systems referred to in Annex III AI systems falling under one or used as a safety component of a AI systems referred to in Annex III
shall also be considered high-risk. more of the critical areas and use product covered by the legislation shall also be considered high-risk.
cases referred to in Annex III shall referred to in paragraph 1, AI
alsobe considered high-risk if they systems referred to in Annex III shall
pose a significant risk of harm to be considered as high risk if it is
the health, safety or fundamental required to undergo a third-party
rights of natural persons. Where an conformity assessment with a view
G 203 G
AI system falls under Annex III to the placing on the market or
point 2, it shall be considered to be putting into service of that product
high-risk if it poses a significant pursuant to above mentioned
risk of harm to the legislation. This provision shall also
environmenthigh-risk. be considered high-riskapply
irrespective of whether the AI
system is placed on the market or
put into service independently from
the product.
The Commission shall, six months

G 203a prior to the entry into force of this G
Regulation, after consulting the AI

Office and relevant stakeholders,
provide guidelines clearly
specifying the circumstances where
the output of AI systems referred to
in Annex III would pose a
significant risk of harm to the
of natural persons or cases in
which it would not.
Article 6(2a), first subparagraph
2a. AI systems referred to in Annex 2a. By derogation from paragraph

III shall be considered high-risk 2 AI systems shall not be considered
unless the output of the system is as high risk if they do not pose a
purely accessory in respect of the significant risk of harm, to the
relevant action or decision to be health, safety or fundamental rights
taken and is not therefore likely to of natural persons, including by not
lead to a significant risk to the materially influencing the outcome
health, safety or fundamental of decision making. This shall be
rights. the case if one or more of the
In order to ensure uniform following criteria are fulfilled:
conditions for the implementation
of this Regulation, the Commission
G 203b G
shall, no later than one year after
the entry into force of this
Regulation, adopt implementing
acts to specify the circumstances
where the output of AI systems
referred to in Annex III would be
purely accessory in respect of the
relevant action or decision to be
taken. Those implementing acts
shall be adopted in accordance with
the examination procedure referred
to in Article 74, paragraph 2.
Article 6(2a), first subparagraph, point (a)
(a) the AI system is intended to

G 203c G
perform a narrow procedural task;
Article 6(2a), first subparagraph, point (b)
(b) the AI system is intended to

G 203d improve the result of a previously G
completed human activity;
Article 6(2a), first subparagraph, point (c)
(c) the AI system is intended to

detect decision-making patterns or
deviations from prior decision-
G 203e making patterns and is not meant to G
replace or influence the previously

completed human assessment,
without proper human review; or
Article 6(2a), first subparagraph, point (d)
(d) the AI system is intended to

perform a preparatory task to an
G 203f G
assessment relevant for the purpose
of the use cases listed in Annex III.
Article 6(2a), second subparagraph
Notwithstanding first subparagraph

G 203g G
of this paragraph, an AI system
shall always be considered high-
risk if the AI system performs
profiling of natural persons.
Article 6(2a new)
2a. Where providers falling under

one or more of the critical areas
and use cases referred to in Annex
III consider that their AI system
does not pose a significant risk as
described in paragraph 2, they shall
submit a reasoned notification to
the national supervisory authority
that they are not subject to the
requirements of Title III Chapter 2
G 203h of this Regulation. Where the AI G
system is intended to be used in two

or more Member States, that
notification shall be addressed to
the AI Office. Without prejudice to
Article 65, the national supervisory
authority shall review and reply to
the notification, directly or via the
AI Office, within three months if
they deem the AI system to be
misclassified.
Article 6(2b new)
2b. Providers that misclassify their

AI system as not subject to the
G 203i requirements of Title III Chapter 2 G
of this Regulation and place it on

the market before the deadline for
objection by national supervisory
authorities shall be subject to fines
pursuant to Article 71.
Article 6(2c new)
2c. National supervisory

authorities shall submit a yearly
report to the AI Office detailing the
G 203j number of notifications received, G
the related high-risk areas at stake

and the decisions taken concerning
received notifications
Article 6(2b)
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
service. Such provider shall be
G 203k G
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.
Article 6(2c)
2c. The Commission shall, after

G 203l consulting the AI Board, and no G
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
pursuant to Article 82b.
Article 6(2d), first subparagraph
2d. The Commission is empowered

to adopt delegated acts in
accordance with Article 73 to
G 203m G
amend the criteria laid down in
points a) to d) of the first
subparagraph of paragraph 2a.
Article 6(2d), second subparagraph
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
G 203n G
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
rights.
Article 6(2d), third subparagraph

G 203o G
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.
Article 6(2d), fourth subparagraph
Any amendment to the criteria laid

down in points a) to d) set out in the
first subparagraph of paragraph 2a
G 203p G
shall not decrease the overall level
of protection of health, safety and
fundamental rights in the Union.
Article 6(2d), fifth subparagraph
When adopting the delegated acts,

the Commission shall ensure
consistency with the delegated acts
G 203q G
adopted pursuant to Article 7(1)
and shall take account of market
and technological developments.
Article 7

G 204 Amendments to Annex III Amendments to Annex III Amendments to Annex III Amendments to Annex III G
Proposal
Article 7(1)
1. The Commission is empowered 1. The Commission is empowered 1. The Commission is empowered 1. The Commission is empowered
to adopt delegated acts in to adopt delegated acts in to adopt delegated acts in to adopt delegated acts in
accordance with Article 73 to update accordance with Article 73 to update accordance with Article 73 to accordance with Article 73 to update
the list in Annex III by adding high- the list inamend Annex III by adding updateamend the list in Annex III by the list inamend Annex III by adding
risk AI systems where both of the or modifying areas or use-cases of adding high-risk AI systems where or modifying use-cases of high-risk
following conditions are fulfilled: high-risk AI systems where both of both of the following conditions are AI systems where both of the
the following conditions are fulfilled: following conditions are fulfilled:
fulfilled:these pose a significant risk
of harm to health and safety, or an
G 205 G
adverse impact on fundamental
rights, to the environment, or to
democracy and the rule of law, and
that risk is, in respect of its severity
and probability of occurrence,
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.
(a) the AI systems are intended to (a) the AI systems are intended to (a) the AI systems are intended to
be used in any of the areas listed in deleted be used in any of the areas listed in be used in any of the areas listed in
G 206 points 1 to 8 of Annex III; points 1 to 8 of Annex III; points 1 to 8 of Annex III; G

Proposal
G 207 G
(b) the AI systems pose a risk of (b) the AI systems pose a risk of (b) the AI systems pose a risk of
harm to the health and safety, or a deleted harm to the health and safety, or a harm to the health and safety, or a
risk of adverse impact on risk of adverse impact on risk ofan adverse impact on
fundamental rights, that is, in respect fundamental rights, that is, in respect fundamental rights, that is, in
of its severity and probability of of its severity and probability of respect of its severity and
occurrence, equivalent to or greater occurrence, equivalent to or greater probability of occurrence,and that
than the risk of harm or of adverse than the risk of harm or of adverse risk is equivalent to or greater than
impact posed by the high-risk AI impact posed by the high-risk AI the risk of harm or of adverse impact
systems already referred to in Annex systems already referred to in Annex posed by the high-risk AI systems
III. III. already referred to in Annex III.
Article 7(1a)
1a. The Commission is also

empowered to adopt delegated acts
in accordance with Article 73 to
G 207a remove use-cases of high-risk AI G
systems from the list in Annex III if

the conditions referred to in
paragraph 1 no longer apply;
Article 7(2)
2. When assessing for the purposes 2. When assessing for the purposes 2. When assessing for the purposes 2. When assessing for the purposes
of paragraph 1 whether an AI system of paragraph 1 whether an AI of paragraph 1 whether an AI system of paragraph 1 whether an AI system
poses a risk of harm to the health system poses a risk of harm to the poses a risk of harm to the health poses a risk of harm to the health
and safety or a risk of adverse health and safety or a risk of adverse and safety or a risk of adverse and safety or a risk of adverse
impact on fundamental rights that is impact on fundamental rights that is impact on fundamental rights that is impact on fundamental rights that is
G 208 equivalent to or greater than the risk equivalent to or greater than the risk equivalent to or greater than the risk equivalent to or greater than the risk G
of harm posed by the high-risk AI of harm posed by the high-risk AI of harm posed by the high-risk AI of harm posed by the high-risk AI
systems already referred to in Annex systems already referred to in Annex systems already referred to in Annex systems already referred to in Annex
III, the Commission shall take into III,for the purposes of paragraph 1 III, the Commission shall take into III, the Commission shall take into
account the following criteria: and 1a the Commission shall take account the following criteria: account the following criteria:
into account the following criteria:
Proposal
(a) the intended purpose of the AI (a) the intended purpose of the AI (a) the intended purpose of the AI (a) the intended purpose of the AI
G 209 system; system; system; system; G
Article 7(2), point (aa)
(aa) the general capabilities and

functionalities of the AI system
G 209a G
independent of its intended
purpose;
(b) the extent to which an AI system (b) the extent to which an AI system (b) the extent to which an AI system (b) the extent to which an AI system
has been used or is likely to be used; has been used or is likely to be used; has been used or is likely to be used; has been used or is likely to be used;
G 210 G

Proposal
(ba) the nature and amount of the (ba) the nature and amount of the
data processed and used by the AI data processed and used by the AI
system; system, in particular whether
G 210a special categories of personal data G
are processed;
Article 7(2), point (bb)

(bb) the extent to which the AI (bb) the extent to which the AI
system acts autonomously; system acts autonomously and the
possibility for a human to override
G 210b a decision or recommendations that G
may lead to potential harm;

(c) the extent to which the use of an (c) the extent to which the use of an (c) the extent to which the use of an (c) the extent to which the use of an
AI system has already caused harm AI system has already caused harm AI system has already caused harm AI system has already caused harm
to the health and safety or adverse to the health and safety, has had an to the health and safety or adverse to the health and safety, has had an
impact on the fundamental rights or or adverse impact on the impact on the fundamental rights or or adverse impact on the
has given rise to significant concerns fundamental rights, the has given rise to significant concerns fundamental rights or has given rise
in relation to the materialisation of environment, democracy and the in relation to the materialisation of to significant concerns in relation to
such harm or adverse impact, as rule of law or has given rise to such harm or adverse impact, as the materialisationlikelihood of such
demonstrated by reports or significant concerns in relation to the demonstrated by reports or harm or adverse impact, as
G 211 documented allegations submitted to materialisationlikelihood of such documented allegations submitted to demonstrated for example by reports G
national competent authorities; harm or adverse impact, as national competent authorities; or documented allegations submitted
demonstrated for example by reports to national competent authorities; or
or documented allegations submitted by other reports, as appropriate.
to national competentsupervisory
authorities, to the Commission, to
the AI Office, to the EDPS, or to
the European Union Agency for
Fundamental Rights;
(d) the potential extent of such harm (d) the potential extent of such harm (d) the potential extent of such harm (d) the potential extent of such harm
G 212 or such adverse impact, in particular or such adverse impact, in particular or such adverse impact, in particular or such adverse impact, in particular G
in terms of its intensity and its in terms of its intensity and its in terms of its intensity and its in terms of its intensity and its
ability to affect a plurality of ability to affect a plurality of persons ability to affect a plurality of ability to affect a plurality of persons
persons; or to disproportionately affect a persons; or to disproportionately affect a
particular group of persons; particular group of persons;
(e) the extent to which potentially (e) the extent to which potentially (e) the extent to which potentially (e) the extent to which potentially
harmed or adversely impacted harmed or adversely impacted harmed or adversely impacted harmed or adversely impacted
persons are dependent on the persons are dependent on the persons are dependent on the persons are dependent on the
outcome produced with an AI outcomeoutput produced outcome produced with an AI outcome produced with an AI
system, in particular because for withinvolving an AI system, and system, in particular because for system, in particular because for
G 213 practical or legal reasons it is not that output is purely accessory in practical or legal reasons it is not practical or legal reasons it is not G
reasonably possible to opt-out from respect of the relevant action or reasonably possible to opt-out from reasonably possible to opt-out from
that outcome; decision to be taken, in particular that outcome; that outcome;
because for practical or legal reasons
it is not reasonably possible to opt- Proposal
out from that outcomeoutput;
Article 7(2), point (ea new)
(ea) the potential misuse and

G 213a malicious use of the AI system and G
of the technology underpinning it;
(f) the extent to which potentially (f) the extent to which there is an (f) the extent to which potentially (f) the extent to which there is an
harmed or adversely impacted imbalance of power, or the harmed or adversely impacted imbalance of power, or the
persons are in a vulnerable position potentially harmed or adversely persons are in a vulnerable position potentially harmed or adversely
G 214 G
in relation to the user of an AI impacted persons are in a vulnerable in relation to the user of an AI impacted persons are in a vulnerable
system, in particular due to an position in relation to the user of an system, in particular due to an position in relation to the user of an
imbalance of power, knowledge, AI system, in particular due to an imbalance of power, knowledge, AI system, in particular due to an
economic or social circumstances, or imbalance of powerstatus, authority, economic or social circumstances, or imbalance of powerstatus, authority,
age; knowledge, economic or social age; knowledge, economic or social
circumstances, or age; circumstances, or age;
(g) the extent to which the outcome (g) the extent to which the outcome (g) the extent to which the outcome (g) the extent to which the outcome
produced with an AI system is easily produced withinvolving an AI produced with an AI system is not produced withinvolving an AI
reversible, whereby outcomes system is easily reversible or easily reversible, whereby outcomes system is easily corrigible or
having an impact on the health or remedied, whereby outcomes having having an impact on the health or reversible, taking into account the
safety of persons shall not be an adverse impact on health, safety, safety of persons shall not be technical solutions available to
G 215 considered as easily reversible; fundamental rights of persons, the considered as easily reversible; correct or reverse, whereby G
environment, or on democracy and outcomes having anand adverse

rule of lawthe health or safety of impact on the health or, safety,
persons shall not be considered as fundamental rights, of persons shall
easily reversible; not be considered as easily
corrigible or reversible;.
Article 7(2), point (ga)
(ga) the extent of the availability

and use of effective technical
G 215a solutions and mechanisms for the G
control, reliability and corrigibility

of the AI system;
Article 7(2), point (ga)
(gb) the magnitude and likelihood (gb) the magnitude and likelihood
of benefit of the deployment of the of benefit of the deployment of the
G 215b G
AI system for individuals, groups, AI system for individuals, groups,
or society at large, including or society at large, including
possible improvements in product possible improvements in product
safety; safety;
Article 7(2), point (gc new)
(gc) the extent of human oversight

and the possibility for a human to
G 215c intercede in order to override a G
decision or recommendations that

may lead to potential harm;
(h) the extent to which existing (h) the extent to which existing (h) the extent to which existing (h) the extent to which existing
G 216 Union legislation provides for: Union legislationlaw provides for: Union legislation provides for: Union legislation provides for: G
Article 7(2), point (h)(i)
(i) effective measures of redress in (i) effective measures of redress in (i) effective measures of redress in (i) effective measures of redress in
relation to the risks posed by an AI relation to the risks poseddamage relation to the risks posed by an AI relation to the risks posed by an AI
G 217 system, with the exclusion of claims caused by an AI system, with the system, with the exclusion of claims system, with the exclusion of claims G
for damages; exclusion of claims for direct or for damages; for damages;
indirect damages;
Article 7(2), point (h)(ii)
(ii) effective measures to prevent or (ii) effective measures to prevent or (ii) effective measures to prevent or (ii) effective measures to prevent or
G 218 substantially minimise those risks. substantially minimise those risks. substantially minimise those risks.; substantially minimise those risks. G
Article 7(2), point (ha)
(ha) the magnitude and likelihood

of benefit of the AI use for
G 218a G
individuals, groups, or society at
large.
Article 7(2a new)
2a. When assessing an AI system

for the purposes of paragraphs 1 or
1a the Commission shall consult
the AI Office and, where relevant,
representatives of groups on which
an AI system has an impact,
industry, independent experts, the
G 218b G
social partners, and civil society
organisations. The Commission
shall also organise public
consultations in this regard and
shall make the results of those
consultations and of the final
assessment publicly available;
Article 7(2a)
2a. The Commission is empowered 2a. The Commission is empowered

to adopt delegated acts in to adopt delegated acts in
accordance with Article 73 to accordance with Article 73 to
G 218c G
amend the list in Annex III by amend the list in Annex III by
removing high-risk AI systems removing high-risk AI systems
where both of the following where both of the following
conditions are fulfilled: conditions are fulfilled:
Article 7(2a), point (a)
(a) the high-risk AI system(s) (a) the high-risk AI system(s)

concerned no longer pose any concerned no longer pose any
significant risks to fundamental significant risks to fundamental
G 218d rights, health or safety, taking into rights, health or safety, taking into G
account the criteria listed in account the criteria listed in

paragraph 2; paragraph 2;
Article 7(2a), point (b)
(b) the deletion does not decrease (b) the deletion does not decrease
the overall level of protection of the overall level of protection of
G 218e health, safety and fundamental health, safety and fundamental G
rights under Union law. rights under Union law.

Article 7(2b new)
2b. The AI Office, national

supervisory authorities or the
European Parliament may request
the Commission to reassess and
G 218f recategorise the risk categorisation G
of an AI systemin accordance with

paragraphs 1 and 1a. The
Commission shall give reasons for
its decision and make them public.
Chapter 2
Chapter 2 Chapter 2 Chapter 2 Chapter 2

requirements for high-risk Ai requirements for high-risk Ai Requirements for high-risk AiAI Requirements for high-risk AiAI
G 219 systems systems systems systems G
Article 8

Compliance with the requirements Compliance with the requirements Compliance with the requirements Compliance with the requirements
G 220 G

Proposal
Article 8(1)
1. High-risk AI systems shall 1. High-risk AI systems shall 1. High-risk AI systems shall 1. High-risk AI systems shall
comply with the requirements comply with the requirements comply with the requirements comply with the requirements
established in this Chapter. established in this Chapter. established in this Chapter, taking established in this Chapter, taking
into account the generally into account its intended purpose as
acknowledged state of the art. well as the generally acknowledged
state of the art on AI and AI related
G 221 technologies. G
The risk management system

referred to in Article 9 shall be
taken into account when ensuring
compliance with those
requirements.
Article 8(1a)
G 221a G
1a. In complying with the 1a.
requirements established in this
Chapter, due account shall be taken
of guidelines developed as referred
to in Article 82b, the generally
acknowledged state of the art,
including as reflected in the
relevant harmonised standards and
common specifications as referred
to in Articles 40 and 41 or those
already set out in Union
harmonisation law.
Article 8(2)
2. The intended purpose of the high- 2. The intended purpose of the high- 2. The intended purpose of the high- 2. The intended purpose of the high-
risk AI system and the risk risk AI system, the reasonably risk AI system and the risk risk AI system and the risk
management system referred to in foreseeable misuses and the risk management system referred to in management system referred to in
G 222 Article 9 shall be taken into account management system referred to in Article 9 shall be taken into account Article 9 shall be taken into account G
when ensuring compliance with Article 9 shall be taken into account when ensuring compliance with when ensuring compliance with
those requirements. when ensuring compliance with those requirements. those requirements.
those requirements.
Text Origin: Auxiliary 1
Article 8(2a)
2a. As long as the requirements of 2a. Where a product contains an

Title III, Chapters 2 and 3 or Title artificial intelligence system, to
VIII, Chapters 1, 2 and 3 for high- which the requirements of this
risk AI systems are addressed by Regulation as well as requirements
G 222a G
Union harmonisation law listed in of the Union harmonisation
Annex II, Section A, the legislation listed in Annex II,
requirements or obligations of those Section A apply, providers shall be
Chapters of this Regulation shall be responsible for ensuring that their
deemed to be fulfilled, as long as product is fully compliant with all
they include the AI component. applicable requirements required
Requirements of Chapters 2 and 3 under the Union harmonisation
of Title III or Title VIII, Chapters legislation.
1, 2 and 3 for high-risk AI systems
not addressed by Union In ensuring the compliance of
harmonisation law listed in Annex high-risk AI systems referred in
II Section A, shall be incorporated paragraph 1 with the requirements
into that Union harmonisation law, set out in Chapter 2 of this Title,
where applicable. The relevant and in order to ensure consistency,
conformity assessment shall be avoid duplications and minimise
carried out as part of the additional burdens, providers shall
procedures laid out under Union have a choice to integrate, as
harmonisation law listed in Annex appropriate, the necessary testing
II, Section A. and reporting processes,
information and documentation
they provide with regard to their
product into already existing
documentation and procedures
required under the Union
Annex II, Section A.
Article 9

Risk management system Risk management system Risk management system Risk management system
G 223 G

Proposal
Article 9(1)
G 224 1. A risk management system shall 1. A risk management system shall 1. A risk management system shall 1. A risk management system shall G
be established, implemented, be established, implemented, be established, implemented, be established, implemented,

documented and maintained in documented and maintained in documented and maintained in documented and maintained in
relation to high-risk AI systems. relation to high-risk AI systems, relation to high-risk AI systems. relation to high-risk AI systems.
throughout the entire lifecycle of
the AI system. The risk Proposal
management system can be
integrated into, or a part of, already
existing risk management
procedures relating to the relevant
Union sectoral law insofar as it
fulfils the requirements of this
article.
Article 9(2)
2. The risk management system 2. The risk management system 2. The risk management system 2. The risk management system
shall consist of a continuous iterative shall consist of a continuous iterative shall consist ofbe understood as a shall consist ofbe understood as a
process run throughout the entire process run throughout the entire continuous iterative process planned continuous iterative process planned
lifecycle of a high-risk AI system, lifecycle of a high-risk AI system, and run throughout the entire and run throughout the entire
requiring regular systematic requiring regular systematicreview lifecycle of a high-risk AI system, lifecycle of a high-risk AI system,
updating. It shall comprise the and updating of the risk requiring regular systematic requiring regular systematic review
G 225 G
following steps: management process, to ensure its updating. It shall comprise the and updating. It shall comprise the
continuing effectiveness, and following steps: following steps:
documentation of any significant
decisions and actions taken subject
to this Article. It shall comprise the
following steps:
(a) identification and analysis of the (a) identification, estimation and (a) identification and analysis of the (a) identification and analysis of the
known and foreseeable risks evaluation and analysis of the known and foreseeable risks known and the reasonably
G 226 associated with each high-risk AI known and the reasonably associated with eachmost likely to foreseeable risks associated with G
system; foreseeable risks associated with occur to health, safety and eachthat the high-risk AI system
eachthat the high-risk AI system fundamental rights in view of the can pose to the health, safety or
can pose to the health or safety of intended purpose of the high-risk AI fundamental rights when the high-
natural persons, their fundamental system; risk AI system is used in
rights including equal access and accordance with its intended
opportunities, democracy and rule purpose ;
of law or the environement when
the high-risk AI system is used in
accordance with its intended
purpose and under conditions of
reasonably foreseeable misuse;
(b) estimation and evaluation of the (b) estimation and evaluation of the
risks that may emerge when the deleted deleted risks that may emerge when the
high-risk AI system is used in high-risk AI system is used in
G 227 G
accordance with its intended purpose accordance with its intended purpose
and under conditions of reasonably and under conditions of reasonably
foreseeable misuse; foreseeable misuse;
(c) evaluation of other possibly (c) evaluation of other possibly (c) evaluation of other possibly (c) evaluation of other possibly
arising risks based on the analysis of arisingemerging significant risks as arising risks based on the analysis of arising risks based on the analysis of
data gathered from the post-market described in point (a) and identified data gathered from the post-market data gathered from the post-market
G 228 monitoring system referred to in based on the analysis of data monitoring system referred to in monitoring system referred to in G
Article 61; gathered from the post-market Article 61; Article 61;
monitoring system referred to in
Article 61;
(d) adoption of suitable risk (d) adoption of suitableappropriate (d) adoption of suitable risk (d) adoption of suitableappropriate
G 229 management measures in accordance and targeted risk management management measures in accordance and targeted risk management G
with the provisions of the following measures designed to address the with the provisions of the following measures designed to address the
paragraphs. risks identified pursuant to points a paragraphs. risks identified pursuant to point a
and b of this paragraph in of this paragraph in accordance
accordance with the provisions of with the provisions of the following
the following paragraphs. paragraphs.
Article 9(2), point (da)
2a. The risks referred to in this 2a. The risks referred to in this
paragraph shall concern only those paragraph shall concern only those
which may be reasonably mitigated which may be reasonably mitigated
or eliminated through the or eliminated through the
G 229a development or design of the high- development or design of the high- G
risk AI system, or the provision of risk AI system, or the provision of

adequate technical information. adequate technical information.
Article 9(3)
3. The risk management measures 3. The risk management measures 3. The risk management measures 3. The risk management measures
referred to in paragraph 2, point (d) referred to in paragraph 2, point (d) referred to in paragraph 2, point (d) referred to in paragraph 2, point (d)
shall give due consideration to the shall give due consideration to the shall give due consideration to the shall give due consideration to the
effects and possible interactions effects and possible interactions effects and possible effects and possible
resulting from the combined resulting from the combined interactionsinteraction resulting interactionsinteraction resulting
application of the requirements set application of the requirements set from the combined application of the from the combined application of the
out in this Chapter 2. They shall take out in this Chapter 2. They shall take requirements set out in this Chapter requirements set out in this Chapter
G 230 into account the generally into account the generally 2. They shall take into account the 2. They shall take into account the G
acknowledged state of the art, acknowledged state of the art, generally acknowledged state of the generally acknowledged state of the
including as reflected in relevant including as reflected in relevant art, including as reflected in relevant art, including as reflected in relevant
harmonised standards or common harmonised standards or common harmonised standards or common harmonised standards or common
specifications. specifications, with a view to specifications, with a view to specifications, with a view to
mitigate risks effectively while minimising risks more effectively minimising risks more effectively
ensuring an appropriate and while achieving an appropriate while achieving an appropriate
proportionate implementation of balance in implementing the balance in implementing the
the requirements. measures to fulfil those measures to fulfil those
requirements. requirements.
4. The risk management measures 4. The risk management measures 4. The risk management measures 4. The risk management measures
referred to in paragraph 2, point (d) referred to in paragraph 2, point (d) referred to in paragraph 2, point (d) referred to in paragraph 2, point (d)
shall be such that any residual risk shall be such that anyrelevant shall be such that any residual risk shall be such that anyrelevant
associated with each hazard as well residual risk associated with each associated with each hazard as well residual risk associated with each
as the overall residual risk of the hazard as well as the overall residual as the overall residual risk of the hazard as well as the overall residual
high-risk AI systems is judged risk of the high-risk AI systems is high-risk AI systems is judged risk of the high-risk AI systems is
acceptable, provided that the high- reasonably judged to be acceptable, acceptable, provided that the high- judged acceptable, provided that the
G 231 risk AI system is used in accordance provided that the high-risk AI risk AI system is used in accordance high-risk AI system is used in G
with its intended purpose or under system is used in accordance with its with its intended purpose or under accordance with its intended
conditions of reasonably foreseeable intended purpose or under conditions conditions of reasonably foreseeable purpose or under conditions of
misuse. Those residual risks shall be of reasonably foreseeable misuse. misuse. Those residual risks shall be reasonably foreseeable misuse.
communicated to the user. Those residual risks and the communicated to the user. Those residual risks shall be
reasoned judgements made shall be communicated to the userto be
communicated to the userdeployer. acceptable.
In identifying the most appropriate In identifying the most appropriate In identifying the most appropriate In identifying the most appropriate
risk management measures, the risk management measures, the risk management measures, the risk management measures, the
G 232 following shall be ensured: following shall be ensured: following shall be ensured: following shall be ensured: G

Proposal
Article 9(4), second subparagraph, point (a)
G 233 G
(a) elimination or reduction of risks (a) elimination or reduction of (a) elimination or reduction of risks (a) elimination or reduction of
as far as possible through adequate identified risks as far as identified and evaluated pursuant to identified risks and evaluated
design and development; possibletechnically feasible through paragraph 2 as far as possible pursuant to paragraph 2 as far as
adequate design and development of through adequate design and possibletechnically feasible through
the high-risk AI system, involving development of the high risk AI adequate design and development;
when relevant, experts and external system; of the high-risk AI system,
stakeholders;
Article 9(4), second subparagraph, point (b)
(b) where appropriate, (b) where appropriate, (b) where appropriate, (b) where appropriate,
implementation of adequate implementation of adequate implementation of adequate implementation of adequate
mitigation and control measures in mitigation and control measures in mitigation and control measures in mitigation and control measures in
G 234 relation to risks that cannot be relation toaddressing significant relation to risks that cannot be relation toaddressing risks that G
eliminated; risks that cannot be eliminated; eliminated; cannot be eliminated;

Article 9(4), second subparagraph, point (c)
(c) provision of adequate (c) provision of adequatethe (c) provision of adequate (c) provision of adequatethe
information pursuant to Article 13, required information pursuant to information pursuant to Article 13, required information pursuant to
in particular as regards the risks Article 13, in particular as regards in particular as regards the risks Article 13, in particular as regards
referred to in paragraph 2, point (b) the risks referred to in paragraph 2, referred to in paragraph 2, point (b) the risks referred to in paragraph 2,
G 235 of this Article, and, where point (b) of this Article, and, where of this Article, and, where point (b) of this Article, and, where G
appropriate, training to users. appropriate, training to appropriate, training to users. appropriate, training to
usersdeployers. usersdeployers.
Article 9(4), third subparagraph
In eliminating or reducing risks In eliminating or reducing risks InWith a view to eliminating or InWith a view to eliminating or
G 236 G
related to the use of the high-risk AI related to the use of the high-risk AI reducing risks related to the use of reducing risks related to the use of
system, due consideration shall be system, due considerationproviders the high-risk AI system, due the high-risk AI system, due
given to the technical knowledge, shall be given totake into due consideration shall be given to the consideration shall be given to the
experience, education, training to be consideration the technical technical knowledge, experience, technical knowledge, experience,
expected by the user and the knowledge, experience, education, education, training to be expected by education, training to be expected by
environment in which the system is training to be expected by the user the user and the environment in the userdeployer and the
intended to be used. and the environment in which the which the system is intended to be environmentpresumable context in
system is intended to be used and used. which the system is intended to be
training the deployer may need, used.
including in relation to the
presumable context of use.
Article 9(5)
5. High-risk AI systems shall be 5. High-risk AI systems shall be 5. High-risk AI systems shall be 5. High-risk AI systems shall be
tested for the purposes of identifying tested for the purposes of identifying tested for the purposes of identifying tested for the purposes of identifying
the most appropriate risk the most appropriate and targeted the most appropriate risk the most appropriate and targeted
management measures. Testing shall risk management measures and management measures. Testing shall risk management measures. Testing
ensure that high-risk AI systems weighing any such measures ensure that high-risk AI systems shall ensure that high-risk AI
perform consistently for their against the potential benefits and perform consistently forin order to systems perform consistently for
G 237 G
intended purpose and they are in intended goals of the system. ensure that high-risk AI systems their intended purpose and they are
compliance with the requirements Testing shall ensure that high-risk perform in a manner that is in compliance with the requirements
set out in this Chapter. AI systems perform consistently for consistent with their intended set out in this Chapter.
their intended purpose and they are purpose and they are in compliance
in compliance with the requirements with the requirements set out in this
set out in this Chapter. Chapter.
Article 9(6)
6. Testing procedures shall be 6. Testing procedures shall be 6. Testing procedures shall be 6. Testing procedures shall be
suitable to achieve the intended suitable to achieve the intended suitable to achieve the intended suitable to achieve the intended
purpose of the AI system and do not purpose of the AI system and do not purpose of the AI system and do not purpose of the AI system and do not
G 238 need to go beyond what is necessary need to go beyond what is necessary need to go beyond what is necessary need to go beyond what is necessary G
to achieve that purpose. to achieve that purpose. to achieve that purposemay include to achieve that purposemay include
testing in real world conditions in testing in real world conditions in
accordance with Article 54a. accordance with Article 54a.
Article 9(7)
7. The testing of the high-risk AI 7. The testing of the high-risk AI 7. The testing of the high-risk AI 7. The testing of the high-risk AI
systems shall be performed, as systems shall be performed, as systems shall be performed, as systems shall be performed, as
appropriate, at any point in time appropriate, at any point in time appropriate, at any point in time appropriate, at any point in time
throughout the development process, throughout the development process, throughout the development process, throughout the development process,
and, in any event, prior to the and, in any event, prior to the and, in any event, prior to the and, in any event, prior to the
placing on the market or the putting placing on the market or the putting placing on the market or the putting placing on the market or the putting
G 239 into service. Testing shall be made into service. Testing shall be made into service. Testing shall be made into service. Testing shall be made G
against preliminarily defined metrics against preliminarilyprior defined against preliminarily defined metrics against preliminarilyprior defined
and probabilistic thresholds that are metrics, and probabilistic thresholds and probabilistic thresholds that are metrics and probabilistic thresholds
appropriate to the intended purpose that are appropriate to the intended appropriate to the intended purpose that are appropriate to the intended
of the high-risk AI system. purpose or reasonably foreseeable of the high-risk AI system. purpose of the high-risk AI system.
misuse of the high-risk AI system.
Article 9(8)
8. When implementing the risk 8. When implementing the risk 8. When implementing The risk 8. When implementing the risk
management system described in management system described in management system described in management system described in
paragraphs 1 to 7, specific paragraphs 1 to 7, specific paragraphs 1 to 7, specific paragraphs 1 to 7, specific 6,
consideration shall be given to consideration shall be consideration shall be given shall providers shall give consideration
whether the high-risk AI system is givenproviders shall give specific give specific consideration to shall be given to whetherto whether
likely to be accessed by or have an consideration to whether the high- whether the high-risk AI system is in view of its intended purpose the
G 240 impact on children. risk AI system is likely to be likely to be accessed by or have an high-risk AI system is likely to be G
accessed by or have an impact impact on childrenpersons under accessed by or have an impact on

onadversely impact vulnerable the age of 18. childrenadversely impact persons
groups of people or children. under the age of 18 and, as
appropriate, other vulnerable
groups of people.
Article 9(9)
9. For credit institutions regulated 9. For providers and AI systems 9. For credit institutions regulated 9. For credit institutions regulated
by Directive 2013/36/EU, the already covered by Union law that by Directive 2013/36/EUproviders by Directive 2013/36/EUproviders
aspects described in paragraphs 1 to require them to establish a specific of high-risk AI systems that are of high-risk AI systems that are
8 shall be part of the risk risk management, including credit subject to requirements regarding subject to requirements regarding
management procedures established institutions regulated by Directive internal risk management processes internal risk management processes
by those institutions pursuant to 2013/36/EU, the aspects described in under relevant sectorial Union law, under relevant sectorial Union law,
G 241 Article 74 of that Directive. paragraphs 1 to 8 shall be part of or the aspects described in paragraphs 1 the aspects described in paragraphs 1 G
combined with the risk management to 8 shallmay be part of the risk to 8 shallmay be part of or
procedures established by those management procedures established combined with the risk management
institutions pursuant to Article 74 of by those institutions pursuant to procedures established by those
that Directivethat Union law. Article 74 of that Directivethat law. institutions pursuant to Article 74 of
that Directivethat law.
Article 10

Data and data governance Data and data governance Data and data governance Data and data governance
G 242 G

Proposal
Article 10(-1)(1)
1. High-risk AI systems which 1. High-risk AI systems which 1. High-risk AI systems which 1. High-risk AI systems which
make use of techniques involving make use of techniques involving make use of techniques involving make use of techniques involving
the training of models with data shall the training of models with data shall the training of models with data shall the training of models with data shall
be developed on the basis of be developed on the basis of be developed on the basis of be developed on the basis of
G 243 training, validation and testing data training, validation and testing data training, validation and testing data training, validation and testing data G
sets that meet the quality criteria sets that meet the quality criteria sets that meet the quality criteria sets that meet the quality criteria
referred to in paragraphs 2 to 5. referred to in paragraphs 2 to 5 as referred to in paragraphs 2 to 5. referred to in paragraphs 2 to 5
far as this is technically feasible whenever such datasets are used.
according to the specific market
segment or scope of application.
Proposal
Article 10(1), second subparagraph new
Techniques that do not require

labelled input data such as
unsupervised learning and
reinforcement learning shall be
G 243a G
developed on the basis of data sets
such as for testing and verification
that meet the quality criteria
referred to in paragraphs 2 to 5.
Article 10(2)
2. Training, validation and testing 2. Training, validation and testing 2. Training, validation and testing 2. Training, validation and testing
data sets shall be subject to data sets shall be subject to data sets shall be subject to data sets shall be subject to
appropriate data governance and appropriate data governance and appropriate data governance and appropriate data governance and
management practices. Those management practicesappropriate management practices. Those management practices appropriate
G 244 practices shall concern in particular, for the context of use as well as the practices shall concern in particular,: for the intended purpose of the AI G
intended purpose of the AI system. system. Those practices shall

Those practicesmeasures shall concern in particular,
concern in particular,
Proposal
(a) the relevant design choices; (a) the relevant design choices; (a) the relevant design choices; (a) the relevant design choices;
G
Proposal
(aa) transparency as regards the (aa) data collection processes and

original purpose of data collection; origin of data, and in the case of
G 245a G
personal data, the original purpose
of data collection;
G 246 (b) data collection; (b) data collection processes; (b) data collection processes; (b) data collection;[deleted] G
(c) relevant data preparation (c) relevant data preparation (c) relevant data preparation (c) relevant data preparation
processing operations, such as processing operations, such as processing operations, such as processing operations, such as
annotation, labelling, cleaning, annotation, labelling, cleaning, annotation, labelling, cleaning, annotation, labelling, cleaning,
G 247 enrichment and aggregation; updating, enrichment and enrichment and aggregation; updating, enrichment and G
aggregation; aggregation;
(d) the formulation of relevant (d) the formulation of relevant (d) the formulation of relevant (d) the formulation of relevant
assumptions, notably with respect to assumptions, notably with respect to assumptions, notably with respect to assumptions, notably with respect to
G 248 the information that the data are the information that the data are the information that the data are the information that the data are G
supposed to measure and represent; supposed to measure and represent; supposed to measure and represent; supposed to measure and represent;
(e) a prior assessment of the (e) a prioran assessment of the (e) a prior assessment of the (e) a prioran assessment of the
G 249 G
availability, quantity and suitability availability, quantity and suitability availability, quantity and suitability availability, quantity and suitability
of the data sets that are needed; of the data sets that are needed; of the data sets that are needed; of the data sets that are needed;
(f) examination in view of possible (f) examination in view of possible (f) examination in view of possible (f) examination in view of possible
biases; biases that are likely to affect the biases that are likely to affect health biases that are likely to affect the
health and safety of persons, and safety of natural persons or health and safety of persons,
negatively impact fundamental lead to discrimination prohibited by negatively impact fundamental
rights or lead to discrimination Union law; rights or lead to discrimination
prohibited under Union law, prohibited under Union law,
G 250 G
especially where data outputs especially where data outputs
influence inputs for future influence inputs for future
operations (‘feedback loops’) and operations;
appropriate measures to detect,
prevent and mitigate possible
biases;
Article 10(2), point (fa)
(fa) appropriate measures to detect, (fa) appropriate measures to detect,

prevent and mitigate possible prevent and mitigate possible biases
G 250a biases; identified according to point f; G
(g) the identification of any possible (g) the identification of any (g) the identification of any possible (g) the identification of any
data gaps or shortcomings, and how possiblerelevant data gaps or data gaps or shortcomings, and how possiblerelevant data gaps or
those gaps and shortcomings can be shortcomings that prevent those gaps and shortcomings can be shortcomings that prevent
G 251 G
addressed. compliance with this Regulation, addressed. compliance with this Regulation,
and how those gaps and and how those gaps and
shortcomings can be addressed. shortcomings can be addressed.
Article 10(3)
3. Training, validation and testing 3. Training datasets, and where 3. Training, validation and testing 3. Training, validation and testing
data sets shall be relevant, they are used, validation and testing data sets shall be relevant, data setsdatasets shall be relevant,
representative, free of errors and data setsdatasets, including the representative, and to the best extent sufficiently representative, and to
complete. They shall have the labels, shall be relevant, sufficiently possible, free of errors and complete. the best extent possible, free of
appropriate statistical properties, representative, free ofappropriately They shall have the appropriate errors and complete in view of the
including, where applicable, as vetted for errors and be as complete statistical properties, including, intended purpose. They shall have
regards the persons or groups of as possible in view of the intended where applicable, as regards the the appropriate statistical properties,
persons on which the high-risk AI purpose. They shall have the persons or groups of persons on including, where applicable, as
system is intended to be used. These appropriate statistical properties, which the high-risk AI system is regards the persons or groups of
G 252 G
characteristics of the data sets may including, where applicable, as intended to be used. These persons on whichin relation to
be met at the level of individual data regards the persons or groups of characteristics of the data sets may whom the high-risk AI system is
sets or a combination thereof. persons on whichin relation to be met at the level of individual data intended to be used. These
whom the high-risk AI system is sets or a combination thereof. characteristics of the data sets may
intended to be used. These be met at the level of individual data
characteristics of the data sets sets or a combination thereof.
maydatasets shall be met at the level
of individual data setsdatasets or a
combination thereof.
Article 10(4)
4. Training, validation and testing 4. Training, validation and testing 4. Training, validation and testing 4. Training, validation and testing
data sets shall take into account, to data setsDatasets shall take into data sets shall take into account, to data setsDatasets shall take into
the extent required by the intended account, to the extent required by the the extent required by the intended account, to the extent required by the
purpose, the characteristics or intended purpose or reasonably purpose, the characteristics or intended purpose, the characteristics
G 253 elements that are particular to the foreseeable misuses of the AI elements that are particular to the or elements that are particular to the G
specific geographical, behavioural or system, the characteristics or specific geographical, behavioural or specific geographical, contextual,
functional setting within which the elements that are particular to the functional setting within which the behavioural or functional setting
high-risk AI system is intended to be specific geographical, contextual, high-risk AI system is intended to be within which the high-risk AI
used. behavioural or functional setting used. system is intended to be used.
within which the high-risk AI
system is intended to be used. Text Origin: EP Mandate
Article 10(4a)(5)
5. To the extent that it is strictly 5. To the extent that it is strictly 5. To the extent that it is strictly 5. To the extent that it is strictly
necessary for the purposes of necessary for the purposes of necessary for the purposes of necessary for the purposes of
ensuring bias monitoring, detection ensuring bias monitoring,negative ensuring bias monitoring, detection ensuring bias monitoring, detection
and correction in relation to the bias detection and correction in and correction in relation to the and correction in relation to the
high-risk AI systems, the providers relation to the high-risk AI systems, high-risk AI systems, the providers high-risk AI systems in accordance
of such systems may process special the providers of such systems may of such systems may process special with the second paragraph, point f
categories of personal data referred exceptionally process special categories of personal data referred and fa, the providers of such
to in Article 9(1) of Regulation (EU) categories of personal data referred to in Article 9(1) of Regulation (EU) systems may exceptionally process
2016/679, Article 10 of Directive to in Article 9(1) of Regulation (EU) 2016/679, Article 10 of Directive special categories of personal data
(EU) 2016/680 and Article 10(1) of 2016/679, Article 10 of Directive (EU) 2016/680 and Article 10(1) of referred to in Article 9(1) of
Regulation (EU) 2018/1725, subject (EU) 2016/680 and Article 10(1) of Regulation (EU) 2018/1725, subject Regulation (EU) 2016/679, Article
to appropriate safeguards for the Regulation (EU) 2018/1725, subject to appropriate safeguards for the 10 of Directive (EU) 2016/680 and
fundamental rights and freedoms of to appropriate safeguards for the fundamental rights and freedoms of Article 10(1) of Regulation (EU)
natural persons, including technical fundamental rights and freedoms of natural persons, including technical 2018/1725, subject to appropriate
limitations on the re-use and use of natural persons, including technical limitations on the re-use and use of safeguards for the fundamental
G 254 G
state-of-the-art security and privacy- limitations on the re-use and use of state-of-the-art security and privacy- rights and freedoms of natural
preserving measures, such as state-of-the-art security and privacy- preserving measures, such as persons, including technical
pseudonymisation, or encryption preserving. In particular, all the pseudonymisation, or encryption limitations on the re-use and use of
where anonymisation may following conditions shall apply in where anonymisation may state-of-the-art security and privacy-
significantly affect the purpose order for this processing to occur: significantly affect the purpose preserving measures, such as
pursued. measures, such as pursued. pseudonymisation, or encryption
pseudonymisation, or encryption where anonymisation may
where anonymisation may significantly affect the purpose
significantly affect the purpose pursued.. In addition to provisions
pursued. 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:
Article 10(5), first subparagraph, point (a new)

(a) the bias detection and (a) the bias detection and
correction cannot be effectively correction cannot be effectively
G 254a fulfilled by processing synthetic or fulfilled by processing other data, G
anonymised data; including synthetic or anonymised

data;
(b) the data are pseudonymised; (b) the special categories of

personal data processed for the
purpose of this paragraph are
subject to technical limitations on
G 254b G
the re-use of the personal data and
state of the art security and privacy-
preserving measures, including
pseudonymisation;
(c) the provider takes appropriate (c) the special categories of

technical and organisational personal data processed for the
measures to ensure that the data purpose of this paragraph are
processed for the purpose of this subject to measures to ensure that
paragraph are secured, protected, the personal data processed are
subject to suitable safeguards and secured, protected, subject to
G 254c only authorised persons have access suitable safeguards, including strict G
to those data with appropriate controls and documentation of the

confidentiality obligations; access, to avoid misuse and ensure
only authorised persons have access
to those personal data with
appropriate confidentiality
obligations;

(d) the data processed for the (d) the special categories of
purpose of this paragraph are not to personal data processed for the
G 254d be transmitted, transferred or purpose of this paragraph are not to G
otherwise accessed by other parties; be transmitted, transferred or

otherwise accessed by other parties;
(e) the data processed for the (e) the special categories of
purpose of this paragraph are personal data processed for the
protected by means of appropriate purpose of this paragraph are
technical and organisational deleted once the bias has been
G 254e G
measures and deleted once the bias corrected or the personal data has
has been corrected or the personal reached the end of its retention
data has reached the end of its period, whatever comes first;
retention period;
Article 10(5), first subparagraph, point (f new)
(f) effective and appropriate

measures are in place to ensure
availability, security and resilience
G 254f G
of processing systems and services
against technical or physical
incidents;
Article 10(5), first subparagraph, point (g new)
(g) effective and appropriate

measures are in place to ensure
G 254g G
physical security of locations where
the data are stored and processed,
internal IT and IT security
governance and management,
certification of processes and
products;
Providers having recourse to this f) the records of processing

provision shall draw up activities pursuant to Regulation
documentation explaining why the (EU) 2016/679, Directive (EU)
processing of special categories of 2016/680 and Regulation (EU)
personal data was necessary to 2018/1725 includes justification
G 254h detect and correct biases. why the processing of special G
categories of personal data was

strictly necessary to detect and
correct biases and this objective
could not be achieved by processing
other data.
Article 10(6)
6. Appropriate data governance and 6. Appropriate data governance and 6. Appropriate data governance and 6. Appropriate data governance and
management practices shall apply management practices shall apply management practices shall apply management practices shall apply
for the development of high-risk AI for the development of high-risk AI For the development of high-risk AI For the development of high-risk AI
systems other than those which systems other than those which systems other than those which systems other than those which
make use of techniques involving make use of techniques involving make use ofnot using techniques make use ofnot using techniques
G 255 the training of models in order to the training of models in order to involving the training of models, involving the training of models, G
ensure that those high-risk AI ensure that those high-risk AI paragraphs 2 to 5 shall apply only paragraphs 2 to 5 shall apply only
systems comply with paragraph 2. systems comply with paragraph 2. to the testing data sets in order to to the testing data sets in order to
ensure that those high-risk AI ensure that those high-risk AI
systems comply with paragraph 2. systems comply with paragraph 2.
Article 10(6a new)
6a. Where the provider cannot

comply with the obligations laid
down in this Article because that
provider does not have access to the
G 255a data and the data is held exclusively G
by the deployer, the deployer may,

on the basis of a contract, be made
responsible for any infringement of
this Article.
Article 11

Technical documentation Technical documentation Technical documentation Technical documentation
G 256 G

Proposal
1. The technical documentation of a 1. The technical documentation of a 1. The technical documentation of a 1. The technical documentation of a
high-risk AI system shall be drawn high-risk AI system shall be drawn high-risk AI system shall be drawn high-risk AI system shall be drawn
up before that system is placed on up before that system is placed on up before that system is placed on up before that system is placed on
G 257 the market or put into service and the market or put into service and the market or put into service and the market or put into service and G
shall be kept up-to date. shall be kept up-to date. shall be kept up-to date. shall be kept up-to date.
Proposal
The technical documentation shall The technical documentation shall The technical documentation shall The technical documentation shall
G 258 G
be drawn up in such a way to be drawn up in such a way to be drawn up in such a way to be drawn up in such a way to
demonstrate that the high-risk AI demonstrate that the high-risk AI demonstrate that the high-risk AI demonstrate that the high-risk AI
system complies with the system complies with the system complies with the system complies with the
requirements set out in this Chapter requirements set out in this Chapter requirements set out in this Chapter requirements set out in this Chapter
and provide national competent and provide national and provide national competent and provide national competent
authorities and notified bodies with competentsupervisory authorities authorities and notified bodies with authorities and notified bodies with
all the necessary information to and notified bodies with all the all the necessary information in a all the necessary information in a
assess the compliance of the AI necessary information to assess the clear and comprehensive form to clear and comprehensive form to
system with those requirements. It compliance of the AI system with assess the compliance of the AI assess the compliance of the AI
shall contain, at a minimum, the those requirements. It shall contain, system with those requirements. It system with those requirements. It
elements set out in Annex IV. at a minimum, the elements set out shall contain, at a minimum, the shall contain, at a minimum, the
in Annex IV or, in the case of SMEs elements set out in Annex IV or, in elements set out in Annex IV.
and start-ups, any equivalent the case of SMEs, including start- SMEs, including start-ups, may
documentation meeting the same ups, any equivalent documentation provide the elements of the
objectives, subject to approval of the meeting the same objectives, unless technical documentation specified
competent national authority. deemed inappropriate by the in Annex IV in a simplified
competent authority. 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.
Article 11(2)
2. Where a high-risk AI system 2. Where a high-risk AI system 2. Where a high-risk AI system 2. Where a high-risk AI system
related to a product, to which the related to a product, to which the related to a product, to which the related to a product, to which the
G 259 G
legal acts listed in Annex II, section legal acts listed in Annex II, section legal acts listed in Annex II, section legal acts listed in Annex II, section
A apply, is placed on the market or A apply, is placed on the market or A apply, is placed on the market or A apply, is placed on the market or
put into service one single technical put into service one single technical put into service one single technical put into service one single technical
documentation shall be drawn up documentation shall be drawn up documentation shall be drawn up documentation shall be drawn up
containing all the information set out containing all the information set out containing all the information set out containing all the information set out
in Annex IV as well as the in Annex IVparagraph 1 as well as in Annex IV as well as the in Annex IVparagraph 1 as well as
information required under those the information required under those information required under those the information required under those
legal acts. legal acts. legal acts. legal acts.
Article 11(3)
accordance with Article 73 to amend accordance with Article 73 to amend accordance with Article 73 to amend accordance with Article 73 to amend
Annex IV where necessary to ensure Annex IV where necessary to ensure Annex IV where necessary to ensure Annex IV where necessary to ensure
that, in the light of technical that, in the light of technical that, in the light of technical that, in the light of technical
progress, the technical progress, the technical progress, the technical progress, the technical
G 260 documentation provides all the documentation provides all the documentation provides all the documentation provides all the
G
necessary information to assess the necessary information to assess the necessary information to assess the necessary information to assess the
compliance of the system with the compliance of the system with the compliance of the system with the compliance of the system with the
requirements set out in this Chapter. requirements set out in this Chapter. requirements set out in this Chapter. requirements set out in this Chapter.
Proposal
Article 11(3a new)
3a. Providers that are credit

institutions regulated by Directive
2013/36/EU shall maintain the
technical documentation as part of
G 260a the documentation concerning G
internal governance, arrangements,

processes and mechanisms
pursuant to Article 74 of that
Directive.
Article 12

Record-keeping Record-keeping Record-keeping Record-keeping
G 261 G

Proposal
Article 12(1)
designed and developed with designed and developed with designed and developed with designed and developed with
capabilities enabling the automatic capabilities enabling the automatic capabilities enablingtechnically capabilities enablingtechnically
recording of events (‘logs’) while recording of events (‘logs’) while allow for the automatic recording of allow for the automatic recording of
the high-risk AI systems is the high-risk AI systems is events (‘logs’) while the high-risk AI events (‘logs’) while the high-risk AI
G 262 operating. Those logging capabilities operating. Those logging capabilities systems is operating. Those logging systems is operating. Those logging G
shall conform to recognised shall conform to the state of the art capabilities shall conform to capabilities shall conform to
standards or common specifications. and recognised standards or recognised standards or common recognised standards or common
common specifications. specificationsover the duration of specificationsover the duration of
the life cycle of the system. the lifetime of the system.
Article 12(2)
2. The logging capabilities shall 2. The logging capabilities shallIn 2. The logging capabilities shallIn 2. The logging capabilities shallIn
ensure a level of traceability of the order to ensure a level of traceability order to ensure a level of traceability order to ensure a level of traceability
AI system’s functioning throughout of the AI system’s functioning of the AI system’s functioning of the AI system’s functioning
its lifecycle that is appropriate to the throughout its lifecycleentire throughout its lifecycle that is throughout its lifecycle that is
intended purpose of the system. lifetime that is appropriate to the appropriate to the intended purpose appropriate to the intended purpose
G 263 G
intended purpose of the system, the of the system., logging capabilities of the system., logging capabilities
logging capabilities shall facilitate shall enable the recording of events shall enable the recording of events
the monitoring of operations as relevant for: relevant for:
referred to in Article 29(4) as well
as the post market monitoring
referred to in Article 61. In
particular, they shall enable the
recording of events relevant for the
identification of situations that
may:
Article 12(2), point (a new)
(a) result in the AI system

G 263a presenting a risk within the G
meaning of Article65(1); or
Article 12(2), point (b new)
(b) lead to a substantial

G 263b G
modification of the AI system.
Article 12(2a new)
2a. High-risk AI systems shall be

designed and developed with, the
logging capabilities enabling the
recording of energy consumption,
G 263c the measurement or calculation of G
resource use and environmental

impact of the high-risk AI system
during all phases of the system’s
lifecycle.
Article 12(2a)
2a. (i) identification of situations 2a. (i) identification of situations

G 263d G
that may result in the AI system that may result in the AI system
presenting a risk within the presenting a risk within the
meaning of Article 65(1) or in a meaning of Article 65(1) or in a
substantial modification; substantial modification;
(ii) facilitation of the post-market (ii) facilitation of the post-market
monitoring referred to in Article monitoring referred to in Article
61; and 61; and
(iii) monitoring of the operation of (iii) monitoring of the operation of
high-risk AI systems referred to in high-risk AI systems referred to in
Article 29(4). Article 29(4).
Article 12(3)
3. In particular, logging capabilities 3. In particular, logging capabilities

shall enable the monitoring of the deleted deleted shall enable the monitoring of the
operation of the high-risk AI system operation of the high-risk AI system
with respect to the occurrence of with respect to the occurrence of
situations that may result in the AI situations that may result in the AI
G 264 G
system presenting a risk within the system presenting a risk within the
meaning of Article 65(1) or lead to a meaning of Article 65(1) or lead to a
substantial modification, and substantial modification, and
facilitate the post-market monitoring facilitate the post-market monitoring
referred to in Article 61. referred to in Article 61.deleted
Article 12(4)
4. For high-risk AI systems referred 4. For high-risk AI systems referred 4. For high-risk AI systems referred 4. For high-risk AI systems referred
to in paragraph 1, point (a) of Annex to in paragraph 1, point (a) of Annex to in paragraph 1, point (a) of Annex to in paragraph 1, point (a) of Annex
III, the logging capabilities shall III, the logging capabilities shall III, the logging capabilities shall III, the logging capabilities shall
G 265 provide, at a minimum: provide, at a minimum: provide, at a minimum: provide, at a minimum:
G

Proposal
(a) recording of the period of each (a) recording of the period of each (a) recording of the period of each (a) recording of the period of each
use of the system (start date and time use of the system (start date and time use of the system (start date and time use of the system (start date and time
G 266 and end date and time of each use); and end date and time of each use); and end date and time of each use); and end date and time of each use); G

Proposal
(b) the reference database against (b) the reference database against (b) the reference database against (b) the reference database against
which input data has been checked which input data has been checked which input data has been checked which input data has been checked
G 267 by the system; by the system; by the system; by the system; G

Proposal
(c) the input data for which the (c) the input data for which the (c) the input data for which the (c) the input data for which the
search has led to a match; search has led to a match; search has led to a match; search has led to a match;
G 268 G

Proposal
(d) the identification of the natural (d) the identification of the natural (d) the identification of the natural (d) the identification of the natural
persons involved in the verification persons involved in the verification persons involved in the verification persons involved in the verification
of the results, as referred to in of the results, as referred to in of the results, as referred to in of the results, as referred to in
G 269 Article 14 (5). Article 14 (5). Article 14 (5). Article 14 (5).
G

Proposal
Article 13

Transparency and provision of Transparency and provision of Transparency and provision of Transparency and provision of
G 270 information to users information to users information to users information to usersdeployers G
Article 13(-1)(1)
1. High-risk AI systems shall be -1. High-risk AI systems shall be 1. High-risk AI systems shall be 1. High-risk AI systems shall be
way to ensure that their operation is way to ensure that their operation is way to ensure that their operation is way to ensure that their operation is
sufficiently transparent to enable sufficiently transparent to enable sufficiently transparent to enable sufficiently transparent to enable
users to interpret the system’s output providers and users to users to interpret the system’s output usersdeployers to interpret the
and use it appropriately. An interpretreasonably understand the and use it appropriately. An system’s output and use it
appropriate type and degree of system’s output and use it appropriate type and degree of appropriately. An appropriate type
transparency shall be ensured, with a appropriately. An appropriate type transparency shall be ensured, with and degree of transparency shall be
view to achieving compliance with and degree of transparency shall be a view to achieving compliance with ensured, with a view to achieving
G 271 G
the relevant obligations of the user ensuredfunctioning. Appropriate the relevant obligations of the user compliance with the relevant
and of the provider set out in transparency shall be ensured in and of the provider set out in obligations of the user and of the
Chapter 3 of this Title. accordance with the intended Chapter 3 of this Title and enabling providerprovider and deployer set
purpose of the AI system, with a users to understand and use the out in Chapter 3 of this Title.
view to achieving compliance with system appropriately.
the relevant obligations of the user
and of the providerprovider and
user set out in Chapter 3 of this
Title.
Transparency shall thereby mean

that, at the time the high-risk AI
G 271a G
system is placed on the market, all
technical means available in
accordance with the generally
acknowledged state of art are used
to ensure that the AI system’s
output is interpretable by the
provider and the user. The user
shall be enabled to understand and
use the AI system appropriately by
generally knowing how the AI
system works and what data it
processes, allowing the user to
explain the decisions taken by the
AI system to the affected person
pursuant to Article 68(c).
Article 13(2)
accompanied by instructions for use accompanied by intelligible accompanied by instructions for use accompanied by instructions for use
in an appropriate digital format or instructions for use in an appropriate in an appropriate digital format or in an appropriate digital format or
otherwise that include concise, digital format or made otherwise otherwise that include concise, otherwise that include concise,
complete, correct and clear available in a durable medium that complete, correct and clear complete, correct and clear
information that is relevant, include concise, complete, correct information that is relevant, information that is relevant,
accessible and comprehensible to and clearcorrect, clear and to the accessible and comprehensible to accessible and comprehensible to
G 272 G
users. extent possible complete users. users.
information that helps operating and
maintaining the AI system as well Proposal
as supporting informed decision-
making by users and is reasonablyis
relevant, accessible and
comprehensible to users.
Article 13(3)
3. The information referred to in 3. To achieve the outcomes 3. The information referred to in 3. The information referred to in
G 273 G
paragraph 2 shall specify: referred to in paragraph 1,The paragraph 2 shall specify: paragraph 2 shall
information referred to in paragraph specifyinstructions for use shall
2 shall specify: contain at least the following
information:
(a) the identity and the contact (a) the identity and the contact (a) the identity and the contact (a) the identity and the contact
details of the provider and, where details of the provider and, where details of the provider and, where details of the provider and, where
applicable, of its authorised applicable, of its authorised applicable, of its authorised applicable, of its authorised
G 274 representative; representativerepresentatives; representative; representative;
G

Proposal
(aa) where it is not the same as the (aa)

provider, the identity and the
contact details of the entity that
G 274a G
carried out the conformity
assessment and, where applicable,
of its authorised representative;
(b) the characteristics, capabilities (b) the characteristics, capabilities (b) the characteristics, capabilities (b) the characteristics, capabilities
and limitations of performance of and limitations of performance of and limitations of performance of and limitations of performance of
G 275 the high-risk AI system, including: the high-risk AI system, including, the high-risk AI system, including: the high-risk AI system, including: G
where appropriate:
Article 13(3), point (b)(i)
G 276 (i) its intended purpose; (i) its intended purpose; (i) its intended purpose, inclusive of (i) its intended purpose; G
the specific geographical,

behavioural or functional setting Text Origin: EP Mandate
within which the high-risk AI
system is intended to be used;
Article 13(3), point (b)(ii)
(ii) the level of accuracy, robustness (ii) the level of accuracy, robustness (ii) the level of accuracy, including (ii) the level of accuracy, including
and cybersecurity referred to in and cybersecurity referred to in its metrics, robustness and its metrics, robustness and
Article 15 against which the high- Article 15 against which the high- cybersecurity referred to in Article cybersecurity referred to in Article
risk AI system has been tested and risk AI system has been tested and 15 against which the high-risk AI 15 against which the high-risk AI
validated and which can be validated and which can be system has been tested and validated system has been tested and validated
expected, and any known and expected, and any clearly known and and which can be expected, and any and which can be expected, and any
G 277 foreseeable circumstances that may foreseeable circumstances that may known and foreseeable known and foreseeable G
have an impact on that expected have an impact on that expected circumstances that may have an circumstances that may have an
level of accuracy, robustness and level of accuracy, robustness and impact on that expected level of impact on that expected level of
cybersecurity; cybersecurity; accuracy, robustness and accuracy, robustness and
cybersecurity; cybersecurity;
Article 13(3), point (b)(iii)
(iii) any known or foreseeable (iii) any clearly known or (iii) any known or foreseeable (iii) any known or foreseeable
circumstance, related to the use of foreseeable circumstance, related to circumstance, related to the use of circumstance, related to the use of
the high-risk AI system in the use of the high-risk AI system in the high-risk AI system in the high-risk AI system in
accordance with its intended purpose accordance with its intended purpose accordance with its intended purpose accordance with its intended purpose
or under conditions of reasonably or under conditions of reasonably or under conditions of reasonably or under conditions of reasonably
foreseeable misuse, which may lead foreseeable misuse, which may lead foreseeable misuse, which may lead foreseeable misuse, which may lead
G 278 G
to risks to the health and safety or to risks to the health and safety, to risks to the health and safety or to risks to the health and safety or
fundamental rights; fundamental rights or the fundamental rights referred to in fundamental rights referred to in
environment, including, where Article 9(2); Article 9(2);
appropriate, illustrative examples of
such limitations and of scenarios
for which the system should not be
used or fundamental rights;
Article 13(3), point (b)(iiia)
(iiia) the degree to which the AI (iiia) where applicable, the

system can provide an explanation technical capabilities and
G 278a for decisions it takes; characteristics of the AI system to G
provide information that is relevant

to explain its output.
Article 13(3), point (b)(iv)
(iv) its performance as regards the (iv) its performance as regards the (iv) when appropriate, its (iv) when appropriate, its
persons or groups of persons on persons or groups of persons on behaviour regarding specificits performance as regards
which the system is intended to be which the system is intended to be performance as regards the persons theregarding specific persons or
G 279 used; used; or groups of persons on which the groups of persons on which the G
system is intended to be used; system is intended to be used;

Proposal
Article 13(3), point (b)(v)
(v) when appropriate, specifications (v) when appropriate, specifications (v) when appropriate, specifications (v) when appropriate, specifications
for the input data, or any other for therelevant information about for the input data, or any other for the input data, or any other
relevant information in terms of the user actions that may influence relevant information in terms of the relevant information in terms of the
training, validation and testing data system performance, including type training, validation and testing data training, validation and testing data
G 280 sets used, taking into account the or quality of input data, or any other sets used, taking into account the sets used, taking into account the G
intended purpose of the AI system. relevant information in terms of the intended purpose of the AI system.; intended purpose of the AI system.
training, validation and testing data
sets used, taking into account the Proposal
intended purpose of the AI system.
Article 13(3), point (b)(va)
(va) when appropriate, description (va) where applicable, information

of the expected output of the to enable deployers to interpret the
G 280a G
system. system’s output and use it
appropriately.
(c) the changes to the high-risk AI (c) the changes to the high-risk AI (c) the changes to the high-risk AI (c) the changes to the high-risk AI
system and its performance which system and its performance which system and its performance which system and its performance which
have been pre-determined by the have been pre-determined by the have been pre-determined by the have been pre-determined by the
G 281 provider at the moment of the initial provider at the moment of the initial provider at the moment of the initial provider at the moment of the initial G
conformity assessment, if any; conformity assessment, if any; conformity assessment, if any; conformity assessment, if any;
Proposal
(d) the human oversight measures (d) the human oversight measures (d) the human oversight measures (d) the human oversight measures
referred to in Article 14, including referred to in Article 14, including referred to in Article 14, including referred to in Article 14, including
the technical measures put in place the technical measures put in place the technical measures put in place the technical measures put in place
to facilitate the interpretation of the to facilitate the interpretation of the to facilitate the interpretation of the to facilitate the interpretation of the
G 282 outputs of AI systems by the users; outputs of AI systems by the users; outputs of AI systems by the users; outputs of AI systems by the
G
usersdeployers;
Proposal
(e) the expected lifetime of the (e) the expected lifetime of the high- (e) the computational and (e) the computational and
G 283 high-risk AI system and any risk AI system and any necessary hardware resources needed, the hardware resources needed, the G
necessary maintenance and care maintenance and care measures to expected lifetime of the high-risk AI expected lifetime of the high-risk AI
measures to ensure the proper ensure the proper functioning of that system and any necessary system and any necessary
functioning of that AI system, AI system, including as regards maintenance and care measures, maintenance and care measures,
including as regards software software updates, through its including their frequency, to ensure including their frequency, to ensure
updates. expected lifetime. the proper functioning of that AI the proper functioning of that AI
system, including as regards system, including as regards
software updates.; software updates.;
Article 13(3), point (ea)
(ea) a description of the (ea)

mechanism included within the AI
G 283a system that allows users to properly G
collect, store and interpret the logs,

where relevant.
Article 13(3), point (eb)
(ea) a description of the (ea) where relevant, a description

mechanisms included within the AI of the mechanisms included within
system that allows users to properly the AI system that allows users to
G 283b collect, store and interpret the logs properly collect, store and interpret G
in accordance with Article 12(1). the logs in accordance with Article

12.
Article 13(3), point (ec)
(eb) The information shall be (ec)

provided at least in the language of
G 283c G
the country where the AI system is
used.
Article 13(3a)
3a. In order to comply with the 3a.

obligations laid down in this
G 283d Article, providers and users shall agreement to delete G
ensure a sufficient level of AI

literacy in line with Article 4b.
Article 14

Human oversight Human oversight Human oversight Human oversight
G 284 G

Proposal
Article 14(1)
way, including with appropriate way, including with appropriate way, including with appropriate way, including with appropriate
human-machine interface tools, that human-machine interface tools, that human-machine interface tools, that human-machine interface tools, that
they can be effectively overseen by they can be effectively overseen by they can be effectively overseen by they can be effectively overseen by
natural persons during the period in natural persons as proportionate to natural persons during the period in natural persons during the period in
which the AI system is in use. the risks associated with those which the AI system is in use. which the AI system is in use.
systems. Natural persons in charge
G 285 G
of ensuring human oversight shall
have sufficient level of AI literacy
in accordance with Article 4b and
the necessary support and authority
to exercise that function, during the
period in which the AI system is in
use and to allow for thorough
investigation after an incident.
Article 14(2)
2. Human oversight shall aim at 2. Human oversight shall aim at 2. Human oversight shall aim at 2. Human oversight shall aim at
preventing or minimising the risks to preventing or minimising the risks to preventing or minimising the risks to preventing or minimising the risks to
health, safety or fundamental rights health, safety or, fundamental rights health, safety or fundamental rights health, safety or fundamental rights
that may emerge when a high-risk or environment that may emerge that may emerge when a high-risk that may emerge when a high-risk
AI system is used in accordance with when a high-risk AI system is used AI system is used in accordance with AI system is used in accordance with
its intended purpose or under in accordance with its intended its intended purpose or under its intended purpose or under
conditions of reasonably foreseeable purpose or under conditions of conditions of reasonably foreseeable conditions of reasonably foreseeable
misuse, in particular when such risks reasonably foreseeable misuse, in misuse, in particular when such risks misuse, in particular when such risks
G 286 persist notwithstanding the particular when such risks persist persist notwithstanding the persist notwithstanding the G
application of other requirements set notwithstanding the application of application of other requirements set application of other requirements set
out in this Chapter. other requirements set out in this out in this Chapter. out in this Chapter.
Chapter and where decisions based
solely on automated processing by
AI systems produce legal or
otherwise significant effects on the
persons or groups of persons on
which the system is to be used.
Article 14(3)
3. Human oversight shall be ensured 3. Human oversight shall take into 3. Human oversight shall be ensured 3. HumanThe oversight measures
through either one or all of the account the specific risks, the level through either one or all of the shall be commensurate to the risks,
following measures: of automation, and context of the following types of measures: level of autonomy and context of
G 287 G
AI system and shall be ensured use of the AI system and shall be
through either one or all of the ensured through either one or all of
following types of measures: the following types of measures:
(a) identified and built, when (a) identified and built, when (a) measures identified and built, (a) measures identified and built,
technically feasible, into the high- technically feasible, into the high- when technically feasible, into the when technically feasible, into the
G 288 G
risk AI system by the provider risk AI system by the provider high-risk AI system by the provider high-risk AI system by the provider
before it is placed on the market or before it is placed on the market or before it is placed on the market or before it is placed on the market or
put into service; put into service; put into service; put into service;
(b) identified by the provider before (b) identified by the provider before (b) measures identified by the (b) measures identified by the
placing the high-risk AI system on placing the high-risk AI system on provider before placing the high-risk provider before placing the high-risk
the market or putting it into service the market or putting it into service AI system on the market or putting it AI system on the market or putting it
G 289 and that are appropriate to be and that are appropriate to be into service and that are appropriate into service and that are appropriate G
implemented by the user. implemented by the user. to be implemented by the user. to be implemented by the user.
Article 14(4)
4. The measures referred to in 4. For the purpose of implementing 4. For the purpose of implementing 4. For the purpose of implementing
paragraph 3 shall enable the paragraphs 1 to 3, the high-risk AI paragraphs 1 to 3, the high-risk AI paragraphs 1 to 3, the high-risk AI
individuals to whom human systemThe measures referred to in systemThe measures referred to in systemThe measures referred to in
oversight is assigned to do the paragraph 3 shall enable the paragraph 3 shall enable the paragraph 3 shall enable the
following, as appropriate to the individualsbe provided to the user in individualsbe provided to the user in individualsbe provided to the user in
G 290 circumstances: such a way that natural persons to such a way that natural persons to such a way that natural persons to G
whom human oversight is assigned whom human oversight is assigned whom human oversight is assigned
to do the followingare enabled, as to do the followingare enabled, as to do the followingare enabled, as
appropriate and proportionate to the appropriate and proportionate to the appropriate and proportionate to the
circumstances: circumstances: circumstances:
(a) fully understand the capacities (a) fullybe aware of and sufficiently (a) fullyto understand the capacities (a) fullyto properly understand the
and limitations of the high-risk AI understand the relevant capacities and limitations of the high-risk AI relevant capacities and limitations of
G 291 G
system and be able to duly monitor and limitations of the high-risk AI system and be able to duly monitor the high-risk AI system and be able
its operation, so that signs of system and be able to duly monitor its operation, so that signs of to duly monitor its operation, so that
anomalies, dysfunctions and its operation, so that signs of anomalies, dysfunctions and signs ofalso in view of detecting and
unexpected performance can be anomalies, dysfunctions and unexpected performance can be addressing anomalies, dysfunctions
detected and addressed as soon as unexpected performance can be detected and addressed as soon as and unexpected performance can be
possible; detected and addressed as soon as possible; detected and addressed as soon as
possible; possible;
(b) remain aware of the possible (b) remain aware of the possible (b) to remain aware of the possible (b) to remain aware of the possible
tendency of automatically relying or tendency of automatically relying or tendency of automatically relying or tendency of automatically relying or
over-relying on the output produced over-relying on the output produced over-relying on the output produced over-relying on the output produced
by a high-risk AI system by a high-risk AI system by a high-risk AI system by a high-risk AI system
(‘automation bias’), in particular for (‘automation bias’), in particular for (‘automation bias’), in particular for (‘automation bias’), in particular for
G 292 high-risk AI systems used to provide high-risk AI systems used to provide high-risk AI systems used to provide high-risk AI systems used to provide G
information or recommendations for information or recommendations for information or recommendations for information or recommendations for
decisions to be taken by natural decisions to be taken by natural decisions to be taken by natural decisions to be taken by natural
persons; persons; persons; persons;
Proposal
(c) be able to correctly interpret the (c) be able to correctly interpret the (c) be able to correctly interpret the (c) be able to correctly interpret the
high-risk AI system’s output, taking high-risk AI system’s output, taking high-risk AI system’s output, taking high-risk AI system’s output, taking
into account in particular the into account in particular the into account in particular the into account in particular the
G 293 characteristics of the system and the characteristics of the system and the characteristics of the system andfor characteristics of the system andfor G
interpretation tools and methods interpretation tools and methods example the interpretation tools and example the interpretation tools and
available; available; methods available; methods available;

G 294 G
(d) be able to decide, in any (d) be able to decide, in any (d) be able to decide, in any (d) be able to decide, in any
particular situation, not to use the particular situation, not to use the particular situation, not to use the particular situation, not to use the
high-risk AI system or otherwise high-risk AI system or otherwise high-risk AI system or otherwise high-risk AI system or otherwise
disregard, override or reverse the disregard, override or reverse the disregard, override or reverse the disregard, override or reverse the
output of the high-risk AI system; output of the high-risk AI system; output of the high-risk AI system; output of the high-risk AI system;
(e) be able to intervene on the (e) be able to intervene on the (e) be able to intervene on the (e) be able to intervene on the
operation of the high-risk AI system operation of the high-risk AI system operation of the high-risk AI system operation of the high-risk AI system
or interrupt the system through a or interrupt, the system through a or interrupt the system through a or interrupt, the system through a
“stop” button or a similar procedure. “stop” button or a similar procedure “stop” button or a similar procedure. “stop”"stop" button or a similar
that allows the system to come to a procedure that allows the system to
G 295 halt in a safe state, except if the come to a halt in a safe state. G
human interference increases the

risks or would negatively impact the
performance in consideration of
generally acknowledged state-of-
the-art.
Article 14(5)
to in point 1(a) of Annex III, the to in point 1(a) of Annex III, the to in point 1(a) of Annex III, the to in point 1(a) of Annex III, the
measures referred to in paragraph 3 measures referred to in paragraph 3 measures referred to in paragraph 3 measures referred to in paragraph 3
shall be such as to ensure that, in shall be such as to ensure that, in shall be such as to ensure that, in shall be such as to ensure that, in
addition, no action or decision is addition, no action or decision is addition, no action or decision is addition, no action or decision is
G 296 G
taken by the user on the basis of the taken by the user on the basis of the taken by the user on the basis of the taken by the userdeployer on the
identification resulting from the identification resulting from the identification resulting from the basis of the identification resulting
system unless this has been verified system unless this has been verified system unless this has been from the system unless this has been
and confirmed by at least two natural and confirmed by at least two natural separately verified and confirmed by separately verified and confirmed by
persons. persons with the necessary at least two natural persons. The at least two natural persons with the
competence, training and authority. requirement for a separate necessary competence, training and
verification by at least two natural authority.
persons shall not apply to high risk
AI systems used for the purpose of The requirement for a separate
law enforcement, migration, border verification by at least two natural
control or asylum, in cases where persons shall not apply to high risk
Union or national law considers the AI systems used for the purpose of
application of this requirement to law enforcement, migration, border
be disproportionate. control or asylum, in cases where
Union or national law considers the
application of this requirement to
be disproportionate.
Article 15

Accuracy, robustness and Accuracy, robustness and Accuracy, robustness and Accuracy, robustness and
G 297 cybersecurity cybersecurity cybersecurity cybersecurity G
Article 15(1)
way that they achieve, in the light of way that they achieve,following the way that they achieve, in the light of way that they achieve, in the light of
their intended purpose, an principle of security by design and their intended purpose, an their intended purpose, an
appropriate level of accuracy, by default. In the light of their appropriate level of accuracy, appropriate level of accuracy,
robustness and cybersecurity, and intended purpose, they should robustness and cybersecurity, and robustness, and cybersecurity, and
G 298 G
perform consistently in those achieve an appropriate level of perform consistently in those perform consistently in those
respects throughout their lifecycle. accuracy, robustness, safety, and respects throughout their lifecycle. respects throughout their lifecycle.
cybersecurity, and perform
consistently in those respects
throughout their lifecycle.
Compliance with these
requirements shall include
implementation of state-of-the-art
measures, according to the specific
market segment or scope of
application.
Article 15(1a)
1a. To address the technical 1a. To address the technical

aspects of how to measure the aspects of how to measure the
appropriate levels of accuracy and appropriate levels of accuracy and
robustness set out in paragraph 1 of robustness set out in paragraph 1 of
this Article, the AI Office shall this Article and any other relevant
bring together national and performance metrics, the
international metrology and Commission shall, in cooperation
G 298a benchmarking authorities and with relevant stakeholder and G
provide non-binding guidance on organisations such as metrology

the matter as set out in Article 56, and benchmarking authorities,
paragraph 2, point (a). encourage as appropriate, the
development of benchmarks and
measurement methodologies.
Article 15(1b new)
1b. To address any emerging issues

across the internal market with
regard to cybersecurity, the
G 298b Cybersecurity (ENISA) shall be G
involved alongside the European

Artificial Intelligence Board as set
out Article 56, paragraph 2, point
(b).
Article 15(2)
2. The levels of accuracy and the 2. The levels of accuracy and the 2. The levels of accuracy and the 2. The levels of accuracy and the
relevant accuracy metrics of high- relevant accuracy metrics of high- relevant accuracy metrics of high- relevant accuracy metrics of high-
risk AI systems shall be declared in risk AI systems shall be declared in risk AI systems shall be declared in risk AI systems shall be declared in
G 299 the accompanying instructions of the accompanying instructions of the accompanying instructions of the accompanying instructions of G
use. use. The language used shall be use. use.

clear, free of misunderstandings or
misleading statements. Proposal
3. High-risk AI systems shall be 3. Technical and organisational 3. High-risk AI systems shall be 3. High-risk AI systems shall be as
resilient as regards errors, faults or measures shall be taken to ensure resilient as regards errors, faults or resilient as regardspossible
inconsistencies that may occur that high-risk AI systems shall be as inconsistencies that may occur regarding errors, faults or
within the system or the resilient as regardspossible within the system or the inconsistencies that may occur
environment in which the system regarding errors, faults or environment in which the system within the system or the
operates, in particular due to their inconsistencies that may occur operates, in particular due to their environment in which the system
G 300 interaction with natural persons or within the system or the interaction with natural persons or operates, in particular due to their G
other systems. environment in which the system other systems. interaction with natural persons or
operates, in particular due to their other systems. Technical and
interaction with natural persons or organisational measures shall be
other systems. taken towards this regard.
Proposal
The robustness of high-risk AI The robustness of high-risk AI The robustness of high-risk AI The robustness of high-risk AI
systems may be achieved through systems may be achieved by the systems may be achieved through systems may be achieved through
G 301 technical redundancy solutions, appropriate provider with input technical redundancy solutions, technical redundancy solutions, G
which may include backup or fail- from the user, where necessary, which may include backup or fail- which may include backup or fail-
safe plans. through technical redundancy safe plans. safe plans.
solutions, which may include backup
or fail-safe plans. Text Origin: EP Mandate
High-risk AI systems that continue High-risk AI systems that continue High-risk AI systems that continue High-risk AI systems that continue
to learn after being placed on the to learn after being placed on the to learn after being placed on the to learn after being placed on the
market or put into service shall be market or put into service shall be market or put into service shall be market or put into service shall be
developed in such a way to ensure developed in such a way to ensure developed in such a way to ensure developed in such a way to ensure
that possibly biased outputs due to that possibly biased outputs due to that possibly biased outputs due to that possibly biased outputs due to
outputs used as an input for future outputs used as aninfluencing input outputs used as aneliminate or outputs used as aneliminate or
G 302 operations (‘feedback loops’) are for future operations (‘feedback reduce as far as possible the risk of reduce as far as possible the risk of G
duly addressed with appropriate loops’) and malicious manipulation possibly biased outputs influencing possibly biased outputs influencing
mitigation measures. of inputs used in learning during input for future operations input for future operations
operation are duly addressed with (‘feedback loops’) are duly (‘feedback loops’) are duly
appropriate mitigation measures. addressed with appropriate addressed with appropriate
mitigation measures. mitigation measures.
resilient as regards attempts by resilient as regards to attempts by resilient as regards attempts by resilient as regards to attempts by
unauthorised third parties to alter unauthorised third parties to alter unauthorised third parties to alter unauthorised third parties to alter
G 303 their use or performance by their use, behaviour, outputs or their use or performance by their use, outputs or performance by G
exploiting the system vulnerabilities. performance by exploiting the exploiting the system vulnerabilities. exploiting the system vulnerabilities.
system vulnerabilities.
The technical solutions aimed at The technical solutions aimed at The technical solutions aimed at The technical solutions aimed at
G 304 ensuring the cybersecurity of high- ensuring the cybersecurity of high- ensuring the cybersecurity of high- ensuring the cybersecurity of high- G
risk AI systems shall be appropriate risk AI systems shall be appropriate risk AI systems shall be appropriate risk AI systems shall be appropriate
to the relevant circumstances and the to the relevant circumstances and the to the relevant circumstances and the to the relevant circumstances and the
risks. risks. risks. risks.
Proposal
The technical solutions to address AI The technical solutions to address AI The technical solutions to address AI The technical solutions to address AI
specific vulnerabilities shall include, specific vulnerabilities shall include, specific vulnerabilities shall include, specific vulnerabilities shall include,
where appropriate, measures to where appropriate, measures to where appropriate, measures to where appropriate, measures to
prevent and control for attacks trying prevent, detect, respond to, resolve prevent and control for attacks trying prevent, detect, respond to, resolve
to manipulate the training dataset and control for attacks trying to to manipulate the training dataset and control for attacks trying to
(‘data poisoning’), inputs designed manipulate the training dataset (‘data (‘data poisoning’), inputs designed manipulate the training dataset (‘data
to cause the model to make a poisoning’), or pre-trained to cause the model to make a poisoning’), or pre-trained
G 305 mistake (‘adversarial examples’), or components used in training mistake (‘adversarial examples’), or components used in training G
model flaws. (‘model poisoning’) , inputs model flaws. (‘model poisoning’) , inputs
designed to cause the model to make designed to cause the model to make
a mistake (‘adversarial examples’ or a mistake (‘adversarial examples’ or
‘model evasion’), confidentiality ‘model evasion’), confidentiality
attacks or model flaws, which could attacks or model flaws.
lead to harmful decision-making.
Chapter 3

OBLIGATIONS OF PROVIDERS OBLIGATIONS OF PROVIDERS OBLIGATIONS OF PROVIDERS OBLIGATIONS OF PROVIDERS
AND USERS OF HIGH-RISK AI AND USERSDEPLOYERS OF AND USERS OF HIGH-RISK AI AND USERSDEPLOYERS OF
G 306 SYSTEMS and other parties HIGH-RISK AI SYSTEMS and SYSTEMS and other partiesAND HIGH-RISK AI SYSTEMS and G
other partiesAND OTHER OTHER PARTIES other partiesAND OTHER

PARTIES PARTIES
Article 16

Obligations of providers of high-risk Obligations of providers and Obligations of providers of high-risk Obligations of providers of high-risk
G 307 AI systems deployers of high-risk AI systems AI systems AI systems G
and other parties

Proposal
Providers of high-risk AI systems Providers of high-risk AI systems Providers of high-risk AI systems Providers of high-risk AI systems
shall: shall: shall: shall:
G 308 G

Proposal
(a) ensure that their high-risk AI (a) ensure that their high-risk AI (a) ensure that their high-risk AI (a) ensure that their high-risk AI
systems are compliant with the systems are compliant with the systems are compliant with the systems are compliant with the
requirements set out in Chapter 2 of requirements set out in Chapter 2 of requirements set out in Chapter 2 of requirements set out in Chapter 2 of
G 309 this Title; this Title before placing them on the this Title; this Title;
G
market or putting them into service;

Proposal
Article 16, first paragraph, point (aa)
(aa) indicate their name, registered (aa) indicate their name, registered
trade name or registered trade trade name or registered trade
mark, the address at which they can mark, the address at which they can
G 309a be contacted on the high-risk AI be contacted on the high-risk AI G
system or, where that is not system or, where that is not
possible, on its packaging or its possible, on its packaging or its
accompanying documentation, as accompanying documentation, as
applicable; applicable;
Article 16, first paragraph, point (ab)
(aa) indicate their name, registered (ab)

trade name or registered trade
mark, and their address and contact
G 309b information on the high-risk AI G
system or, where that is not

possible, on its accompanying
documentation, as appropriate;
Article 16, first paragraph, point (ab new)
(ab) ensure that natural persons to

whom human oversight of high-risk
G 309c AI systems is assigned are G
specifically made aware of the risk

of automation or confirmation bias;
Article 16, first paragraph, point (ac new)
(ac) provide specifications for the

input data, or any other relevant
information in terms of the datasets
used, including their limitation and
G 309d assumptions, taking into account G
the intended purpose and the

foreseeable and reasonably
foreseeable misuses of the AI
system;

(b) have a quality management (b) have a quality management (b) have a quality management (b) have a quality management
system in place which complies with system in place which complies with system in place which complies with system in place which complies with
G 310 Article 17; Article 17; Article 17; Article 17; G

Proposal
(c) draw-up the technical (c) draw-up and keep the technical (c) draw-up the technicalkeep the (c) draw-up the technicalkeep the
G 311 documentation of the high-risk AI documentation of the high-risk AI documentation of the high-risk AI documentation of the high-risk AI G
system; system referred to in Article 11; systemreferred to in Article 18; system referred to in Article 18;
(d) when under their control, keep (d) when under their control, keep (d) when under their control, keep (d) when under their control, keep
the logs automatically generated by the logs automatically generated by the logs automatically generated by the logs automatically generated by
their high-risk AI systems; their high-risk AI systems that are their high-risk AI systems as their high-risk AI systems as
G 312 required for ensuring and referred to in Article 20; referred to in Article 20; G
demonstrating compliance with this

Regulation, in accordance with
Article 20;
(e) ensure that the high-risk AI (e) ensure that the high-risk AI (e) ensure that the high-risk AI (e) ensure that the high-risk AI
system undergoes the relevant system undergoes the relevant system undergoes the relevant system undergoes the relevant
conformity assessment procedure, conformity assessment procedure, conformity assessment procedure as conformity assessment procedure as
G 313 prior to its placing on the market or prior to its placing on the market or referred to in Article 43, prior to its referred to in Article 43, prior to its G
putting into service; putting into service, in accordance placing on the market or putting into placing on the market or putting into
with Article 43; service; service;
(ea) draw up an EU declaration of (ea) draw up an EU declaration of

conformity in accordance with conformity in accordance with
G 313a Article 48; Article 48; G
Article 16, first paragraph, point (eb)
(eb) affix the CE marking to the (eb) affix the CE marking to the
high-risk AI system to indicate high-risk AI system to indicate
G 313b conformity with this Regulation, in conformity with this Regulation, in G
accordance with Article 49; accordance with Article 49;

Article 16, first paragraph, point (f)
(f) comply with the registration (f) comply with the registration (f) comply with the registration (f) comply with the registration
obligations referred to in Article 51; obligations referred to in Article 51; obligations referred to in Article obligations referred to in Article
G 314 5151(1); 5151(1); G
Article 16, first paragraph, point (g)
(g) take the necessary corrective (g) take the necessary corrective (g) take the necessary corrective (g) take the necessary corrective
actions, if the high-risk AI system is actions, if the high-risk AI system is actions as referred to in Article 21, actions, if the high-risk AI system is
not in conformity with the not in conformity with the if the high-risk AI system is not in not in conformity with the
G 315 requirements set out in Chapter 2 of requirements set out in Chapter 2 of conformity with the requirements set requirements set out in Chapter 2 of G
this Title; this Title as referred to in Article 21 out in Chapter 2 of this Title; this Title and provide information
and provide information in that as required in Article 21;
regard;
Article 16, first paragraph, point (h)
(h) inform the national competent (h) inform the relevant national
authorities of the Member States in deleted competent authoritiesauthority of
which they made the AI system the Member States in which they
available or put it into service and, made the AI system available or put
G 316 G
where applicable, the notified body it into service and, where applicable,
of the non-compliance and of any the notified body of the non-
corrective actions taken; compliance and of any corrective
actions taken;
Article 16, first paragraph, point (i)
(i) to affix the CE marking to their (i) to affix the CE marking to their (i) to affix the CE marking to their
high-risk AI systems to indicate the deleted high-risk AI systems to indicate the high-risk AI systems to indicate the
G 317 conformity with this Regulation in conformity with this Regulation in conformity with this Regulation in G
accordance with Article 49; accordance with Article 49; accordance with Article 49;Moved
above in line 313b
Article 16, first paragraph, point (j)
(j) upon request of a national (j) upon a reasoned request of a (j) upon request of a national (j) upon a reasoned request of a
competent authority, demonstrate the national competentsupervisory competent authority, demonstrate the national competent authority,
conformity of the high-risk AI authority, demonstrate the conformity of the high-risk AI demonstrate the conformity of the
G 318 G
system with the requirements set out conformity of the high-risk AI system with the requirements set out high-risk AI system with the
in Chapter 2 of this Title. system with the requirements set out in Chapter 2 of this Title. requirements set out in Chapter 2 of
in Chapter 2 of this Title. this Title.
Article 16, first paragraph, point (ja)
G 318a (ja) ensure that the high-risk AI (ja) ensure that the high-risk AI G
system complies with accessibility system complies with accessibility

requirements. 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 Quality management system Quality management system Quality management system
G 319 G

Proposal
Article 17(1)
1. Providers of high-risk AI systems 1. Providers of high-risk AI systems 1. Providers of high-risk AI systems 1. Providers of high-risk AI systems
shall put a quality management shall puthave a quality management shall put a quality management shall put a quality management
system in place that ensures system in place that ensures system in place that ensures system in place that ensures
compliance with this Regulation. compliance with this Regulation. compliance with this Regulation. compliance with this Regulation.
That system shall be documented in That systemIt shall be documented That system shall be documented in That system shall be documented in
a systematic and orderly manner in in a systematic and orderly manner a systematic and orderly manner in a systematic and orderly manner in
G 320 the form of written policies, in the form of written policies, the form of written policies, the form of written policies, G
procedures and instructions, and procedures andor instructions, and procedures and instructions, and procedures and instructions, and
shall include at least the following can be incorporated into an existing shall include at least the following shall include at least the following
aspects: quality management system under aspects: aspects:
Union sectoral legislative acts. It
shall include at least the following
aspects:

G 321 G
(a) a strategy for regulatory (a) a strategy for regulatory (a) a strategy for regulatory
compliance, including compliance deleted compliance, including compliance compliance, including compliance
with conformity assessment with conformity assessment with conformity assessment
procedures and procedures for the procedures and procedures for the procedures and procedures for the
management of modifications to the management of modifications to the management of modifications to the
high-risk AI system; high-risk AI system; high-risk AI system;
(b) techniques, procedures and (b) techniques, procedures and (b) techniques, procedures and (b) techniques, procedures and
systematic actions to be used for the systematic actions to be used for the systematic actions to be used for the systematic actions to be used for the
design, design control and design design, design control and design design, design control and design design, design control and design
G 322 verification of the high-risk AI verification of the high-risk AI verification of the high-risk AI verification of the high-risk AI G
system; system; system; system;

Proposal
(c) techniques, procedures and (c) techniques, procedures and (c) techniques, procedures and (c) techniques, procedures and
systematic actions to be used for the systematic actions to be used for the systematic actions to be used for the systematic actions to be used for the
development, quality control and development, quality control and development, quality control and development, quality control and
G 323 quality assurance of the high-risk AI quality assurance of the high-risk AI quality assurance of the high-risk AI quality assurance of the high-risk AI G
system; system; system; system;

Proposal
(d) examination, test and validation (d) examination, test and validation (d) examination, test and validation (d) examination, test and validation
G 324 procedures to be carried out before, procedures to be carried out before, procedures to be carried out before, procedures to be carried out before, G
during and after the development of during and after the development of during and after the development of during and after the development of
the high-risk AI system, and the the high-risk AI system, and the the high-risk AI system, and the the high-risk AI system, and the
frequency with which they have to frequency with which they have to frequency with which they have to frequency with which they have to
be carried out; be carried out; be carried out; be carried out;
Proposal
(e) technical specifications, (e) technical specifications, (e) technical specifications, (e) technical specifications,
including standards, to be applied including standards, to be applied including standards, to be applied including standards, to be applied
and, where the relevant harmonised and, where the relevant harmonised and, where the relevant harmonised and, where the relevant harmonised
standards are not applied in full, the standards are not applied in full, or standards are not applied in full, the standards are not applied in full, or
means to be used to ensure that the do not cover all of the relevant means to be used to ensure that the do not cover all of the relevant
G 325 high-risk AI system complies with requirements, the means to be used high-risk AI system complies with requirements set out in Chapter II G
the requirements set out in Chapter 2 to ensure that the high-risk AI the requirements set out in Chapter 2 of this Title, the means to be used to
of this Title; system complies with the of this Title; ensure that the high-risk AI system
requirements set out in Chapter 2 of complies with thethose requirements
this Title; set out in Chapter 2 of this Title;
(f) systems and procedures for data (f) systems and procedures for data (f) systems and procedures for data (f) systems and procedures for data
management, including data management, including data management, including data management, including data
collection, data analysis, data acquisition, data collection, data collection, data analysis, data acquisition, data collection, data
labelling, data storage, data analysis, data labelling, data storage, labelling, data storage, data analysis, data labelling, data storage,
filtration, data mining, data data filtration, data mining, data filtration, data mining, data data filtration, data mining, data
G 326 aggregation, data retention and any aggregation, data retention and any aggregation, data retention and any aggregation, data retention and any G
other operation regarding the data other operation regarding the data other operation regarding the data other operation regarding the data
that is performed before and for the that is performed before and for the that is performed before and for the that is performed before and for the
purposes of the placing on the purposes of the placing on the purposes of the placing on the purposes of the placing on the
market or putting into service of market or putting into service of market or putting into service of market or putting into service of
high-risk AI systems; high-risk AI systems; high-risk AI systems; high-risk AI systems;
(g) the risk management system (g) the risk management system (g) the risk management system (g) the risk management system
referred to in Article 9; referred to in Article 9; referred to in Article 9; referred to in Article 9;
G 327 G

Proposal
(h) the setting-up, implementation (h) the setting-up, implementation (h) the setting-up, implementation (h) the setting-up, implementation
and maintenance of a post-market and maintenance of a post-market and maintenance of a post-market and maintenance of a post-market
monitoring system, in accordance monitoring system, in accordance monitoring system, in accordance monitoring system, in accordance
G 328 with Article 61; with Article 61; with Article 61; with Article 61;
G

Proposal
Article 17(1), point (i)
(i) procedures related to the (i) procedures related to the (i) procedures related to the (i) procedures related to the
reporting of serious incidents and of reporting of serious incidents and of reporting of serious incidents and of reporting of serious incidents and of
G 329 malfunctioning in accordance with malfunctioning in accordance with malfunctioninga serious incident in malfunctioninga serious incident in G
Article 62; Article 62; accordance with Article 62; accordance with Article 62;
Article 17(1), point (j)
(j) the handling of communication (j) the handling of communication (j) the handling of communication (j) the handling of communication
G 330 with national competent authorities, with nationalrelevant competent with national competent authorities, with national competent authorities, G
competent authorities, including authorities, competent authorities, competent authorities, including competentother relevant authorities,
sectoral ones, providing or including sectoral ones, providing or sectoral ones, providing or including sectoral ones,those
supporting the access to data, supporting the access to data, supporting the access to data, providing or supporting the access to
notified bodies, other operators, notified bodies, other operators, notified bodies, other operators, data, notified bodies, other
customers or other interested parties; customers or other interested customers or other interested parties; operators, customers or other
parties; interested parties;
Article 17(1), point (k)
(k) systems and procedures for (k) systems and procedures for (k) systems and procedures for (k) systems and procedures for
record keeping of all relevant record keeping of all relevant record keeping of all relevant record keeping of all relevant
G 331 documentation and information; documentation and information; documentation and information; documentation and information; G

Proposal
Article 17(1), point (l)
(l) resource management, including (l) resource management, including (l) resource management, including (l) resource management, including
security of supply related measures; security of supply related measures; security of supply related measures; security of supply related measures;
G 332 G

Proposal
Article 17(1), point (m)
(m) an accountability framework (m) an accountability framework (m) an accountability framework (m) an accountability framework
setting out the responsibilities of the setting out the responsibilities of the setting out the responsibilities of the setting out the responsibilities of the
management and other staff with management and other staff with management and other staff with management and other staff with
G 333 regard to all aspects listed in this regard to all aspects listed in this regard to all aspects listed in this regard to all aspects listed in this G
paragraph. paragraph. paragraph. paragraph.

Proposal
Article 17(2)
G 334 G
2. The implementation of aspects 2. The implementation of aspects 2. The implementation of aspects 2. The implementation of aspects
referred to in paragraph 1 shall be referred to in paragraph 1 shall be referred to in paragraph 1 shall be referred to in paragraph 1 shall be
proportionate to the size of the proportionate to the size of the proportionate to the size of the proportionate to the size of the
provider’s organisation. provider’s organisation. Providers provider’s organisation. provider’s organisation. Providers
shall in any event respect the degree shall in any event respect the degree
of rigour and the level of protection of rigour and the level of protection
required to ensure compliance of required to ensure compliance of
their AI systems with this their AI systems with this
Regulation. Regulation.
Article 17(2a)
2a. For providers of high-risk AI 2a. For providers of high-risk AI

systems that are subject to systems that are subject to
obligations regarding quality obligations regarding quality
management systems under management systems or their
relevant sectorial Union law, the equivalent function under relevant
G 334a aspects described in paragraph 1 sectorial Union law, the aspects G
may be part of the quality described in paragraph 1 may be

management systems pursuant to part of the quality management
that law. systems pursuant to that law.
Article 17(3)
3. For providers that are credit 3. For providers that are credit 3. For providers that are 3. For providers that are
institutions regulated by Directive institutions regulated by Directive creditfinancial institutions regulated creditfinancial institutions regulated
2013/36/ EU, the obligation to put a 2013/36/ EU, the obligation to put a by Directive 2013/36/ EUsubject to by Directive 2013/36/ EUsubject to
G 335 quality management system in place quality management system in place requirements regarding their requirements regarding their G
shall be deemed to be fulfilled by shall be deemed to be fulfilled by internal governance, arrangements internal governance, arrangements
complying with the rules on internal complying with the rules on internal or processes under Union financial or processes under Union financial
governance arrangements, processes governance arrangements, processes services legislation, the obligation to services legislation, the obligation to
and mechanisms pursuant to Article and mechanisms pursuant to Article put in place a quality management put in place a quality management
74 of that Directive. In that context, 74 of that Directive. In that context, system in placewith the exception of system in placewith the exception of
any harmonised standards referred to any harmonised standards referred to paragraph 1, points (g), (h) and (i) paragraph 1, points (g), (h) and (i)
in Article 40 of this Regulation shall in Article 40 of this Regulation shall shall be deemed to be fulfilled by shall be deemed to be fulfilled by
be taken into account. be taken into account. complying with the rules on internal complying with the rules on internal
governance arrangements, processes governance arrangements, processes
and mechanisms or processes and mechanisms or processes
pursuant to Article 74 of that pursuant to Article 74 of that
Directivethe relevant Union Directivethe relevant Union
financial services legislation. In that financial services legislation. In that
context, any harmonised standards context, any harmonised standards
referred to in Article 40 of this referred to in Article 40 of this
Regulation shall be taken into Regulation shall be taken into
account. account.
Article 18

Obligation to draw up technical deleted Obligation to draw up technical Obligation to draw up technical
G 336 documentation documentationDocumentation documentationDocumentation G
keeping keeping
Article 18(1)
1. Providers of high-risk AI systems 1. Providers of high-risk AI systems 1. Providers of high-risk AI systems

shall draw up the technical deleted shall draw up the technical shall draw up the technical
documen-tation referred to in Article documen-tation referred to in Article documen-tation referred to in Article
11 in accordance with Annex IV. 11 in accordance with Annex IV.The 11 in accordance with Annex IV.The
G 337 provider shall, for a period ending provider shall, for a period ending G
10 years after the AI system has 10 years after the AI system has
been placed on the market or put been placed on the market or put
into service, keep at the disposal of into service, keep at the disposal of
the national competent authorities: the national competent authorities:
(a) the technical documentation (a) the technical documentation

G 337a referred to in Article 11; referred to in Article 11; G
(b) the documentation concerning (b) the documentation concerning

the quality management system the quality management system
G 337b referred to in Article 17; referred to in Article 17; G
(c) the documentation concerning (c) the documentation concerning

the changes approved by notified the changes approved by notified
G 337c bodies where applicable; bodies where applicable; G
(d) the decisions and other (d) the decisions and other
documents issued by the notified documents issued by the notified
G 337d bodies where applicable; bodies where applicable; G

G 337e G
(e) the EU declaration of (e) the EU declaration of
conformity referred to in Article 48. conformity referred to in Article 48.
1a. Each Member State shall 1a. Each Member State shall
determine conditions under which determine conditions under which
the documentation referred to in the documentation referred to in
paragraph 1 remains at the disposal paragraph 1 remains at the disposal
of the national competent of the national competent
authorities for the period indicated authorities for the period indicated
G 337f in that paragraph for the cases in that paragraph for the cases G
when a provider or its authorised when a provider or its authorised

representative established on its representative established on its
territory goes bankrupt or ceases its territory goes bankrupt or ceases its
activity prior to the end of that activity prior to the end of that
period. period.
Article 18(2)
2. Providers that are credit 2. Providers that are creditfinancial 2. Providers that are creditfinancial
institutions regulated by Directive deleted institutions regulated by Directive institutions regulated by Directive
2013/36/EU shall maintain the 2013/36/EUsubject to requirements 2013/36/EUsubject to requirements
technical documentation as part of regarding their internal regarding their internal
the documentation concerning governance, arrangements or governance, arrangements or
G 338 internal governance, arrangements, processes under Union financial processes under Union financial G
processes and mechanisms pursuant services legislation shall maintain services legislation shall maintain
to Article 74 of that Directive. the technical documentation as part the technical documentation as part
of the documentation concerning of the documentation concerning
internal governance, arrangements, internal governance, arrangements,
processes and mechanisms pursuant processes and mechanisms pursuant
to Article 74 of that Directivekept to Article 74 of that Directivekept
under the relevant Union financial under the relevant Union financial
services legislation. services legislation.
Article 19

G 339 G
Conformity assessment deleted Conformity assessment Conformity assessmentdeleted
Article 19(1)
1. Providers of high-risk AI systems 1. Providers of high-risk AI systems 1. Providers of high-risk AI systems

shall ensure that their systems deleted shall ensure that their systems shall ensure that their systems
undergo the relevant conformity undergo the relevant conformity undergo the relevant conformity
assessment procedure in accordance assessment procedure in accordance assessment procedure in accordance
with Article 43, prior to their placing with Article 43, prior to their placing with Article 43, prior to their
on the market or putting into service. on the market or putting into service. placing on the market or putting into
Where the compliance of the AI Where the compliance of the AI service. Where the compliance of the
systems with the requirements set systems with the requirements set AI systems with the requirements set
G 340 G
out in Chapter 2 of this Title has out in Chapter 2 of this Title has out in Chapter 2 of this Title has
been demonstrated following that been demonstrated following that been demonstrated following that
conformity assessment, the providers conformity assessment, the providers conformity assessment, the providers
shall draw up an EU declaration of shall draw up an EU declaration of shall draw up an EU declaration of
conformity in accordance with conformity in accordance with conformity in accordance with
Article 48 and affix the CE marking Article 48 and affix the CE marking Article 48 and affix the CE marking
of conformity in accordance with of conformity in accordance with of conformity in accordance with
Article 49. Article 49. Article 49.deleted
Article 19(2)
2. For high-risk AI systems referred 2. For high-risk AI systems referred

G 341 G
to in point 5(b) of Annex III that are deleted deleted to in point 5(b) of Annex III that are
placed on the market or put into placed on the market or put into
service by providers that are credit service by providers that are credit
institutions regulated by Directive institutions regulated by Directive
2013/36/EU, the conformity 2013/36/EU, the conformity
assessment shall be carried out as assessment shall be carried out as
part of the procedure referred to in part of the procedure referred to in
Articles 97 to101 of that Directive. Articles 97 to101 of that
Directive.deleted
Article 20

Automatically generated logs Automatically generated logs Automatically generated logs Automatically generated logs
G 342 G

Proposal
Article 20(1)
1. Providers of high-risk AI systems 1. Providers of high-risk AI systems 1. Providers of high-risk AI systems 1. Providers of high-risk AI systems
shall keep the logs automatically shall keep the logs automatically shall keep the logs, referred to in shall keep the logs, referred to in
generated by their high-risk AI generated by their high-risk AI Article 12(1), automatically Article 12(1), automatically
systems, to the extent such logs are systems, to the extent such logs are generated by their high-risk AI generated by their high-risk AI
under their control by virtue of a under their control by virtue of a systems, to the extent such logs are systems, to the extent such logs are
contractual arrangement with the contractual arrangement with the under their control by virtue of a under their control by virtue of a
user or otherwise by law. The logs user or otherwise by law.. Without contractual arrangement with the contractual arrangement with the
shall be kept for a period that is prejudice to applicable Union or user or otherwise by law. The user or otherwise by law.. Without
G 343 G
appropriate in the light of the national law, the logs shall be kept logsThey shall be keptkeep them for prejudice to applicable Union or
intended purpose of high-risk AI for a period that is appropriate in a period that is appropriate in the national law, the logs shall be kept
system and applicable legal the light of the intended purpose of light of the intended purpose of high- for a period that is appropriate in the
obligations under Union or national high-risk AI system and applicable risk AI system and applicable legal light ofto the intended purpose of the
law. legal obligations under Union or obligations under Union or national high-risk AI system, of at least 6
national lawof at least 6 months. lawof at least six months, unless months, unless provided otherwise
The retention period shall be in provided otherwise in applicable in applicable and applicable legal
accordance with industry standards Union or national law, in particular obligations under Union or national
and appropriate to the intended in Union law on the protection of law, in particular in Union law on
purpose of high-risk AI system. personal data. the protection of personal data.
Article 20(2)
2. Providers that are credit 2. Providers that are credit 2. Providers that are creditfinancial 2. Providers that are creditfinancial
institutions regulated by Directive institutions regulated by Directive institutions regulated by Directive institutions regulated by Directive
2013/36/EU shall maintain the logs 2013/36/EU shall maintain the logs 2013/36/EUsubject to requirements 2013/36/EUsubject to requirements
automatically generated by their automatically generated by their regarding their internal regarding their internal
high-risk AI systems as part of the high-risk AI systems as part of the governance, arrangements or governance, arrangements or
documentation under Articles 74 of documentation under Articles 74 of processes under Union financial processes under Union financial
that Directive. that Directive. services legislation shall maintain services legislation shall maintain
G 344 the logs automatically generated by the logs automatically generated by G
their high-risk AI systems as part of their high-risk AI systems as part of

the documentation kept under the documentation kept under
Articles 74 of that Directivethe Articles 74 of that Directivethe
relevant financial service relevant financial service
legislation. legislation.
Article 21

Corrective actions Corrective actions Corrective actions Corrective actions and duty of
G 345 information G

Proposal
Article 21
G 345a G
deleted

Providers of high-risk AI systems Providers of high-risk AI systems Providers of high-risk AI systems Providers of high-risk AI systems
which consider or have reason to which consider or have reason to which consider or have reason to which consider or have reason to
consider that a high-risk AI system consider that a high-risk AI system consider that a high-risk AI system consider that a high-risk AI system
which they have placed on the which they have placed on the which they have placed on the which they have placed on the
market or put into service is not in market or put into service is not in market or put into service is not in market or put into service is not in
conformity with this Regulation conformity with this Regulation conformity with this Regulation conformity with this Regulation
shall immediately take the necessary shall immediately take the necessary shall immediately investigate, where shall immediately take the necessary
corrective actions to bring that corrective actions to bring that applicable, the causes in corrective actions to bring that
system into conformity, to withdraw system into conformity, to withdraw collaboration with the reporting system into conformity, to withdraw
it or to recall it, as appropriate. They it, to disable it or to recall it, as user and take the necessary it, to disable it, or to recall it, as
shall inform the distributors of the appropriate. corrective actions to bring that appropriate. They shall inform the
high-risk AI system in question and, In the cases referred to in the first system into conformity, to withdraw distributors of the high-risk AI
G 346 where applicable, the authorised paragraph, providers They shall it or to recall it, as appropriate. They system in question and, where G
representative and importers immediately inform: shall inform the distributors of the applicable, the deployers, the
accordingly. a. the distributors; high-risk AI system in question and, authorised representative and
b. the importers; where applicable, the authorised importers accordingly.
c. the national competent representative and importers
authorities of the high-riskMember accordingly.
States in which they made the AI
system in question and,available or
put it into service; and
d. where applicable, the
authorised representative and
importers accordinglypossible, the
deployer.
The providers shall also inform the Where the high-risk AI system
authorised representative, if one presents a risk within the meaning
was appointed in accordance with of Article 65(1) and the provider
G 346a G
Article 25, and the notified body if becomes aware of that risk, they
the high-risk AI system had to shall immediately investigate the
undergo a third-party conformity causes, in collaboration with the
assessment in accordance with reporting deployer, where
Article 43. Where applicable, they applicable, and inform the market
shall also investigate the causes in surveillance authorities of the
collaboration with the deployer. 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 22

Duty of information Duty of information Duty of information Duty of informationdeleted
G 347 G

Proposal
Where the high-risk AI system Where the high-risk AI system Where the high-risk AI system Where the high-risk AI system
presents a risk within the meaning of presents a risk within the meaning of presents a risk within the meaning of presents a risk within the meaning of
Article 65(1) and that risk is known Article 65(1) and that risk is known Article 65(1) and that risk is known Article 65(1) and that risk is known
to the provider of the system, that to the provider of the systemthe to the provider of the system, that to the provider of the system, that
provider shall immediately inform provider of the system becomes provider shall immediately inform provider shall immediately inform
G 348 the national competent authorities of aware of that risk, that provider the national competent authorities of the national competent authorities of G
the Member States in which it made shall immediately inform the the Member States in which it made the Member States in which it made
the system available and, where national competentsupervisory the system available and, where the system available and, where
applicable, the notified body that authorities of the Member States in applicable, the notified body that applicable, the notified body that
issued a certificate for the high-risk which it made the system available issued a certificate for the high-risk issued a certificate for the high-risk
AI system, in particular of the non- and, where applicable, the notified AI system, in particular of the non- AI system, in particular of the non-
compliance and of any corrective body that issued a certificate for the compliance and of any corrective compliance and of any corrective
actions taken. high-risk AI system, in particular the actions taken. actions taken.
nature of the non-compliance and of
any relevant corrective actions
taken.
1a In the cases referred to inthe

first paragraph, providers of the
high-risk AI system shall
immediately inform:
a) the distributors;
G 348a b) the importers; G
c) the national competent

authorities of the Member States in
which they made the AI system
available or put it into service; and
d) where possible, the deployers.
1b The providers shall also inform

the authorised representative, if one
G 348b G
was appointed in accordance with
Article 25.
G 348c G
deleted
Article 22, fifth paragraph

G 348d G
deleted
Article 22, sixth paragraph
G 348e G
deleted
Article 23

Cooperation with competent Cooperation with competent Cooperation with competent Cooperation with competent
G 349 G
authorities authorities, the Office and the authorities authorities
Commission
Providers of high-risk AI systems Providers and where applicable, Providers of high-risk AI systems Providers of high-risk AI systems
shall, upon request by a national deployers of high-risk AI systems shall, upon request by a national shall, upon a reasoned request by a
competent authority, provide that shall, upon a reasoned request by a competent authority, provide that national competent authority,
authority with all the information national competent authority or authority with all the information provide that authority with all the
and documentation necessary to where applicable, by the AI Office and documentation necessary to information and documentation
demonstrate the conformity of the or the Commission, provide them, demonstrate the conformity of the necessary to demonstrate the
high-risk AI system with the provide that authority with all the high-risk AI system with the conformity of the high-risk AI
requirements set out in Chapter 2 of information and documentation requirements set out in Chapter 2 of system with the requirements set out
G 350 G
this Title, in an official Union necessary to demonstrate the this Title, in an official Union in Chapter 2 of this Title, in an
language determined by the Member conformity of the high-risk AI language determineda language official Uniona language determined
State concerned. Upon a reasoned system with the requirements set out which can be easily understood by by the Member State concerned.
request from a national competent in Chapter 2 of this Title, in an the authority of the Member State Upon a reasoned request from a
authority, providers shall also give official Union language determined concerned. Upon a reasoned request national competent authority,
that authority access to the logs by the Member State concerned. from a national competent authority, providers shall also give that
automatically generated by the high- Upon a reasoned request from a providers shall also give that authority access to the logs
risk AI system, to the extent such national competent authority, authority access to the logs, referred automatically generatedwhich can
logs are under their control by virtue providers shall also give that to in Article 12(1), automatically be easily understood by the high-
of a contractual arrangement with authority access to the logs generated by the high-risk AI risk AI system, to the extent such
the user or otherwise by law. automatically generated by the high- system, to the extent such logs are logs are under their control by virtue
risk AI system, to the extent such under their control by virtue of a of a contractual arrangement with
logs are under their control by virtue contractual arrangement with the the user or otherwise by
of a contractual arrangement with user or otherwise by law. lawauthority in an official Union
the user or otherwise by law. language determined by the
Member State concerned.
G 350a G
deleted
1a Upon a reasoned request by a 1a Upon a reasoned request by a

national competent authority or, national competent authority
where applicable, by the providers shall also give the
Commission, providers and, where requesting national competent
applicable, deployers shall also give authority, as applicable, access to
G 350b the requesting national competent the logs referred to in Article 12(1) G
authority or the Commission, as automatically generated by the

applicable, access to the logs high-risk AI system to the extent
automatically generated by the such logs are under their control.
high-risk AI system, to the extent
such logs are under their control.
Article 23, paragraph 1b
(1b) Any information obtained by a (1b) Any information obtained by a

national competent authority or by national competent authority
G 350c G
the Commission pursuant to the pursuant to the provisions of this
provisions of this Article shall be Article shall be treated in
considered a trade secret and be compliance with the confidentiality
treated in compliance with the obligations set out in Article 70.
confidentiality obligations set out in
Article 70.
Article 23a
Article 23a
Conditions for other persons to be Deleted from here, included in article
G 350d 28
G
subject to the obligations of a
provider
Article 23a(1)
1. Any natural or legal person shall

be considered a provider of a new
high-risk AI system for the
G 350e purposes of this Regulation and G
shall be subject to the obligations of

the provider under Article 16, in
any of the following circumstances:
Article 23a(1), point (a)
(a) they put their name or

trademark on a high-risk AI system
already placed on the market or put
G 350f into service, without prejudice to G
contractual arrangements
stipulating that the obligations are
allocated otherwise;
Article 23a(1), point (b)

G 350g G
(b) they make a substantial
modification to a high-risk AI
system already placed on the
market or put into service;
Article 23a(1), point (c)
(c) they modify the intended

purpose of an AI system which is
not high-risk and is already placed
G 350h G
on the market or put ito service, in
a way which makes the modified
system a high-risk AI system;
Article 23a(1), point (d)
(d) they place on the market or put

into service a general purpose AI
G 350i system as a high-risk AI system or G
as a component of a high-risk AI
system.
Article 23a(2)
2. Where the circumstances

referred to in paragraph 1, point (a)
or (c), occur, the provider that
initially placed the high-risk AI
G 350j G
system on the market or put it into
service shall no longer be
considered a provider for the
purposes of this Regulation.
Article 23a(3), first subparagraph

3. For high-risk AI systems that

are safety components of products
to which the legal acts listed in
Annex II, section A apply, the
manufacturer of those products
G 350k G
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:
Article 23a(3), second subparagraph
(i) the high-risk AI system is

placed on the market together with
the product under the name or
trademark of the product
manufacturer;
G 350l G
(ii) the high-risk AI system is put
into service under the the name or
trademark of the product
manufacturer after the product has
been placed on the market.
Article 23a
G 350m G
deleted
Article 24
G 351 Article 24 Article 24 G
Obligations of product Obligations of product deleted

manufacturers manufacturers
Where a high-risk AI system related Where a high-risk AI system related

to products to which the legal acts to products to which the legal acts deleted
listed in Annex II, section A, apply, listed in Annex II, section A, apply,
is placed on the market or put into is placed on the market or put into
service together with the product service together with the product
manufactured in accordance with manufactured in accordance with
those legal acts and under the name those legal acts and under the name
G 352 of the product manufacturer, the of the product manufacturer, the G
manufacturer of the product shall manufacturer of the product shall

take the responsibility of the take the responsibility of the
compliance of the AI system with compliance of the AI system with
this Regulation and, as far as the AI this Regulation and, as far as the AI
system is concerned, have the same system is concerned, have the same
obligations imposed by the present obligations imposed by the present
Regulation on the provider. Regulation on the provider.
Article 25

Authorised representatives Authorised representatives Authorised representatives Authorised representatives
G 353 G

Proposal
Article 25(1)
1. Prior to making their systems 1. Prior to making their systems 1. Prior to making their systems 1. Prior to making their systems
G 354 available on the Union market, available on the Union market, available on the Union market, available on the Union market, G
where an importer cannot be where an importer cannot be where an importer cannot be where an importer cannot be
identified, providers established identified, providers established identified, providers established identified, providers established
outside the Union shall, by written outside the Union shall, by written outside the Union shall, by written outside the Union shall, by written
mandate, appoint an authorised mandate, appoint an authorised mandate, appoint an authorised mandate, appoint an authorised
representative which is established representative which is established representative which is established representative which is established
in the Union. in the Union. in the Union. in the Union.
Article 25(1a)
1a. The authorised representative

shall reside or be established in one
G 354a of the Member States where the G
activities pursuant to Article 2,

paragraphs 1(cb) are taking place.
Article 25(1b)
1b. The provider shall provide its 1b. The provider shall enable its
authorised representative with the authorised representative to
G 354b necessary powers and resources to perform its tasks under this G
comply with its tasks under this Regulation.

Regulation.
Article 25(1c)(2)
2. The authorised representative 2. The authorised representative 2. The authorised representative 2. The authorised representative
shall perform the tasks specified in shall perform the tasks specified in shall perform the tasks specified in shall perform the tasks specified in
the mandate received from the the mandate received from the the mandate received from the the mandate received from the
provider. The mandate shall provider. It shall provide a copy of provider. For the purpose of this provider. It shall provide a copy of
G 355 G
empower the authorised the mandate to the market Regulation, the mandate shall the mandate to the market
representative to carry out the surveillance authorities upon empower the authorised surveillance authorities upon
following tasks: request, in one of the official representative to carry out only the request, in one of the official
languages of the institution of the following tasks: languages of the institution of the
Union determined by the national Union determined by the national
competent authority. For the competent authority. For the
purpose of this Regulation, the purpose of this Regulation, the
mandate shall empower the mandate shall empower the
authorised representative to carry out authorised representative to carry out
the following tasks: the following tasks:
Article 25(1c)(2), point (-a)
(-a) verify that the EU declaration (-a) verify that the EU declaration
of conformity and the technical of conformity and the technical
documentation have been drawn up documentation have been drawn up
G 355a and that an appropriate conformity and that an appropriate conformity G
assessment procedure has been assessment procedure has been

carried out by the provider; carried out by the provider;
Article 25(1c)(2), point (a)
(a) keep a copy of the EU (a) keep a copy ofensure that the (a) keep a copyat the disposal of the (a) keep a copyat the disposal of the
declaration of conformity and the EU declaration of conformity and EU declaration of conformity and EU declaration of conformity and
technical documentation at the the technical documentation at the the technical documentation at the the technical documentation at the
disposal of the national competent disposal of the national competent disposalnational competent disposalnational competent
authorities and national authorities authorities and national authorities authorities and national authorities authorities and national authorities
referred to in Article 63(7); referred to in Article 63(7)have been referred to in Article 63(7), for a referred to in Article 63(7), for a
drawn up and that an appropriate period ending 10 years after the period ending 10 years after the
G 356 G
conformity assessment procedure high-risk AI system has been placed high-risk AI system has been placed
has been carried out by the on the market or put into service, on the market or put into service,
provider; the contact details of the national the contact details of the national
competent authorities and national competent authorities and national
authorities referred to in Article authorities referred to in Article
63(7)provider by which the 63(7)provider by which the
authorised representative has been authorised representative has been
appointed, a copy of the EU appointed, a copy of the EU
declaration of conformity, the declaration of conformity, the
technical documentation and, if technical documentation and, if
applicable, the certificate issued by applicable, the certificate issued by
the notified body; the notified body;
Article 25, second paragraph, point (aa)
(aa) keep at the disposal of the

national competent authorities and
national authorities referred to in
Article 63(7), a copy of the EU
G 356a G
declaration of conformity, the
technical documentation and, if
applicable, the certificate issued by
the notified body;
Article 25(1c)(2), point (b)
(b) provide a national competent (b) provide a national competent (b) provide a national competent (b) provide a national competent
authority, upon a reasoned request, authority, upon a reasoned request, authority, upon a reasoned request, authority, upon a reasoned request,
with all the information and with all the information and with all the information and with all the information and
documentation necessary to documentation necessary to documentation, including that kept documentation, including that kept
demonstrate the conformity of a demonstrate the conformity of a according to point (b), necessary to according to point (a), necessary to
high-risk AI system with the high-risk AI system with the demonstrate the conformity of a demonstrate the conformity of a
requirements set out in Chapter 2 of requirements set out in Chapter 2 of high-risk AI system with the high-risk AI system with the
G 357 G
this Title, including access to the this Title, including access to the requirements set out in Chapter 2 of requirements set out in Chapter 2 of
logs automatically generated by the logs automatically generated by the this Title, including access to the this Title, including access to the
high-risk AI system to the extent high-risk AI system to the extent logs, referred to in Article 12(1), logs, as referred to in Article 12(1),
such logs are under the control of the such logs are under the control of the automatically generated by the high- automatically generated by the high-
provider by virtue of a contractual provider by virtue of a contractual risk AI system to the extent such risk AI system to the extent such
arrangement with the user or arrangement with the user or logs are under the control of the logs are under the control of the
otherwise by law; otherwise by law; provider by virtue of a contractual provider by virtue of a contractual
arrangement with the user or arrangement with the user or
otherwise by law; otherwise by law;
Article 25(1c)(2), point (c)
(c) cooperate with competent (c) cooperate with competent (c) cooperate with competent (c) cooperate with competent
national authorities, upon a reasoned national supervisory authorities, national competent authorities, upon national authorities, upon a reasoned
request, on any action the latter takes upon a reasoned request, on any a reasoned request, on any action the request, on any action the latter takes
in relation to the high-risk AI action the latterauthority takes in latter takes in relation to the high- in relation to the high-risk AI
G 358 system. relation toto reduce and mitigate risk AI system.; system., in particular to reduce and G
the risks posed by the high-risk AI mitigate the risks posed by the high-
system.; risk AI system;
(ca) comply with the registration

obligations referred to in Article
51(1) and, if the registration of the
G 358a system is carried out by the provider G
itself, verify that the information

referred to in Annex VIII, Part II, 1
to 11, is correct.
Article 25(1c)(2), point (ca)
(ca) where applicable, comply with (ca) where applicable, comply with
the registration obligations referred the registration obligations referred
in Article 51, or, if the registration in Article 51(1), or, if the
G 358b G
is carried out by the provider itself, registration is carried out by the
ensure that the information provider itself, ensure that the
referred to in point 3 of Annex VIII information referred to in [point 3]
is correct. of Annex VIII is correct.
Article 25, paragraph 2a
2a The authorised representative 2a The mandate shall empower the

shall be mandated to be addressed, authorised representative to be
in addition to or instead of the addressed, in addition to or instead
provider, by, in particular, the of the provider, by the competent
G 358c national supervisory authority or authorities, on all issues related to G
the national competent authorities, ensuring compliance with this

on all issues related to ensuring Regulation.
compliance with this Regulation.
Article 25, paragraph 2b
(2b) The authorised representative (2b) The authorised representative

shall terminate the mandate if it shall terminate the mandate if it
considers or has reason to consider considers or has reason to consider
that the provider acts contrary to its that the provider acts contrary to its
obligations under this Regulation. obligations under this Regulation.
In such a case, it shall also In such a case, it shall also
immediately inform the national immediately inform the market
G 358d supervisory authority of the surveillance authority of the G
Member State in which it is Member State in which it is

established, as well as, where established, as well as, where
applicable, the relevant notified applicable, the relevant notified
body, about the termination of the body, about the termination of the
mandate and the reasons thereof. mandate and the reasons thereof.

G 358e G
2a. The authorised representative
shall terminate the mandate if it has
sufficient reasons to consider that
the provider acts contrary to its
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 25(1d)
The authorised representative shall

be legally liable for defective AI
systems on the same basis as, and
G 358f jointly and severally with, the G
provider in respect of its potential

liability under Council Directive
85/374/EEC.
Article 26

Obligations of importers Obligations of importers Obligations of importers Obligations of importers
G 359 G

Proposal
Article 26(1)
G 360 G
1. Before placing a high-risk AI 1. Before placing a high-risk AI 1. Before placing a high-risk AI 1. Before placing a high-risk AI
system on the market, importers of system on the market, importers of system on the market, importers of system on the market, importers of
such system shall ensure that: such system shall ensure that such a such system shall ensure that such a such system shall ensure that such a
system is in conformity with this system is in conformity with this system is in conformity with this
Regulation by ensuring that: Regulation by verifying that: Regulation by verifying that:
(a) the appropriate conformity (a) the appropriaterelevant (a) the appropriaterelevant (a) the appropriaterelevant
assessment procedure has been conformity assessment procedure conformity assessment procedure conformity assessment procedure
carried out by the provider of that AI referred to in Article 43 has been referred to in Article 43 has been referred to in Article 43 has been
G 361 system carried out by the provider of that AI carried out by the provider of that AI carried out by the provider of that AI G
system; system; system;

(b) the provider has drawn up the (b) the provider has drawn up the (b) the provider has drawn up the (b) the provider has drawn up the
technical documentation in technical documentation in technical documentation in technical documentation in
G 362 accordance with Annex IV; accordance with Article 11 and accordance with Annex IV; accordance with Article 11 and G
Annex IV; Annex IV;

(c) the system bears the required (c) the system bears the required (c) the system bears the required CE (c) the system bears the required CE
conformity marking and is conformity marking and is conformity marking and is conformity marking and is
G 363 accompanied by the required accompanied by the required accompanied by the required accompanied by the required G
documentation and instructions of documentation and instructions of documentationEU declaration of documentationEU declaration of
use. use. conformity and instructions of use.; conformity and instructions of use.;
(ca) the authorised representative

G 363a referred to in Article 25 has been G
established by the provider.
(ca) where applicable, the provider (ca) the provider has appointed an
has appointed an authorised authorised representative in
G 363b representative in accordance with accordance with Article 25(1). G
Article 25(1).
Article 26(2)
2. Where an importer considers or 2. Where an importer considers or 2. Where an importer considers or 2. Where an importer considers or
has reason to consider that a high- has reason to consider that a high- has reasonhas sufficient reasons to hashas sufficient reason to consider
risk AI system is not in conformity risk AI system is not in conformity consider that a high-risk AI system that a high-risk AI system is not in
with this Regulation, it shall not with this Regulation, or is is not in conformity with this conformity with this Regulation, or
place that system on the market until counterfeit, or accompanied by Regulation, or is falsified, or is falsified, or accompanied by
that AI system has been brought into falsified documentation it shall not accompanied by falsified falsified documentation, it shall not
conformity. Where the high-risk AI place that system on the market until documentation, it shall not place place that system on the market until
G 364 system presents a risk within the that AI system has been brought into that system on the market until that that AI system has been brought into G
meaning of Article 65(1), the conformity. Where the high-risk AI AI system has been brought into conformity. Where the high-risk AI
importer shall inform the provider of system presents a risk within the conformity. Where the high-risk AI system presents a risk within the
the AI system and the market meaning of Article 65(1), the system presents a risk within the meaning of Article 65(1), the
surveillance authorities to that effect. importer shall inform the provider of meaning of Article 65(1), the importer shall inform the provider of
the AI system and the market importer shall inform the provider of the AI system , the authorised
surveillance authorities to that effect. the AI system, the authorised representatives and the market
representatives and the market surveillance authorities to that effect.
surveillance authorities to that effect.
Article 26(3)
3. Importers shall indicate their 3. Importers shall indicate their 3. Importers shall indicate their 3. Importers shall indicate their
name, registered trade name or name, registered trade name or name, registered trade name or name, registered trade name or
registered trade mark, and the registered trade mark, and the registered trade mark, and the registered trade mark, and the
address at which they can be address at which they can be address at which they can be address at which they can be
G 365 contacted on the high-risk AI system contacted on the high-risk AI system contacted on the high-risk AI system contacted on the high-risk AI system G
or, where that is not possible, on its or, where that is not possible,and on or, where that is not possible, on its or, where that is not possible,and on
packaging or its accompanying its packaging or its accompanying packaging or its accompanying its packaging or its accompanying
documentation, as applicable. documentation, aswhere applicable. documentation, as applicable. documentation, aswhere applicable.
Article 26(4)
4. Importers shall ensure that, while 4. Importers shall ensure that, while 4. Importers shall ensure that, while 4. Importers shall ensure that, while
a high-risk AI system is under their a high-risk AI system is under their a high-risk AI system is under their a high-risk AI system is under their
responsibility, where applicable, responsibility, where applicable, responsibility, where applicable, responsibility, where applicable,
storage or transport conditions do storage or transport conditions do storage or transport conditions do storage or transport conditions do
G 366 not jeopardise its compliance with not jeopardise its compliance with not jeopardise its compliance with not jeopardise its compliance with G
the requirements set out in Chapter 2 the requirements set out in Chapter 2 the requirements set out in Chapter 2 the requirements set out in Chapter 2
of this Title. of this Title. of this Title. of this Title.
Article 26(4a)
4a. Importers shall keep, for a 4a. Importers shall keep, for a
period ending 10 years after the AI period ending 10 years after the AI
system has been placed on the system has been placed on the
G 366a G
market or put into service, a copy of market or put into service, a copy of
the certificate issued by the notified the certificate issued by the notified
body, where applicable, of the body, where applicable, of the
instructions for use and of the EU instructions for use and of the EU
declaration of conformity. declaration of conformity.
Article 26(5)
5. Importers shall provide national 5. Importers shall provide national 5. Importers shall provide national 5. Importers shall provide national
competent authorities, upon a competent authorities, upon a competent authorities, upon a competent authorities, upon a
reasoned request, with all necessary reasoned request, with all the reasoned request, with all necessary reasoned request, with all the
information and documentation to necessary information and information and documentation, necessary information and
demonstrate the conformity of a documentation to demonstrate the including that kept in accordance documentation including that kept
high-risk AI system with the conformity of a high-risk AI system with paragraph 5, to demonstrate in accordance with paragraph 4a to
requirements set out in Chapter 2 of with the requirements set out in the conformity of a high-risk AI demonstrate the conformity of a
this Title in a language which can be Chapter 2 of this Title in a language system with the requirements set out high-risk AI system with the
easily understood by that national which can be easily understood by in Chapter 2 of this Title in a requirements set out in Chapter 2 of
competent authority, including that national competent language which can be easily this Title in a language which can be
access to the logs automatically authoritythem, including access to understood by that national easily understood by that national
generated by the high-risk AI system the logs automatically generated by competent authority, including competent authority, including
G 367 to the extent such logs are under the the high-risk AI system to the extent access to the logs automatically access to the logs automatically G
control of the provider by virtue of a such logs are under the control of the generated by the high-risk AI system generated by the high-risk AI system
contractual arrangement with the provider by virtue of a contractual to the extent such logs are under the to the extent such logs are under the
user or otherwise by law. They shall arrangement with the user or control of the provider by virtue of a control of the provider by virtue of a
also cooperate with those authorities otherwise by law. They shall also contractual arrangement with the contractual arrangement with the
on any action national competent cooperate with those authorities on user or otherwise by law.. To this user or otherwise by law.them. To
authority takes in relation to that any action national competent purpose they shall also cooperate this purpose they shall also
system. authority takes in relation to that with those authorities on any action cooperate with those authorities on
system.in accordance with Article national competent authority takes any action national competent
20. in relation to that systemensure that authority takes in relation to that
the technical documentation can be systemensure that the technical
made available to those authorities. documentation can be made
available to those authorities.
Article 26(5a)
G 367a 5a. Importers shall cooperate with G

national competent authorities on
any action those authorities take in
relation to an AI system, of which
they are the importer.
Article 26(5b)
5a. Importers shall cooperate with 5a. Importers shall cooperate with
national competent authorities on national competent authorities on
any action those authorities take to any action those authorities take, in
G 367b reduce and mitigate the risks posed particular to reduce and mitigate G
by the high-risk AI system. the risks posed by the high-risk AI

system.
Article 27

Obligations of distributors Obligations of distributors Obligations of distributors Obligations of distributors
G 368 G

Proposal
Article 27(1)
1. Before making a high-risk AI 1. Before making a high-risk AI 1. Before making a high-risk AI 1. Before making a high-risk AI
system available on the market, system available on the market, system available on the market, system available on the market,
distributors shall verify that the distributors shall verify that the distributors shall verify that the distributors shall verify that the
high-risk AI system bears the high-risk AI system bears the high-risk AI system bears the high-risk AI system bears the
G 369 G
required CE conformity marking, required CE conformity marking, required CE conformity marking, required CE conformity marking,
that it is accompanied by the that it is accompanied by the that it is accompanied by the that it is accompanied by the
required documentation and required documentation and required documentationa copy of required documentationa copy of
instruction of use, and that the instruction of use, and that the EU declaration of conformity and EU declaration of conformity and
provider and the importer of the provider and the importer of the instruction of use, and that the instruction of use, and that the
system, as applicable, have complied system, as applicable, have complied provider and the importer of the provider and the importer of the
with the obligations set out in this with thetheir obligations set out in system, as applicable, have complied system, as applicable, have complied
Regulation. this Regulation in Articles 16 and 26 with thetheir obligations set out in with thetheir obligations set out in
respectively. this RegulationArticle 16, point (b) this RegulationArticle 16, point (aa)
and 26(3) respectively. and (b) and 26(3) respectively.
Article 27(2)
2. Where a distributor considers or 2. Where a distributor considers or 2. Where a distributor considers or 2. Where a distributor considers or
has reason to consider that a high- has reason to consider, on the basis has reason to consider that a high- has reason to consider, on the basis
risk AI system is not in conformity of the information in its possession risk AI system is not in conformity of the information in its possession,
with the requirements set out in that a high-risk AI system is not in with the requirements set out in that a high-risk AI system is not in
Chapter 2 of this Title, it shall not conformity with the requirements set Chapter 2 of this Title, it shall not conformity with the requirements set
make the high-risk AI system out in Chapter 2 of this Title, it shall make the high-risk AI system out in Chapter 2 of this Title, it shall
available on the market until that not make the high-risk AI system available on the market until that not make the high-risk AI system
system has been brought into available on the market until that system has been brought into available on the market until that
G 370 conformity with those requirements. system has been brought into conformity with those requirements. system has been brought into G
Furthermore, where the system conformity with those requirements. Furthermore, where the system conformity with those requirements.
presents a risk within the meaning of Furthermore, where the system presents a risk within the meaning of Furthermore, where the system
Article 65(1), the distributor shall presents a risk within the meaning of Article 65(1), the distributor shall presents a risk within the meaning of
inform the provider or the importer Article 65(1), the distributor shall inform the provider or the importer Article 65(1), the distributor shall
of the system, as applicable, to that inform the provider or the importer of the system, as applicable, to that inform the provider or the importer
effect. of the system, the relevant national effect. of the system, as applicable, to that
competent authority, as applicable, effect.
to that effect.
Article 27(3)
3. Distributors shall ensure that, 3. Distributors shall ensure that, 3. Distributors shall ensure that, 3. Distributors shall ensure that,
while a high-risk AI system is under while a high-risk AI system is under while a high-risk AI system is under while a high-risk AI system is under
their responsibility, where their responsibility, where their responsibility, where their responsibility, where
G 371 G
applicable, storage or transport applicable, storage or transport applicable, storage or transport applicable, storage or transport
conditions do not jeopardise the conditions do not jeopardise the conditions do not jeopardise the conditions do not jeopardise the
compliance of the system with the compliance of the system with the compliance of the system with the compliance of the system with the
this Title. this Title. this Title. this Title.
Article 27(4)
4. A distributor that considers or has 4. A distributor that considers or has 4. A distributor that considers or has 4. A distributor that considers or has
reason to consider that a high-risk AI reason to consider, on the basis of reason to consider that a high-risk AI reason to consider, on the basis of
system which it has made available the information in its possession, system which it has made available the information in its possession,
on the market is not in conformity that a high-risk AI system which it on the market is not in conformity that a high-risk AI system which it
with the requirements set out in has made available on the market is with the requirements set out in has made available on the market is
Chapter 2 of this Title shall take the not in conformity with the Chapter 2 of this Title shall take the not in conformity with the
corrective actions necessary to bring requirements set out in Chapter 2 of corrective actions necessary to bring requirements set out in Chapter 2 of
that system into conformity with this Title shall take the corrective that system into conformity with this Title shall take the corrective
those requirements, to withdraw it or actions necessary to bring that those requirements, to withdraw it or actions necessary to bring that
recall it or shall ensure that the system into conformity with those recall it or shall ensure that the system into conformity with those
provider, the importer or any requirements, to withdraw it or recall provider, the importer or any requirements, to withdraw it or recall
relevant operator, as appropriate, it or shall ensure that the provider, relevant operator, as appropriate, it or shall ensure that the provider,
takes those corrective actions. the importer or any relevant takes those corrective actions. the importer or any relevant
G 372 Where the high-risk AI system operator, as appropriate, takes those Where the high-risk AI system operator, as appropriate, takes those G
presents a risk within the meaning of corrective actions. Where the high- presents a risk within the meaning of corrective actions. Where the high-
Article 65(1), the distributor shall risk AI system presents a risk within Article 65(1), the distributor shall risk AI system presents a risk within
immediately inform the national the meaning of Article 65(1), the immediately inform the national the meaning of Article 65(1), the
competent authorities of the Member distributor shall immediately inform competent authorities of the Member distributor shall immediately inform
States in which it has made the the provider or importer of the States in which it has made the the provider or importer of the
product available to that effect, system and the national competent product available to that effect, system and the national competent
giving details, in particular, of the authorities of the Member States in giving details, in particular, of the authorities of the Member States in
non-compliance and of any which it has made the product non-compliance and of any which it has made the product
corrective actions taken. available to that effect, giving corrective actions taken. available to that effect, giving
details, in particular, of the non- details, in particular, of the non-
compliance and of any corrective compliance and of any corrective
actions taken. actions taken.
Article 27(5)
5. Upon a reasoned request from a 5. Upon a reasoned request from a 5. Upon a reasoned request from a 5. Upon a reasoned request from a
national competent authority, national competent authority, national competent authority, national competent authority,
distributors of high-risk AI systems distributors of the high-risk AI distributors of high-risk AI systems distributors of high-risk AI
shall provide that authority with all systemssystem shall provide that shall provide that authority with all systemsthe high- risk AI system
the information and documentation authority with all the information the information and documentation shall provide that authority with all
necessary to demonstrate the and documentation in their necessary to demonstrate the the information and documentation
conformity of a high-risk system possession or available to them, in conformity of a high-risk system with regarding its activities as described
with the requirements set out in accordance with the obligations of the requirements set out in Chapter in paragraph 1 to 4 necessary to
G 373 Chapter 2 of this Title. Distributors distributors as outlined in 2 of this Title. Distributors shall also demonstrate the conformity of a G
shall also cooperate with that paragraph 1, that are necessary to cooperate with that national high-risk system with the
national competent authority on any demonstrate the conformity of a competent authority on any action requirements set out in Chapter 2 of
action taken by that authority. high-risk system with the taken by that authorityregarding its this Title. Distributors shall also
requirements set out in Chapter 2 of activities as described in paragraph cooperate with that national
this Title. Distributors shall also 1 to 4. competent authority on any action
cooperate with that national taken by that authority.
competent authority on any action
taken by that authority.
Article 27(5a)
5a. Distributors shall cooperate 5a. Distributors shall cooperate

with national competent authorities with national competent authorities
on any action those authorities take on any action those authorities take
in relation to an AI system, of in relation to an AI system, of
G 373a which they are the distributor. which they are the distributor, in G
particular to reduce or mitigate the

risk posed by the high-risk AI
system.
Article 27(5a)
G 373b G
5a. Distributors shall cooperate
with national competent authorities
on any action those authorities take
to reduce and mitigate the risks
posed by the high-risk AI system.
Article 28

Obligations of distributors, Obligations of Responsibilities deleted Obligations of distributors,
importers, users or any other third- along the AI value chain of importers, users or any other third-
G 374 party providers, distributors, importers, partyResponsibilities along the AI G
users or any deployers or other value chain

third-party third parties
Article 28(1)
1. Any distributor, importer, user or 1. Any distributor, importer, 1. Any distributor, importer,
other third-party shall be considered userdeployer or other third-party deleted userdeployer or other third-party
a provider for the purposes of this shall be considered a provider of a shall be considered a provider of a
Regulation and shall be subject to high-risk AI system for the purposes high-risk AI system for the purposes
G 375 the obligations of the provider under of this Regulation and shall be of this Regulation and shall be G
Article 16, in any of the following subject to the obligations of the subject to the obligations of the
circumstances: provider under Article 16, in any of provider under Article 16, in any of
the following circumstances: the following circumstances:
(a) they place on the market or put (a) they place on the market or put (a) they placeput their name or
into service a high-risk AI system into serviceput their name or deleted trademark on a high-risk AI system
G 376 G
under their name or trademark; trademarkt on a high-risk AI system already placed on the market or put
under their name or into service, without prejudice to
trademarkalready placed on the contractual arrangements
market or put into service; stipulating that the obligations are
allocated otherwise. a high-risk AI
system under their name or
trademark;
(b) they modify the intended (b) they modify the intended (b) they modify the intended
purpose of a high-risk AI system purpose ofmake a substantial deleted purpose ofmake a substantial
already placed on the market or put modification to a high-risk AI modification to a high-risk AI
into service; system that has already been placed system that has already been placed
G 377 on the market or has already been on the market or has already been G
put into service and in a way that it put into service and in a way that it
remains a high-risk AI system in remains a high-risk AI system in
accordance with Article 6; accordance with Article 6;
(ba) they make a substantial (ba) they modify the intended (ba) they modify the intended
modification to an AI system, purpose of an AI system which is purpose of an AI system, including
including a general purpose AI not high-risk and is already placed a general purpose AI system, which
system, which has not been on the market or put ito service, in has not been classified as high-risk
classified as high-risk and has a way which makes the modified and has already been placed on the
G 377a already been placed on the market system a high-risk AI system; market or put into service in such G
or put into service in such manner manner that the AI system becomes
that the AI system becomes a high a high risk AI system in accordance
risk AI system in accordance with with Article 6
Article 6
G 378 G
(c) they make a substantial (c) they make a substantial (c) they make a substantial
modification to the high-risk AI modification to the high-risk AI deleted modification to the high-risk AI
system. system. system.deleted
Article 28(2)
2. Where the circumstances referred 2. Where the circumstances referred 2. Where the circumstances referred
to in paragraph 1, point (b) or (c), to in paragraph 1, point (b) or (c),(a) deleted to in paragraph 1, point (b) or (c),(a)
occur, the provider that initially to (ba) occur, the provider that to (ba) occur, the provider that
placed the high-risk AI system on initially placed the high-risk AI initially placed the high-risk AI
the market or put it into service shall system on the market or put it into system on the market or put it into
no longer be considered a provider service shall no longer be considered service shall no longer be considered
for the purposes of this Regulation. a provider of that specific AI system a provider of that specific AI system
for the purposes of this Regulation. for the purposes of this Regulation.
This former provider shall provide This former provider shall closely
the new provider with the technical cooperate and shall make available
documentation and all other the necessary information and
relevant and reasonably expected provide the reasonably expected
information capabilities of the AI technical access and other
G 379 system, technical access or other assistance that are required for the G
assistance based on the generally fulfilment of the obligations set out

acknowledged state of the art that in this Regulation, in particular
are required for the fulfilment of regarding the compliance with the
the obligations set out in this conformity assessment of high-risk
Regulation. AI systems.
This paragraph shall also apply to
providers of foundation models as This paragraph shall not apply in
defined in Article 3 when the the cases where the former provider
foundation model is directly has expressly excluded the change
integrated in an high-risk AI of its system into a high-risk system
system. and therefore the obligation to
hand over the documentation.
Article 28(2a)
2a. The provider of a high risk AI 2a. For high-risk AI systems that 2a. For high-risk AI systems that
system and the third party that are safety components of products are safety components of products
supplies tools, services, components to which the legal acts listed in to which the legal acts listed in
or processes that are used or Annex II, section A apply, the Annex II, section A apply, the
integrated in the high risk AI manufacturer of those products manufacturer of those products
system shall, by written agreement shall be considered the provider of shall be considered the provider of
specify the information, the high-risk AI system and shall be the high-risk AI system and shall be
capabilities, technical access, and subject to the obligations under subject to the obligations under
or other assistance, based on the Article 16 under either of the Article 16 under either of the
generally acknowledged state of the following scenarios: following scenarios:
art, that the third party is required
to provide in order to enable the (i) the high-risk AI system is (i) the high-risk AI system is
provider of the high risk AI system placed on the market together with placed on the market together with
to fully comply with the obligations the product under the name or the product under the name or
under this Regulation. trademark of the product trademark of the product
The Commission shall develop manufacturer; manufacturer;
and recommend non-binding model (ii) the high-risk AI system is put (ii) the high-risk AI system is put
G 379a contractual terms between into service under the the name or into service under the the name or G
providers of high-risk AI systems trademark of the product trademark of the product

and third parties that supply tools, manufacturer after the product has manufacturer after the product has
services, components or processes been placed on the market. been placed on the market.
risk AI systems in order to assist 2b. The provider of a high risk AI
both parties in drafting and system and the third party that
negotiating contracts with balanced supplies an AI system, tools,
contractual rights and obligations, services, components, or processes
consistent with each party’s level of that are used or integrated in a
control. When developing non- high-risk AI system shall, by written
binding model contractual terms, agreement, specify the necessary
the Commission shall take into information, capabilities, technical
account possible contractual access and other assistance based
requirements applicable in specific on the generally acknowledged state
sectors or business cases. The non- of the art, in order to enable the
binding contractual terms shall be provider of the high risk AI system
published and be available free of to fully comply with the obligations
charge in an easily usable set out in this Regulation. This
electronic format on the AI Office’s obligation shall not apply to third
website. 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,
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.
Article 28(2b)
2b. For the purposes of this Article, 2b. Paragraphs 2 and 2a are
trade secrets shall be preserved and without prejudice to the need to
G 379b shall only be disclosed provided that respect and protect intellectual G
all specific necessary measures property rights and confidential

pursuant to Directive (EU) business information or trade
2016/943 are taken in advance to secrets in accordance with Union
preserve their confidentiality, in and national law.
particular with respect to third
parties. Where necessary,
appropriate technical and
organizational arrangements can
be agreed to protect intellectual
property rights or trade secrets.
Article 28a
Article 28a
Unfair contractual terms
unilaterally imposed on an SME or
startup
1. A contractual term concerning
the supply of tools, services,
components or processes that are
used or integrated in a high risk AI
system or the remedies for the
breach or the termination of related
obligations which has been
unilaterally imposed by an
G 379c enterprise on a SME or startup G
shall not be binding on the latter

enterprise if it is unfair.
2. A contractual term is not to be
considered unfair where it arises
from applicable Union law.
3. A contractual term is unfair if
it is of such a nature that it
objectively impairs the ability of the
party upon whom the term has been
unilaterally imposed to protect its
legitimate commercial interest in
the information in question or its
use grossly deviates from good
commercial practice in the supply
processes that are used or
integrated in a high-risk AI system,
contrary to good faith and fair
dealing or creates a significant
imbalance between the rights and
the obligations of the parties in the
contract. A contractual term is also
unfair if it has the effect of shifting
penalties referred to in Article 71 or
associated litigation costs across
parties to the contract, as referred
to in Article 71(8).
4. A contractual term is unfair for
the purposes of this Article if its
object or effect is to:
(a) exclude or limit the liability of
the party that unilaterally imposed
the term for intentional acts or
gross negligence;
(b) exclude the remedies available
to the party upon whom the term
has been unilaterally imposed in
the case of non-performance of
contractual obligations or the
liability of the party that
unilaterally imposed the term in the
case of a breach of those
obligations;
(c) give the party that unilaterally
imposed the term the exclusive right
to determine whether the technical
documentation, information
supplied are in conformity with the
contract or to interpret any term of
the contract.
5. A contractual term shall be
considered to be unilaterally
imposed within the meaning of this
Article if it has been supplied by
one contracting party and the other
contracting party has not been able
to influence its content despite an
attempt to negotiate it. The
contracting party that supplied a
contractual term shall bears the
burden of proving that that term
has not been unilaterally imposed.
6. Where the unfair contractual
term is severable from the
remaining terms of the contract,
those remaining terms shall remain
binding. The party that supplied the
contested term shall not argue that
the term is an unfair term.
7. This Article shall apply to all
new contracts entered into force
after ... [date of entry into force of
this Regulation]. Businesses shall
review existing contractual
obligations that are subject to this
Regulation by …[three years after
the date of entry into force of this
Regulation].
8. Given the rapidity in which
innovations occur in the markets,
the list of unfair contractual terms
within Article 28a shall be reviewed
regularly by the Commission and be
updated to new business practices if
necessary.
Article 28a
Article 28b
Obligations of the provider of a
foundation model
1. A provider of a foundation
model shall, prior to making it
available on the market or putting it
into service, ensure that it is
compliant with the requirements set
out in this Article, regardless of
whether it is provided as a
standalone model or embedded in
an AI system or a product, or
provided under free and open
source licences, as a service, as well
as other distribution channels.
2. For the purpose of paragraph
1, the provider of a foundation
G 379d model shall: G
(a) demonstrate through

appropriate design, testing and
analysis the identification, the
reduction and mitigation of
reasonably foreseeable risks to
health, safety, fundamental rights,
the environment and democracy
and the rule of law prior and
throughout development with
appropriate methods such as with
the involvement of independent
experts, as well as the
documentation of remaining non-
mitigable risks after development
(b) process and incorporate only
datasets that are subject to
appropriate data governance
measures for foundation models, in
particular measures to examine the
suitability of the data sources and
possible biases and appropriate
mitigation
(c) design and develop the
foundation model in order to
achieve throughout its lifecycle
appropriate levels of performance,
predictability, interpretability,
corrigibility, safety and
cybersecurity assessed through
appropriate methods such as model
evaluation with the involvement of
independent experts, documented
analysis, and extensive testing
during conceptualisation, design,
and development;
(d) design and develop the
foundation model, making use of
applicable standards to reduce
energy use, resource use and waste,
as well as to increase energy
efficiency, and the overall
efficiency of the system, whithout
prejudice to relevant existing Union
and national law. This obligation
shall not apply before the standards
referred to in Article 40 are
published. Foundation models shall
be designed with capabilities
enabling the measurement and
logging of the consumption of
energy and resources, and, where
technically feasible, other
environmental impact the
deployment and use of the systems
may have over their entire lifecycle;
(e) draw up extensive technical
documentation and intelligible
instructions for use, in order to
enable the downstream providers to
comply with their obligations
pursuant to Articles 16 and 28(1);.
(f) establish a quality
management system to ensure and
document compliance with this
Article, with the possibility to
experiment in fulfilling this
requirement,
(g) register that foundation model
in the EU database referred to in
Article 60, in accordance with the
instructions outlined in Annex VIII
point C.
When fulfilling those
requirements, the generally
acknowledged state of the art shall
be taken into account, including as
reflected in relevant harmonised
standards or common
specifications, as well as the latest
assessment and measurement
methods, reflected in particular in
benchmarking guidance and
capabilities referred to in Article
58a;
3. Providers of foundation models
shall, for a period ending 10 years
after their foundation models have
been placed on the market or put
into service, keep the technical
documentation referred to in
paragraph 2(e) at the disposal of
the national competent authorities
4. Providers of foundation models
used in AI systems specifically
intended to generate, with varying
levels of autonomy, content such as
complex text, images, audio, or
video (“generative AI”) and
providers who specialise a
foundation model into a generative
AI system, shall in addition
a) comply with the transparency
obligations outlined in Article 52
(1),
b) train, and where applicable,
design and develop the foundation
model in such a way as to ensure
adequate safeguards against the
generation of content in breach of
Union law in line with the
generally-acknowledged state of the
art, and without prejudice to
fundamental rights, including the
freedom of expression,
c) without prejudice to Union or
national or Union legislation on
copyright, document and make
publicly available a sufficiently
detailed summary of the use of
training data protected under
copyright law.
Article 29

G 380 Obligations of users of high-risk AI Obligations of users of high-risk AI Obligations of users of high-risk AI Obligations of usersdeployers of G
systems systems systems high-risk AI systems
Proposal
Article 29(1)
1. Users of high-risk AI systems 1. UsersDeployers of high-risk AI 1. Users of high-risk AI systems 1. UsersDeployers of high-risk AI
shall use such systems in accordance systems shall take appropriate shall use such systems in accordance systems shall take appropriate
with the instructions of use technical and organisational with the instructions of use technical and organisational
accompanying the systems, pursuant measures to ensure they use such accompanying the systems, pursuant measures to ensure they use such
G 381 to paragraphs 2 and 5. systems in accordance with the to paragraphs 2 and 5 of this Article. systems in accordance with the G
instructions of use accompanying the instructions of use accompanying the

systems, pursuant to paragraphs 2 systems, pursuant to paragraphs 2
and 5 of this Article. and 5 of this Article.
Article 29(1a)
1a. Users shall assign human 1a. Deployers shall assign human
oversight to natural persons who oversight to natural persons who
G 381a have the necessary competence, have the necessary competence, G
training and authority. training and authority, as well as

the necessary support.
Article 29(1b)
1a. 1a.
To the extent deployers exercise To the extent deployers exercise
control over the high-risk AI control over the high-risk AI
system, they shall system, they shall ensure that the
G 381b G
natural persons assigned to ensure
i) implement human oversight human oversight of the high-risk
according to the requirements laid AI systems have the necessary
down in this Regulation competence, training and authority
as well as the necessary support
(ii) ensure that the natural persons
assigned to ensure human oversight
of the high-risk AI systems are
competent, properly qualified and
trained, and have the necessary
resources in order to ensure the
effective supervision of the AI
system in accordance with Article
14
(iii) ensure that relevant and

appropriate robustness and
cybersecurity measures are
regularly monitored for
effectiveness and are regularly
adjusted or updated.
Article 29(2)
2. The obligations in paragraph 1 2. The obligations in paragraph 1 2. The obligations in paragraph 1 2. The obligations in paragraph 1
are without prejudice to other user and 1a, are without prejudice to and 1a are without prejudice to other and 1a, are without prejudice to
obligations under Union or national other userdeployer obligations under user obligations under Union or other userdeployer obligations under
law and to the user’s discretion in Union or national law and to the national law and to the user’s Union or national law and to the
organising its own resources and userdeployer’s discretion in discretion in organising its own userdeployer’s discretion in
G 382 activities for the purpose of organising its own resources and resources and activities for the organising its own resources and G
implementing the human oversight activities for the purpose of purpose of implementing the human activities for the purpose of
measures indicated by the provider. implementing the human oversight oversight measures indicated by the implementing the human oversight
measures indicated by the provider. provider. measures indicated by the provider.
Article 29(3)
G 383 3. Without prejudice to paragraph 1, 3. Without prejudice to paragraph 1 3. Without prejudice to paragraph 1, 3. Without prejudice to paragraph 1 G
to the extent the user exercises and 1a, to the extent the to the extent the user exercises and 1a, to the extent the
control over the input data, that user userdeployer exercises control over control over the input data, that user userdeployer exercises control over
shall ensure that input data is the input data, that userdeployer shall ensure that input data is the input data, that userdeployer
relevant in view of the intended shall ensure that input data is relevant in view of the intended shall ensure that input data is
purpose of the high-risk AI system. relevant and sufficiently purpose of the high-risk AI system. relevant and sufficiently
representative in view of the representative in view of the
intended purpose of the high-risk AI intended purpose of the high-risk AI
system. system.
4. Users shall monitor the operation 4. UsersDeployers shall monitor the 4. Users shall implement human 4. Users4. Deployers shall monitor
of the high-risk AI system on the operation of the high-risk AI system oversight and monitor the operation the operation of the high-risk AI
basis of the instructions of use. on the basis of the instructions of use of the high-risk AI system on the system on the basis of the
When they have reasons to consider and when relevant, inform basis of the instructions of use. instructions of use and when
that the use in accordance with the providers in accordance with When they have reasons to consider relevant, inform providers in
instructions of use may result in the Article 61. When they have reasons that the use in accordance with the accordance with Article 61. When
AI system presenting a risk within to consider that the use in instructions of use may result in the they have reasons to consider that
the meaning of Article 65(1) they accordance with the instructions of AI system presenting a risk within the use in accordance with the
shall inform the provider or use may result in the AI system the meaning of Article 65(1) they instructions of use may result in the
distributor and suspend the use of presenting a risk within the meaning shall inform the provider or AI system presenting a risk within
the system. They shall also inform of Article 65(1) they shall, without distributor and suspend the use of the meaning of Article 65(1) they
G 384 the provider or distributor when they undue delay, inform the provider or the system. They shall also inform shall, without undue delay, inform G
have identified any serious incident distributor and relevant national the provider or distributor when they the provider or distributor and
or any malfunctioning within the supervisory authorities and suspend have identified any serious incident relevant market surveillance
meaning of Article 62 and interrupt the use of the system. They shall or any malfunctioning within the authority and suspend the use of the
the use of the AI system. In case the also immediately inform first the meaning of Article 62 and interrupt system. They shall also immediately
user is not able to reach the provider, provider, and then the importer or the use of the AI system. In case the inform first the provider, and then
Article 62 shall apply mutatis distributor and relevant national user is not able to reach the provider, the importer or distributor and
mutandis. supervisory authorities when they Article 62 shall apply mutatis relevant market surveillance
have identified any serious incident mutandis. This obligation shall not authorities when they have
or any malfunctioning within the cover sensitive operational data of identified any serious incident or
meaning of Article 62 and interrupt users of AI systems which are law any malfunctioning within the
the use of the AI system. In case the enforcement authorities. meaning of Article 62 and interrupt
userIf the deployer is not able to the use of the AI system. In case the
reach the provider, Article 62 shall user is not able to reach the
apply mutatis mutandis. provider, Article 62 shall apply
mutatis mutandisIf the deployer is
not able to reach the provider,
Article 62 shall apply mutatis
mutandis. This obligation shall not
cover sensitive operational data of
users of AI systems which are law
enforcement authorities.
For users that are credit institutions For usersdeployers that are credit For users that are creditfinancial For usersdeployers that are
regulated by Directive 2013/36/EU, institutions regulated by Directive institutions regulated by Directive creditfinancial institutions regulated
the monitoring obligation set out in 2013/36/EU, the monitoring 2013/36/EUsubject to requirements by Directive 2013/36/EUsubject to
the first subparagraph shall be obligation set out in the first regarding their internal requirements regarding their
deemed to be fulfilled by complying subparagraph shall be deemed to be governance, arrangements or internal governance, arrangements
with the rules on internal governance fulfilled by complying with the rules processes under Union financial or processes under Union financial
arrangements, processes and on internal governance services legislation, the monitoring services legislation, the monitoring
mechanisms pursuant to Article 74 arrangements, processes and obligation set out in the first obligation set out in the first
G 385 of that Directive. mechanisms pursuant to Article 74 subparagraph shall be deemed to be subparagraph shall be deemed to be G
of that Directive. fulfilled by complying with the rules fulfilled by complying with the rules
on internal governance on internal governance
arrangements, processes and arrangements, processes and
mechanisms pursuant to Article 74 mechanisms pursuant to Article 74
of that Directivethe relevant of that Directivethe relevant
financial service legislation. financial service legislation.
G 386 5. Users of high-risk AI systems 5. UsersDeployers of high-risk AI 5. Users of high-risk AI systems 5. UsersDeployers of high-risk AI G
shall keep the logs automatically systems shall keep the logs shall keep the logs, referred to in systems shall keep the logs
generated by that high-risk AI automatically generated by that Article 12(1), automatically automatically generated by that
system, to the extent such logs are high-risk AI system, to the extent generated by that high-risk AI high-risk AI system, to the extent
under their control. The logs shall be that such logs are under their control system, to the extent such logs are such logs are under their control.
kept for a period that is appropriate and are required for ensuring and under their control. The logsThey The logs shall be kept for a period
in the light of the intended purpose demonstrating compliance with this shall be keptkeep them for a period that is appropriate in the light ofto
of the high-risk AI system and Regulation, for ex-post audits of that is appropriate in the light of the the intended purpose of the high-risk
applicable legal obligations under any reasonably foreseeable intended purpose of the high-risk AI AI system, of at least six months,
Union or national law. malfunction, incidents or misuses system and applicable legal unless provided otherwise in
of the system, or for ensuring and obligations under Union or national applicable and applicable legal
monitoring for the proper lawof at least six months, unless obligations under Union or national
functioning of the system provided otherwise in applicable law, in particular in Union law on
throughout its lifecycle. Without Union or national law, in particular the protection of personal data.
prejudice to applicable Union or in Union law on the protection of
national law, . the logs shall be kept personal data.
for a period that is appropriate in
the light of the intended purpose of
the high-risk AI system and
applicable legal obligations under
Union or national lawof at least six
months. The retention period shall
be in accordance with industry
standards and appropriate to the
intended purpose of the high-risk
AI system.
Users that are credit institutions UsersDeployers that are credit Users that are creditfinancial UsersDeployers that are
regulated by Directive 2013/36/EU institutions regulated by Directive institutions regulated by Directive creditfinancial institutions regulated
shall maintain the logs as part of the 2013/36/EU shall maintain the logs 2013/36/EUsubject to requirements by Directive 2013/36/EUsubject to
documentation concerning internal as part of the documentation regarding their internal requirements regarding their
G 387 G
governance arrangements, processes concerning internal governance governance, arrangements or internal governance, arrangements
and mechanisms pursuant to Article arrangements, processes and processes under Union financial or processes under Union financial
74 of that Directive. mechanisms pursuant to Article 74 services legislation shall maintain services legislation shall maintain
of that Directive. the logs as part of the documentation the logs as part of the documentation
concerning internal governance concerning internal governance
arrangements, processes and arrangements, processes and
mechanismskept pursuant to Article mechanismskept pursuant to Article
74 of that Directivethe relevant 74 of that Directivethe relevant
Union financial service legislation. Union financial service legislation.
Article 29(5), second subparagraph, point (a)
(a) Prior to putting into service or (a) Prior to putting into service or
use a high-risk AI system at the use a high-risk AI system at the
workplace, deployers shall consult workplace, deployers who are
workers representatives with a view employers shall inform workers
to reaching an agreement in representatives and the affected
accordance with Directive workers that they will be subject to
2002/14/EC and inform the affected the system. This information shall
G 387a employees that they will be subject be provided, where applicable, in G
to the system. accordance with the rules and

procedures laid down in Union and
national law and practice on
information of workers and their
representatives.
Article 29(5), second subparagraph, point (b)
(b) Deployers of high-risk AI (b) Deployers of high-risk AI

systems that are public authorities systems that are public authorities
or Union institutions, bodies, or Union institutions, bodies,
offices and agencies or offices and agencies shall comply
G 387b G
undertakings referred to in Article with the registration obligations
51(1a)(b) shall comply with the referred to in Article 51. When they
registration obligations referred to find that the system that they
in Article 51. 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.
Article 29(5), second subparagraph, point (c)
5a. Users of high-risk AI systems (c) Deployers of high-risk AI

that are public authorities, agencies systems that are public authorities,
or bodies, with the exception of law including Union institutions,
enforcement, border control, bodies, offices and agencies
immigration or asylum authorities, referred to in Article 51(1a)(b) shall
shall comply with the registration comply with the registration
obligations referred to in Article 51. obligations referred to in Article 51.
G 387c G
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.
Article 29(6)
6. Users of high-risk AI systems 6. UsersWhere applicable, 6. Users of high-risk AI systems 6. UsersWhere applicable,
shall use the information provided deployers of high-risk AI systems shall use the information provided deployers of high-risk AI systems
under Article 13 to comply with shall use the information provided under Article 13 to comply with shall use the information provided
their obligation to carry out a data under Article 13 to comply with their obligation to carry out a data under Article 13 to comply with
G 388 G
protection impact assessment under their obligation to carry out a data protection impact assessment under their obligation to carry out a data
Article 35 of Regulation (EU) protection impact assessment under Article 35 of Regulation (EU) protection impact assessment under
2016/679 or Article 27 of Directive Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive Article 35 of Regulation (EU)
(EU) 2016/680, where applicable. 2016/679 or Article 27 of Directive (EU) 2016/680, where applicable. 2016/679 or Article 27 of Directive
(EU) 2016/680, where applicablea (EU) 2016/680, where applicable.
summary of which shall be
published, having regard to the
specific use and the specific context
in which the AI system is intended
to operate. Deployers may revert in
part to those data protection impact
assessments for fulfilling some of
the obligations set out in this
article, insofar as the data
protection impact assesment fulfill
those obligations.
Article 29(6a)
6a. Users shall cooperate with

national competent authorities on
G 388a any action those authorities take in G
relation to an AI system, of which

they are the user.
Article 29(6a)
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
G 388b G
AI system for post-remote biometric
identification shall request an
authorisation, prior, or without
undue delay and no later than
48hours, 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.
In any case, such AI system for post

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
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
systems.
Article 29(6b)
6b. Without prejudice to Article 52, 6b. Without prejudice to Article 52,
deployers of high-risk AI systems deployers of high-risk AI systems
referred to in Annex III, which referred to in Annex III that make
make decisions or assist in making decisions or assist in making
decisions related to natural persons, decisions related to natural persons
shall inform the natural persons shall inform the natural persons
that they are subject to the use of that they are subject to the use of
G 388c G
the high-risk AI system. This the high-risk AI system. For high
information shall include the risk AI systems used for law
intended purpose and the type of enforcement purposes Article 13 of
decisions it makes. The deployer Directive 2016/680 shall apply.
shall also inform the natural person
about its right to an explanation
referred to in Article 68c.
Article 29(6c)
6c. Deployers shall cooperate with 6c. Deployers shall cooperate with
the relevant national competent the relevant national competent
authorities on any action those authorities on any action those
G 388d authorities take in relation with the authorities take in relation with the G
high-risk system in order to high-risk system in order to

implement this Regulation. implement this Regulation.
Article 29(6d)
G 388e G
Article 29a
Article 29a Article 29a

Fundamental rights impact
assessment for high-risk AI systems Fundamental rights impact
Prior to putting a high-risk AI assessment for high-risk AI systems
system as defined in Article 6(2)
into use, with the exception of AI 1. Prior to deploying a high-risk AI
systems intended to be used in area system as defined in Article 6(2)
2 of Annex III, deployers shall into use, with the exception of AI
conduct an assessment of the systems intended to be used in the
systems’ impact in the specific area listed in point 2 of Annex III,
context of use. This assessment deployers that are bodies governed
shall include, at a minimum, the by public law or private operators
following elements: providing public services and
(a) a clear outline of the intended operators deploying high-risk
purpose for which the system will systems referred to in Annex III,
G 388f G
be used; point 5, b) and d) shall perform an
(b) a clear outline of the intended assessment of the impact on
geographic and temporal scope of fundamental rights that the use of
the system’s use; the system may produce. For that
(c) categories of natural persons purpose, deployers shall perform an
and groups likely to be affected by assessment consisting of:
the use of the system;
(d) verification that the use of the a) a description of the deployer’s
system is compliant with relevant processes in which the high-risk AI
Union and national law on system will be used in line with its
fundamental rights; intended purpose;
(e) the reasonably foreseeable
impact on fundamental rights of b) a description of the period of
putting the high-risk AI system into time and frequency in which each
use; high-risk AI system is intended to
(f) specific risks of harm likely to be used
impact marginalised persons or
vulnerable groups; c) the categories of natural
(g) the reasonably foreseeable persons and groups likely to be
adverse impact of the use of the affected by its use in the specific
system on the environment; context;
(h) a detailed plan as to how the
harms and the negative impact on d) the specific risks of harm likely
fundamental rights identified will to impact the categories of persons
be mitigated. or group of persons identified
(j) the governance system the pursuant point (c), taking into
deployer will put in place, including account the information given by
human oversight, complaint- the provider pursuant to article 13;
handling and redress.
2. If a detailed plan to mitigate e) a description of the
the risks outlined in the course of implementation of human oversight
the assessment outlined in measures, according to the
paragraph 1 cannot be identified, instructions of use;
the deployer shall refrain from
putting the high-risk AI system into f) the measures to be taken
use and inform the provider and the in case of the materialization of
National supervisory authority these risks, including their
without undue delay. National arrangements for internal
supervisory authorities, pursuant to governance and complaint
Articles 65 and 67, shall take this mechanisms.
information into account when
investigating systems which present 2. The obligation laid down in
a risk at national level. paragraph 1 applies to the first use
3. The obligation outlined under of the high-risk AI system. The
paragraph 1 applies for the first use deployer may, in similar cases, rely
of the high-risk AI system. The on previously conducted
deployer may, in similar cases, fundamental rights impact
draw back on previously conducted assessments or existing impact
fundamental rights impact assessments carried out by provider.
assessment or existing assessment If, during the use of the high-risk
carried out by providers. If, during AI system, the deployer considers
the use of the high-risk AI system, that any of the factors listed in
the deployer considers that the paragraph 1change are or no
criteria listed in paragraph 1 are longer up to date, the deployer will
not longer met, it shall conduct a take the necessary steps to update
new fundamental rights impact the information.
assessment.
4. In the course of the impact 3. Once the impact assessment has
assessment, the deployer, with the been performed, the deployer shall
exception of SMEs, shall shall notify the market surveillance
notify national supervisory authority of the results of the
authority and relevant stakeholders assessment, submitting the filled
and shall, to best extent possible, template referred to in paragraph 5
involve representatives of the as a part of the notification. In the
persons or groups of persons that case referred to in Article 47(1),
are likely to be affected by the high- deployers may be exempted from
risk AI system, as identified in these obligations.
paragraph 1, including but not
limited to: equality bodies, 4. If any of the obligations laid
consumer protection agencies, down in this article are already met
social partners and data protection through the data protection impact
agencies, with a view to receiving assessment conducted pursuant to
input into the impact assessment. Article 35 of Regulation (EU)
The deployer shall allow a period of 2016/679 or Article 27 of Directive
six weeks for bodies to respond. (EU) 2016/680, the fundamental
SMEs may voluntarily apply the rights impact assessment referred to
provisions laid down in this in paragraph 1 shall be conducted
paragraph. in conjunction with that data
In the case referred to in Article protection impact assessment.
47(1), public authorities may be
exempted from this obligations. 5. The AI Office shall develop a
5. The deployer that is a public template for a questionnaire,
authority or an undertaking including through an automated
referred to in Article 51(1a) (b) tool, to facilitate users to implement
shall publish a summary of the the obligations of this Article in a
results of the impact assessment as simplified manner.
part of the registration of use
pursuant to their obligation under
Article 51(2).
6. Where the deployer is already
required to carry out a data
protection impact assessment under
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 the data
protection impact assessment. The
data protection impact assessment
shall be published as an addendum.
Chapter 4

NOTIFIYING AUTHORITIES NOTIFIYING AUTHORITIES NOTIFIYING AUTHORITIES NOTIFIYING AUTHORITIES
G 389 AND NOTIFIED BODIES AND NOTIFIED BODIES AND NOTIFIED BODIES AND NOTIFIED BODIES G

Proposal
Article 30

Notifying authorities Notifying authorities Notifying authorities Notifying authorities
G 390 G

Proposal
Article 30(1)
1. Each Member State shall 1. Each Member State shall 1. Each Member State shall 1. Each Member State shall
G 391 designate or establish a notifying designate or establish a notifying designate or establish aat least one designate or establish aat least one G
authority responsible for setting up authority responsible for setting up notifying authority responsible for notifying authority responsible for
and carrying out the necessary and carrying out the necessary setting up and carrying out the setting up and carrying out the
procedures for the assessment, procedures for the assessment, necessary procedures for the necessary procedures for the
designation and notification of designation and notification of assessment, designation and assessment, designation and
conformity assessment bodies and conformity assessment bodies and notification of conformity notification of conformity
for their monitoring. for their monitoring. Those assessment bodies and for their assessment bodies and for their
procedures shall be developed in monitoring. monitoring. These procedures shall
cooperation between the notifying be developed in cooperation
authorities of all Member States. between the notifying authorities of
all Member States.
Article 30(2)
2. Member States may designate a 2. Member States may designate a 2. Member States may 2. Member States may
national accreditation body referred national accreditation body referred designatedecide that the assessment designatedecide that the assessment
to in Regulation (EC) No 765/2008 to in Regulation (EC) No 765/2008 and monitoring referred to in and monitoring referred to in
as a notifying authority. as a notifying authority. paragraph 1 shall be carried out by paragraph 1 shall be carried out by
G 392 a national accreditation body a national accreditation body G
referred to in within the meaning of referred to in within the meaning of

and in accordance with Regulation and in accordance with Regulation
(EC) No 765/2008 as a notifying (EC) No 765/2008 as a notifying
authority. authority.
Article 30(3)
3. Notifying authorities shall be 3. Notifying authorities shall be 3. Notifying authorities shall be 3. Notifying authorities shall be
established, organised and operated established, organised and operated established, organised and operated established, organised and operated
in such a way that no conflict of in such a way that no conflict of in such a way that no conflict of in such a way that no conflict of
interest arises with conformity interest arises with conformity interest arises with conformity interest arises with conformity
G 393 assessment bodies and the assessment bodies and the assessment bodies and the assessment bodies and the G
objectivity and impartiality of their objectivity and impartiality of their objectivity and impartiality of their objectivity and impartiality of their
activities are safeguarded. activities are safeguarded. activities are safeguarded. activities are safeguarded.
Proposal
Article 30(4)
4. Notifying authorities shall be 4. Notifying authorities shall be 4. Notifying authorities shall be 4. Notifying authorities shall be
organised in such a way that organised in such a way that organised in such a way that organised in such a way that
decisions relating to the notification decisions relating to the notification decisions relating to the notification decisions relating to the notification
of conformity assessment bodies are of conformity assessment bodies are of conformity assessment bodies are of conformity assessment bodies are
G 394 taken by competent persons different taken by competent persons different taken by competent persons different taken by competent persons different G
from those who carried out the from those who carried out the from those who carried out the from those who carried out the
assessment of those bodies. assessment of those bodies. assessment of those bodies. assessment of those bodies.
Proposal
Article 30(5)
5. Notifying authorities shall not 5. Notifying authorities shall not 5. Notifying authorities shall not 5. Notifying authorities shall not
offer or provide any activities that offer or provide any activities that offer or provide any activities that offer or provide any activities that
conformity assessment bodies conformity assessment bodies conformity assessment bodies conformity assessment bodies
perform or any consultancy services perform or any consultancy services perform or any consultancy services perform or any consultancy services
G 395 on a commercial or competitive on a commercial or competitive on a commercial or competitive on a commercial or competitive
G
basis. basis. basis. basis.

Proposal
Article 30(6)
6. Notifying authorities shall 6. Notifying authorities shall 6. Notifying authorities shall 6. Notifying authorities shall
safeguard the confidentiality of the safeguard the confidentiality of the safeguard the confidentiality of the safeguard the confidentiality of the
G 396 G
information they obtain. information they obtain. information they obtain in information they obtain in
accordance with Article 70. accordance with Article 70.
Article 30(7)
G 397 7. Notifying authorities shall have a 7. Notifying authorities shall have a 7. Notifying authorities shall have a 7. Notifying authorities shall have G
sufficient number of competent sufficient number of competent sufficientan adequate number of an adequate a sufficient number of
personnel at their disposal for the personnel at their disposal for the competent personnel at their disposal competent personnel at their disposal
proper performance of their tasks. proper performance of their tasks. for the proper performance of their for the proper performance of their
Where applicable, competent tasks. tasks. Competent personnel shall
personnel shall have the necessary have the necessary expertise, where
expertise, such as a degree in an applicable, for their function, in
appropriate legal field, in the fields such as information
supervision of fundamental rights technologies, artificial intelligence
enshrined in the Charter of and law, including the supervision
Fundamental Rights of the of fundamental rights.
European Union.
Article 30(8)
8. Notifying authorities shall make 8. Notifying authorities shall make

sure that conformity assessments are sure that conformity assessments are deleted
carried out in a proportionate carried out in a proportionate and
manner, avoiding unnecessary timely manner, avoiding unnecessary
burdens for providers and that burdens for providers, and that
notified bodies perform their notified bodies perform their
activities taking due account of the activities taking due account of the
size of an undertaking, the sector in size of an undertaking, the sector in
G 398 which it operates, its structure and which it operates, its structure and G
the degree of complexity of the AI the degree of complexity of the AI

system in question. system in question. Particular
attention shall be paid to
minimising administrative burdens
and compliance costs for micro and
small enterprises as defined in the
Annex to Commission
Recommendation 2003/361/EC.
Article 31
G 399 Article 31 Article 31 Article 31 Article 31 G
Application of a conformity Application of a conformity Application of a conformity Application of a conformity

assessment body for notification assessment body for notification assessment body for notification assessment body for notification
Proposal
Article 31(1)
1. Conformity assessment bodies 1. Conformity assessment bodies 1. Conformity assessment bodies 1. Conformity assessment bodies
shall submit an application for shall submit an application for shall submit an application for shall submit an application for
notification to the notifying authority notification to the notifying authority notification to the notifying authority notification to the notifying authority
G 400 of the Member State in which they of the Member State in which they of the Member State in which they of the Member State in which they G
are established. are established. are established. are established.

Proposal
Article 31(2)
2. The application for notification 2. The application for notification 2. The application for notification 2. The application for notification
shall be accompanied by a shall be accompanied by a shall be accompanied by a shall be accompanied by a
description of the conformity description of the conformity description of the conformity description of the conformity
assessment activities, the conformity assessment activities, the conformity assessment activities, the conformity assessment activities, the conformity
assessment module or modules and assessment module or modules and assessment module or modules and assessment module or modules and
the artificial intelligence the artificial intelligence the artificial intelligence the artificial intelligence
technologies for which the technologies for which the technologiesAI systems for which technologiestypes of AI systems for
conformity assessment body claims conformity assessment body claims the conformity assessment body which the conformity assessment
G 401 to be competent, as well as by an to be competent, as well as by an claims to be competent, as well as by body claims to be competent, as well G
accreditation certificate, where one accreditation certificate, where one an accreditation certificate, where as by an accreditation certificate,
exists, issued by a national exists, issued by a national one exists, issued by a national where one exists, issued by a
accreditation body attesting that the accreditation body attesting that the accreditation body attesting that the national accreditation body attesting
conformity assessment body fulfils conformity assessment body fulfils conformity assessment body fulfils that the conformity assessment body
the requirements laid down in the requirements laid down in the requirements laid down in fulfils the requirements laid down in
Article 33. Any valid document Article 33. Any valid document Article 33. Any valid document Article 33. Any valid document
related to existing designations of related to existing designations of related to existing designations of related to existing designations of
the applicant notified body under the applicant notified body under the applicant notified body under the applicant notified body under
any other Union harmonisation any other Union harmonisation any other Union harmonisation any other Union harmonisation
legislation shall be added. legislation shall be added. legislation shall be added. legislation shall be added.
Article 31(3)
3. Where the conformity assessment 3. Where the conformity assessment 3. Where the conformity assessment 3. Where the conformity assessment
body concerned cannot provide an body concerned cannot provide an body concerned cannot provide an body concerned cannot provide an
accreditation certificate, it shall accreditation certificate, it shall accreditation certificate, it shall accreditation certificate, it shall
provide the notifying authority with provide the notifying authority with provide the notifying authority with provide the notifying authority with
the documentary evidence necessary the documentary evidence necessary all the documentary evidence all the documentary evidence
for the verification, recognition and for the verification, recognition and necessary for the verification, necessary for the verification,
regular monitoring of its compliance regular monitoring of its compliance recognition and regular monitoring recognition and regular monitoring
with the requirements laid down in with the requirements laid down in of its compliance with the of its compliance with the
Article 33. For notified bodies which Article 33. For notified bodies which requirements laid down in Article requirements laid down in Article
are designated under any other are designated under any other 33. For notified bodies which are 33. For notified bodies which are
Union harmonisation legislation, all Union harmonisation legislation, all designated under any other Union designated under any other Union
documents and certificates linked to documents and certificates linked to harmonisation legislation, all harmonisation legislation, all
those designations may be used to those designations may be used to documents and certificates linked to documents and certificates linked to
G 402 G
support their designation procedure support their designation procedure those designations may be used to those designations may be used to
under this Regulation, as under this Regulation, as support their designation procedure support their designation procedure
appropriate. appropriate. under this Regulation, as under this Regulation, as
appropriate. The notified body shall appropriate. The notified body shall
update the documentation referred update the documentation referred
to in paragraph 2 and paragraph 3 to in paragraph 2 and paragraph 3
whenever relevant changes occur, whenever relevant changes occur,
in order to enable the authority in order to enable the authority
responsible for notified bodies to responsible for notified bodies to
monitor and verify continuous monitor and verify continuous
compliance with all the compliance with all the
requirements laid down in Article requirements laid down in Article
33. 33.
Article 32
Notification procedure Notification procedure Notification procedure Notification procedure


Proposal
Article 32(1)
1. Notifying authorities may notify 1. Notifying authorities mayshall 1. Notifying authorities may only 1. Notifying authorities may notify
only conformity assessment bodies notify only conformity assessment notify only conformity assessment only notify conformity assessment
G 404 which have satisfied the bodies which have satisfied the bodies which have satisfied the bodies which have satisfied the G
requirements laid down in Article requirements laid down in Article requirements laid down in Article requirements laid down in Article
33. 33. 33. 33.
Article 32(2)
2. Notifying authorities shall notify 2. Notifying authorities shall notify 2. Notifying authorities shall notify 2. Notifying authorities shall notify
the Commission and the other the Commission and the other those bodies to the Commission and the Commission and the other
Member States using the electronic Member States using the electronic the other Member States using the Member States using the electronic
notification tool developed and notification tool developed and electronic notification tool notification tool developed and
G 405 managed by the Commission. managed by the Commission of developed and managed by the managed by the Commission of G
each conformity assessment body Commission. each conformity assessment body

referred to in paragraph 1. referred to in paragraph 1.
Article 32(3)
3. The notification shall include full 3. The notification referred to in 3. The notification referred to in 3. The notification referred to in
details of the conformity assessment paragraph 2 shall include full paragraph 2 shall include full paragraph 2 shall include full
activities, the conformity assessment details of the conformity assessment details of the conformity assessment details of the conformity assessment
module or modules and the artificial activities, the conformity assessment activities, the conformity assessment activities, the conformity assessment
G 406 G
intelligence technologies concerned. module or modules and the artificial module or modules and the artificial module or modules and the artificial
intelligence technologies concerned, intelligence technologies intelligence technologiestypes of AI
as well as the relevant attestation of concernedAI systems concerned systems concerned and the relevant
competence. and the relevant attestation of attestation of competence. Where a
competence. Where a notification is notification is not based on an
not based on an accreditation accreditation certificate as referred
certificate as referred to in Article to in Article 31 (2), the notifying
31 (2), the notifying authority shall authority shall provide the
provide the Commission and the Commission and the other Member
other Member States with States with documentary evidence
documentary evidence which attests which attests to the conformity
to the conformity assessment body's assessment body's competence and
competence and the arrangements the arrangements in place to ensure
in place to ensure that that body that that body will be monitored
will be monitored regularly and will regularly and will continue to
continue to satisfy the requirements satisfy the requirements laid down
laid down in Article 33. in Article 33.
Article 32(4)
4. The conformity assessment body 4. The conformity assessment body 4. The conformity assessment body 4. The conformity assessment body
concerned may perform the activities concerned may perform the activities concerned may perform the activities concerned may perform the activities
of a notified body only where no of a notified body only where no of a notified body only where no of a notified body only where no
objections are raised by the objections are raised by the objections are raised by the objections are raised by the
Commission or the other Member Commission or the other Member Commission or the other Member Commission or the other Member
States within one month of a States within one month of atwo States within one monthtwo weeks of States within one monthtwo weeks of
notification. weeks of the validation of the a notification by a notifying a notification by a notifying
G 407 G
notification where it includes an authority where it includes an authority where it includes an
accreditation certificate referred to accreditation certificate referred to accreditation certificate referred to
in Article 31(2), or within two in Article 31(2), or within two in Article 31(2), or within two
months of the notification where it months of a notification by the months of a notification by the
incudes documentary evidence notifying authority where it notifying authority where it
referred to in Article 31(3. includes documentary evidence includes documentary evidence
referred to in Article 31(3). referred to in Article 31(3).
Article 32(4a)
4a. Where objections are raised, 4a. Where objections are raised,
G 407a G
the Commission shall without delay the Commission shall without delay
enter into consultation with the enter into consultation with the
relevant Member States and the relevant Member States and the
conformity assessment body. In conformity assessment body. In
view thereof, the Commission shall view thereof, the Commission shall
decide whether the authorisation is decide whether the authorisation is
justified or not. The Commission justified or not. The Commission
shall address its decision to the shall address its decision to the
Member State concerned and the Member State concerned and the
relevant conformity assessment relevant conformity assessment
body. body.
Article 32(4b)
4b. Member States shall notify the 4b. Deleted [covered by par.2]
Commission and the other Member
G 407b G
States of conformity assessment
bodies.
Article 32(5)
5. Notifying authorities shall notify 5. Notifying authorities shall notify

the Commission and the other the Commission and the other deleted
G 408 G
Member States of any subsequent Member States of any subsequent
relevant changes to the notification. relevant changes to the notification.
Article 33

Notified bodies Notified bodies Requirements relating to notified Requirements relating to notified
G 409 bodies notified bodies bodies notified bodies G
Article 33(1)
1. Notified bodies shall verify the 1. Notified bodies shall verify the 1. A notified bodiesbody shall verify 1. A notified bodiesbody shall verify
conformity of high-risk AI system in conformity of high-risk AI system in the conformity of high-risk AI system the conformity of high-risk AI system
accordance with the conformity accordance with the conformity in accordance with the conformity in accordance with the conformity
G 410 assessment procedures referred to in assessment procedures referred to in assessment procedures referred to in assessment procedures referred to in G
Article 43. Article 43. Article 43be established under Article 43be established under
national law and have legal national law of a Member State and
personality. have legal personality.
Article 33(2)
2. Notified bodies shall satisfy the 2. Notified bodies shall satisfy the 2. Notified bodies shall satisfy the 2. Notified bodies shall satisfy the
organisational, quality management, organisational, quality management, organisational, quality management, organisational, quality management,
resources and process requirements resources and process requirements resources and process requirements resources and process requirements
that are necessary to fulfil their that are necessary to fulfil their tasks that are necessary to fulfil their that are necessary to fulfil their
tasks. as well as the minimum tasks. tasks, as well as suitable
G 411 G
cybersecurity requirements set out cybersecurity requirements.
for public administration entities
identified as operators of essential
services pursuant to Directive (EU
2022/2555.
Article 33(3)
3. The organisational structure, 3. The organisational structure, 3. The organisational structure, 3. The organisational structure,
allocation of responsibilities, allocation of responsibilities, allocation of responsibilities, allocation of responsibilities,
reporting lines and operation of reporting lines and operation of reporting lines and operation of reporting lines and operation of
notified bodies shall be such as to notified bodies shall be such as to notified bodies shall be such as to notified bodies shall be such as to
G 412 ensure that there is confidence in the ensure that there is confidence in the ensure that there is confidence in the ensure that there is confidence in the G
performance by and in the results of performance by and in the results of performance by and in the results of performance by and in the results of
the conformity assessment activities the conformity assessment activities the conformity assessment activities the conformity assessment activities
that the notified bodies conduct. that the notified bodies conduct. that the notified bodies conduct. that the notified bodies conduct.
Proposal
Article 33(4)
4. Notified bodies shall be 4. Notified bodies shall be 4. Notified bodies shall be 4. Notified bodies shall be
independent of the provider of a independent of the provider of a independent of the provider of a independent of the provider of a
high-risk AI system in relation to high-risk AI system in relation to high-risk AI system in relation to high-risk AI system in relation to
which it performs conformity which it performs conformity which it performs conformity which it performs conformity
assessment activities. Notified assessment activities. Notified assessment activities. Notified assessment activities. Notified
bodies shall also be independent of bodies shall also be independent of bodies shall also be independent of bodies shall also be independent of
any other operator having an any other operator having an any other operator having an any other operator having an
economic interest in the high-risk AI economic interest in the high-risk AI economic interest in the high-risk AI economic interest in the high-risk AI
G 413 system that is assessed, as well as of system that is assessed, as well as of system that is assessed, as well as of system that is assessed, as well as of G
any competitors of the provider. any competitors of the provider. any competitors of the provider. any competitors of the provider.
This shall not preclude the use of This shall not preclude the use of
assessed AI systems that are assessed AI systems that are
necessary for the operations of the necessary for the operations of the
conformity assessment body or the conformity assessment body or the
use of such systems for personal use of such systems for personal
purposes. purposes.
Article 33(4a)
4a. A conformity assessment 4a. A conformity assessment body,

pursuant to paragraph 1 shall be its top-level management and the
performed by employees of notified personnel responsible for carrying
bodies who have not provided any out the conformity assessment tasks
other other service related to the shall not be directly involved in the
G 413a G
matter assessed than the conformity design, development, marketing or
assessment to the provider of a use of high-risk AI systems, or
high-risk AI system nor to any legal represent the parties engaged in
person connected to that provider in those activities. They shall not
the 12 months’ period before the engage in any activity that may
assessment and have committed to conflict with their independence of
not providing them with such judgement or integrity in relation to
services in the 12 month period conformity assessment activities for
following the completion of the which they are notified. This shall
assessment. in particular apply to consultancy
services.
Article 33(5)
5. Notified bodies shall be 5. Notified bodies shall be 5. Notified bodies shall be 5. Notified bodies shall be
organised and operated so as to organised and operated so as to organised and operated so as to organised and operated so as to
safeguard the independence, safeguard the independence, safeguard the independence, safeguard the independence,
objectivity and impartiality of their objectivity and impartiality of their objectivity and impartiality of their objectivity and impartiality of their
activities. Notified bodies shall activities. Notified bodies shall activities. Notified bodies shall activities. Notified bodies shall
document and implement a structure document and implement a structure document and implement a structure document and implement a structure
G 414 and procedures to safeguard and procedures to safeguard and procedures to safeguard and procedures to safeguard G
impartiality and to promote and impartiality and to promote and impartiality and to promote and impartiality and to promote and
apply the principles of impartiality apply the principles of impartiality apply the principles of impartiality apply the principles of impartiality
throughout their organisation, throughout their organisation, throughout their organisation, throughout their organisation,
personnel and assessment activities. personnel and assessment activities. personnel and assessment activities. personnel and assessment activities.
Proposal
Article 33(6)
6. Notified bodies shall have 6. Notified bodies shall have 6. Notified bodies shall have 6. Notified bodies shall have
documented procedures in place documented procedures in place documented procedures in place documented procedures in place
ensuring that their personnel, ensuring that their personnel, ensuring that their personnel, ensuring that their personnel,
committees, subsidiaries, committees, subsidiaries, committees, subsidiaries, committees, subsidiaries,
G 415 subcontractors and any associated subcontractors and any associated subcontractors and any associated subcontractors and any associated G
body or personnel of external bodies body or personnel of external bodies body or personnel of external bodies body or personnel of external bodies
respect the confidentiality of the respect the confidentiality of the respect the confidentiality of the respect the confidentiality of the
information which comes into their information which comes into their information in accordance with information in accordance with
possession during the performance possession during the performance Article 70 which comes into their Article 70 which comes into their
of conformity assessment activities, of conformity assessment activities, possession during the performance possession during the performance
except when disclosure is required except when disclosure is required of conformity assessment activities, of conformity assessment activities,
by law. The staff of notified bodies by law. The staff of notified bodies except when disclosure is required except when disclosure is required
shall be bound to observe shall be bound to observe by law. The staff of notified bodies by law. The staff of notified bodies
professional secrecy with regard to professional secrecy with regard to shall be bound to observe shall be bound to observe
all information obtained in carrying all information obtained in carrying professional secrecy with regard to professional secrecy with regard to
out their tasks under this Regulation, out their tasks under this Regulation, all information obtained in carrying all information obtained in carrying
except in relation to the notifying except in relation to the notifying out their tasks under this Regulation, out their tasks under this Regulation,
authorities of the Member State in authorities of the Member State in except in relation to the notifying except in relation to the notifying
which their activities are carried out. which their activities are carried out. authorities of the Member State in authorities of the Member State in
Any information and which their activities are carried out. which their activities are carried out.
documentation obtained by notified
bodies pursuant to the provisions of
this Article shall be treated in
compliance with the confidentiality
obligations set out in Article 70.
Article 33(7)
procedures for the performance of procedures for the performance of procedures for the performance of procedures for the performance of
activities which take due account of activities which take due account of activities which take due account of activities which take due account of
the size of an undertaking, the sector the size of an undertaking, the sector the size of an undertaking, the sector the size of an undertaking, the sector
G 416 in which it operates, its structure, the in which it operates, its structure, the in which it operates, its structure, the in which it operates, its structure, the G
degree of complexity of the AI degree of complexity of the AI degree of complexity of the AI degree of complexity of the AI
system in question. system in question. system in question. system in question.
Proposal
Article 33(8)
8. Notified bodies shall take out 8. Notified bodies shall take out 8. Notified bodies shall take out 8. Notified bodies shall take out
G 417 appropriate liability insurance for appropriate liability insurance for appropriate liability insurance for appropriate liability insurance for G
their conformity assessment their conformity assessment their conformity assessment their conformity assessment
activities, unless liability is assumed activities, unless liability is assumed activities, unless liability is assumed activities, unless liability is assumed
by the Member State concerned in by the Member State concerned in by the Member State concernedin by the Member State concernedin
accordance with national law or that accordance with national law or that which they are located in which they are established in
Member State is directly responsible Member State is directly responsible accordance with national law or that accordance with national law or that
for the conformity assessment. for the conformity assessment. Member State is itself directly Member State is itself directly
responsible for the conformity responsible for the conformity
assessment. assessment.
Article 33(9)
9. Notified bodies shall be capable 9. Notified bodies shall be capable 9. Notified bodies shall be capable 9. Notified bodies shall be capable
of carrying out all the tasks falling to of carrying out all the tasks falling to of carrying out all the tasks falling to of carrying out all the tasks falling to
them under this Regulation with the them under this Regulation with the them under this Regulation with the them under this Regulation with the
highest degree of professional highest degree of professional highest degree of professional highest degree of professional
integrity and the requisite integrity and the requisite integrity and the requisite integrity and the requisite
competence in the specific field, competence in the specific field, competence in the specific field, competence in the specific field,
G 418 whether those tasks are carried out whether those tasks are carried out whether those tasks are carried out whether those tasks are carried out
G
by notified bodies themselves or on by notified bodies themselves or on by notified bodies themselves or on by notified bodies themselves or on
their behalf and under their their behalf and under their their behalf and under their their behalf and under their
responsibility. responsibility. responsibility. responsibility.
Proposal
Article 33(10)
sufficient internal competences to be sufficient internal competences to be sufficient internal competences to be sufficient internal competences to be
able to effectively evaluate the tasks able to effectively evaluate the tasks able to effectively evaluate the tasks able to effectively evaluate the tasks
conducted by external parties on conducted by external parties on conducted by external parties on conducted by external parties on
G 419 G
their behalf. To that end, at all times their behalf. To that end, at all times their behalf. To that end, at all times their behalf. To that end, at all times
and for each conformity assessment and for each conformity assessment and for each conformity assessment and for each conformity assessment
procedure and each type of high-risk procedure and each type of high-risk procedure and each type of high-risk procedure and each type of high-risk
AI system in relation to which they AI system in relation to which they AI system in relation to which they AI system in relation to which they
have been designated, the notified have been designated, the notified have been designated, The notified have been designated, The notified
body shall have permanent body shall have permanent body shall have permanent body shall have permanent
availability of sufficient availability of sufficient availability of sufficient availability of sufficient
administrative, technical and administrative, technical and administrative, technical, legal and administrative, technical, legal and
scientific personnel who possess scientific personnel who possess scientific personnel who possess scientific personnel who possess
experience and knowledge relating experience and knowledge relating experience and knowledge relating experience and knowledge relating
to the relevant artificial intelligence to the relevant artificial intelligence to the relevant artificial intelligence to the relevant types of artificial
technologies, data and data technologies, data and data technologies, data and data intelligence technologiessystems,
computing and to the requirements computing and to the requirements computing and to the requirements data and data computing and to the
set out in Chapter 2 of this Title. set out in Chapter 2 of this Title. set out in Chapter 2 of this Title. requirements set out in Chapter 2 of
this Title.
Article 33(11)
11. Notified bodies shall participate 11. Notified bodies shall participate 11. Notified bodies shall participate 11. Notified bodies shall participate
in coordination activities as referred in coordination activities as referred in coordination activities as referred in coordination activities as referred
to in Article 38. They shall also take to in Article 38. They shall also take to in Article 38. They shall also take to in Article 38. They shall also take
part directly or be represented in part directly or be represented in part directly or be represented in part directly or be represented in
European standardisation European standardisation European standardisation European standardisation
G 420 organisations, or ensure that they are organisations, or ensure that they are organisations, or ensure that they are organisations, or ensure that they are
G
aware and up to date in respect of aware and up to date in respect of aware and up to date in respect of aware and up to date in respect of
relevant standards. relevant standards. relevant standards. relevant standards.
Proposal
Article 33(12)
12. Notified bodies shall make 12. Notified bodies shall make
available and submit upon request available and submit upon request deleted
all relevant documentation, all relevant documentation,
G 421 G
including the providers’ including the providers’
documentation, to the notifying documentation, to the notifying
authority referred to in Article 30 to authority referred to in Article 30 to
allow it to conduct its assessment, allow it to conduct its assessment,
designation, notification, monitoring designation, notification, monitoring
and surveillance activities and to and surveillance activities and to
facilitate the assessment outlined in facilitate the assessment outlined in
this Chapter. this Chapter.
Article 33a

Presumption of conformity with Presumption of conformity with
G 421a requirements relating to notified requirements relating to notified G
bodies bodies
Article 33a, first paragraph
Where a conformity assessment Where a conformity assessment

body demonstrates its conformity body demonstrates its conformity
with the criteria laid down in the with the criteria laid down in the
relevant harmonised standards or relevant harmonised standards or
parts thereof the references of parts thereof the references of
which have been published in the which have been published in the
G 421b Official Journal of the European Official Journal of the European G
Union it shall be presumed to Union it shall be presumed to

comply with the requirements set comply with the requirements set
out in Article 33 in so far as the out in Article 33 in so far as the
applicable harmonised standards applicable harmonised standards
cover those requirements. cover those requirements.
Article 34
Subsidiaries of and subcontracting Subsidiaries of and subcontracting Subsidiaries of and subcontracting Subsidiaries of and subcontracting
by notified bodies by notified bodies by notified bodies by notified bodies
Proposal
Article 34(1)
1. Where a notified body 1. Where a notified body 1. Where a notified body 1. Where a notified body
subcontracts specific tasks subcontracts specific tasks subcontracts specific tasks subcontracts specific tasks
connected with the conformity connected with the conformity connected with the conformity connected with the conformity
assessment or has recourse to a assessment or has recourse to a assessment or has recourse to a assessment or has recourse to a
subsidiary, it shall ensure that the subsidiary, it shall ensure that the subsidiary, it shall ensure that the subsidiary, it shall ensure that the
G 423 subcontractor or the subsidiary subcontractor or the subsidiary subcontractor or the subsidiary subcontractor or the subsidiary G
meets the requirements laid down in meets the requirements laid down in meets the requirements laid down in meets the requirements laid down in
Article 33 and shall inform the Article 33 and shall inform the Article 33 and shall inform the Article 33 and shall inform the
notifying authority accordingly. notifying authority accordingly. notifying authority accordingly. notifying authority accordingly.
Proposal
Article 34(2)
2. Notified bodies shall take full 2. Notified bodies shall take full 2. Notified bodies shall take full 2. Notified bodies shall take full
responsibility for the tasks responsibility for the tasks responsibility for the tasks responsibility for the tasks
performed by subcontractors or performed by subcontractors or performed by subcontractors or performed by subcontractors or
G 424 subsidiaries wherever these are subsidiaries wherever these are subsidiaries wherever these are subsidiaries wherever these are G
established. established. established. established.

Proposal
Article 34(3)
3. Activities may be subcontracted 3. Activities may be subcontracted 3. Activities may be subcontracted 3. Activities may be subcontracted
G 425 G
or carried out by a subsidiary only or carried out by a subsidiary only or carried out by a subsidiary only or carried out by a subsidiary only
with the agreement of the provider. with the agreement of the provider. with the agreement of the provider. with the agreement of the provider.
Notified bodies shall make a list of Notified bodies shall make a list of
their subsidiaries publicly available. their subsidiaries publicly available.
Article 34(4)
4. Notified bodies shall keep at the 4. Notified bodies shall keep at the 4. Notified bodies shall keep at the 4. Notified bodies shall keep at the
disposal of the notifying authority disposal of the notifying authority disposal of the notifying authority disposal of the notifying authority
the relevant documents concerning the relevant documents concerning The relevant documents concerning The relevant documents concerning
the assessment of the qualifications the assessmentverification of the the assessment of the qualifications the assessment of the qualifications
of the subcontractor or the qualifications of the subcontractor or of the subcontractor or the of the subcontractor or the
G 426 subsidiary and the work carried out the subsidiary and the work carried subsidiary and the work carried out subsidiary and the work carried out G
by them under this Regulation. out by them under this Regulation. by them under this Regulation shall by them under this Regulation shall
be kept at the disposal of the be kept at the disposal of the
notifying authority for a period of 5 notifying authority for a period of 5
years from the termination date of years from the termination date of
the subcontracting activity. the subcontracting activity.
Article 34a

Operational obligations of notified Operational obligations of notified
G 426a bodies bodies G
Article 34a(1)
1. Notified bodies shall verify the 1. Notified bodies shall verify the
conformity of high-risk AI system conformity of high-risk AI system
G 426b in accordance with the conformity in accordance with the conformity G
assessment procedures referred to assessment procedures referred to

in Article 43. in Article 43.
Article 34a(2)
2. Notified bodies shall perform 2. Notified bodies shall perform

their activities while avoiding their activities while avoiding
unnecessary burdens for providers, unnecessary burdens for providers,
and taking due account of the size and taking due account of the size
of an undertaking, the sector in of an undertaking, the sector in
which it operates, its structure and which it operates, its structure and
the degree of complexity of the high the degree of complexity of the high
risk AI system in question. In so risk AI system in question. In so
doing, the notified body shall doing, the notified body shall
nevertheless respect the degree of nevertheless respect the degree of
G 426c G
rigour and the level of protection rigour and the level of protection
required for the compliance of the required for the compliance of the
high risk AI system with the high risk AI system with the
requirements of this Regulation. requirements of this Regulation.
Particular attention shall be paid to
minimising administrative burdens
and compliance costs for micro and
small enterprises as defined in
2003/361/EC.
Article 34a(3)
3. Notified bodies shall make 3. Notified bodies shall make

available and submit upon request available and submit upon request
all relevant documentation, all relevant documentation,
G 426d including the providers’ including the providers’ G
documentation, to the notifying documentation, to the notifying

authority referred to in Article 30 to authority referred to in Article 30 to
allow that authority to conduct its allow that authority to conduct its
assessment, designation, assessment, designation,
notification, monitoring activities notification, monitoring activities
and to facilitate the assessment and to facilitate the assessment
outlined in this Chapter. outlined in this Chapter.
Article 35

Identification numbers and lists of Identification numbers and lists of Identification numbers and lists of Identification numbers and lists of
notified bodies designated under this notified bodies designated under this notified bodies designated under this notified bodies designated under this
G 427 Regulation Regulation Regulation Regulation
G

Proposal
Article 35(1)
1. The Commission shall assign an 1. The Commission shall assign an 1. The Commission shall assign an 1. The Commission shall assign an
identification number to notified identification number to notified identification number to notified identification number to notified
bodies. It shall assign a single bodies. It shall assign a single bodies. It shall assign a single bodies. It shall assign a single
G 428 number, even where a body is number, even where a body is number, even where a body is number, even where a body is G
notified under several Union acts. notified under several Union acts. notified under several Union acts. notified under several Union acts.
Proposal
Article 35(2)
2. The Commission shall make 2. The Commission shall make 2. The Commission shall make 2. The Commission shall make
publicly available the list of the publicly available the list of the publicly available the list of the publicly available the list of the
bodies notified under this bodies notified under this bodies notified under this bodies notified under this
G 429 Regulation, including the Regulation, including the Regulation, including the Regulation, including the G
identification numbers that have identification numbers that have identification numbers that have identification numbers that have
been assigned to them and the been assigned to them and the been assigned to them and the been assigned to them and the
activities for which they have been activities for which they have been activities for which they have been activities for which they have been
notified. The Commission shall notified. The Commission shall notified. The Commission shall notified. The Commission shall
ensure that the list is kept up to date. ensure that the list is kept up to date. ensure that the list is kept up to date. ensure that the list is kept up to date.
Proposal
Article 36

Changes to notifications Changes to notifications Changes to notifications Changes to notifications
G 430 G

Proposal
Article 36(-1)
-1. The notifying authority shall -1. The notifying authority shall
notify the Commission and the notify the Commission and the
other Member States of any other Member States of any
relevant changes to the notification relevant changes to the notification
G 430a of a notified body via the electronic of a notified body via the electronic G
notification tool referred to in notification tool referred to in

Article 32(2). Article 32(2).
Article 36(-1a), first subparagraph
-1a. The procedures described in -1a. The procedures described in

Article 31 and 32 shall apply to Article 31 and 32 shall apply to
extensions of the scope of the extensions of the scope of the
G 430b notification. For changes to the notification. For changes to the G
notification other than extensions notification other than extensions
of its scope, the procedures laid of its scope, the procedures laid
down in the following paragraphs down in the following paragraphs
shall apply. shall apply.
Article 36(-1a), second subparagraph
Where a notified body decides to Where a notified body decides to

cease its conformity assessment cease its conformity assessment
activities it shall inform the activities it shall inform the
notifying authority and the notifying authority and the
providers concerned as soon as providers concerned as soon as
possible and in the case of a possible and in the case of a
planned cessation one year before planned cessation one year before
ceasing its activities. The ceasing its activities. The
certificates may remain valid for a certificates may remain valid for a
temporary period of nine months temporary period of nine months
after cessation of the notified body's after cessation of the notified body's
activities on condition that another activities on condition that another
G 430c notified body has confirmed in notified body has confirmed in G
writing that it will assume writing that it will assume

responsibilities for the AI systems responsibilities for the AI systems
covered by those certificates. The covered by those certificates. The
new notified body shall complete a new notified body shall complete a
full assessment of the AI systems full assessment of the AI systems
affected by the end of that period affected by the end of that period
before issuing new certificates for before issuing new certificates for
those systems. Where the notified those systems. Where the notified
body has ceased its activity, the body has ceased its activity, the
notifying authority shall withdraw notifying authority shall withdraw
the designation. the designation.
Article 36(1)
G 431 1. Where a notifying authority has 1. Where a notifying authority has 1. Where a notifying authority has 1. Where a notifying authority has G
suspicions or has been informed that suspicions or has been informed that suspicions or has been suspicions or has been
a notified body no longer meets the a notified body no longer meets the informedsufficient reasons to informedsufficient reasons to
requirements laid down in Article requirements laid down in Article consider that a notified body no consider that a notified body no
33, or that it is failing to fulfil its 33, or that it is failing to fulfil its longer meets the requirements laid longer meets the requirements laid
obligations, that authority shall obligations, that authority shall down in Article 33, or that it is down in Article 33, or that it is
without delay investigate the matter without delay investigate the matter failing to fulfil its obligations, that failing to fulfil its obligations,
with the utmost diligence. In that with the utmost diligence. In that authority shall without delay thatthe notifying authority shall
context, it shall inform the notified context, it shall inform the notified investigate the matter with the without delay investigate the matter
body concerned about the objections body concerned about the objections utmost diligence. In that context, it with the utmost diligence. In that
raised and give it the possibility to raised and give it the possibility to shall informthe notifying authority context, it shall inform the notified
make its views known. If the make its views known. If the shall, provided that the the notified body concerned about the objections
notifying authority comes to the notifying authority comes to the body concerned about the objections raised and give it the possibility to
conclusion that the notified body conclusion that the notified body raised and give it the possibilityhad make its views known. If the
investigation no longer meets the investigation no longer meets the the opportunity to make its views notifying authority comes to the
requirements laid down in Article 33 requirements laid down in Article 33 known. If the notifying authority conclusion that the notified body
or that it is failing to fulfil its or that it is failing to fulfil its comes to the conclusion that the investigation no longer meets the
obligations, it shall restrict, suspend obligations, it shall restrict, suspend notified body investigation no longer requirements laid down in Article 33
or withdraw the notification as or withdraw the notification as meets the requirements laid down in or that it is failing to fulfil its
appropriate, depending on the appropriate, depending on the Article 33 or that it is failing to fulfil obligations, it shall restrict, suspend
seriousness of the failure. It shall seriousness of the failure. It shall its obligations, it shall , restrict, or withdraw the notification as
also immediately inform the also immediately inform the suspend or withdraw the notification appropriate, depending on the
Commission and the other Member Commission and the other Member as appropriate, depending on the seriousness of the failure to meet
States accordingly. States accordingly. seriousness of the failure to meet those requirements or fulfil those
those requirements or fulfil those obligations. It shall also
obligations. It shall also immediately inform the Commission
immediately inform the Commission and the other Member States
and the other Member States accordingly.
accordingly.
Article 36(2)
2. In the event of restriction, 2. In the event of restriction,

suspension or withdrawal of suspension or withdrawal of deleted
G 432 G
notification, or where the notified notification, or where the notified
body has ceased its activity, the body has ceased its activity, the
notifying authority shall take notifying authority shall take
appropriate steps to ensure that the appropriate steps to ensure that the
files of that notified body are either files of that notified body are either
taken over by another notified body taken over by another notified body
or kept available for the responsible or kept available for the responsible
notifying authorities at their request. notifying authorities, and market
surveillance authority at their
request.
Article 36(2a)
2a. Where its designation has been 2a. Where its designation has been
suspended, restricted, or fully or suspended, restricted, or fully or
partially withdrawn, the notified partially withdrawn, the notified
G 432a G
body shall inform the body shall inform the
manufacturers concerned at the manufacturers concerned at the
latest within 10 days. latest within 10 days.
Article 36(2b)
2b. In the event of restriction, 2b. In the event of restriction,

suspension or withdrawal of a suspension or withdrawal of a
notification, the notifying authority notification, the notifying authority
shall take appropriate steps to shall take appropriate steps to
ensure that the files of the notified ensure that the files of the notified
G 432b G
body concerned are kept and make body concerned are kept and make
them available to notifying them available to notifying
authorities in other Member States authorities in other Member States
and to market surveillance and to market surveillance
authorities at their request. authorities at their request.
Article 36(2c)
G 432c 2c. In the event of restriction, 2c. In the event of restriction, G
suspension or withdrawal of a suspension or withdrawal of a

designation, the notifying authority designation, the notifying authority
shall: shall:
Article 36(2c), point (a)
(a) assess the impact on the (a) assess the impact on the
certificates issued by the notified certificates issued by the notified
G 432d body; body; G
Article 36(2c), point (b)
(b) submit a report on its findings (b) submit a report on its findings
to the Commission and the other to the Commission and the other
Member States within three months Member States within three months
G 432e of having notified the changes to of having notified the changes to G
the notification; the notification;

Article 36(2c), point (c)
(c) require the notified body to (c) require the notified body to
suspend or withdraw, within a suspend or withdraw, within a
reasonable period of time reasonable period of time
determined by the authority, any determined by the authority, any
G 432f certificates which were unduly certificates which were unduly G
issued in order to ensure the issued in order to ensure the

conformity of AI systems on the conformity of AI systems on the
market; market;
Article 36(2c), point (d)

(d) inform the Commission and the (d) inform the Commission and the
Member States about certificates of Member States about certificates of
G 432g which it has required their which it has required their G
suspension or withdrawal; suspension or withdrawal;

Article 36(2c), point (e)
(e) provide the national competent (e) provide the national competent
authorities of the Member State in authorities of the Member State in
which the provider has its which the provider has its
registered place of business with all registered place of business with all
relevant information about the relevant information about the
certificates for which it has certificates for which it has
G 432h required suspension or withdrawal. required suspension or withdrawal. G
That competent authority shall take That competent authority shall take
the appropriate measures, where the appropriate measures, where
necessary, to avoid a potential risk necessary, to avoid a potential risk
to health, safety or fundamental to health, safety or fundamental
rights. rights.
Article 36(2d)
2d. With the exception of 2d. With the exception of

certificates unduly issued, and certificates unduly issued, and
where a notification has been where a notification has been
G 432i suspended or restricted, the suspended or restricted, the G
certificates shall remain valid in the certificates shall remain valid in the
following circumstances: following circumstances:
Article 36(2d), point (a)
(a) the notifying authority has (a) the notifying authority has
confirmed, within one month of the confirmed, within one month of the
suspension or restriction, that there suspension or restriction, that there
is no risk to health, safety or is no risk to health, safety or
fundamental rights in relation to fundamental rights in relation to
certificates affected by the certificates affected by the
G 432j suspension or restriction, and the suspension or restriction, and the G
notifying authority has outlined a notifying authority has outlined a

timeline and actions anticipated to timeline and actions anticipated to
remedy the suspension or remedy the suspension or
restriction; or restriction; or
Article 36(2d), point (b)
(b) the notifying authority has (b) the notifying authority has
confirmed that no certificates confirmed that no certificates
relevant to the suspension will be relevant to the suspension will be
issued, amended or re-issued issued, amended or re-issued
during the course of the suspension during the course of the suspension
or restriction, and states whether or restriction, and states whether
the notified body has the capability the notified body has the capability
of continuing to monitor and of continuing to monitor and
G 432k remain responsible for existing remain responsible for existing G
certificates issued for the period of certificates issued for the period of
the suspension or restriction. In the the suspension or restriction. In the
event that the authority responsible event that the authority responsible
for notified bodies determines that for notified bodies determines that
the notified body does not have the the notified body does not have the
capability to support existing capability to support existing
certificates issued, the provider certificates issued, the provider
shall provide to the national shall provide to the national
competent authorities of the competent authorities of the
Member State in which the provider Member State in which the provider
of the system covered by the of the system covered by the
certificate has its registered place of certificate has its registered place of
business, within three months of the business, within three months of the
suspension or restriction, a written suspension or restriction, a written
confirmation that another qualified confirmation that another qualified
notified body is temporarily notified body is temporarily
assuming the functions of the assuming the functions of the
notified body to monitor and notified body to monitor and
remain responsible for the remain responsible for the
certificates during the period of certificates during the period of
suspension or restriction. suspension or restriction.
Article 36(2e), first subparagraph
2e. With the exception of 2e. With the exception of

certificates unduly issued, and certificates unduly issued, and
where a designation has been where a designation has been
withdrawn, the certificates shall withdrawn, the certificates shall
G 432l remain valid for a period of nine remain valid for a period of nine G
months in the following months in the following

circumstances: circumstances:
Article 36(2e), first subparagraph, point (a)
(a) where the national competent (a) where the national competent
authority of the Member State in authority of the Member State in
which the provider of the AI system which the provider of the AI system
G 432m G
covered by the certificate has its covered by the certificate has its
registered place of business has registered place of business has
confirmed that there is no risk to confirmed that there is no risk to
health, safety and fundamental health, safety and fundamental
rights associated with the systems in rights associated with the systems in
question; and question; and
Article 36(2e), first subparagraph, point (b)
(b) another notified body has (b) another notified body has
confirmed in writing that it will confirmed in writing that it will
assume immediate responsibilities assume immediate responsibilities
for those systems and will have for those systems and will have
G 432n completed assessment of them completed assessment of them G
within twelve months of the within twelve months of the

withdrawal of the designation. withdrawal of the designation.
Article 36(2e), second subparagraph
In the circumstances referred to in In the circumstances referred to in

the first subparagraph, the national the first subparagraph, the national
competent authority of the Member competent authority of the Member
State in which the provider of the State in which the provider of the
system covered by the certificate system covered by the certificate
G 432o has its place of business may extend has its place of business may extend G
the provisional validity of the the provisional validity of the

certificates for further periods of certificates for further periods of
three months, which altogether three months, which altogether
shall not exceed twelve months. shall not exceed twelve months.
Article 36(2f)
The national competent authority 2f. The national competent

G 432p G
or the notified body assuming the authority or the notified body
functions of the notified body assuming the functions of the
affected by the change of notified body affected by the change
notification shall immediately of notification shall immediately
inform the Commission, the other inform the Commission, the other
Member States and the other Member States and the other
notified bodies thereof. notified bodies thereof.
Article 37

Challenge to the competence of Challenge to the competence of Challenge to the competence of Challenge to the competence of
G 433 notified bodies notified bodies notified bodies notified bodies G

Proposal
Article 37(1)
1. The Commission shall, where 1. The Commission shall, where 1. The Commission shall, where 1. The Commission shall, where
necessary, investigate all cases necessary, investigate all cases necessary, investigate all cases necessary, investigate all cases
where there are reasons to doubt where there are reasons to doubt where there are reasons to doubt where there are reasons to doubt
whether a notified body complies whetherthe competence of a notified whether a notified body complies whetherthe competence of a notified
G 434 with the requirements laid down in body complies with the requirements with the requirements laid down in body complies withor the continued G
Article 33. laid down in Article 33or the Article 33. fulfilment by a notified body of the
continued fulfilment by a notified requirements laid down in Article 33
body of the applicable requirements and their applicable responsibilities.
and responsibilities.
Article 37(2)
2. The Notifying authority shall 2. The Notifying authority shall 2. The notifying authority shall 2. The Notifying authority shall
G 435 provide the Commission, on request, provide the Commission, on request, provide the Commission, on request, provide the Commission, on request, G
with all relevant information relating with all relevant information relating with all relevant information relating with all relevant information relating
to the notification of the notified to the notification or the to the notification of the notified to the notification or the
body concerned. maintenance of the competence of body concerned. maintenance of the competence of
the notified body concerned. the notified body concerned.
Article 37(3)
3. The Commission shall ensure that 3. The Commission shall ensure that 3. The Commission shall ensure that 3. The Commission shall ensure that
all confidential information obtained all confidentialsensitive information all confidential information obtained all confidentialsensitive information
in the course of its investigations obtained in the course of its in the course of its investigations obtained in the course of its
G 436 pursuant to this Article is treated investigations pursuant to this pursuant to this Article is treated investigations pursuant to this G
confidentially. Article is treated confidentially. confidentially in accordance with Article is treated confidentially in
Article 70. accordance with Article 70.
Article 37(4)
4. Where the Commission ascertains 4. Where the Commission ascertains 4. Where the Commission ascertains 4. Where the Commission ascertains
that a notified body does not meet or that a notified body does not meet or that a notified body does not meet or that a notified body does not meet or
no longer meets the requirements no longer meets the requirements no longer meets the requirements no longer meets the requirements
laid down in Article 33, it shall laid down in Article 33for its laid down in Article 33, it shall laid down in Article 33for its
adopt a reasoned decision requesting notification, it shall adopt a adopt a reasoned decision notification, it shall adopt a
the notifying Member State to take reasoned decision requestinginform requesting the notifying Member reasoned decision requesting inform
the necessary corrective measures, the notifying Member State Stateinform the notifying authority -the notifying Member State
including withdrawal of notification accordingly and request it to take of the reasons of such an accordingly and request it to take
G 437 if necessary. That implementing act the necessary corrective measures, ascertainment and request it to take the necessary corrective measures, G
shall be adopted in accordance with including suspension or withdrawal the necessary corrective measures, including suspension or withdrawal
the examination procedure referred of the notification if necessary. including the suspension, restriction of the notification if necessary.
to in Article 74(2). Where the Member State fails to or withdrawal of notificationthe Where the Member State fails to
take the necessary corrective designation if necessary. Where the take the necessary corrective
measures, the Commission may, by notifying authority fails to take the measures, the Commission may, by
means of an implementing act, necessary corrective measures, the means of implementing acts,
suspend, restrict or withdraw the Commission may, by means of suspend, restrict or withdraw the
designation. That implementing act implementing acts, suspend, restrict designation. That implementing act
shall be adopted in accordance with or withdraw the notification. That shall be adopted in accordance with
the examination procedure referred implementing act shall be adopted in the examination procedure referred
to in Article 74(2). accordance with the examination to in Article 74(2).
procedure referred to in Article
74(2).
Article 38

Coordination of notified bodies Coordination of notified bodies Coordination of notified bodies Coordination of notified bodies
G 438 G

Proposal
Article 38(1)
1. The Commission shall ensure 1. The Commission shall ensure 1. The Commission shall ensure 1. The Commission shall ensure
that, with regard to the areas covered that, with regard to the areas covered that, with regard to the areas that, with regard to the areas
by this Regulation, appropriate by this Regulation, appropriate covered by this Regulationhigh-risk covered by this Regulationhigh-risk
coordination and cooperation coordination and cooperation AI systems, appropriate coordination AI systems, appropriate coordination
between notified bodies active in the between notified bodies active in the and cooperation between notified and cooperation between notified
G 439 conformity assessment procedures of conformity assessment procedures of bodies active in the conformity bodies active in the conformity G
AI systems pursuant to this AI systems pursuant to this assessment procedures of AI systems assessment procedures of AI systems
Regulation are put in place and Regulation are put in place and pursuant to this Regulation are put in pursuant to this Regulation are put in
properly operated in the form of a properly operated in the form of a place and properly operated in the place and properly operated in the
sectoral group of notified bodies. sectoral group of notified bodies. form of a sectoral group of notified form of a sectoral group of notified
bodies. bodies.
Article 38(2)
2. Member States shall ensure that 2. Member States shall ensure that 2. Member StatesThe notifying 2. Member StatesThe notifying
the bodies notified by them the bodies notified by them authority shall ensure that the bodies authority shall ensure that the bodies
G 440 participate in the work of that group, participate in the work of that group, notified by them participate in the notified by them participate in the G
directly or by means of designated directly or by means of designated work of that group, directly or by work of that group, directly or by
representatives. representatives. means of designated representatives. means of designated representatives.
Article 38(2a)
2a. The Commission shall provide 2a. The Commission shall provide
for the exchange of knowledge and for the exchange of knowledge and
G 440a best practices between the Member best practices between the Member G
States' national authorities States' notifying authorities.

responsible for notification policy.
Article 39

Conformity assessment bodies of Conformity assessment bodies of Conformity assessment bodies of Conformity assessment bodies of
G 441 third countries third countries third countries third countries G

Proposal
Conformity assessment bodies Conformity assessment bodies Conformity assessment bodies Conformity assessment bodies
established under the law of a third established under the law of a third established under the law of a third established under the law of a third
country with which the Union has country with which the Union has country with which the Union has country with which the Union has
concluded an agreement may be concluded an agreement may be concluded an agreement may be concluded an agreement may be
authorised to carry out the activities authorised to carry out the activities authorised to carry out the activities authorised to carry out the activities
G 442 G
of notified Bodies under this of notified Bodies under this of notified Bodies under this of notified Bodies under this
Regulation. Regulation. Regulation, provided that they meet Regulation, provided that they meet
the requirements in Article 33. the requirements in Article 33 or
they ensure an equivalent level of
compliance.
Chapter 5

STANDARDS, CONFORMITY STANDARDS, CONFORMITY STANDARDS, CONFORMITY STANDARDS, CONFORMITY
ASSESSMENT, CERTIFICATES, ASSESSMENT, CERTIFICATES, ASSESSMENT, CERTIFICATES, ASSESSMENT, CERTIFICATES,
G 443 REGISTRATION REGISTRATION REGISTRATION REGISTRATION
G

Proposal
Article 40

Harmonised standards Harmonised standards Harmonised standards Harmonised standards and
G 444 standardisation deliverables G

Proposal
High-risk AI systems which are in High-risk AI systems and High-risk AI systems or general High-risk AI systems which are in
conformity with harmonised foundation models which are in purpose AI systems which are in conformity with harmonised
standards or parts thereof the conformity with harmonised conformity with harmonised standards or parts thereof the
references of which have been standards or parts thereof the standards or parts thereof the references of which have been
published in the Official Journal of references of which have been references of which have been published in the Official Journal of
the European Union shall be published in the Official Journal of published in the Official Journal of the European Union in accordance
presumed to be in conformity with the European Union in accordance the European Union shall be with Regulation (EU) 1025/2012
G 445 G
the requirements set out in Chapter 2 with Regulation (EU) 1025/2012 presumed to be in conformity with shall be presumed to be in
of this Title, to the extent those shall be presumed to be in the requirements set out in conformity with the requirements set
standards cover those requirements. conformity with the requirements set Chapter 2 of this Title or, as out in Chapter 2 of this Title or, as
out in Chapter 2 of this Title or applicable, with requirements set applicable, with the requirements
Article 28b, to the extent those out in Article 4a and Article 4b, to set out in [Chapter on GPAI], to the
standards cover those requirements. the extent those standards cover extent those standards cover those
those requirements. requirements.

-1. When issuing a standardisation 2. The Commission shall issue

request to European standardisation requests covering
standardisation organisations in all requirements of Title II Chapter
accordance with Article 10 of III and as applicable [GPAI
Regulation 1025/2012, the Chapter] of this Regulation, in
Commission shall specify that accordance with Article 10 of
standards are coherent, clear and Regulation EU (No)1025/2012
drafted in such a way that they aim without undue delay. The
to fulfil in particular the following standardisation request shall also
objectives: ask for deliverables on reporting
and documentation processes to
G 445a improve AI systems resource G
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.
(a) ensure that AI systems placed When issuing a standardisation

on the market or put into service in request to European
the Union are safe and respect standardisation organisations, the
G 445b Union values and strengthen the Commission shall specify that G
Union's open strategic autonomy; 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
Union meet the relevant
requirements laid down in this
Regulation.
Article 40, third paragraph, point (a)
(b) promote investment and

innovation in AI, including through Text Origin: Council Mandate
G 445c increasing legal certainty, as well as G
competitiveness and growth of the

Union market;
Article 40, third paragraph, point (b)
(c) enhance multistakeholder

governance, representative of all
G 445d relevant European stakeholders G
(e.g. industry, SMEs, civil society,

researchers);
Article 40, third paragraph, point (c)
(d) contribute to strengthening

global cooperation on
G 445e standardisation in the field of AI G
that is consistent with Union values

and interests.

The Commission shall request the The Commission shall request the
European standardisation European standardisation
organisations to provide organisations to provide
evidence of their best efforts to evidence of their best efforts to
G 445f fulfil the above objectives. fulfil the above objectives in G
accordance with Article 24 of

Regulation EU 1025/2012.
Article 40, (1a)
1a. The Commission shall issue

standardisation requests covering
all requirements of this Regulation,
in accordance with Article 10 of
Regulation EU (No)1025/2012 by...
G 445g G
[two months after the date of entry
into force of this Regulation]. When
preparing standardisation request,
the Commission shall consult the
AI Office and the Advisory Forum;
1c The actors involved in the 1c The actors involved in the

standardisation process shall take standardisation process shall seek
into account the general principles to promote investment and
for trustworthy AI set out in Article innovation in AI, including through
G 445h G
4(a), seek to promote investment increasing legal certainty, as well as
and innovation in AI as well as competitiveness and growth of the
competitiveness and growth of the Union market, and contribute to
Union market, and contribute to strengthening global cooperation
strengthening global cooperation on standardisation and taking into
on standardisation and taking into account existing international
account existing international standards in the field of AI that are
standards in the field of AI that are consistent with Union values,
consistent with Union values, fundamental rights and interests,
fundamental rights and interests, and enhance multi-stakeholder
and ensure a balanced governance ensuring a balanced
representation of interests and representation of interests and
effective participation of all effective participation of all
relevant stakeholders in accordance relevant stakeholders in accordance
with Articles 5, 6, and 7 of with Articles 5, 6, and 7 of
Regulation (EU) No 1025/2012 Regulation (EU) No 1025/2012
Article 40, (1b)
1b When issuing a standardisation

request to European
standardisation organisations, the
Commission shall specify that
standards have to be consistent,
including with the sectorial law
G 445i listed in Annex II, and aimed at G
ensuring that AI systems or

foundation models placed on the
Union meet the relevant
requirements laid down in this
Regulation;
Article 41

G 446 Common specifications Common specifications Common specifications Common specifications G

Proposal
Article 41(1)
1. Where harmonised standards 1. Where harmonised standards 1. Where harmonised standards

referred to in Article 40 do not exist deleted referred to in Article 40 do not exist referred to in Article 40 do not exist
or where the Commission considers or where The Commission considers or where the Commission considers
that the relevant harmonised that the relevant harmonised that the relevant harmonised
standards are insufficient or that standards are insufficient or that standards are insufficient or that
there is a need to address specific there is a need to address specific there is a need to address specific
safety or fundamental right safety or fundamental right safety or fundamental right
concerns, the Commission may, by concerns, the Commission may, by concerns, the Commission may, by
means of implementing acts, adopt means of implementing acts, adoptis means of implementing acts, adopt
common specifications in respect of empowered to adopt, after common specifications in respect of
the requirements set out in Chapter 2 consulting the AI Board referred to theThe Commission is empowered
of this Title. Those implementing in Article 56, implementing acts in to adopt, after consulting the
acts shall be adopted in accordance accordance with the examination Advisory Forum referred to in
with the examination procedure procedure referred to in Article Article 58, implementing acts in
G 447 G
referred to in Article 74(2). 74(2) establishing common accordance with the examination
technical specifications in respect procedure referred to in Article
offor the requirements set out in 74(2) establishing common
Chapter 2 of this Title. Those specifications for the requirements
implementing acts shall be adopted set out in Chapter 2 of this Title or,
in accordance with the examination as applicable, with requirements set
procedure referred to in Article out in Chapter 2 of this Title. Those
74(2)., or, as applicable, with implementing acts shall be adopted
requirements set out in Article 4a in accordance with the examination
and Article 4b, where the following procedure referred to in Article
conditions have been fulfilled: 74(2).Article [GPAI Chapter], for
AI systems within the scope of this
Regulation, where the following
conditions have been fulfilled:

G 447a G
(a) no reference to harmonised (a) the Commission has requested,
standards covering the relevant pursuant to Article 10(1) of
essential safety or fundamental Regulation 1025/2012, one or more
right concerns is published in the European standardisation
Official Journal of the European organisations to draft a harmonised
Union in accordance with standard for the requirements set
Regulation (EU) No 1025/2012; 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
(iv) the harmonised standards do
not comply with the request; and
(b) the Commission has requested, (b) no reference to harmonised

pursuant to Article 10(1) of standards covering the
Regulation 1025/2012, one or more requirements referred to in Chapter
European standardisation II of this Title has been published
organisations to draft a harmonised in the Official Journal of the
G 447b standard for the requirements set European Union, in accordance G
out in Chapter 2 of this Title; with Regulation (EU) No

1025/2012, and no such reference is
expected to be published within a
reasonable period.
(c) the request referred to in point (c)

(b) has not been accepted by any of
the European standardisation
organisations or the harmonised
standards addressing that request
G 447c G
are not delivered within the
deadline set in accordance with
article 10(1) of Regulation
1025/2012 or those standards do
not comply with the request.
1a. Before preparing a draft 1a. Before preparing a draft

implementing act, the Commission implementing act, the Commission
shall inform the committee referred shall inform the committee referred
to in Article 22 of Regulation EU to in Article 22 of Regulation EU
G 447d (No) 1025/2012 that it considers (No) 1025/2012 that it considers G
that the conditions in paragraph 1 that the conditions in paragraph 1

are fulfilled. are fulfilled.
1a. The Commission may, by

means of implementing act adopted Included in row 477
G 447e in accordance with the examination G

74(2) and after consulting the AI
Office and the AI Advisory Forum,
adopt common specifications in
respect of the requirements set out
in Chapter 2 of this Title or Article
28b wherein all of the following
conditions are fulfilled:
(a) there is no reference to
harmonised standards already
published in the Official Journal of
the European Union related to the
essential requirement(s), unless the
harmonised standard in question is
an existing standard that must be
revised;
(b) the Commission has requested
one or more European
standardisation organisations to
draft a harmonised standard for the
essential requirement(s) set out in
Chapter 2;
(c) the request referred to in point
(b) has not been accepted by any of
the European standardisation
organisations; or there are undue
delays in the establishment of an
appropriate harmonised standard;
or the standard provided does not
satisfy the requirements of the
relevant Union law, or does not
comply with the request of the
Commission.
1b. The Commission shall develop

G 447f G
common specifications for the
methodology to fulfil the reporting
and documentation requirement on
the consumption of energy and
resources during development,
training and deployment of the high
risk AI system.
Article 41(1c)
1c. Where the Commission

considers there to be a need to
address specific fundamental rights
concerns, common specifications
G 447g G
adopted by the Commission in
accordance with paragraph 1a shall
also address those specific
fundamental rights concerns.
Article 41(2)
2. The Commission, when preparing 2. The Commission shall, 2. In the early preparation of the
the common specifications referred throughout the whole process of draft implementing act
to in paragraph 1, shall gather the drafting, when preparing the establishingThe Commission, when
views of relevant bodies or expert common specifications referred to in preparing the common
groups established under relevant paragraph 1, shall gather the views specificationsspecification, the
sectorial Union law. of relevantparagraphs 1a and 1b, Commission shall fulfil the
regularly consult the AI Office and objectives referred to in paragraph
G 448 the Advisory Forum, the European 1, shallArticle 40(2) and gather the G
standardisation organisations and views of relevant bodies or expert

bodies or expert groups established groups established under relevant
under relevant sectorial Union law sectorial Union law. Based on that
as well as other relevant consultation, the Commission shall
stakeholders. The Commission shall prepare the draft implementing act.
fulfil the objectives referred to in
Article 40 (1c) and duly justify why
it decided to resort to common
specifications.
Where the Commission intends to
adopt common specifications
pursuant to paragraph 1a of this
Article, it shall also clearly identify
the specific fundamental rights
concern to be addressed.
When adopting common
specifications pursuant to
paragraphs 1a and 1b of this
Article, the Commission shall take
into account the opinion issued by
the AI Office referred to in Article
56e(b) of this Regulation. Where
the Commission decides not to
follow the opinion of the AI Office,
it shall provide a reasoned
explanation to the AI Office.
Article 41(3)
3. High-risk AI systems which are 3. High-risk AI systems which are 3. High-risk AI systems or general 3. High-risk AI systems which are
in conformity with the common in conformity with the common purpose AI systems which are in in conformity with the common
specifications referred to in specifications referred to in conformity with the common specifications referred to in
paragraph 1 shall be presumed to be paragraph 1paragraphs 1a and 1b specifications referred to in paragraph 1, or parts thereof, shall
in conformity with the requirements shall be presumed to be in paragraph 1 shall be presumed to be be presumed to be in conformity
set out in Chapter 2 of this Title, to conformity with the requirements set in conformity with the requirements with the requirements set out in
G 449 G
the extent those common out in Chapter 2 of this Title, to the set out in Chapter 2 of this Title or, Chapter 2 of this Title, to the extent
specifications cover those extent those common specifications as applicable, with requirements set those common specifications cover
requirements. cover those requirements. out in Article 4a and Article 4b, to those requirements.
the extent those common
specifications cover those
requirements.
Article 41(3a)
3a. Where a harmonised standard 3a. Where a harmonised standard

is adopted by a European is adopted by a European
standardisation organisation and standardisation organisation and
proposed to the Commission for the proposed to the Commission for the
publication of its reference in the publication of its reference in the
Official Journal of the European Official Journal of the European
Union, the Commission shall assess Union, the Commission shall assess
the harmonised standard in the harmonised standard in
accordance with Regulation (EU) accordance with Regulation (EU)
G 449a No 1025/2012. When reference of a No 1025/2012. When reference of a G
harmonised standard is published harmonised standard is published

in the Official Journal of the in the Official Journal of the
European Union, the Commission European Union, the Commission
shall repeal acts referred to in shall repeal acts referred to in
paragraph 1 and 1b, or parts paragraph 1 and 1b, or parts
thereof which cover the same thereof which cover the same
requirements set out in Chapter 2 of requirements set out in Chapter 2 of
this Title. this Title.
Article 41(4)
4. Where providers do not comply 4. Where providers of high-risk AI 4. Where providers of high-risk AI
with the common specifications systems do not comply with the deleted systems do not comply with the
referred to in paragraph 1, they shall common specifications referred to in common specifications referred to in
duly justify that they have adopted paragraph 1, they shall duly justify paragraph 1, they shall duly justify
technical solutions that are at least that they have adopted technical that they have adopted technical
G 450 equivalent thereto. solutions that aremeet the solutions that aremeet the G
requirements referred to in Chapter requirements referred to in Chapter

II to a level at least equivalent II to a level at least equivalent
thereto.; thereto.
Article 41(4a)
4a. When references of a

harmonised standard are published
in the Official Journal of the
European Union, implementing
acts referred to in paragraph 1,
G 450a G
which cover the requirements set
out in Chapter 2 of this Title or
requirements set out in Article 4a
and Article 4b, shall be repealed, as
applicable.
Article 41(4a)
4b. When a Member State 4b. When a Member State

considers that a common considers that a common
specification does not entirely specification does not entirely
satisfy the requirements set out in satisfy the requirements set out in
Chapter 2 of this Title or Chapter 2 of this Title, it shall
requirements set out in Article 4a inform the Commission thereof
and Article 4b, as applicable, it with a detailed explanation and the
G 450b G
shall inform the Commission Commission shall assess that
thereof with a detailed explanation information and, if appropriate,
and the Commission shall assess amend the implementing act
that information and, if establishing the common
appropriate, amend the specification in question.
implementing act establishing the
common specification in question.
Article 42

G 451 G
Presumption of conformity with Presumption of conformity with Presumption of conformity with Presumption of conformity with
certain requirements certain requirements certain requirements certain requirements

Proposal
Article 42(1)
1. Taking into account their 1. Taking into account their 1. Taking into account their 1. Taking into account their
intended purpose, high-risk AI intended purpose, high-risk AI intended purpose, High-risk AI intended purpose, High-risk AI
systems that have been trained and systems that have been trained and systems that have been trained and systems that have been trained and
tested on data concerning the tested on data concerning the tested on data concerningreflecting tested on data concerningreflecting
specific geographical, behavioural specific geographical, behavioural the specific geographical, the specific geographical,
and functional setting within which contextual and functional setting behavioural andor functional setting behavioural, contextual or and
G 452 G
they are intended to be used shall be within which they are intended to be within which they are intended to be functional setting within which they
presumed to be in compliance with used shall be presumed to be in used shall be presumed to be in are intended to be used shall be
the requirement set out in Article compliance with the compliance with the presumed to be in compliance with
10(4). requirementrespective requirements requirementrespective requirements the requirementrespective
set out in Article 10(4). set out in Article 10(4). requirements set out in Article
10(4).
Article 42(2)
2. High-risk AI systems that have 2. High-risk AI systems that have 2. High-risk AI systems or general 2. High-risk AI systems that have
been certified or for which a been certified or for which a purpose AI systems that have been been certified or for which a
statement of conformity has been statement of conformity has been certified or for which a statement of statement of conformity has been
issued under a cybersecurity scheme issued under a cybersecurity scheme conformity has been issued under a issued under a cybersecurity scheme
pursuant to Regulation (EU) pursuant to Regulation (EU) cybersecurity scheme pursuant to pursuant to Regulation (EU)
2019/881 of the European 2019/881 of the European Regulation (EU) 2019/881 of the 2019/881 of the European
G 453 Parliament and of the Council1 and Parliament and of the Council1 and European Parliament and of the Parliament and of the Council11 and G
the references of which have been the references of which have been Council1 and the references of which the references of which have been
published in the Official Journal of published in the Official Journal of have been published in the Official published in the Official Journal of
the European Union shall be the European Union shall be Journal of the European Union shall the European Union shall be
presumed to be in compliance with presumed to be in compliance with be presumed to be in compliance presumed to be in compliance with
the cybersecurity requirements set the cybersecurity requirements set with the cybersecurity requirements the cybersecurity requirements set
out in Article 15 of this Regulation out in Article 15 of this Regulation set out in Article 15 of this out in Article 15 of this Regulation
in so far as the cybersecurity in so far as the cybersecurity Regulation in so far as the in so far as the cybersecurity
certificate or statement of certificate or statement of cybersecurity certificate or statement certificate or statement of
conformity or parts thereof cover conformity or parts thereof cover of conformity or parts thereof cover conformity or parts thereof cover
those requirements. those requirements. those requirements. those requirements.
_________ _________ _________ _________
European Parliament and of the Council of European Parliament and of the Council of the European Parliament and of the Council European Parliament and of the Council of
17 April 2019 on ENISA (the European 17 April 2019 on ENISA (the European of 17 April 2019 on ENISA (the European 17 April 2019 on ENISA (the European
Union Agency for Cybersecurity) and on Union Agency for Cybersecurity) and on Union Agency for Cybersecurity) and on Union Agency for Cybersecurity) and on
information and communications technology information and communications technology information and communications technology information and communications technology
cybersecurity certification and repealing cybersecurity certification and repealing cybersecurity certification and repealing cybersecurity certification and repealing
Regulation (EU) No 526/2013 Regulation (EU) No 526/2013 Regulation (EU) No 526/2013 Regulation (EU) No 526/2013
(Cybersecurity Act) (OJ L 151, 7.6.2019, p. (Cybersecurity Act) (OJ L 151, 7.6.2019, p. (Cybersecurity Act) (OJ L 151, 7.6.2019, p. (Cybersecurity Act) (OJ L 151, 7.6.2019, p.
1). 1). 1). 1).
Article 43

Conformity assessment Conformity assessment Conformity assessment Conformity assessment
G 454 G

Proposal
1. For high-risk AI systems listed in 1. For high-risk AI systems listed in 1. For high-risk AI systems listed in 1. For high-risk AI systems listed in
point 1 of Annex III, where, in point 1 of Annex III, where, in point 1 of Annex III, where, in point 1 of Annex III, where, in
demonstrating the compliance of a demonstrating the compliance of a demonstrating the compliance of a demonstrating the compliance of a
high-risk AI system with the high-risk AI system with the high-risk AI system with the high-risk AI system with the
this Title, the provider has applied this Title, the provider has applied this Title, the provider has applied this Title, the provider has applied
G 455 G
harmonised standards referred to in harmonised standards referred to in harmonised standards referred to in harmonised standards referred to in
Article 40, or, where applicable, Article 40, or, where applicable, Article 40, or, where applicable, Article 40, or, where applicable,
common specifications referred to in common specifications referred to in common specifications referred to in common specifications referred to in
Article 41, the provider shall follow Article 41, the provider shall Article 41, the provider shall Article 41, the provider shall
one of the following procedures: followopt for one of the following followopt for one of the following followopt for one of the following
procedures:; procedures: procedures:
Article 43(1), first subparagraph, point (a)
(a) the conformity assessment (a) the conformity assessment (a) the conformity assessment (a) the conformity assessment
procedure based on internal control procedure based on internal control procedure based on internal control procedure based on internal control
G 456 referred to in Annex VI; referred to in Annex VI; or referred to in Annex VI; or referred to in Annex VI; or G
Article 43(1), first subparagraph, point (b)
(b) the conformity assessment (b) the conformity assessment (b) the conformity assessment (b) the conformity assessment
procedure based on assessment of procedure based on assessment of procedure based on assessment of procedure based on assessment of
the quality management system and the quality management system and the quality management system and the quality management system and
assessment of the technical assessment of the technical assessment of the technical assessment of the technical
G 457 documentation, with the documentation, with the documentation, with the documentation, with the G
involvement of a notified body, involvement of a notified body, involvement of a notified body, involvement of a notified body,
referred to in Annex VII. referred to in Annex VII.; referred to in Annex VII. referred to in Annex VII.
Where, in demonstrating the Where, In demonstrating the Where, in demonstrating the Where, In demonstrating the
compliance of a high-risk AI system compliance of a high-risk AI system compliance of a high-risk AI system compliance of a high-risk AI system
with the requirements set out in with the requirements set out in with the requirements set out in with the requirements set out in
Chapter 2 of this Title, the provider Chapter 2 of this Title, the provider Chapter 2 of this Title, the provider Chapter 2 of this Title, the provider
has not applied or has applied only has not applied or has applied only has not applied or has applied only has not applied or has applied only
in part harmonised standards in partshall follow the conformity in part harmonised standards in partshall follow the conformity
G 458 G
referred to in Article 40, or where assessment procedure set out in referred to in Article 40, or where assessment procedure set out in
such harmonised standards do not Annex VII in the following cases: such harmonised standards do not Annex VII in the following cases:
exist and common specifications (a) where harmonised standards exist and common specifications (a) where harmonised standards
referred to in Article 41 are not referred to in Article 40, or where referred to in Article 41 are not referred to in Article 40, or where
available, the provider shall follow such harmonised standardsthe available, the provider shall follow such harmonised standards do not
the conformity assessment procedure reference number of which has the conformity assessment procedure exist and common specifications
set out in Annex VII. been published in the Official set out in Annex VII. referred to in Article 41 are not
Journal of the European Union, available,;
covering all relevant safety (aa) the provider shall follow the
requirements for the AI system, do conformity assessment procedure set
not exist and common specifications out in Annex VII.has not applied or
referred to in Article 41 are not has applied only in part the
available,; harmonised standard;
(b) where the technical (b) where the common
specifications referred to in point specifications referred to in point
(a) exist but the provider has not (a) exist but the provider has not
applied them or has applied them applied them;
only in part; (c) where one or more of the
(c) where one or more of the harmonised standards referred to in
technical specifications referred to point (a) has been published with a
in point (a) has been published with restriction and only on the part of
a restriction and only on the part of the standard that was restricted;
the standard that was restricted;
(d) when the provider shall follow
the conformity assessment procedure
set out in Annex VIIconsiders that
the nature, design, construction or
purpose of the AI system necessitate
third party verification, regardless
of its risk level.
For the purpose of the conformity For the purpose of carrying out the For the purpose of the conformity For the purpose of the conformity
assessment procedure referred to in conformity assessment procedure assessment procedure referred to in assessment procedure referred to in
Annex VII, the provider may choose referred to in Annex VII, the Annex VII, the provider may choose Annex VII, the provider may choose
any of the notified bodies. However, provider may choose any of the any of the notified bodies. However, any of the notified bodies. However,
G 459 when the system is intended to be notified bodies. However, when the when the system is intended to be when the system is intended to be G
put into service by law enforcement, system is intended to be put into put into service by law enforcement, put into service by law enforcement,
immigration or asylum authorities as service by law enforcement, immigration or asylum authorities as immigration or asylum authorities as
well as EU institutions, bodies or immigration or asylum authorities as well as EU institutions, bodies or well as EU institutions, bodies or
agencies, the market surveillance well as EU institutions, bodies or agencies, the market surveillance agencies, the market surveillance
authority referred to in Article 63(5) agencies, the market surveillance authority referred to in Article 63(5) authority referred to in Article 63(5)
or (6), as applicable, shall act as a authority referred to in Article 63(5) or (6), as applicable, shall act as a or (6), as applicable, shall act as a
notified body. or (6), as applicable, shall act as a notified body. notified body.
notified body.
Article 43(2)
to in points 2 to 8 of Annex III, to in points 2 to 8 of Annex III, to in points 2 to 8 of Annex III and to in points 2 to 8 of Annex III,
providers shall follow the providers shall follow the for general purpose AI systems providers shall follow the
conformity assessment procedure conformity assessment procedure referred in Title 1a, providers shall conformity assessment procedure
based on internal control as referred based on internal control as referred follow the conformity assessment based on internal control as referred
to in Annex VI, which does not to in Annex VI, which does not procedure based on internal control to in Annex VI, which does not
provide for the involvement of a provide for the involvement of a as referred to in Annex VI, which provide for the involvement of a
notified body. For high-risk AI notified body. For high-risk AI does not provide for the involvement notified body. For high-risk AI
G 460 systems referred to in point 5(b) of systems referred to in point 5(b) of of a notified body. For high-risk AI systems referred to in point 5(b) of G
Annex III, placed on the market or Annex III, placed on the market or systems referred to in point 5(b) of Annex III, placed on the market or
put into service by credit institutions put into service by credit institutions Annex III, placed on the market or put into service by credit institutions
regulated by Directive 2013/36/EU, regulated by Directive 2013/36/EU, put into service by credit institutions regulated by Directive 2013/36/EU,
the conformity assessment shall be the conformity assessment shall be regulated by Directive 2013/36/EU, the conformity assessment shall be
carried out as part of the procedure carried out as part of the procedure the conformity assessment shall be carried out as part of the procedure
referred to in Articles 97 to101 of referred to in Articles 97 to101 of carried out as part of the procedure referred to in Articles 97 to101 of
that Directive. that Directive. referred to in Articles 97 to101 of that Directive.
that Directive.
3. For high-risk AI systems, to 3. For high-risk AI systems, to 3. For high-risk AI systems, to 3. For high-risk AI systems, to
which legal acts listed in Annex II, which legal acts listed in Annex II, which legal acts listed in Annex II, which legal acts listed in Annex II,
section A, apply, the provider shall section A, apply, the provider shall section A, apply, the provider shall section A, apply, the provider shall
G 461 follow the relevant conformity follow the relevant conformity follow the relevant conformity follow the relevant conformity G
assessment as required under those assessment as required under those assessment as required under those assessment as required under those
legal acts. The requirements set out legal acts. The requirements set out legal acts. The requirements set out legal acts. The requirements set out
in Chapter 2 of this Title shall apply in Chapter 2 of this Title shall apply in Chapter 2 of this Title shall apply in Chapter 2 of this Title shall apply
to those high-risk AI systems and to those high-risk AI systems and to those high-risk AI systems and to those high-risk AI systems and
shall be part of that assessment. shall be part of that assessment. shall be part of that assessment. shall be part of that assessment.
Points 4.3., 4.4., 4.5. and the fifth Points 4.3., 4.4., 4.5. and the fifth Points 4.3., 4.4., 4.5. and the fifth Points 4.3., 4.4., 4.5. and the fifth
paragraph of point 4.6 of Annex VII paragraph of point 4.6 of Annex VII paragraph of point 4.6 of Annex VII paragraph of point 4.6 of Annex VII
shall also apply. shall also apply. shall also apply. shall also apply.
For the purpose of that assessment, For the purpose of that assessment, For the purpose of that assessment, For the purpose of that assessment,
notified bodies which have been notified bodies which have been notified bodies which have been notified bodies which have been
notified under those legal acts shall notified under those legal acts shall notified under those legal acts shall notified under those legal acts shall
be entitled to control the conformity be entitled to control the conformity be entitled to control the conformity be entitled to control the conformity
of the high-risk AI systems with the of the high-risk AI systems with the of the high-risk AI systems with the of the high-risk AI systems with the
this Title, provided that the this Title, provided that the this Title, provided that the this Title, provided that the
G 462 compliance of those notified bodies compliance of those notified bodies compliance of those notified bodies compliance of those notified bodies G
with requirements laid down in with requirements laid down in with requirements laid down in with requirements laid down in
Article 33(4), (9) and (10) has been Article 33(4), (9) and (10) has been Article 33(4), (9) and (10) has been Article 33(4), (9) and (10) has been
assessed in the context of the assessed in the context of the assessed in the context of the assessed in the context of the
notification procedure under those notification procedure under those notification procedure under those notification procedure under those
legal acts. legal acts. legal acts. legal acts.
Where the legal acts listed in Annex Where the legal acts listed in Annex Where the legal acts listed in Annex Where the legal acts listed in Annex
II, section A, enable the II, section A, enable the II, section A, enable the II, section A, enable the
manufacturer of the product to opt manufacturer of the product to opt manufacturer of the product to opt manufacturer of the product to opt
out from a third-party conformity out from a third-party conformity out from a third-party conformity out from a third-party conformity
G 463 G
assessment, provided that that assessment, provided that that assessment, provided that that assessment, provided that that
manufacturer has applied all manufacturer has applied all manufacturer has applied all manufacturer has applied all
harmonised standards covering all harmonised standards covering all harmonised standards covering all harmonised standards covering all
the relevant requirements, that the relevant requirements, that the relevant requirements, that the relevant requirements, that
manufacturer may make use of that manufacturer may make use of that manufacturer may make use of that manufacturer may make use of that
option only if he has also applied option only if he has also applied option only if he has also applied option only if he has also applied
harmonised standards or, where harmonised standards or, where harmonised standards or, where harmonised standards or, where
applicable, common specifications applicable, common specifications applicable, common specifications applicable, common specifications
referred to in Article 41, covering referred to in Article 41, covering referred to in Article 41, covering referred to in Article 41, covering
the requirements set out in Chapter 2 the requirements set out in Chapter 2 the requirements set out in Chapter 2 the requirements set out in Chapter 2
of this Title. of this Title. of this Title. of this Title.
4. High-risk AI systems shall 4. High-risk AI systems that have 4. High-risk AI systems that have
undergo a new conformity already been subject to a deleted already been subject to a
assessment procedure whenever they conformity assessment procedure conformity assessment procedure
are substantially modified, shall undergo a new conformity shall undergo a new conformity
regardless of whether the modified assessment procedure whenever they assessment procedure whenever they
G 464 G
system is intended to be further are substantially modified, are substantially modified,
distributed or continues to be used regardless of whether the modified regardless of whether the modified
by the current user. system is intended to be further system is intended to be further
distributed or continues to be used distributed or continues to be used
by the current user.deployer; by the current userdeployer.
For high-risk AI systems that For high-risk AI systems that For high-risk AI systems that
continue to learn after being placed continue to learn after being placed deleted continue to learn after being placed
on the market or put into service, on the market or put into service, on the market or put into service,
changes to the high-risk AI system changes to the high-risk AI system changes to the high-risk AI system
and its performance that have been and its performance that have been and its performance that have been
G 465 G
pre-determined by the provider at pre-determined by the provider at pre-determined by the provider at
the moment of the initial conformity the moment of the initial conformity the moment of the initial conformity
assessment and are part of the assessment and are part of the assessment and are part of the
information contained in the information contained in the information contained in the
technical documentation referred to technical documentation referred to technical documentation referred to
in point 2(f) of Annex IV, shall not in point 2(f) of Annex IV, shall not in point 2(f) of Annex IV, shall not
constitute a substantial modification. constitute a substantial modification. constitute a substantial modification.
Article 43(4a)
4a The specific interests and needs

of SMEs shall be taken into
account when setting the fees for
G 465a third-party conformity assessment G
under this Article, reducing those

fees proportionately to their size
and market share;
Article 43(5)
accordance with Article 73 for the accordance with Article 73 for the accordance with Article 73 for the accordance with Article 73 for the
purpose of updating Annexes VI and purpose of updating Annexes VI and purpose of updating Annexes VI and purpose of updating Annexes VI and
Annex VII in order to introduce Annex VII in order to introduce Annex VII in order to introduce Annex VII in order to introduce
elements of the conformity elements of the conformity elements of the conformity elements of the conformity
G 466 G
assessment procedures that become assessment procedures that become assessment procedures that become assessment procedures that become
necessary in light of technical necessary in light of technical necessary in light of technical necessary in light of technical
progress. progress. When preparing such progress. progress.
delegated acts, the Commission
shall consult the AI Office and the
stakeholders affected.
Article 43(6)
G 467 G
to adopt delegated acts to amend to adopt delegated acts to amend to adopt delegated acts to amend to adopt delegated acts to amend
paragraphs 1 and 2 in order to paragraphs 1 and 2 in order to paragraphs 1 and 2 in order to paragraphs 1 and 2 in order to
subject high-risk AI systems referred subject high-risk AI systems referred subject high-risk AI systems referred subject high-risk AI systems referred
to in points 2 to 8 of Annex III to the to in points 2 to 8 of Annex III to the to in points 2 to 8 of Annex III to the to in points 2 to 8 of Annex III to the
referred to in Annex VII or parts referred to in Annex VII or parts referred to in Annex VII or parts referred to in Annex VII or parts
thereof. The Commission shall adopt thereof. The Commission shall adopt thereof. The Commission shall adopt thereof. The Commission shall adopt
such delegated acts taking into such delegated acts taking into such delegated acts taking into such delegated acts taking into
account the effectiveness of the account the effectiveness of the account the effectiveness of the account the effectiveness of the
based on internal control referred to based on internal control referred to based on internal control referred to based on internal control referred to
in Annex VI in preventing or in Annex VI in preventing or in Annex VI in preventing or in Annex VI in preventing or
minimizing the risks to health and minimizing the risks to health and minimizing the risks to health and minimizing the risks to health and
safety and protection of fundamental safety and protection of fundamental safety and protection of fundamental safety and protection of fundamental
rights posed by such systems as well rights posed by such systems as well rights posed by such systems as well rights posed by such systems as well
as the availability of adequate as the availability of adequate as the availability of adequate as the availability of adequate
capacities and resources among capacities and resources among capacities and resources among capacities and resources among
notified bodies. notified bodies. When preparing notified bodies. notified bodies.
such delegated acts, the
Commission shall consult the AI
Office and the stakeholders
affected.
Article 44

Certificates Certificates Certificates Certificates
G 468 G

Proposal
Article 44(1)
1. Certificates issued by notified 1. Certificates issued by notified 1. Certificates issued by notified 1. Certificates issued by notified
G 469 bodies in accordance with Annex bodies in accordance with Annex bodies in accordance with Annex bodies in accordance with Annex G
VII shall be drawn-up in an official VII shall be drawn-up in anone or VII shall be drawn-up in an official VII shall be drawn-up in an official
Union language determined by the several official Union Uniona a language determined by Union language determineda
Member State in which the notified languagelanguages determined by the Member State in which the language which can be easily
body is established or in an official the Member State in which the notified body is established or in an understood by the relevant
Union language otherwise notified body is established or in official Union language otherwise authorities in the Member State in
acceptable to the notified body. anone or several official Union acceptable towhich can be easily which the notified body is
languagelanguages otherwise understood by the relevant established. or in an official Union
acceptable to the notified body. authorities in the Member State in language otherwise acceptable to
which the notified body is the notified body.
established.
Article 44(2)
2. Certificates shall be valid for the 2. Certificates shall be valid for the 2. Certificates shall be valid for the 2. Certificates shall be valid for the
period they indicate, which shall not period they indicate, which shall not period they indicate, which shall not period they indicate, which shall not
exceed five years. On application by exceed fivefour years. On exceed five years. On application by exceed five years for AI systems
the provider, the validity of a application by the provider, the the provider, the validity of a covered by Annex II and four years
certificate may be extended for validity of a certificate may be certificate may be extended for for AI systems covered by Annex
further periods, each not exceeding extended for further periods, each further periods, each not exceeding III. On application by the provider,
five years, based on a re-assessment not exceeding fivefour years, based five years, based on a re-assessment the validity of a certificate may be
in accordance with the applicable on a re-assessment in accordance in accordance with the applicable extended for further periods, each
conformity assessment procedures. with the applicable conformity conformity assessment procedures. not exceeding five years for AI
G 470 G
assessment procedures. Any supplement to a certificate systems covered by Annex II and
shall remain valid as long as the four years for AI systems covered
certificate which it supplements is by Annex III, based on a re-
valid. 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.
Article 44(3)
3. Where a notified body finds that 3. Where a notified body finds that 3. Where a notified body finds that 3. Where a notified body finds that
G 471 G
an AI system no longer meets the an AI system no longer meets the an AI system no longer meets the an AI system no longer meets the
this Title, it shall, taking account of this Title, it shall, taking account of this Title, it shall, taking account of this Title, it shall, taking account of
the principle of proportionality, the principle of proportionality, the principle of proportionality, the principle of proportionality,
suspend or withdraw the certificate suspend or withdraw the certificate suspend or withdraw the certificate suspend or withdraw the certificate
issued or impose any restrictions on issued or impose any restrictions on issued or impose any restrictions on issued or impose any restrictions on
it, unless compliance with those it, unless compliance with those it, unless compliance with those it, unless compliance with those
requirements is ensured by requirements is ensured by requirements is ensured by requirements is ensured by
appropriate corrective action taken appropriate corrective action taken appropriate corrective action taken appropriate corrective action taken
by the provider of the system within by the provider of the system within by the provider of the system within by the provider of the system within
an appropriate deadline set by the an appropriate deadline set by the an appropriate deadline set by the an appropriate deadline set by the
notified body. The notified body notified body. The notified body notified body. The notified body notified body. The notified body
shall give reasons for its decision. shall give reasons for its decision. shall give reasons for its decision. shall give reasons for its decision.
Article 45

G 472 Appeal against decisions of notified Appeal against decisions of notified Appeal against decisions of notified G
bodies bodies bodies
Member States shall ensure that an Member States shall ensure that an Member States shall ensure that An Member States shall ensure that An
appeal procedure against decisions appeal procedure against decisions appeal procedure against decisions appeal procedure against decisions
of the notified bodies is available to of the notified bodies, including on of the notified bodies is available to of the notified bodies is available to
G 473 parties having a legitimate interest in issued conformity certificates is parties having a legitimate interest parties having a legitimate interest G
that decision. available to parties having a in that decisionshall be available. in that decision, including on issued
legitimate interest in that decision. conformity certificates, shall be
available.
Article 46
Information obligations of notified Information obligations of notified Information obligations of notified Information obligations of notified
bodies bodies bodies bodies
Article 46(1)
1. Notified bodies shall inform the 1. Notified bodies shall inform the 1. Notified bodies shall inform the 1. Notified bodies shall inform the
G 475 notifying authority of the following: notifying authority of the following: notifying authority of the following: notifying authority of the following: G
(a) any Union technical (a) any Union technical (a) any Union technical (a) any Union technical
documentation assessment documentation assessment documentation assessment documentation assessment
certificates, any supplements to certificates, any supplements to certificates, any supplements to certificates, any supplements to
those certificates, quality those certificates, quality those certificates, quality those certificates, quality
G 476 management system approvals management system approvals management system approvals management system approvals G
issued in accordance with the issued in accordance with the issued in accordance with the issued in accordance with the
requirements of Annex VII; requirements of Annex VII; requirements of Annex VII; requirements of Annex VII;
(b) any refusal, restriction, (b) any refusal, restriction, (b) any refusal, restriction, (b) any refusal, restriction,
suspension or withdrawal of a Union suspension or withdrawal of a Union suspension or withdrawal of a Union suspension or withdrawal of a Union
technical documentation assessment technical documentation assessment technical documentation assessment technical documentation assessment
certificate or a quality management certificate or a quality management certificate or a quality management certificate or a quality management
G 477 system approval issued in system approval issued in system approval issued in system approval issued in G
accordance with the requirements of accordance with the requirements of accordance with the requirements of accordance with the requirements of
Annex VII; Annex VII; Annex VII; Annex VII;
(c) any circumstances affecting the (c) any circumstances affecting the (c) any circumstances affecting the (c) any circumstances affecting the
scope of or conditions for scope of or conditions for scope of or conditions for scope of or conditions for
G 478 notification; notification; notification; notification; G
(d) any request for information (d) any request for information (d) any request for information (d) any request for information
which they have received from which they have received from which they have received from which they have received from
market surveillance authorities market surveillance authorities market surveillance authorities market surveillance authorities
G 479 regarding conformity assessment regarding conformity assessment regarding conformity assessment regarding conformity assessment G
activities; activities; activities; activities;

(e) on request, conformity (e) on request, conformity (e) on request, conformity (e) on request, conformity
assessment activities performed assessment activities performed assessment activities performed assessment activities performed
within the scope of their notification within the scope of their notification within the scope of their notification within the scope of their notification
G 480 and any other activity performed, and any other activity performed, and any other activity performed, and any other activity performed, G
including cross-border activities and including cross-border activities and including cross-border activities and including cross-border activities and
subcontracting. subcontracting. subcontracting. subcontracting.
Article 46(2)
2. Each notified body shall inform 2. Each notified body shall inform 2. Each notified body shall inform 2. Each notified body shall inform
G 481 the other notified bodies of: the other notified bodies of: the other notified bodies of: the other notified bodies of: G
(a) quality management system (a) quality management system (a) quality management system (a) quality management system
approvals which it has refused, approvals which it has refused, approvals which it has refused, approvals which it has refused,
suspended or withdrawn, and, upon suspended or withdrawn, and, upon suspended or withdrawn, and, upon suspended or withdrawn, and, upon
G 482 request, of quality system approvals request, of quality system approvals request, of quality system approvals request, of quality system approvals G
which it has issued; which it has issued; which it has issued; which it has issued;
(b) EU technical documentation (b) EU technical documentation (b) EU technical documentation (b) EU technical documentation
assessment certificates or any assessment certificates or any assessment certificates or any assessment certificates or any
supplements thereto which it has supplements thereto which it has supplements thereto which it has supplements thereto which it has
refused, withdrawn, suspended or refused, withdrawn, suspended or refused, withdrawn, suspended or refused, withdrawn, suspended or
G 483 otherwise restricted, and, upon otherwise restricted, and, upon otherwise restricted, and, upon otherwise restricted, and, upon G
request, of the certificates and/or request, of the certificates and/or request, of the certificates and/or request, of the certificates and/or
supplements thereto which it has supplements thereto which it has supplements thereto which it has supplements thereto which it has
issued. issued. issued. issued.
Article 46(3)
3. Each notified body shall provide 3. Each notified body shall provide 3. Each notified body shall provide 3. Each notified body shall provide
the other notified bodies carrying out the other notified bodies carrying out the other notified bodies carrying out the other notified bodies carrying out
similar conformity assessment similar conformity assessment similar conformity assessment similar conformity assessment
activities covering the same artificial activities covering the same artificial activities covering the same artificial activities covering the same artificial
G 484 G
intelligence technologies with intelligence technologies with intelligence technologiesAI systems intelligence technologiestypes ofAI
relevant information on issues relevant information on issues with relevant information on issues systems with relevant information on
relating to negative and, on request, relating to negative and, on request, relating to negative and, on request, issues relating to negative and, on
positive conformity assessment positive conformity assessment positive conformity assessment request, positive conformity
results. results. results. assessment results.
Article 46(3a)
3a. The obligations referred to in 3a. The obligations referred to in

paragraphs 1 to 3 shall be complied paragraphs 1 to 3 shall be complied
G 484a with in accordance with Article 70. with in accordance with Article 70. G
Article 47

Derogation from conformity Derogation from conformity Derogation from conformity Derogation from conformity
G 485 assessment procedure assessment procedure assessment procedure assessment procedure G

Proposal
Article 47(1)
1. By way of derogation from 1. By way of derogation from 1. By way of derogation from 1. 1. By way of derogation from
Article 43, any market surveillance Article 43, any market Article 43 and upon a duly justified Article 43 and upon a duly justified
authority may authorise the placing surveillancenational supervisory request, any market surveillance request, any market surveillance
on the market or putting into service authority may request a judicial authority may authorise the placing authority may authorise the placing
of specific high-risk AI systems authority to authorise the placing on on the market or putting into service on the market or putting into service
within the territory of the Member the market or putting into service of of specific high-risk AI systems of specific high-risk AI systems
State concerned, for exceptional specific high-risk AI systems within within the territory of the Member within the territory of the Member
G 486 G
reasons of public security or the the territory of the Member State State concerned, for exceptional State concerned, for exceptional
protection of life and health of concerned, for exceptional reasons reasons of public security or the reasons of public security or the
persons, environmental protection of public security or the protection protection of life and health of protection of life and health of
and the protection of key industrial of life and health of persons, persons, environmental protection persons, environmental protection
and infrastructural assets. That environmental protection and the and the protection of key industrial and the protection of key industrial
authorisation shall be for a limited protection of key industrial and and infrastructural assets. That and infrastructural assets. That
period of time, while the necessary infrastructural assetscritical authorisation shall be for a limited authorisation shall be for a limited
conformity assessment procedures infrastructure. That authorisation period of time, while the necessary period of time, while the necessary
are being carried out, and shall shall be for a limited period of time, conformity assessment procedures conformity assessment procedures
terminate once those procedures while the necessary conformity are being carried out, and shall are being carried out, and shall
have been completed. The assessment procedures are being terminate once those procedures terminate once those procedures
completion of those procedures shall carried out, and shall terminate once have been completedtaking into have been completedtaking into
be undertaken without undue delay. those procedures have been account the exceptional reasons account the exceptional reasons
completed. The completion of those justifying the derogation. The justifying the derogation. The
procedures shall be undertaken completion of those procedures shall completion of those procedures shall
without undue delay. be undertaken without undue delay. be undertaken without undue delay.
Article 47(1a)
1a. In a duly justified situation of 1a. In a duly justified situation of

urgency for exceptional reasons of urgency for exceptional reasons of
public security or in case of public security or in case of
specific, substantial and imminent specific, substantial and imminent
threat to the life or physical safety threat to the life or physical safety
of natural persons, law of natural persons, law
enforcement authorities or civil enforcement authorities or civil
protection authorities may put a protection authorities may put a
specific high-risk AI system into specific high-risk AI system into
G 486a service without the authorisation service without the authorisation G
referred to in paragraph 1 provided referred to in paragraph 1 provided

that such authorisation is requested that such authorisation is requested
during or after the use without during or after the use without
undue delay, and if such undue delay, and if such
authorisation is rejected, its use authorisation is rejected, its use
shall be stopped with immediate shall be stopped with immediate
effect and all the results and effect and all the results and
outputs of this use shall be outputs of this use shall be
immediately discarded. immediately discarded.
Article 47(2)
G 487 2. The authorisation referred to in 2. The authorisation referred to in 2. The authorisation referred to in 2. The authorisation referred to in G
paragraph 1 shall be issued only if paragraph 1 shall be issued only if paragraph 1 shall be issued only if paragraph 1 shall be issued only if
the market surveillance authority the market surveillancenational the market surveillance authority the market surveillance authority
concludes that the high-risk AI supervisory authority and judicial concludes that the high-risk AI concludes that the high-risk AI
system complies with the authority concludesconclude that the system complies with the system complies with the
requirements of Chapter 2 of this high-risk AI system complies with requirements of Chapter 2 of this requirements of Chapter 2 of this
Title. The market surveillance the requirements of Chapter 2 of this Title. The market surveillance Title. The market surveillance
authority shall inform the Title. The market authority shall inform the authority shall inform the
Commission and the other Member surveillancenational supervisory Commission and the other Member Commission and the other Member
States of any authorisation issued authority shall inform the States of any authorisation issued States of any authorisation issued
pursuant to paragraph 1. Commission, the AI office, and the pursuant to paragraph 1. This pursuant to paragraph 1. This
other Member States of any request obligation shall not cover sensitive obligation shall not cover sensitive
made and any subsequent operational data in relation to the operational data in relation to the
authorisation issued pursuant to activities of law enforcement activities of law enforcement
paragraph 1. authorities. authorities.
Article 47(3)
3. Where, within 15 calendar days 3. Where, within 15 calendar days 3. Where, within 15 calendar days
of receipt of the information referred of receipt of the information referred deleted of receipt of the information referred
to in paragraph 2, no objection has to in paragraph 2, no objection has to in paragraph 2, no objection has
been raised by either a Member State been raised by either a Member State been raised by either a Member State
or the Commission in respect of an or the Commission in respect to the or the Commission in respect of an
authorisation issued by a market request of the national supervisory authorisation issued by a market
G 488 surveillance authority of a Member authority for of an authorisation surveillance authority of a Member G
State in accordance with paragraph issued by a market State in accordance with paragraph
1, that authorisation shall be deemed surveillancenational supervisory 1, that authorisation shall be deemed
justified. authority of a Member State in justified.
accordance with paragraph 1, that
authorisation shall be deemed Proposal
justified.
Article 47(4)
4. Where, within 15 calendar days 4. Where, within 15 calendar days 4. Where, within 15 calendar days
G 489 G
of receipt of the notification referred of receipt of the notification referred deleted of receipt of the notification referred
to in paragraph 2, objections are to in paragraph 2, objections are to in paragraph 2, objections are
raised by a Member State against an raised by a Member State against an raised by a Member State against an
authorisation issued by a market authorisationa request issued by a authorisation issued by a market
surveillance authority of another market surveillancenational surveillance authority of another
Member State, or where the supervisory authority of another Member State, or where the
Commission considers the Member State, or where the Commission considers the
authorisation to be contrary to Union Commission considers the authorisation to be contrary to Union
law or the conclusion of the Member authorisation to be contrary to Union law or the conclusion of the Member
States regarding the compliance of law or the conclusion of the Member States regarding the compliance of
the system as referred to in States regarding the compliance of the system as referred to in
paragraph 2 to be unfounded, the the system as referred to in paragraph 2 to be unfounded, the
Commission shall without delay paragraph 2 to be unfounded, the Commission shall without delay
enter into consultation with the Commission shall without delay enter into consultation with the
relevant Member State; the enter into consultation with the relevant Member State; the
operator(s) concerned shall be relevant Member State and the AI operator(s) concerned shall be
consulted and have the possibility to Office; the operator(s) concerned consulted and have the possibility to
present their views. In view thereof, shall be consulted and have the present their views. In view thereof,
the Commission shall decide possibility to present their views. In the Commission shall decide
whether the authorisation is justified view thereof, the Commission shall whether the authorisation is justified
or not. The Commission shall decide whether the authorisation is or not. The Commission shall
address its decision to the Member justified or not. The Commission address its decision to the Member
State concerned and the relevant shall address its decision to the State concerned and the relevant
operator or operators. Member State concerned and the operator or operators.
relevant operator or operators(s).
Article 47(5)
5. If the authorisation is considered 5. If the authorisation is considered 5. If the authorisation is considered

unjustified, this shall be withdrawn unjustified, this shall be withdrawn deleted unjustified, this shall be withdrawn
G 490 by the market surveillance authority by the market surveillancenational by the market surveillance authority G
of the Member State concerned. supervisory authority of the Member of the Member State concerned.
State concerned.
Article 47(6)
G 491 G
6. By way of derogation from 6. By way of derogation from 6. By way of derogation from 6. By way of derogation from
paragraphs 1 to 5, for high-risk AI paragraphs 1 to 5, for high-risk AI paragraphs 1 to 5, For high-risk AI paragraphs 1 to 5, For high-risk AI
systems intended to be used as safety systems intended to be used as safety systems intended to be used as safety systems intended to be used as safety
components of devices, or which are components of devices, or which are components of devices, or which are components of devices, or which are
themselves devices, covered by themselves devices, covered by themselves devices,related to themselves devices,related to
Regulation (EU) 2017/745 and Regulation (EU) 2017/745 and products covered by Regulation products covered by Regulation
Regulation (EU) 2017/746, Article Regulation (EU) 2017/746, Article (EU) 2017/745 and Regulation (EU) (EU) 2017/745 and Regulation (EU)
59 of Regulation (EU) 2017/745 and 59 of Regulation (EU) 2017/745 and 2017/746, Article 59 of Regulation 2017/746, Article 59 of Regulation
Article 54 of Regulation (EU) Article 54 of Regulation (EU) (EU) 2017/745 and Article 54 of (EU) 2017/745 and Article 54 of
2017/746 shall apply also with 2017/746 shall apply also with Regulation (EU) 2017/746 shall Regulation (EU) 2017/746 shall
regard to the derogation from the regard to the derogation from the apply also with regard to the apply also with regard to the
conformity assessment of the conformity assessment of the derogation fromUnion derogation fromUnion
compliance with the requirements compliance with the requirements harmonisation legislation referred harmonisation legislation referred
set out in Chapter 2 of this Title. set out in Chapter 2 of this Title. to in Annex II Section A, only the to in Annex II Section A, only the
conformity assessment of the conformity assessment of the
compliance with the requirements compliance with the requirements
set out in Chapter 2 of this set out in Chapter 2 of this
Titlederogation procedures Titlederogation procedures
established in that legislation shall established in that legislation shall
apply. apply.
Article 48

EU declaration of conformity EU declaration of conformity EU declaration of conformity EU declaration of conformity
G 492 G

Proposal
Article 48(1)
1. The provider shall draw up a 1. The provider shall draw up a 1. The provider shall draw up a 1. The provider shall draw up a
written EU declaration of conformity written machine readable, physical written or electronically signed EU written machine readable, physical
G 493 G
for each AI system and keep it at the or electronic EU declaration of declaration of conformity for each or electronically signed EU
disposal of the national competent conformity for each high-risk AI AI system and keep it at the disposal declaration of conformity for each
authorities for 10 years after the AI system and keep it at the disposal of of the national competent authorities high-risk AI system and keep it at
system has been placed on the the national supervisory authority for 10 years after the AI system has the disposal of the national
market or put into service. The EU and the national competent been placed on the market or put competent authorities for 10 years
declaration of conformity shall authorities for 10 years after the AI into service. The EU declaration of after the AI high-risk system has
identify the AI system for which it high-risk system has been placed on conformity shall identify the AI been placed on the market or put
has been drawn up. A copy of the the market or put into service. The system for which it has been drawn into service. The EU declaration of
EU declaration of conformity shall EU declaration of conformity shall up. A copy of the EU declaration of conformity shall identify the high-
be given to the relevant national identify the AI system for which it conformity shall be givensubmitted risk AI system for which it has been
competent authorities upon request. has been drawn up. A copy of the to the relevant national competent drawn up. Aup.A copy of the EU
EU declaration of conformity shall authorities upon request. declaration of conformity shall be
be given tosubmitted to the national givensubmitted to the relevant
supervisory authority and the national competent authorities upon
relevant national competent request.
authorities upon request.
Article 48(2)
2. The EU declaration of conformity 2. The EU declaration of conformity 2. The EU declaration of conformity 2. The EU declaration of conformity
shall state that the high-risk AI shall state that the high-risk AI shall state that the high-risk AI shall state that the high-risk AI
system in question meets the system in question meets the system in question meets the system in question meets the
this Title. The EU declaration of this Title. The EU declaration of this Title. The EU declaration of this Title. The EU declaration of
conformity shall contain the conformity shall contain the conformity shall contain the conformity shall contain the
information set out in Annex V and information set out in Annex V and information set out in Annex V and information set out in Annex V and
G 494 shall be translated into an official shall be translated into an official shall be translated into an official shall be translated into an official G
Union language or languages Union language or languages Union language or languages Union language or languages
required by the Member State(s) in required by the Member State(s) in required bya language that can be requireda language that can be
which the high-risk AI system is which the high-risk AI system is easily understood by the national easily understood by the national
made available. placed on the market or made competent authorities of the competent authorities of the
available. Member State(s) in which the high- Member State(s) in which the high-
risk AI system is made available. risk AI system is placed on the
market or made available.
Article 48(3)
G 495 G
3. Where high-risk AI systems are 3. Where high-risk AI systems are 3. Where high-risk AI systems are 3. Where high-risk AI systems are
subject to other Union harmonisation subject to other Union harmonisation subject to other Union harmonisation subject to other Union harmonisation
legislation which also requires an legislation which also requires an legislation which also requires an legislation which also requires an
EU declaration of conformity, a EU declaration of conformity, a EU declaration of conformity, a EU declaration of conformity, a
single EU declaration of conformity single EU declaration of conformity single EU declaration of conformity single EU declaration of conformity
shall be drawn up in respect of all shallmay be drawn up in respect of shall be drawn up in respect of all shall be drawn up in respect of all
Union legislations applicable to the all Union legislations applicable to Union legislations applicable to the Union legislations applicable to the
high-risk AI system. The declaration the high-risk AI system. The high-risk AI system. The declaration high-risk AI system. The declaration
shall contain all the information declaration shall contain all the shall contain all the information shall contain all the information
required for identification of the information required for required for identification of the required for identification of the
Union harmonisation legislation to identification of the Union Union harmonisation legislation to Union harmonisation legislation to
which the declaration relates. harmonisation legislation to which which the declaration relates. which the declaration relates.
the declaration relates.
Article 48(4)
4. By drawing up the EU 4. By drawing up the EU 4. By drawing up the EU 4. By drawing up the EU

declaration of conformity, the declaration of conformity, the declaration of conformity, the declaration of conformity, the
provider shall assume responsibility provider shall assume responsibility provider shall assume responsibility provider shall assume responsibility
for compliance with the for compliance with the for compliance with the for compliance with the
G 496 this Title. The provider shall keep this Title. The provider shall keep this Title. The provider shall keep this Title. The provider shall keep
G
the EU declaration of conformity up- the EU declaration of conformity up- the EU declaration of conformity up- the EU declaration of conformity up-
to-date as appropriate. to-date as appropriate. to-date as appropriate. to-date as appropriate.
Proposal
Article 48(5)
5. The Commission shall be 5. After consulting the AI Office, 5. The Commission shall be 5. The Commission shall be
empowered to adopt delegated acts the Commission shall be empowered empowered to adopt delegated acts empowered to adopt delegated acts
G 497 in accordance with Article 73 for the to adopt delegated acts in in accordance with Article 73 for the in accordance with Article 73 for the G
purpose of updating the content of accordance with Article 73 for the purpose of updating the content of purpose of updating the content of
the EU declaration of conformity set purpose of updating the content of the EU declaration of conformity set the EU declaration of conformity set
out in Annex V in order to introduce the EU declaration of conformity set out in Annex V in order to introduce out in Annex V in order to introduce
elements that become necessary in out in Annex V in order to introduce elements that become necessary in elements that become necessary in
light of technical progress. elements that become necessary in light of technical progress. light of technical progress.
light of technical progress.
Article 49

CE marking of conformity CE marking of conformity CE marking of conformity CE marking of conformity
G 498 G

Proposal
Article 49(1)
1. The CE marking shall be affixed 1. The physical CE marking shall be 1. The CE marking shall be affixed 1. The CE marking shall be affixed
visibly, legibly and indelibly for affixed visibly, legibly and indelibly visibly, legibly and indelibly for visibly, legibly and indelibly for
high-risk AI systems. Where that is for high-risk AI systems. before the high-risk AI systems. Where that is high-risk AI systems. Where that is
not possible or not warranted on high-risk AI system is placed on the not possible or not warranted on not possible or not warranted on
account of the nature of the high-risk market Where that is not possible or account of the nature of the high-risk account of the nature of the high-risk
AI system, it shall be affixed to the not warranted on account of the AI system, itof conformity shall be AI system, itof conformity shall be
G 499 packaging or to the accompanying nature of the high-risk AI system, it affixedsubject to the packaging or to affixedsubject to the packaging or to G
documentation, as appropriate. shall be affixed to the packaging or the accompanying documentation, as the accompanying documentation, as
to the accompanying documentation, appropriategeneral principles set appropriategeneral principles set
as appropriate. It may be followed out in Article 30 of Regulation (EC) out in Article 30 of Regulation (EC)
by a pictogram or any other No 765/2008. No 765/2008.
marking indicating a special risk of
use.
Article 49(1a)
1a. For digital only high-risk AI 1a. For high-risk AI systems

G 499a systems, a digital CE marking shall provided digitally, a digital CE G
be used, only if it can be easily marking shall be used, only if it can

accessed via the interface from be easily accessed via the interface
which the AI system is accessed or from which the AI system is
via an easily accessible machine- accessed or via an easily accessible
readable code or other electronic machine-readable code or other
means. electronic means.
Article 49(2)
2. The CE marking referred to in 2. The CE marking referred to in 2. The CE marking referred to in 2. The CE marking referred to in
paragraph 1 of this Article shall be paragraph 1 of this Article shall be paragraph 1 of this Articleshall be paragraph 1 of this Articleshall be
subject to the general principles set subject to the general principles set affixed visibly, legibly and indelibly affixed visibly, legibly and indelibly
out in Article 30 of Regulation (EC) out in Article 30 of Regulation (EC) for high-risk AI systems. Where for high-risk AI systems. Where
No 765/2008. No 765/2008. that is not possible or not warranted that is not possible or not warranted
on account of the nature of the on account of the nature of the
high-risk AI system, it shall be high-risk AI system, it shall be
G 500 subjectaffixed to the general subjectaffixed to the general G
principles set out in Article 30 of principles set out in Article 30 of

Regulation (EC) No Regulation (EC) No
765/2008packaging or to the 765/2008packaging or to the
accompanying documentation, as accompanying documentation, as
appropriate. appropriate.
Article 49(3)
3. Where applicable, the CE 3. Where applicable, the CE 3. Where applicable, the CE 3. Where applicable, the CE
marking shall be followed by the marking shall be followed by the marking shall be followed by the marking shall be followed by the
identification number of the notified identification number of the notified identification number of the notified identification number of the notified
body responsible for the conformity body responsible for the conformity body responsible for the conformity body responsible for the conformity
G 501 G
assessment procedures set out in assessment procedures set out in assessment procedures set out in assessment procedures set out in
Article 43. The identification Article 43. The identification Article 43. The identification Article 43. The identification
number shall also be indicated in any number of the notified body shall be number shall also be indicated in any number of the notified body shall be
promotional material which affixed by the body itself or, under promotional material which affixed by the body itself or, under
mentions that the high-risk AI its instructions, by the provider’s mentions that the high-risk AI its instructions, by the provider or
system fulfils the requirements for authorised representative. The system fulfils the requirements for by its authorised representative.
CE marking. identification number shall also be CE marking. The identification number shall also
indicated in any promotional be indicated in any promotional
material which mentions that the material which mentions that the
high-risk AI system fulfils the high-risk AI system fulfils the
requirements for CE marking. requirements for CE marking.
Article 49(3a)
3a. Where high-risk AI systems are 3a. Where high-risk AI systems are
subject to other Union law which subject to other Union law which
also provides for the affixing of the also provides for the affixing of the
G 501a CE marking, the CE marking shall CE marking, the CE marking shall G
indicate that the high-risk AI indicate that the high-risk AI

system also fulfil the requirements system also fulfil the requirements
of that other law. of that other law.
Article 50

G 502 Document retention Document retention deleted Document retentionMoved to Article G
18
The provider shall, for a period The provider shall, for a period
ending 10 years after the AI system ending 10 years, after the AI system deleted
has been placed on the market or put has been placed on the market or put
G 503 into service, keep at the disposal of into service, keep at the disposal of G
the national competent authorities: the national supervisory authority

and the national competent
authorities:

(a) the technical documentation (a) the technical documentation

G 504 G
referred to in Article 11; referred to in Article 11; deleted
(b) the documentation concerning (b) the documentation concerning

G 505 the quality management system the quality management system deleted G
referred to Article 17; referred to Article 17;
(c) the documentation concerning (c) the documentation concerning

G 506 the changes approved by notified the changes approved by notified deleted G
bodies where applicable; bodies where applicable;
(d) the decisions and other (d) the decisions and other
G 507 documents issued by the notified documents issued by the notified deleted G
bodies where applicable; bodies where applicable;
(e) the EU declaration of conformity (e) the EU declaration of conformity

G 508 G
referred to in Article 48. referred to in Article 48. deleted
Article 51

G 509 G
Registration Registration Registration of relevant operators Registration
and of high-risk AI systems listed in
Annex IIIRegistration Text Origin: Commission
Proposal
Before placing on the market or Before placing on the market or Before placing on the market or Before placing on the market or
putting into service a high-risk AI putting into service a high-risk AI putting into service a high-risk AI putting into service a high-risk AI
system referred to in Article 6(2), system referred to in Article 6(2), system listed in Annex III with the system listed in Annex III, with the
the provider or, where applicable, the provider or, where applicable, exception of high-risk AI systems exception of high risk AI systems
the authorised representative shall the authorised representative shall referred to in Article 6(2)Annex III, referred to in Article 6(2)Annex III
register that system in the EU register that system in the EU points 1, 6 and 7 in the areas of law point 2, the provider or, where
database referred to in Article 60. database referred to in Article 60., in enforcement, migration, asylum applicable, the authorised
accordance with Article 60(2); and border control management, representative shall register
and high risk AI systems referred to thatthemselves and their system in
G 510 G
in Annex III point 2, the provider the EU database referred to in
or,and where applicable, the Article 60.
authorised representative shall
register that systemthemselves in the
EU database referred to in Article
60. The provider or, where
applicable the authorised
representative, shall also register
their systems in that database.
-1. Before using a high-risk AI

system listed in Annex III, users of
high-risk AI systems that are public
authorities, agencies or bodies, or
G 510a G
entities acting on their behalf, shall
register themselves in the EU
database referred to in Article 60
and select the system that they
envisage to use.
The obligations laid down in the

previous subparagraph shall not
apply to law enforcement, border
control, immigration or asylum
G 510b authorities, agencies or bodies and G
authorities, agencies or bodies

using high-risk AI systems referred
to Annex III point 2, as well as to
entities acting on their behalf.
1a Before putting into service or 1a. Before placing on the market or

using a high-risk AI system in putting into service an AI system
accordance with Article 6(2), the for which the provider has
following categories of deployers concluded that it is not high-risk in
shall register the use of that AI application of the procedure under
system in the EU database referred Article 6(2a), the provider or, where
to in Article 60: applicable, the authorised
G 510c a) deployers who are public representative shall register G
authorities or Union institutions, themselves and that system in the

bodies, offices or agencies or EU database referred to in Article
deployers acting on their behalf; 60.
b) deployers who are
undertakings designated as a
gatekeeper under Regulation (EU)
2022/1925.
G 510d G
Article 51, sixth paragraph
G 510e G
Article 51, seventh paragraph
G 510f G
Article 51, eighth paragraph
1b Deployers who do not fall under 1b. Before putting into service or
subparagraph 1a. shall be entitled using a high-risk AI system listed in
to voluntarily register the use of a Annex III, with the exception of
high-risk AI system referred to in high-risk AI systems listed in
Article 6(2) in the EU database Annex III, point 2, deployers who
G 510g referred to in Article 60. are public authorities, agencies or G
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.
Article 51, ninth paragraph
1c An updated registration entry 1c. For high-risk AI systems

must be completed immediately referred to Annex III, points 1, 6
following each substantial and 7 in the areas of law
modification. enforcement, migration, asylum
and border control management,
G 510h the registration referred to in G
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
section B
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
TITLE IV TITLE IV TITLE IV TITLE IV

TRANSPARENCY TRANSPARENCY TRANSPARENCY TRANSPARENCY
OBLIGATIONS FOR CERTAIN AI OBLIGATIONS FOR CERTAIN AI OBLIGATIONS FOR PROVIDERS OBLIGATIONS FOR PROVIDERS
G 511 SYSTEMS SYSTEMS AND USERS OF CERTAIN AI AND DEPLOYERS OF CERTAIN G
SYSTEMS AI SYSTEMS AND GPAI

MODELS
Article 52

G 512 G
Transparency obligations for certain Transparency obligations for certain Transparency obligations for Transparency obligations for
AI systems AI systems providers and users of certain AI providers and users of certain AI
systemsTransparency obligations for systems and GPAI
certain AI systems modelsTransparency obligations for
certain AI systems
Article 52(1)
1. Providers shall ensure that AI 1. Providers shall ensure that AI 1. Providers shall ensure that AI 1. Providers shall ensure that AI
systems intended to interact with systems intended to interact with systems intended to interact with systems intended to directly interact
natural persons are designed and natural persons are designed and natural persons are designed and with natural persons are designed
developed in such a way that natural developed in such a way that the AI developed in such a way that natural and developed in such a way that the
persons are informed that they are system, the provider itself or the persons are informed that they are concerned natural persons are
interacting with an AI system, unless user informs the natural persons are interacting with an AI system, unless informed that they are interacting
this is obvious from the informedperson exposed to an AI this is obvious from the point of with an AI system, unless this is
circumstances and the context of system that they are interacting with view of a natural person who is obvious from the point of view of a
use. This obligation shall not apply an AI system in a timely, clear and reasonably well-informed, natural person who is reasonably
to AI systems authorised by law to intelligible manner, unless this is observant and circumspect, taking well-informed, observant and
detect, prevent, investigate and obvious from the circumstances and into account the circumstances and circumspect, taking into account
prosecute criminal offences, unless the context of use. the context of use. This obligation the circumstances and the context of
those systems are available for the Where appropriate and relevant, shall not apply to AI systems use.
G 513 public to report a criminal offence. this information shall also include authorised by law to detect, prevent, This obligation shall not apply to AI G
which functions are AI enabled, if investigate and prosecute criminal systems authorised by law to detect,
there is human oversight, and who offences, subject to appropriate prevent, investigate and prosecute
is responsible for the decision- safeguards for the rights and criminal offences, subject to
making process, as well as the freedoms of third parties, unless appropriate safeguards for the
existing rights and processes that, those systems are available for the rights and freedoms of third parties
according to Union and national public to report a criminal offence. unless those systems are available
law, allow natural persons or their for the public to report a criminal
representatives to object against the offence.
application of such systems to them
and to seek judicial redress against 1a. Providers of AI systems,
decisions taken by or harm caused including GPAI systems, generating
by AI systems, including their right synthetic audio, image, video or text
to seek an explanation. This content, shall ensure the outputs of
obligation shall not apply to AI the AI system are marked in a
systems authorised by law to detect, machine-readable format and
prevent, investigate and prosecute detectable as artificially generated
criminal offences, unless those or manipulated. Providers shall
systems are available for the public ensure their technical solutions are
to report a criminal offence. effective, interoperable, robust and
reliable as far as this 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.
Article 52(2)
2. Users of an emotion recognition 2. Users of an emotion recognition 2. Users of an emotion recognition 2. UsersDeployers of an emotion
system or a biometric categorisation system or a biometric categorisation system or a biometric categorisation recognition system or a biometric
system shall inform of the operation system which is not prohibited system shall inform of the operation categorisation system shall inform of
of the system the natural persons pursuant to Article 5 shall inform in of the system the natural persons the operation of the system the
G 514 exposed thereto. This obligation a timely, clear and intelligible exposed thereto. This obligation natural persons exposed thereto and G
shall not apply to AI systems used manner of the operation of the shall not apply to AI systems used process the personal data in
for biometric categorisation, which system the natural persons exposed for biometric categorisation, which accordance with Regulation (EU)
are permitted by law to detect, thereto and obtain their consent are permitted by law to detect, 2016/679, Regulation (EU)
prevent and investigate criminal prior to the processing of their prevent and investigate criminal 2016/1725 and Directive (EU)
offences. biometric and other personal data offences, subject to appropriate 2016/280, as applicable. This
in accordance with Regulation safeguards for the rights and obligation shall not apply to AI
(EU) 2016/679, Regulation (EU) freedoms of third parties. systems used for biometric
2016/1725 and Directive (EU) categorisationcategorization and
2016/280, as applicable. This emotion recognition, which are
obligation shall not apply to AI permitted by law to detect, prevent
systems used for biometric and investigate criminal offences,
categorisation, which are permitted subject to appropriate safeguards
by law to detect, prevent and for the rights and freedoms of third
investigate criminal offences. parties, and in compliance with
Union law.
Article 52(2a)
2a. Users of an emotion

recognition system shall inform of
the operation of the system the
natural persons exposed thereto.
This obligation shall not apply to AI
systems used for emotion
G 514a G
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.
3. Users of an AI system that 3. Users of an AI system that 3. Users of an AI system that 3. UsersDeployers of an AI system
generates or manipulates image, generates or manipulates imagetext, generates or manipulates image, that generates or manipulates image,
audio or video content that audio or videovisual content that audio or video content that audio or video content constituting a
G 515 G
appreciably resembles existing appreciably resembles existing appreciably resembles existing deep fake, shall disclose that the
persons, objects, places or other persons, objects, places or other persons, objects, places or other content has been artificially
entities or events and would falsely entities or events and would falsely entities or events and would falsely generated or manipulated.
appear to a person to be authentic or appear to a person to be authentic appear to a person to be authentic or This obligation shall not apply
truthful (‘deep fake’), shall disclose or truthfulwould falsely appear to be truthful (‘deep fake’), shall disclose where the use is authorised by law
that the content has been artificially authentic or truthful and which that the content has been artificially to detect, prevent, investigate and
generated or manipulated. features depictions of people generated or manipulated. prosecute criminal offence. Where
appearing to say or do things they the content forms part of an
did not say or do, without their evidently artistic, creative, satirical,
consent (‘deep fake’), shall disclose fictional analogous work or
in an appropriate, timely, clear and programme, the transparency
visible manner that the content has obligations set out in this
been artificially generated or paragraph are limited to disclosure
manipulated, as well as, whenever of the existence of suchthat
possible, the name of the natural or appreciably resembles existing
legal person that generated or persons, objects, places or other
manipulated it. Disclosure shall entities or events and would falsely
mean labelling the content in a way appear to a person to be authentic
that informs that the content is or truthful (‘deep fake’), shall
inauthentic and that is clearly disclose that the content has been
visible for the recipient of that artificially generated or manipulated
content. To label the content, users content in an appropriate manner
shall take into account the that does not hamper the display or
generally acknowledged state of the enjoyment of the work.
art and relevant harmonised
standards and specifications.
However, the first subparagraph 3a However, the first subparagraph However, the first subparagraph However, the first
shall not apply where the use is Paragraph 3 shall not apply where shall not apply where the use is subparagraphDeployers of an AI
authorised by law to detect, prevent, the use is authorised by law to authorised by law to detect, prevent, system that generates or
investigate and prosecute criminal detect, prevent, investigate and investigate and prosecute criminal manipulates text which is published
offences or it is necessary for the prosecute criminal offences or of an offences or it is necessary for the with the purpose of informing the
G 516 G
exercise of the right to freedom of AI system that generates or exercise of the right to freedom of public on matters of public interest
expression and the right to freedom manipulates text, audio or visual expression and the right to freedom shall disclose that the text has been
of the arts and sciences guaranteed content is authorized by law or if it of the arts and sciences guaranteed artificially generated or
in the Charter of Fundamental is necessary for the exercise of the in the Charter of Fundamental manipulated. This obligation shall
Rights of the EU, and subject to right to freedom of expression and Rights of the EU, andwhere the not apply where the use is authorised
appropriate safeguards for the rights the right to freedom of the arts and content is part of an evidently by law to detect, prevent, investigate
and freedoms of third parties. sciences guaranteed in the Charter of creative, satirical, artistic or and prosecute criminal offences or it
Fundamental Rights of the EU, and fictional work or programme is necessary for the exercise of the
subject to appropriate safeguards for subject to appropriate safeguards for right to freedom of expression and
the rights and freedoms of third the rights and freedoms of third the right to freedom of the arts and
parties. Where the content forms parties. sciences guaranteed in the Charter
part of an evidently creative, of Fundamental Rights of the EU,
satirical, artistic or fictional and subject to appropriate
cinematographic, video games safeguardswhere the AI-generated
visuals and analogous work or content has undergone a process of
programme, transparency human review or editorial control
obligations set out in paragraph 3 and where a natural or legal person
are limited to disclosing of the holds editorial responsibility for the
existence of such generated or rights and freedoms of third
manipulated content in an partiespublication of the content.
appropriate clear and visible
manner that does not hamper the
display of the work and disclosing
the applicable copyrights, where
relevant. It shall also not prevent
law enforcement authorities from
using AI systems intended to detect
deep fakes and prevent, investigate
and prosecute criminal offences
linked with their use.
Article 52(3a)
3b The information referred to in 3a. The information referred to in

paragraphs 1 to 3 shall be provided paragraphs 1 to 3 shall be provided
to the natural persons at the latest to the concerned natural persons in
at the time of the first interaction or a clear and distinguishable manner
G 516a G
exposure. It shall be accessible to at the latest at the time of the first
vulnerable persons, such as persons interaction or exposure. The
with disabilities or children, information shall respect the
complete, where relevant and applicable accessibility
appropriate, with intervention or requirements.
flagging procedures for the exposed
natural person taking into account
the generally acknowledged state of
the art and relevant harmonised
standards and common
specifications.
Article 52(3b)
3a. The information referred to in

paragraphs 1 to 3 shall be provided
to natural persons in a clear and
G 516b G
distinguishable manner at the latest
at the time of the first interaction or
exposure.
Article 52(4)
4. Paragraphs 1, 2 and 3 shall not 4. Paragraphs 1, 2 and 3 shall not 4. Paragraphs 1, 2, 2a and 3 and 3a 4. Paragraphs 1, 2 and 3 shall not
affect the requirements and affect the requirements and shall not affect the requirements and affect the requirements and
obligations set out in Title III of this obligations set out in Title III of this obligations set out in Title III of this obligations set out in Title III of this
Regulation. Regulation. Regulation and shall be without Regulation and shall be without
prejudice to other transparency prejudice to other transparency
obligations for users of AI systems obligations for users of AI systems
laid down in Union or national law. laid down in Union or national law.
G 517 G
4a. The AI Office shall encourage
and facilitate the drawing up of
codes of practice at Union level to
facilitate the effective
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.
Article 52a
TITLE VIIIA
GENERAL PURPOSE AI
MODELS
CHAPTER 1
G 517a CLASSIFICATION RULES G
Article 52a
Classification of general-purpose
AI models as general purpose AI
models with systemic risk
Article 52a(1)
1. A general-purpose AI model
shall be classified as general-
G 517b purpose AI model with systemic risk G
if it meets any of the following

criteria:
(a) it has high impact capabilities

evaluated on the basis of
G 517c appropriate technical tools and G
methodologies, including indicators

and benchmarks;
(b) based on a decision of the

Commission, ex officio or following
a qualified alert by the scientific
G 517d G
panel that a general purpose AI
model has capabilities or impact
equivalent to those of point a).
Article 52a(2)
2. A general-purpose AI model
shall be presumed to have high
impact capabilities pursuant to
point a) of paragraph 1 when the
G 517e G
cumulative amount of compute
used for its training measured in
floating point operations (FLOPs)
is greater than 10^25.
Article 52a(3)
3. The Commission shall adopt

G 517f delegated acts in accordance with G
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.
Title IVa
G 517g G
Chapter I
G 517h G
Article 52b
Article 52b
G 517i G
Procedure
Article 52b(1)
1. Where a general-purpose AI
model meets the requirements
referred to in points (a) of Article
A(1), the relevant provider shall
G 517j G
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.
Article 52b(2)
2. The provider of a general-

purpose AI model that meets the
requirements referred to in points
(a) of Article A(1) may present, with
its notification, sufficiently
substantiated arguments to
demonstrate that, exceptionally,
G 517k G
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.
Article 52b(3)
3. Where the Commission

concludes that the arguments
G 517l G
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.
Article 52b(4)
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 [Alerts of systemic
risks by the scientific panel] (1) on
the basis of criteria set out in
Annex YY. The Commission shall
be empowered to specify and update
the criteria in Annex YY by means
of delegated acts in accordance
G 517m G
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 YY. 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
systemic risk, providers may request
reassessment at the earliest six
months after this decision.
Article 52b(5)
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
G 517n G
need to respect and protect
intellectual property rights and
confidential business information
or trade secrets in accordance with
Union and national law.
Chapter II
Chapter II
G 517o Obligations for providers of general G
purpose AI models
Article 52c
Article 52c
G 517p Obligations for providers of general G
purpose AI models
Article 52c(1)

G 517q G
models shall:
Article 52c(1), point (a)
(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
G 517r G
a minimum, the elements set out in
Annex XX for the purpose of
providing it, upon request, to the AI
Office and the national competent
authorities;
Article 52c(1), point (b)
(b) draw up, keep up-to-date and

make available information and
documentation to providers of AI
systems who intend to integrate the
G 517s G
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:
Article 52c(1), point (b)(i)
(i) enable providers of AI systems

to have a good understanding of the
capabilities and limitations of the
G 517t G
general purpose AI model and to
comply with their obligations
pursuant to this Regulation; and
Article 52c(1), point (b)(ii)
(ii) contain, at a minimum, the

G 517u G
elements set out in Annex XY;
Article 52c(1), point (c)
(c) put in place a policy to respect

Union copyright law in particular
to identify and respect, including
G 517v through state of the art G
technologies, the reservations of

rights expressed pursuant to Article
4(3) of Directive (EU) 2019/790;
Article 52c(2)
G 517w -2. The obligations set out in G
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.

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.
Article 52c(1), point (d)
(d) draw up and make publicly

available a sufficiently detailed
summary about the content used for
G 517x G
training of the general-purpose AI
model, according to a template
provided by the AI Office;
Article 52c(3)
G 517y G
models may rely on codes of
practice within the meaning of
Article E 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-
risks who do not adhere to an
approved code of practice shall
demonstrate alternative adequate
means of compliance for approval
of the Commission.
Article 52c(4)
4. For the purpose of facilitating

compliance with Annex XX, 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
G 517z G
verifiable documentation.
4a. The Commission is empowered

to adopt delegated acts in
accordance with Article 73(2) to
amend Annexes XX and XY 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
Article 70.
New 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;
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
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
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.
Chapter III
Chapter III
G 517aa G
Obligations for providers of general
risk
Article 52d
Article 52d
Obligations for providers of
G 517ab G
systemic risk
Article 52d(1)
1. In addition to the obligations

listed in Article C, providers of
G 517ac G
systemic risk shall:
Article 52d(1), point (a)
(a) perform model evaluation in

accordance with standardised
protocols and tools reflecting the
state of the art, including
G 517ad G
conducting and documenting
adversarial testing of the model
with a view to identify and mitigate
systemic risk;
Article 52d(1), point (b)
(b) assess and mitigate possible

G 517ae systemic risks at Union level, G
including their sources, that may

stem from the development, placing
on the market, or use of general
risk;
Article 52d(1), point (c)
(c) keep track of, document and

report without undue delay to the
AI Office and, as appropriate, to
G 517af national competent authorities, G
relevant information about serious

incidents and possible corrective
measures to address them;
Article 52d(1), point (d)
(d) ensure an adequate level of

cybersecurity protection for the
G 517ag general purpose AI model with G
systemic risk and the physical

infrastructure of the model.
Article 52d(2)

models with systemic risk may rely
on codes of practice within the
meaning of Article E to
G 517ah demonstrate compliance with the G
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-
risks who do not adhere to an
approved code of practice shall
demonstrate alternative adequate
means of compliance for approval
of the Commission.
Article 52d(3)
3. Any information and

documentation obtained pursuant
to the provisions of this Article,
G 517ai including trade secrets, shall be G
treated in compliance with the

Article 70.
Article 52e
Article 52e
G 517aj G
Codes of practice
Article 52e(1)
1. The AI Office shall encourage

and facilitate the drawing up of
codes of practice at Union level as
G 517ak an element to contribute to the G
proper application of this

Regulation, taking into account
international approaches.
Article 52e(2)
2. The AI Office and the AI Board

shall aim to ensure that the codes of
practice cover, but not necessarily
G 517al G
be limited to, the obligations
provided for in Articles C and D,
including the following issues:
Article 52e(2), point (a)
(a) means to ensure that the

information referred to in Article C
(a) and (b) is kept up to date in the
G 517am light of market and technological G
developments, and the adequate

level of detail for the summary
about the content used for training;
Article 52e(2), point (b)
(b) the identification of the type

and nature of the systemic risks at
G 517an G
Union level, including their sources
when appropriate;
Article 52e(2), point (c)
(c) the measures, procedures and

modalities for the assessment and
management of the systemic risks at
G 517ao G
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.
Article 52e(3)
3. The AI Office may invite the

models, as well as relevant national
competent authorities, to participate
in the drawing up of codes of
G 517ap practice. Civil society organisations, G
industry, academia and other

relevant stakeholders, such as
downstream providers and
independent experts, may support
the process.
Article 52e(4)
4. The AI Office and the Board

shall aim to ensure that the codes of
practice clearly set out their specific
objectives and contain
G 517aq commitments or measures, G
including key performance

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.
Article 52e(5)
5. The AI Office may invite all

models to participate in the codes of
practice. For providers of general-
purpose AI models not presenting
G 517ar systemic risks this participation G
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.
Article 52e(6)
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
G 517as G
performance indicators as
appropriate. Key performance
indicators and reporting
commitments shall take into
account differences in size and
capacity between different
participants.
Article 52e(7)
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 C and D, including the
issues listed in paragraph 2 of this
G 517at Article, and shall regularly monitor G
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).
Article 52e(8)
8. As appropriate, the AI Office

shall also encourage and facilitate
review and adaptation of the codes
G 517au G
of practice, in particular in light of
emerging standards. The AI Office
shall assist in the assessment of
available standards.
Article 52e(9)
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 6, the Commission may
G 517av G
provide, by means of implementing
acts, common rules for the
provided for in Articles C [Article
52c] and D [Article 52d], including
the issues set out in paragraph 2.
TITLE V
TITLE V TITLE V TITLE V TITLE V

MEASURES IN SUPPORT OF MEASURES IN SUPPORT OF MEASURES IN SUPPORT OF MEASURES IN SUPPORT OF
G 518 INNOVATION INNOVATION INNOVATION INNOVATION G

Proposal
Article 53

AI regulatory sandboxes AI regulatory sandboxes AI regulatory sandboxes AI regulatory sandboxes
G 519 G

Proposal
Article 53(-1)
-1. National competent authorities

may establish AI regulatory
sandboxes for the development,
training, testing and validation of
innovative AI systems under the
direct supervision, guidance and
G 519a support by the national competent G
authority, before those systems are

service. Such regulatory sandboxes
may include testing in real world
conditions supervised by the
national competent authorities.
Article 53(-1a)
-1a. Where appropriate, national

competent authorities shall
cooperate with other relevant
G 519b G
authorities and may allow for the
involvement of other actors within
the AI ecosystem.
Article 53(-1b)
-1b. This Article shall not affect

other regulatory sandboxes
established under national or
Union law, including in cases
G 519c G
where the products or services that
are tested in them are linked to the
use of innovative AI systems.
Member States shall ensure an
appropriate level of cooperation
between the authorities supervising
those other sandboxes and the
Article 53(1)
1. AI regulatory sandboxes 1. AI regulatory sandboxes 1. AI regulatory sandboxes

established by one or more Member established by one or more Member deleted established by one or more Member
States competent authorities or the States competent authorities or the States competent authorities or the
European Data Protection European Data Protection European Data Protection
Supervisor shall provide a controlled SupervisorMember States shall SupervisorMember States shall
environment that facilitates the establish at least one AI regulatory ensure that their competent
development, testing and validation sandbox at national level, which authorities establish at least one AI
of innovative AI systems for a shall provide a controlled regulatory sandbox at national
limited time before their placement environment that facilitates the level, which shall provide a
on the market or putting into service development, testing and validation controlled environment that
pursuant to a specific plan. This of innovative AI systems for a limited facilitates the development, testing
shall take place under the direct time before their placement on the and validation of innovative AI
supervision and guidance by the market or putting into service systems for a limited time before
competent authorities with a view to pursuant to a specific plan. This their placement on the market or
G 520 ensuring compliance with the shall take place under the direct putting into service pursuant to a G
requirements of this Regulation and, supervision and guidance by the specific plan. This shall take place
where relevant, other Union and competent authorities with a view to under the direct supervision and
Member States legislation ensuring compliance with the guidance by the competent
supervised within the sandbox. requirements of this Regulation and, authorities with a view to ensuring
where relevant,be operational at the compliance with the requirements of
latest on the day of the entry into this Regulation and, where relevant,
application of this Regulation This other Union and Member States
sandbox can also be established legislation supervised within the
jointly with one or several other sandboxbe operational 24 months
Union and Member States after entry into force. This sandbox
legislation supervised within the may also be established jointly with
sandbox. 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.
Article 53(1a)
1a. The establishment of AI

regulatory sandboxes under this
G 520a Regulation shall aim to contribute G
to one or more of the following

objectives:
(a) foster innovation and

G 520b competitiveness and facilitate the G
development of an AI ecosystem;
(b) facilitate and accelerate access

to the Union market for AI systems,
G 520c in particular when provided by G
small and medium enterprises

(SMEs), including start-ups;
Article 53(1a), point (c)

(c) improve legal certainty and

contribute to the sharing of best
practices through cooperation with
the authorities involved in the AI
G 520d regulatory sandbox with a view to G
ensuring future compliance with

this Regulation and, where
appropriate, with other Union and
Member States legislation;
Article 53(1a), point (d)
(d) contribute to evidence-based

G 520e G
regulatory learning.
Article 53(1a)
1a. Additional AI regulatory 1a. Additional AI regulatory

sandboxes at regional or local sandboxes at regional or local
levels or jointly with other Member levels or jointly with other Member
G 520f States may also be established; States' competent authorities may G
also be established;
Article 53(1b)
1b. The Commission and the 1b. The European Data Protection
European Data Protection Supervisor may also establish an AI
G 520g Supervisor, on their own, jointly or regulatory sandbox for the EU G
in collaboration with one or more institutions, bodies and agencies

Member States may also establish and exercise the roles and the tasks
AI regulatory sandboxes at Union of national competent authorities in
level; accordance with this chapter.
Article 53(1c)
1c. Establishing authorities shall 1c. Member States shall ensure

allocate sufficient resources to that competent authorities referred
comply with this Article effectively to in paragraphs 1 and 1a allocate
and in a timely manner. 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
G 520h involvement of other actors within G
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
Article 53(1d)
1d. AI regulatory sandboxes shall, 1d. AI regulatory sandboxes

G 520i G
in accordance with criteria set out established under Article 53(1) of
in Article 53a, provide for a this Regulation shall, in accordance
controlled environment that fosters with Articles 53 and 53a, provide
innovation and facilitates the for a controlled environment that
development, testing and validation fosters innovation and facilitates
of innovative AI systems for a the development, training, testing
limited time before their placement and validation of innovative AI
on the market or putting into systems for a limited time before
service pursuant to a specific plan their placement on the market or
agreed between the prospective putting into service pursuant to a
providers and the establishing specific sandbox plan agreed
authority. between the prospective providers
and the competent authority. Such
regulatory sandboxes may include
testing in real world conditions
supervised in the sandbox.
Article 53(1e)
1e. Establishing authorities shall 1e. Competent authorities shall

provide guidance and supervision provide, as appropriate, guidance,
within the sandbox with a view to supervision and support within the
identify risks, in particular to sandbox with a view to identifying
fundamental rights, democracy and risks, in particular to fundamental
rule of law, health and safety and rights, health and safety, testing,
the environment, test and mitigation measures, and their
G 520j G
demonstrate mitigation measures effectiveness in relation to the
for identified risks, and their obligations and requirements of this
effectiveness and ensure Regulation and, where relevant,
compliance with the requirements other Union and Member States
of this Regulation and, where legislation supervised within the
relevant, other Union and Member sandbox.
States legislation.
Article 53(1f)
G 520k G
1f. Establishing authorities shall 1f. Competent authorities shall
provide sandbox prospective provide providers and prospective
providers who develop high-risk AI providers with guidance on
systems with guidance and regulatory expectations and how to
supervision on how to fulfil the fulfil the requirements and
requirements set out in this obligations set out in this
Regulation, so that the AI systems Regulation.
may exit the sandbox being in
presumption of conformity with the Upon request of the provider or
specific requirements of this prospective provider of the AI
Regulation that were assessed system, the competent authority
within the sandbox. Insofar as the shall provide a written proof of the
AI system complies with the activities successfully carried out in
requirements when exiting the the sandbox. The competent
sandbox, it shall be presumed to be authority shall also provide an exit
in conformity with this regulation. report detailing the activities
In this regard, the exit reports carried out in the sandbox and the
created by the establishing related results and learning
authority shall be taken into outcomes. Providers may use such
account by market surveillance documentation to demonstrate the
authorities or notified bodies, as compliance with this Regulation
applicable, in the context of through the conformity assessment
conformity assessment procedures process or relevant market
or market surveillance checks. 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.
Article 53(1g)
1g. The establishment of AI 1g. The establishment of AI

regulatory sandboxes shall aim to regulatory sandboxes shall aim to
contribute to the following contribute to the following
objectives: objectives:
a) for the competent authorities to
provide guidance to AI systems a) improve legal certainty to
prospective providers providers to achieve regulatory compliance with
achieve regulatory compliance with this Regulation or, where relevant,
this Regulation or where relevant other applicable Union and
other applicable Union and Member States legislation;
G 520l G
Member States legislation;
b) for the prospective providers to b) support the sharing of best
allow and facilitate the testing and practices through cooperation with
development of innovative solutions the authorities involved in the AI
related to AI systems; regulatory sandbox;
c) regulatory learning in a
controlled environment. 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.
Article 53(2)
2. Member States shall ensure that 2. Member StatesEstablishing 2. Member StatesNational

to the extent the innovative AI authorities shall ensure that, to the deleted competent authorities shall ensure
systems involve the processing of extent the innovative AI systems that, to the extent the innovative AI
personal data or otherwise fall under involve the processing of personal systems involve the processing of
the supervisory remit of other data or otherwise fall under the personal data or otherwise fall under
national authorities or competent supervisory remit of other national the supervisory remit of other
authorities providing or supporting authorities or competent authorities national authorities or competent
access to data, the national data providing or supporting access to authorities providing or supporting
protection authorities and those other personal data, the national data access to data, the national data
G 521 G
national authorities are associated to protection authorities, or in cases protection authorities, and those
the operation of the AI regulatory referred to in paragraph 1b the other national authorities are
sandbox. EDPS, and those other national associated to the operation of the AI
authorities are associated to the regulatory sandbox and involved in
operation of the AI regulatory the supervision of those aspects to
sandbox and involved in the the extent of their respective tasks
supervision of those aspects to the and powers, as applicable.
full extent of their respective tasks
and powers.
2a. Access to the AI regulatory

G 521a sandboxes shall be open to any G
provider or prospective provider of

an AI system who fulfils the
eligibility and selection criteria
referred to in paragraph 6(a) and
who has been selected by the
national competent authorities
following the selection procedure
referred to in paragraph 6(b).
Providers or prospective providers
may also submit applications in
partnership with users or any other
relevant third parties.
Participation in the AI regulatory

sandbox shall be limited to a period
that is appropriate to the complexity
G 521b G
and scale of the project. This period
may be extended by the national
competent authority.
Article 53(2a), third subparagraph
Participation in the AI regulatory

sandbox shall be based on a specific
plan referred to in paragraph 6 of
G 521c this Article that shall be agreed G
between the participant(s) and the

national competent authoritie(s), as
applicable.
Article 53(3)
G 522 3. The AI regulatory sandboxes 3. The AI regulatory sandboxes 3. The participation in the AI 3. The AI regulatory sandboxes G
shall not affect the supervisory and shall not affect the supervisory and regulatory sandboxes shall not affect shall not affect the supervisory and
corrective powers of the competent corrective powers of the competent the supervisory and corrective corrective powers of the competent
authorities. Any significant risks to authorities, including at regional or powers of the competent authorities. authorities supervising the
health and safety and fundamental local level. Any significant risks to Any significant risks to health and sandboxes, including at regional or
rights identified during the fundamental rights, democracy and safety and fundamental rights local level. Any significant risks to
development and testing of such rule of law, health and safety and identified during the development health and safety and fundamental
systems shall result in immediate fundamental rightsor the and testing of such systems shall rights identified during the
mitigation and, failing that, in the environment identified during the result in immediate mitigation and, development and testing of such AI
suspension of the development and development and testing of such AI failing that, in the suspension of the systems shall result in immediatean
testing process until such mitigation systems shall result in immediate development and testing process adequate mitigation. National
takes place. and adequate mitigation. Competent until such mitigation takes competent authorities shall have the
authorities shall have the power to placeauthorities supervising the power to temporarily or
temporarily or permanently sandbox. Those authorities shall permanently suspend the testing
suspend the testing process, or exercise their supervisory powers in process, or participation and,
participation and, failing that, in a flexible manner within the limits failing that, in the
the suspension of the development of the relevant legislation, using suspensionsandbox if no effective
and testing process until such their discretionary powers when mitigation is possible and inform
mitigation takes placesandbox if no implementing legal provisions to a the AI Office of such decision.
effective mitigation is possible and specific AI sandbox project, with National competent authorities
inform the AI office of such the objective of supporting shall exercise their supervisory
decision. innovation in AI in the Union. powers within the limits of the
development and testing process
until such mitigation takes
placerelevant 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.
3a. Provided that the participant(s)

respect the sandbox plan and the
G 522a G
terms and conditions for their
participation as referred to in
paragraph 6(c) and follow in good
faith the guidance given by the
authorities, no administrative fines
shall be imposed by the authorities
for infringement of applicable
Union or Member State legislation
relating to the AI system supervised
in the sandbox, including the
provisions of this Regulation.
Article 53(4)
4. Participants in the AI regulatory 4. ParticipantsProspective 4. Participants in the AI regulatory 4. ParticipantsProviders and

sandbox shall remain liable under providers in the AI regulatory sandbox shallThe participants prospective providers in the AI
applicable Union and Member States sandbox shall remain liable under remain liable under applicable Union regulatory sandbox shall remain
liability legislation for any harm applicable Union and Member States and Member States liability liable under applicable Union and
inflicted on third parties as a result liability legislation for any harm legislation for any harm inflicted on Member States liability legislation
from the experimentation taking inflicted on third parties as a result third parties as a result from the for any harm damage inflicted on
place in the sandbox. fromof the experimentation taking experimentation taking place in third parties as a result fromof the
place in the sandbox. However, thedamage caused in the course of experimentation taking place in the
provided that the prospective their participation in an AI sandbox. However, provided that
provider(s) respect the specific plan regulatory sandbox. the prospective provider(s) respect
referred to in paragraph 1c and the the specific plan and the terms and
terms and conditions for their conditions for their participation
G 523 G
participation and follow in good and follow in good faith the
faith the guidance given by the guidance given by the national
establishing authorities, no competent authority, no
administrative fines shall be administrative fines shall be
imposed by the authorities for imposed by the authorities for
infringements of this Regulation. 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 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
4a. Upon request of the provider or

prospective provider of the AI
system, the national competent
authority shall provide, where
applicable, a written proof of the
activities successfully carried out in
the sandbox. The national
competent authority shall also
provide an exit report detailing the
G 523a G
activities carried out in the sandbox
and the related results and learning
outcomes. Such written proof and
exit report could be taken into
account by market surveillance
authorities or notified bodies, as
applicable, in the context of
conformity assessment procedures
or market surveillance checks.
G 523b Subject to the confidentiality G
provisions in Article 70 and with

the agreement of the sandbox
participants, the European
Commission and the AI Board shall
be authorised to access the exit
reports and shall take them into
account, as appropriate, when
Regulation. If both the participant
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
article 55(3)(b).
Article 53(4b)
4b. The AI regulatory sandboxes

shall be designed and implemented
in such a way that, where relevant,
G 523c G
they facilitate cross-border
cooperation between the national
Article 53(5)
5. Member States’ competent 5. Member States’ 5. Member States’National 5. Member States’National

authorities that have established AI competentEstablishing authorities competent authorities that have competent authorities that have
regulatory sandboxes shall that have established AI regulatory establishedshall make publicly established AI regulatory sandboxes
coordinate their activities and sandboxes shall coordinate their available annual reports on the shall coordinate their activities and
G 524 G
cooperate within the framework of activities and cooperate within the implementation of the AI regulatory cooperate within the framework of
the European Artificial Intelligence framework of the European sandboxes, including good the European Artificial Intelligence
Board. They shall submit annual Artificial Intelligence Board. They practices, lessons learnt and Board. They shall submit annual
reports to the Board and the shall submit annual reports to the recommendations on shall reports to the Board and the
Commission on the results from the Board and the Commission on the coordinate their activities and Commission on the results from the
implementation of those scheme, results from the implementation of cooperate within the framework of implementation of those scheme,
including good practices, lessons those scheme, including good the European Artificial Intelligence including good practices, lessons
learnt and recommendations on their practices, lessons learnt and Board. They shall submitsetup and, learnt and recommendations on their
setup and, where relevant, on the recommendations on their setup and, where relevant, on the application setup and, where relevant, on the
application of this Regulation and where relevant, on the application of of this Regulation and other Union application of this Regulation and
other Union legislation supervised this Regulation and other Union legislation supervised within the other Union legislation supervised
within the sandbox. legislation supervised within the sandbox. Those annual reports to the within the sandbox.
sandboxAI office. Board and the Commission on the
results from the implementation of
those scheme, includingshall be
submitted to the AI Board which
shall make publicly available a
summary of all good practices,
lessons learnt and recommendations.
This obligation to make annual
reports publicly available shall not
cover sensitive operational data in
relation to the activities of law
enforcement, border control,
immigration or asylum authorities.
The Commission and the AI Board
shall, where appropriate, take the
annual reports into account when
Regulation on their setup and,
where relevant, on the application of
this Regulation and other Union
legislation supervised within the
sandbox.
Article 53(5a)
5a. The Commission shall ensure

G 524a that information about AI G
regulatory sandboxes, including

about those established under this
Article, is available through the
single information platform
referred to in Article 55(3)(b).
Article 53(5a)
5a. Establishing authorities shall 5a. National competent authorities

inform the AI Office of the shall inform the AI Office and the
establishment of a sandbox and Board of the establishment of a
may ask for support and guidance. sandbox and may ask for support
A list of planned and existing and guidance. A list of planned and
G 524b sandboxes shall be made publicly existing AI sandboxes shall be G
available by the AI office and kept made publicly available by the AI

up to date in order to encourage Office and kept up to date in order
more interaction in the regulatory to encourage more interaction in
sandboxes and transnational the regulatory sandboxes and cross-
cooperation. border cooperation.
Article 53(5b)
5b. Establishing authorities shall 5b. National competent authorities

submit to the AI office and, unless shall submit to the AI Office and to
the Commission is the sole the Board, annual reports, starting
establishing authority, to the one year after the establishment of
Commission, annual reports, the AI regulatory sandbox and then
starting one year after the every year until its termination and
establishment of the sandbox and a final report. Those reports shall
G 524c G
then every year until its termination provide information on the progress
and a final report. Those reports and results of the implementation
shall provide information on the of those sandboxes, including best
progress and results of the practices, incidents, lessons learnt
implementation of those sandboxes, and recommendations on their
including best practices, incidents, setup and, where relevant, on the
lessons learnt and application and possible revision of
recommendations on their setup this Regulation, including its
and, where relevant, on the delegated and implementing acts,
application and possible revision of and other Union law supervised
this Regulation and other Union within the sandbox. Those annual
law supervised within the sandbox. reports or abstracts thereof shall be
Those annual reports or abstracts made available to the public,
thereof shall be made available to online.
the public, online. The Commission shall, where
appropriate, take the annual reports
into account when exercising their
tasks under this Regulation.
Article 53(6)
6. The modalities and the conditions 6. The modalities and the conditions 6. The modalities and the conditions 6. The modalities and the conditions
of the operation of the AI regulatory of the operation of the AI of the for the establishment and of the operation of the AI regulatory
sandboxes, including the eligibility regulatoryCommission shall operation of the AI regulatory sandboxes, including the eligibility
criteria and the procedure for the develop a single and dedicated sandboxes, including the eligibility criteria and the procedure for the
application, selection, participation interface containing all relevant criteria and the procedure for the application, selection, participation
and exiting from the sandbox, and information related to sandboxes, application, selection, participation and exiting from the sandbox, and
the rights and obligations of the including the eligibility criteria and and exiting from the sandbox, and the rights and obligations of the
participants shall be set out in the procedure for the application, the rights and obligations of the participants shall be set out in
implementing acts. Those selection, participation and exiting participants under this Regulation implementing acts. Those
implementing acts shall be adopted from the sandbox, and the rights and shall be set out inadopted through implementing acts shall be adopted
G 525 G
in accordance with the examination obligations of the participants shall implementing acts. Those in accordance with the examination
procedure referred to in Article be set out in implementing acts. implementing acts shall be adopted procedure referred to in Article
74(2). Those implementing actstogether in accordance with the examination 74(2)Commission shall develop a
with a single contact point at Union procedure referred to in Article single and dedicated interface
level to interact with the regulatory 74(2). containing all relevant information
sandboxes and to allow related to sandboxes to allow
stakeholders to raise enquiries with stakeholders to interact with
competent authorities, and to seek regulatory sandboxes and to raise
non-binding guidance on the enquiries with competent
conformity of innovative products, authorities, and to seek non-
services, business models binding guidance on the conformity
embedding AI technologies; of innovative products, services,
The Commission shall be adopted business models embedding AI
in accordance with the examination technologies, in accordance with
procedure referred to in Article Article 55(1)(c).
74(2)proactively coordinate with The Commission shall proactively
national, regional and also local coordinate with national competent
authorities, where relevant. authorities, where relevant.
6a. The modalities and conditions

shall to the best extent possible
support flexibility for national
competent authorities to establish
and operate their AI regulatory
G 525a sandboxes, foster innovation and G
regulatory learning and shall

particularly take into account the
special circumstances and
capacities of participating SMEs,
including start-ups.
Those implementing acts shall

G 525b include common main principles on G
the following issues:
Article 53(6a), second subparagraph, point (a)
G 525c (a) eligibility and selection for G
participation in the AI regulatory
sandbox;
Article 53(6a), second subparagraph, point (b)
(b) procedure for the application,

participation, monitoring, exiting
G 525d from and termination of the AI G
regulatory sandbox, including the

sandbox plan and the exit report;
Article 53(6a), second subparagraph, point (c)
(c) the terms and conditions

G 525e G
applicable to the participants.
Article 53(6a)
6a. For the purpose of paragraph 1 6a.

and 1a, the Commission shall play
a complementary role, enabling
Member States to build on their
expertise and, on the other hand,
G 525f G
assisting and providing technical
understanding and resources to
those Member States that seek
guidance on the set-up and running
of these regulatory sandboxes.
Article 53(6b)
53 a Modalities and functioning ARTICLE 53A

G 525g G
of AI regulatory sandboxes Modalities and functioning of AI
1. In order to avoid fragmentation regulatory sandboxes
across the Union, the Commission,
in consultation with the AI office, In order to avoid fragmentation
shall adopt a delegated act detailing across the Union, the Commission
the modalities for the shall adopt a an implementing act
establishment, development, detailing the modalities for the
implementation, functioning and establishment, development,
supervision of the AI regulatory implementation, operation and
sandboxes, including the eligibility supervision of the AI regulatory
criteria and the procedure for the sandboxes.
application, selection, participation The implementing act shall include
and exiting from the sandbox, and common principles on the following
the rights and obligations of the issues:
participants based on the provisions
set out in this Article; a) eligibility and selection for
2. The Commission is empowered participation in the AI regulatory
to adopt delegated acts in sandbox;
accordance with the procedure
referred to in Article 73, no later b) procedure for the application,
than 12 months following the entry participation, monitoring, exiting
into force of this Regulation and from and termination of the AI
shall ensure that: regulatory sandbox, including the
a) regulatory sandboxes are open sandbox plan and the exit report;
to any applying prospective provider
of an AI system who fulfils c) the terms and conditions
eligibility and selection criteria. The applicable to the participants.
criteria for accessing to the
regulatory sandbox are transparent The implementing acts shall ensure
and fair and establishing that:
authorities inform applicants of
their decision within 3 months of a) regulatory sandboxes are open to
the application; any applying prospective provider
b) regulatory sandboxes allow of an AI system who fulfils
broad and equal access and keep up eligibility and selection criteria. The
with demand for participation; criteria for accessing to the
c) access to the AI regulatory regulatory sandbox are transparent
sandboxes is free of charge for and fair and establishing
SMEs and start-ups without authorities inform applicants of
prejudice to exceptional costs that their decision within 3 months of
establishing authorities may the application;
recover in a fair and proportionate
manner; b) regulatory sandboxes allow
d) regulatory sandboxes facilitate broad and equal access and keep up
the involvement of other relevant with demand for participation;
actors within the AI ecosystem, prospective providers may also
such as notified bodies and submit applications in partnerships
standardisation organisations with users and other relevant third
(SMEs, start-ups, enterprises, parties;
innovators, testing and
experimentation facilities, research c) the modalities and conditions
and experimentation labs and concerning regulatory sandboxes
digital innovation hubs, centers of shall to the best extent possible
excellence, individual researchers), support flexibility for national
in order to allow and facilitate competent authorities to establish
cooperation with the public and and operate their AI regulatory
private sector; sandboxes;
e) they allow prospective
providers to to fulfil, in a controlled d) access to the AI regulatory
environment, the conformity sandboxes is free of charge for
assessment obligations of this SMEs and start-ups without
Regulation or the voluntary prejudice to exceptional costs that
application of the codes of conduct national competent authorities may
referred to in Article 69; recover in a fair and proportionate
f) procedures, processes and manner;
administrative requirements for
application, selection, participation e) they facilitate prospective
and exiting the sandbox are simple, providers, by means of the learning
easily intelligible, clearly outcomes of the sandboxes, to
communicated in order to facilitate conduct the conformity assessment
the participation of SMEs and start- obligations of this Regulation or the
ups with limited legal and voluntary application of the codes
administrative capacities and are of conduct referred to in Article 69;
streamlined across the Union, in
order to avoid fragmentation and f) regulatory sandboxes facilitate
that participation in a regulatory the involvement of other relevant
sandbox established by a Member actors within the AI ecosystem,
State, by the Commission, or by the such as notified bodies and
EDPS is mutually and uniformly standardisation organisations
recognised and carries the same (SMEs, start-ups, enterprises,
legal effects across the Union; innovators, testing and
g) participation in the AI experimentation facilities, research
regulatory sandbox is limited to a and experimentation labs and
period that is appropriate to the digital innovation hubs, centers of
complexity and scale of the project. excellence, individual researchers),
h) the sandboxes shall facilitate in order to allow and facilitate
the development of tools and cooperation with the public and
infrastructure for testing, private sector;
benchmarking, assessing and
explaining dimensions of AI g) procedures, processes and
systems relevant to sandboxes, such administrative requirements for
as accuracy, robustness and application, selection, participation
cybersecurity as well as and exiting the sandbox are simple,
minimisation of risks to easily intelligible, clearly
fundamental rights, environment communicated in order to facilitate
and the society at large the participation of SMEs and start-
3. Prospective providers in the ups with limited legal and
sandboxes, in particular SMEs and administrative capacities and are
start-ups, shall be facilitated access streamlined across the Union, in
to pre-deployment services such as order to avoid fragmentation and
guidance on the implementation of that participation in a regulatory
this Regulation, to other value- sandbox established by a Member
adding services such as help with State, or by the EDPS is mutually
standardisation documents and and uniformly recognised and
certification and consultation, and carries the same legal effects across
to other Digital Single Market the Union;
initiatives such as Testing &
Experimentation Facilities, Digital h) participation in the AI regulatory
Hubs, Centres of Excellence, and sandbox is limited to a period that is
EU benchmarking capabilities. 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,[environment]
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, Centres of
Excellence, and [EU benchmarking
capabilities].
Article 53(6c)
6b. When national competent 4. When national competent

authorities consider authorising authorities consider authorising
testing in real world conditions testing in real world conditions
G 525h G
supervised within the framework of supervised within the framework of
an AI regulatory sandbox an AI regulatory sandbox
established under this Article, they established under this Article, they
shall specifically agree with the shall specifically agree with the
participants on the terms and participants on the terms and
conditions of such testing and in conditions of such testing and in
particular on the appropriate particular on the appropriate
safeguards with the view to protect safeguards with the view to protect
fundamental rights, health and fundamental rights, health and
safety. Where appropriate, they safety. Where appropriate, they
shall cooperate with other national shall cooperate with other national
competent authorities with a view to competent authorities with a view to
ensure consistent practices across ensure consistent practices across
the Union. the Union.
Article 54

Further processing of personal data Further processing of personal data Further processing of personal data Further processing of personal data
for developing certain AI systems in for developing certain AI systems in for developing certain AI systems in for developing certain AI systems in
G 526 the public interest in the AI the public interest in the AI the public interest in the AI the public interest in the AI G
regulatory sandbox regulatory sandbox regulatory sandbox regulatory sandbox

Article 54(1)
1. In the AI regulatory sandbox 1. In the AI regulatory sandbox 1. In the AI regulatory sandbox 1. In the AI regulatory sandbox
personal data lawfully collected for personal data lawfully collected for personal data lawfully collected for personal data lawfully collected for
other purposes shall be processed for other purposes shallmay be other purposes shallmay be other purposes shallmay be
the purposes of developing and processed solely for the purposes of processed for the purposes of processed solely for the purposes of
G 527 G
testing certain innovative AI systems developing and testing certain developing, testing and training of developing, training and testing
in the sandbox under the following innovative AI systems in the and testing certain innovative AI certain innovative AI systems in the
conditions: sandbox underwhen all of the systems in the sandbox under the sandbox underwhen all of the
following conditions are met: following cumulative conditions: following conditions are met:
(a) the innovative AI systems shall (a) the innovative AI systems shall (a) the innovative AI systems shall (a) the innovative AI systems shall
be developed for safeguarding be developed for safeguarding be developed for safeguarding be developed for safeguarding
substantial public interest in one or substantial public interest in one or substantial public interest by a substantial public interest by a
G 528 more of the following areas: more of the following areas: public authority or another natural public authority or another natural G
or legal person governed by public or legal person governed by public

law or by private law and in one or law or by private law and in one or
more of the following areas: more of the following areas:
Article 54(1), point (a)(i)
(i) the prevention, investigation,

detection or prosecution of criminal deleted deleted
offences or the execution of criminal
penalties, including the safeguarding
against and the prevention of threats
G 529 G
to public security, under the control
and responsibility of the competent
authorities. The processing shall be
based on Member State or Union
law;
Article 54(1), point (a)(ii)
(ii) public safety and public health, (ii) public safety and public health, (ii) public safety and public health, (ii) public safety and public health,
including disease prevention, control including disease detection, including disease prevention, control including disease detection,
and treatment; diagnosis prevention, control and and treatment of disease and diagnosis prevention, control and
G 530 G
treatment;public safety and public improvement of health care treatment and improvement of
health, including disease prevention, systems; health care systems;
control and treatment;
Article 54(1), point (a)(iii)
G 531 G
(iii) a high level of protection and (iii) a high level of protection and (iii) a high level of protection and (iii) a high level of protection and
improvement of the quality of the improvement of the quality of the improvement of the quality of the improvement of the quality of the
environment; environment, protection of environment, including green environment, protection of
biodiversity, pollution as well as transition, climate change biodiversity, pollution as well as
climate change mitigation and mitigation and adaptation; green transition, climate change
adaptation; mitigation and adaptation;
Article 54(1), point (a)(iiia)
(iiia) energy sustainability, (iiia) energy sustainability

G 531a G
transport and mobility;
Article 54(1), point (a)(iiib)
(iiia) safety and resilience of (iiib) safety and resilience of

transport systems, critical transport systems and mobility,
G 531b G
infrastructure and networks. critical infrastructure and
networks;
Article 54(1), point (a)(iiic)
(iiib) efficiency and quality of (iiic) efficiency and quality of

G 531c public administration and public public administration and public G
services; services;
Article 54(1), point (a)(iiic)
(iiic) cybersecurity and resilience

G 531d G
of critical infrastructure.
G 532 G
(b) the data processed are necessary (b) the data processed are necessary (b) the data processed are necessary (b) the data processed are necessary
for complying with one or more of for complying with one or more of for complying with one or more of for complying with one or more of
the requirements referred to in Title the requirements referred to in Title the requirements referred to in Title the requirements referred to in Title
III, Chapter 2 where those III, Chapter 2 where those III, Chapter 2 where those III, Chapter 2 where those
requirements cannot be effectively requirements cannot be effectively requirements cannot be effectively requirements cannot be effectively
fulfilled by processing anonymised, fulfilled by processing anonymised, fulfilled by processing anonymised, fulfilled by processing anonymised,
synthetic or other non-personal data; synthetic or other non-personal data; synthetic or other non-personal data; synthetic or other non-personal data;
(c) there are effective monitoring (c) there are effective monitoring (c) there are effective monitoring (c) there are effective monitoring
mechanisms to identify if any high mechanisms to identify if any high mechanisms to identify if any high mechanisms to identify if any high
risks to the fundamental rights of the risks to the fundamental rightsrights risks to the fundamental rightsrights risks to the fundamental rightsrights
data subjects may arise during the and freedoms of the data subjects, and freedoms of the data subjects, and freedoms of the data subjects,
sandbox experimentation as well as as referred to in Article 35 of as referred to in Article 35 of as referred to in Article 35 of
response mechanism to promptly Regulation (EU) 2016/679 and in Regulation (EU) 2016/679 and in Regulation (EU) 2016/679 and in
G 533 mitigate those risks and, where Article 35 of Regulation (EU) Article 39 of Regulation (EU) Article 39 of Regulation (EU) G
necessary, stop the processing; 2018/1725 may arise during the 2018/1725, may arise during the 2018/1725, may arise during the
sandbox experimentation as well as sandbox experimentation as well as sandbox experimentation as well as
response mechanism to promptly response mechanism to promptly response mechanism to promptly
mitigate those risks and, where mitigate those risks and, where mitigate those risks and, where
necessary, stop the processing; necessary, stop the processing; necessary, stop the processing;
(d) any personal data to be (d) any personal data to be (d) any personal data to be (d) any personal data to be
processed in the context of the processed in the context of the processed in the context of the processed in the context of the
sandbox are in a functionally sandbox are in a functionally sandbox are in a functionally sandbox are in a functionally
G 534 separate, isolated and protected data separate, isolated and protected data separate, isolated and protected data separate, isolated and protected data G
processing environment under the processing environment under the processing environment under the processing environment under the
control of the participants and only control of the control of the participants and only control of the
authorised persons have access to participantsprospective provider and authorised persons have access to participantsprospective provider and
that data; only authorised persons have access that data; only authorised persons have access
to that those data; to that those data;
(e) any personal data processed are (e) any personal data processed are (e) any personal data processed are (e) Providers can only further
not be transmitted, transferred or not be transmitted, transferred or not to be transmitted, transferred or share the originaly collected data in
otherwise accessed by other parties; otherwise accessed by other parties; otherwise accessed by other parties compliance with EU data protection
that are not participants in the law. Any personal data processed
sandbox, unless such disclosure are not be transmitted, transferred
G 535 occurs in compliance with or otherwise accessed by other G
Regulation (EU) 2016/679 or, parties;crated in the sandbox

where applicable, Regulation cannot be shared outside the
2018/725, and all participants have sandbox
agreed to it;
(f) any processing of personal data (f) any processing of personal data (f) any processing of personal data (f) any processing of personal data
in the context of the sandbox do not in the context of the sandbox do not in the context of the sandbox do not in the context of the sandbox do not
lead to measures or decisions lead to measures or decisions lead to measures or decisions lead to measures or decisions
affecting the data subjects; affecting the data subjects nor affect affectingshall not affect the affecting the data subjects nor affect
the application of their rights laid application of the rights of the data the application of their rights laid
G 536 down in Union law on the subjects as provided for under down in Union law on the G
protection of personal data; Union law on the protection of protection of personal data;
personal data, in particular in
2016/679 and Article 24 of
G 537 G
(g) any personal data processed in (g) any personal data processed in (g) any personal data processed in (g) (g) any personal data processed
the context of the sandbox are the context of the sandbox are the context of the sandbox are in the context of the sandbox are
deleted once the participation in the protected by means of appropriate protected by means of appropriate protected by means of appropriate
sandbox has terminated or the technical and organisational technical and organisational technical and organisational
personal data has reached the end of measures and deleted once the measures and deleted once the measures and deleted once the
its retention period; participation in the sandbox has participation in the sandbox has participation in the sandbox has
terminated or the personal data has terminated or the personal data has terminated or the personal data has
reached the end of its retention reached the end of its retention reached the end of its retention
period; period; period;
(h) the logs of the processing of (h) the logs of the processing of (h) the logs of the processing of (h) the logs of the processing of
personal data in the context of the personal data in the context of the personal data in the context of the personal data in the context of the
sandbox are kept for the duration of sandbox are kept for the duration of sandbox are kept for the duration of sandbox are kept for the duration of
the participation in the sandbox and the participation in the sandbox and the participation in the sandbox and the participation in the sandbox and
1 year after its termination, solely 1 year after its termination, solely 1 year after its termination, solely 1 year after its termination, solely
for the purpose of and only as long for the purpose of and only as long for the purpose of and only as long for the purpose of and only as long
G 538 as necessary for fulfilling as necessary for fulfilling as necessary for fulfilling as necessary for fulfilling G
accountability and documentation accountability and documentation accountability and documentation accountability and documentation
obligations under this Article or obligations under this Article or obligations under this Article or obligations under this Article or
other application Union or Member other application Union or Member other application, unless provided other application, unless provided
States legislation; States legislation; otherwise by Union or Member otherwise by Union or Member
States legislationnational law; States legislationnational law;
(i) complete and detailed (i) complete and detailed (i) complete and detailed (i) complete and detailed
description of the process and description of the process and description of the process and description of the process and
rationale behind the training, testing rationale behind the training, testing rationale behind the training, testing rationale behind the training, testing
G 539 G
and validation of the AI system is and validation of the AI system is and validation of the AI system is and validation of the AI system is
kept together with the testing results kept together with the testing results kept together with the testing results kept together with the testing results
as part of the technical as part of the technical as part of the technical as part of the technical
documentation in Annex IV; documentation in Annex IV; documentation in Annex IV; documentation in Annex IV;
Article 54(1), point (j)
(j) a short summary of the AI (j) a short summary of the AI (j) a short summary of the AI (j) a short summary of the AI
project developed in the sandbox, its projectsystem developed in the project developed in the sandbox, its project developed in the sandbox, its
objectives and expected results sandbox, its objectives, hypotheses, objectives and expected results objectives and expected results
published on the website of the and expected results, published on published on the website of the published on the website of the
competent authorities. the website of the competent competent authorities. This competent authorities. This
G 540 authorities.; obligation shall not cover sensitive obligation shall not cover sensitive G
operational data in relation to the operational data in relation to the

activities of law enforcement, activities of law enforcement,
border control, immigration or border control, immigration or
asylum authorities. asylum authorities.
Article 54(1), point (ja)
1a. For the purpose of prevention, 1a. For the purpose of prevention,
investigation, detection or investigation, detection or
prosecution of criminal offences or prosecution of criminal offences or
the execution of criminal penalties, the execution of criminal penalties,
including the safeguarding against including the safeguarding against
and the prevention of threats to and the prevention of threats to
public security, under the control public security, under the control
G 540a and responsibility of law and responsibility of law G
enforcement authorities, the enforcement authorities, the

processing of personal data in AI processing of personal data in AI
regulatory sandboxes shall be based regulatory sandboxes shall be based
on a specific Member State or on a specific Member State or
Union law and subject to the same Union law and subject to the same
cumulative conditions as referred to cumulative conditions as referred to
in paragraph 1. in paragraph 1.
Article 54(2)
2. Paragraph 1 is without prejudice 2. Paragraph 1 is without prejudice 2. Paragraph 1 is without prejudice 2. Paragraph 1 is without prejudice
to Union or Member States to Union or Member States to Union or Member States to Union or Member States
legislation excluding processing for legislation excluding processing for legislation excludinglaws laying legislation excluding processing for
other purposes than those explicitly other purposes than those explicitly down the basis for the processing of other purposes than those explicitly
mentioned in that legislation. mentioned in that legislation. personal data which is necessary mentioned in that legislation, as well
for the purpose of developing, as to Union or Member States laws
testing and training of innovative laying down the basis for the
G 541 AI systems or any other legal basis, processing of personal data which G
in compliance with Union law on is necessary for the purpose of

the protection of personal datafor developing, testing and training of
other purposes than those explicitly innovative AI systems or any other
mentioned in that legislation. legal basis, in compliance with
Union law on the protection of
personal data.
Article 54a new
54a Promotion of AI research and

development in support of socially
and environmentally beneficial
outcomes
1. Member States shall promote
G 541a research and development of AI G
solutions which support socially

and environmentally beneficial
outcomes, including but not limited
to development of AI-based
solutions to increase accessibility
for persons with disabilities, tackle
socio-economic inequalities, and
meet sustainability and
environmental targets, by:
(a) providing relevant projects
with priority access to the AI
regulatory sandboxes to the extent
that they fulfil the eligibility
conditions;
(b) earmarking public funding,
including from relevant EU funds,
for AI research and development in
support of socially and
environmentally beneficial
outcomes;
(c) organising specific awareness
raising activities about the
application of this Regulation, the
availability of and application
procedures for dedicated funding,
tailored to the needs of those
projects;
(d) where appropriate,
establishing accessible dedicated
channels, including within the
sandboxes, for communication with
projects to provide guidance and
respond to queries about the
implementation of this Regulation.
Member States shall support civil
society and social stakeholders to
lead or participate in such projects.
Article 54a
G 541b Article 54a Article 54a G
Testing of high-risk AI systems in Testing of high-risk AI systems in

real world conditions outside AI real world conditions outside AI
regulatory sandboxes regulatory sandboxes
1. Testing of AI systems in real 1. Testing of AI systems in real

world conditions outside AI world conditions outside AI
regulatory sandboxes may be regulatory sandboxes may be
conducted by providers or conducted by providers or
prospective providers of high-risk prospective providers of high-risk
G 541c AI systems listed in Annex III, in AI systems listed in Annex III, in G
accordance with the provisions of accordance with the provisions of

this Article and the real-world this Article and the real-world
testing plan referred to in this testing plan referred to in this
Article. Article, without prejudice
to the prohibitions under Article 5.
The detailed elements of the real- The detailed elements of the real-
world testing plan shall be specified world testing plan shall be specified
in implementing acts adopted by the in implementing acts adopted by the
G 541d G
Commission in accordance with the Commission in accordance with the
examination procedure referred to examination procedure referred to
in Article 74(2). in Article 74(2).
Article 54a(2)
This provision shall be without This provision shall be without

prejudice to Union or Member State prejudice to Union or national law
G 541e legislation for the testing in real for the testing in real world G
world conditions of high-risk AI conditions of high-risk AI systems

systems related to products covered related to products covered by
by legislation listed in Annex II. legislation listed in Annex II.
Article 54a(3)
2. Providers or prospective 2. Providers or prospective

providers may conduct testing of providers may conduct testing of
high-risk AI systems referred to in high-risk AI systems referred to in
Annex III in real world conditions Annex III in real world conditions
G 541f at any time before the placing on at any time before the placing on G
the market or putting into service of the market or putting into service of
the AI system on their own or in the AI system on their own or in
partnership with one or more partnership with one or more
prospective users. prospective deployers.
Article 54a(4)
3. The testing of high-risk AI 3. The testing of high-risk AI

systems in real world conditions systems in real world conditions
under this Article shall be without under this Article shall be without
G 541g G
prejudice to ethical review that may prejudice to ethical review that may
be required by national or Union be required by national or Union
law. law.
Article 54a(5)

providers may conduct the testing providers may conduct the testing
G 541h in real world conditions only where in real world conditions only where G
all of the following conditions are all of the following conditions are
met: met:
G 541i G
(a) the provider or prospective (a) the provider or prospective
provider has drawn up a real-world provider has drawn up a real-world
testing plan and submitted it to the testing plan and submitted it to the
market surveillance authority in the market surveillance authority in the
Member State(s) where the testing Member State(s) where the testing
in real world conditions is to be in real world conditions is to be
conducted; conducted;
(b) the market surveillance (b) the market surveillance

authority in the Member State(s) authority in the Member State(s)
where the testing in real world where the testing in real world
conditions is to be conducted have conditions is to be conducted has
not objected to the testing within 30 approved the testing in real world
days after its submission; conditions and the real-world
testing plan. Where the market
surveillance authority in that
G 541j Member State has not provided with G
an answer in 30 days, the testing in

real world conditions and the real-
world testing plan shall be
understood as approved. In cases
where national law does not foresee
a tacit approval, the testing in real
world conditions shall be subject to
an authorisation;
Article 54a(5), point (c)
(c) the provider or prospective (c) the provider or prospective

provider with the exception of high- provider with the exception of high-
G 541k risk AI systems referred to in Annex risk AI systems referred to in Annex G
III, points 1, 6 and 7 in the areas of III, points 1, 6 and 7 in the areas of
law enforcement, migration, asylum law enforcement, migration, asylum
and border control management, and border control management,
and high risk AI systems referred to and high risk AI systems referred to
in Annex III point 2, has registered in Annex III point 2, has registered
the testing in real world conditions the testing in real world conditions
in the EU database referred to in in the non public part of the EU
Article 60(5a) with a Union-wide database referred to in Article 60(3)
unique single identification number with a Union-wide unique single
and the information specified in identification number and the
Annex VIIIa; information specified in Annex
VIIIa.
Article 54a(5), point (d)
(d) the provider or prospective (d) the provider or prospective

provider conducting the testing in provider conducting the testing in
real world conditions is established real world conditions is established
in the Union or it has appointed a in the Union or it has appointed a
G 541l G
legal representative for the purpose legal representative who is
of the testing in real world established in the Union;
conditions who is established in the
Union;
Article 54a(5), point (e)
(e) data collected and processed for (e) Data collected and processed
the purpose of the testing in real for the purpose of the testing in real
world conditions shall not be world conditions shall only be
transferred to countries outside the transferred to third countries
G 541m G
Union, unless the transfer and the outside the Union provided
processing provides equivalent appropriate and applicable
safeguards to those provided under safeguards under Union law are
Union law; implemented;
Article 54a(5), point (f)

G 541n G
(f) the testing in real world (f) the testing in real world
conditions does not last longer than conditions does not last longer than
necessary to achieve its objectives necessary to achieve its objectives
and in any case not longer than 12 and in any case not longer than 6
months; 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;
Article 54a(5), point (g)
(g) persons belonging to vulnerable (g) persons belonging to vulnerable

groups due to their age, physical or groups due to their age, physical or
G 541o G
mental disability are appropriately mental disability are appropriately
protected; protected;
Article 54a(5), point (h)
(h) where a provider or prospective (h) where a provider or prospective

provider organises the testing in provider organises the testing in
real world conditions in real world conditions in
cooperation with one or more cooperation with one or more
prospective users, the latter have prospective deployers, the latter
been informed of all aspects of the have been informed of all aspects of
G 541p testing that are relevant to their the testing that are relevant to their G
decision to participate, and given decision to participate, and given

the relevant instructions on how to the relevant instructions on how to
use the AI system referred to in use the AI system referred to in
Article 13; the provider or Article 13; the provider or
prospective provider and the user(s) prospective provider and the
shall conclude an agreement deployer(s) shall conclude an
specifying their roles and agreement specifying their roles
responsibilities with a view to and responsibilities with a view to
ensuring compliance with the ensuring compliance with the
provisions for testing in real world provisions for testing in real world
conditions under this Regulation conditions under this Regulation
and other applicable Union and and other applicable Union and
Member States legislation; Member States legislation;
Article 54a(5), point (i)
(i) the subjects of the testing in real (i) the subjects of the testing in real
world conditions have given world conditions have given
informed consent in accordance informed consent in accordance
with Article 54b, or in the case of with Article 54b, or in the case of
law enforcement, where the seeking law enforcement, where the seeking
of informed consent would prevent of informed consent would prevent
G 541q the AI system from being tested, the the AI system from being tested, the G
testing itself and the outcome of the testing itself and the outcome of the
testing in the real world conditions testing in the real world conditions
shall not have a negative effect on shall not have any negative effect
the subject; on the subject and his or her
personal data shall be deleted after
the test is performed.
Article 54a(5), point (j)
(j) the testing in real world (j) the testing in real world
conditions is effectively overseen by conditions is effectively overseen by
the provider or prospective provider the provider or prospective provider
and user(s) with persons who are and deployer(s) with persons who
G 541r G
suitably qualified in the relevant are suitably qualified in the
field and have the necessary relevant field and have the
capacity, training and authority to necessary capacity, training and
perform their tasks; authority to perform their tasks;
Article 54a(5), point (k)

(k) the predictions, (k) the predictions,

recommendations or decisions of recommendations or decisions of
G 541s G
the AI system can be effectively the AI system can be effectively
reversed or disregarded. reversed and disregarded.
Article 54a(6)
5. Any subject of the testing in real 5 Any subject of the testing in real
world conditions, or his or her world conditions, or his or her
legally designated representative, as legally designated representative, as
appropriate, may, without any appropriate, may, without any
resulting detriment and without resulting detriment and without
having to provide any justification, having to provide any justification,
withdraw from the testing at any withdraw from the testing at any
time by revoking his or her time by revoking his or her
informed consent. The withdrawal informed consent and request the
of the informed consent shall not immediate and permanent deletion
affect the activities already carried of their personal data. The
out and the use of data obtained withdrawal of the informed consent
based on the informed consent shall not affect the activities already
G 541t before its withdrawal. carried out. G
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.
Article 54a(6)
6. Any serious incident identified 6. Any serious incident identified

in the course of the testing in real in the course of the testing in real
world conditions shall be reported world conditions shall be reported
to the national market surveillance to the national market surveillance
authority in accordance with Article authority in accordance with Article
62 of this Regulation. The provider 62 of this Regulation. The provider
or prospective provider shall adopt or prospective provider shall adopt
immediate mitigation measures or, immediate mitigation measures or,
G 541u failing that, suspend the testing in failing that, suspend the testing in G
real world conditions until such real world conditions until such
mitigation takes place or otherwise mitigation takes place or otherwise
terminate it. The provider or terminate it. The provider or
prospective provider shall establish prospective provider shall establish
a procedure for the prompt recall of a procedure for the prompt recall of
the AI system upon such the AI system upon such
termination of the testing in real termination of the testing in real
world conditions. world conditions.
Article 54a(7)

providers shall notify the national providers shall notify the national
market surveillance authority in the market surveillance authority in the
Member State(s) where the testing Member State(s) where the testing
G 541v in real world conditions is to be in real world conditions is to be G
conducted of the suspension or conducted of the suspension or

world conditions and the final world conditions and the final
outcomes. outcomes.
Article 54a(8)
8. The provider and prospective 8. The provider and prospective

provider shall be liable under provider shall be liable under
applicable Union and Member applicable Union and Member
G 541w States liability legislation for any States liability legislation for any G
damage caused in the course of damage caused in the course of

their participation in the testing in their participation in the testing in
real world conditions. real world conditions.
Article 54a(10)
G 541x G
Article 54a(11)
Article 54b Article 54b

Informed consent to participate in Informed consent to participate in
G 541y G
testing in real world conditions testing in real world conditions
outside AI regulatory sandboxes outside AI regulatory sandboxes
1. For the purpose of testing in real 1. For the purpose of testing in

world conditions under Article 54a, real world conditions under Article
informed consent shall be freely 54a, informed consent shall be
given by the subject of testing prior freely given by the subject of testing
G 541z to his or her participation in such prior to his or her participation in G
testing and after having been duly such testing and after having been
informed with concise, clear, duly informed with concise, clear,
relevant, and understandable relevant, and understandable
information regarding: information regarding:

G 541aa G
(i) the nature and objectives of the (i) the nature and objectives of the
testing in real world conditions and testing in real world conditions and
the possible inconvenience that may the possible inconvenience that may
be linked to his or her participation; be linked to his or her participation;
(ii) the conditions under which (ii) the conditions under which the
the testing in real world conditions testing in real world conditions is to
is to be conducted, including the be conducted, including the
expected duration of the subject's expected duration of the subject's
participation; participation;
(iii) the subject's rights and (iii) the subject's rights and
guarantees regarding participation, guarantees regarding participation,
in particular his or her right to in particular his or her right to
refuse to participate in and the right refuse to participate in and the right
to withdraw from testing in real to withdraw from testing in real
world conditions at any time world conditions at any time
without any resulting detriment and without any resulting detriment and
without having to provide any without having to provide any
justification; justification;
(iv) the modalities for requesting (iv) the modalities for requesting
the reversal or the disregard of the the reversal or the disregard of the
predictions, recommendations or predictions, recommendations or
decisions of the AI system; decisions of the AI system;
(v) the Union-wide unique single (v) the Union-wide unique single
identification number of the testing identification number of the testing
in real world conditions in in real world conditions in
accordance with Article 54a(4c) accordance with Article 54a(4c)
and the contact details of the and the contact details of the
provider or its legal representative provider or its legal representative
from whom further information can from whom further information can
be obtained. be obtained.
Article 54a(13)
2. The informed consent shall be 2 The informed consent shall be

G 541ab G
dated and documented and a copy dated and documented and a copy
shall be given to the subject or his shall be given to the subject or his
or her legal representative. or her legal representative.
Article 55

Measures for small-scale providers Measures for small-scale Support measures for operators, in Measures for small-scale providers
G 542 and users providersSMEs, start-ups and users particular SMEs, including start- and users deployers, in particular G
ups measures for small-scale SMEs, including start-ups

providers and users
Article 55(1)
1. Member States shall undertake 1. Member States shall undertake 1. Member States shall undertake 1. Member States shall undertake
G 543 the following actions: the following actions: the following actions: the following actions: G
(a) provide small-scale providers (a) provide small-scale (a) provide small-scale providers (a) provide small-scale providers
and start-ups with priority access to providersSMEs and start-ups, andSMEs, including start-ups, with andSMEs, including start-ups,
the AI regulatory sandboxes to the established in the Union, with priority access to the AI regulatory having a registered office or a
extent that they fulfil the eligibility priority access to the AI regulatory sandboxes to the extent that they branch in the Union, with priority
conditions; sandboxes, to the extent that they fulfil the eligibility conditionsand access to the AI regulatory
fulfil the eligibility conditions; selection criteria; sandboxes, to the extent that they
fulfil the eligibility conditions and
G 544 G
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 (b) organise specific awareness (b) organise specific awareness (b) organise specific awareness
raising activities about the raising and enhanced digital skills raising and training activities about raising and training activities
application of this Regulation development activities abouton the the application of this Regulation abouton the application of this
tailored to the needs of the small- application of this Regulation tailored to the needs of the small- Regulation tailored to the needs of
G 545 G
scale providers and users; tailored to the needs of the small- scale providers and usersSMEs, the small-scale providers and
scale providersSMEs, start-ups and including start-ups, and, as usersSMEs including start-ups,
users; appropriate, local public users and, as appropriate, local
authorities; public authorities;
(c) where appropriate, establish a (c) utilise existing dedicated (c) where appropriate, establish a (c) utilise existing dedicated
dedicated channel for channels and where appropriate, dedicated channel for channels and where appropriate,
communication with small-scale establish anew dedicated communication with small-scale establish a dedicated channelnew
providers and user and other channelchannels for communication providers and user and other ones for communication with small-
innovators to provide guidance and with small-scale providers and innovatorsSMEs, including start- scale providers and user and other
respond to queries about the userSMEs, start-ups, users and ups and, as appropriate, local innovatorsSMEs including start-
G 546 implementation of this Regulation. other innovators to provide guidance public authorities to provide ups, users, other innovators and, as G
and respond to queries about the guidanceadvice and respond to appropriate, local public authorities
implementation of this Regulation.; queries about the implementation of to provide guidanceadvice and
this Regulation, including as respond to queries about the
regards participation in AI implementation of this Regulation,
regulatory sandboxes. including as regards participation
in AI regulatory sandboxes.;
(ca) foster the participation of (ca) facilitate the participation of

G 546a G
SMEs and other relevant SMEs and other relevant
stakeholders in the standardisation stakeholders in the standardisation
development process. development process.
Article 55(2)
2. The specific interests and needs 2. The specific interests and needs 2. The specific interests and needs 2. The specific interests and needs
of the small-scale providers shall be of the small-scale providersSMEs, of the small-scaleSME providers, of the small-scaleSME providers,
taken into account when setting the start-ups and users shall be taken including start-ups, shall be taken including start-ups, shall be taken
fees for conformity assessment into account when setting the fees into account when setting the fees into account when setting the fees
under Article 43, reducing those fees for conformity assessment under for conformity assessment under for conformity assessment under
proportionately to their size and Article 43, reducing those fees Article 43, reducing those fees Article 43, reducing those fees
market size. proportionately to development proportionately to their size, market proportionately to their size, market
stage, their size, market size and size and other relevant indicators size and other relevant indicators
market sizedemand. The and market size. and market size.
Commission shall regularly assess
the certification and compliance
G 547 costs for SMEs and start-ups, G
including through transparent

consultations with SMEs, start-ups
and users and shall work with
Member States to lower such costs
where possible. The Commission
shall report on these findings to the
European Parliament and to the
Council as part of the report on the
evaluation and review of this
Regulation provided for in Article
84(2).
Article 55(2a)
2a. The Commission shall 2a. The AI Office shall undertake

G 547a G
undertake the following actions: the following actions:
(a) upon request of the AI Board, (a) upon request of the AI Board,
provide standardised templates for provide standardised templates for
G 547b G
the areas covered by this the areas covered by this
Regulation; Regulation;
(b) develop and maintain a single (b) develop and maintain a single
information platform providing information platform providing
G 547c easy to use information in relation easy to use information in relation G
to this Regulation for all operators to this Regulation for all operators
across the Union; across the Union;
Article 55(2a), point (c)
(c) organise appropriate (c) organise appropriate

communication campaigns to raise communication campaigns to raise
G 547d G
awareness about the obligations awareness about the obligations
arising from this Regulation; arising from this Regulation;
Article 55(2a), point (d)
(d) evaluate and promote the (d) evaluate and promote the
convergence of best practices in convergence of best practices in
G 547e G
public procurement procedures in public procurement procedures in
relation to AI systems. relation to AI systems.
Article 55(2a), point (e)
Article 55a Article 55a Derogations for

G 547f G
Derogations for specific operators specific operators
Article 55(2b)
1. The obligations laid down in 2b. Microenterprises as defined in

Article 17 of this Regulation shall Article 2(3) of the Annex to the
not apply to microenterprises as Commission Recommendation
defined in Article 2(3) of the Annex 2003/361/EC concerning the
to the Commission definition of micro, small and
Recommendation 2003/361/EC medium-sized enterprises, provided
concerning the definition of micro, those enterprises do not have
small and medium-sized partner enterprises or linked
enterprises, provided those enterprises as defined in Article 3 of
enterprises do not have partner the same Annex may fulfil certain
enterprises or linked enterprises as elements of the quality management
defined in Article 3 of the same system required
G 547g Annex. by Article 17 of this Regulation in a G
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.
Article 55(2c)
2. Paragraph 1 shall not be 2c. 2. Paragraph 1 shall not be

G 547h G
interpreted as exempting those interpreted as exempting those
operators from fulfilling any other operators from fulfilling any other
requirements and obligations laid requirements and obligations laid
down in this Regulation, including down in this Regulation, including
those established in Articles 9, 61 those established in Articles 9, 10,
and 62. 11, 12, 13, 14, 15, 61 and 62.
Article 55a(3)
3. Requirements and obligations

for general purpose AI systems laid
down in Article 4b shall not apply
to micro, small and medium-sized
enterprises, provided those
enterprises do not have partner
G 547i enterprises or linked enterprises as G
defined in Article 3 of the the

Annex to the Commission
Recommendation 2003/361/EC
concerning the definition of micro,
small and medium-sized
enterprises.
TITLE VI
TITLE VI TITLE VI TITLE VI TITLE VI

GOVERNANCE GOVERNANCE GOVERNANCE GOVERNANCE
G 548 TO discuss with the governance paper
G

Proposal
Chapter -1
G 548a G
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
[…]”
2. Member States shall
facilitate the tasks entrusted to the
AI Office, as reflected in this
Regulation
Chapter 1
Chapter 1 Chapter 1 Chapter 1

European Artificial Intelligence European Artificial Intelligence European Artificial Intelligence
G 549 Board Board Board G

Proposal
Article -56 - SECTION 1 - title
SECTION 1
General provisions on the
G 549a G
European Artificial Intelligence
Office
Article 56

G 550 G
Establishment of the European Establishment of the European Establishment and structure of the Establishment and structure of the
Artificial Intelligence Board Artificial Intelligence BoardOffice European Artificial Intelligence European Artificial Intelligence
BoardEstablishment of the Board Establishment of the
European Artificial Intelligence European Artificial Intelligence
Board Board
Article 56(1)
1. A ‘European Artificial 1. AThe ‘European Artificial 1. A ‘European Artificial 1. A ‘European Artificial

Intelligence Board’ (the ‘Board’) is Intelligence BoardOffice’ (the Intelligence Board’ (the ‘Board’) is Intelligence Board’ (the ‘Board’) is
established. ‘Board’) is AI Office’) is hereby established. established.
G 551 G
established. The AI Office shall be
an independent body of the Union.
It shall have legal personality.
Article 56(2)
2. The Board shall provide advice 2. The BoardAI Office shall provide
and assistance to the Commission in advice and assistance to the deleted
order to: Commission in order to:have a
G 552 secretariat, and shall be adequately G
funded and staffed for the purpose

of performing its tasks pursuant to
this Regulation.
Article 56(2a)
2a. The seat of the AI Office shall

G 552a G
be in Brussels.
Article 56b new
56 b Article 56 b
G 552b G
Tasks of the AI Office
The AI Office shall carry out the
following tasks:
a) support, advise, and cooperate
with Member States, national
supervisory authorities, the
Commission and other Union
institutions, bodies, offices and
agencies with regard to the
implementation of this Regulation;
b) monitor and ensure the
effective and consistent application
of this Regulation, without
prejudice to the tasks of national
supervisory authorities;
c) contribute to the coordination
among national supervisory
authorities responsible for the
application of this Regulation,
d) serve as a mediator in
discussions about serious
disagreements that may arise
between competent authorities
regarding the application of the
Regulation
e) coordinate joint investigations,
pursuant to Article 66a;
f) contribute to the effective
cooperation with the competent
authorities of third countries and
with international organisations,
g) collect and share Member
States’ expertise and best practices
and to assist Member States
national supervisory authorities
and the Commission in developing
the organizational and technical
expertise required for the
including by means of facilitating
the creation and maintenance of a
Union pool of experts
h) examine, on its own initiative
or upon the request of its
management board or the
Commission, questions relating to
Regulation and to issue opinions,
recommendations or written
contributions including with regard
to:
(i) technical specifications or
existing standards; (ii) the
Commission’s guidelines
(iii) codes of conduct and the
application thereof, in close
cooperation with industry and other
relevant stakeholders;
(iv) the possible revision of the
Regulation, the preparation of the
delegated acts, and possible
alignments of this Regulation with
the legal acts listed in Annex II;
(v) trends, such as European
global competitiveness in artificial
intelligence, the uptake of artificial
intelligence in the Union, the
development of digital skills, and
emerging systemic threats relating
to artificial intelligence
(vi) guidance on how this
Regulation applies to the ever
evolving typology of AI value
chains, in particular on the
resulting implications in terms of
accountability of all the entities
involved
i) issue:
(i) an annual report that includes
an evaluation of the
a review of serious incident reports
as referred to in Article 62 and the
functioning of the database referred
to in Article 60 and
(ii) recommendations to the
Commission on the categorisation
of prohibited practices, high-risk AI
systems referred to in Annex III,
the codes of conduct referred to in
Article 69, and the application of
the general principles outlines in
Article 4a
j) assist authorities in the
establishment and development of
regulatory sandboxes and to
facilitate cooperation among
regulatory sandboxes;
k) organise meetings with Union
agencies and governance bodies
whose tasks are related to artificial
intelligence and the implementation
of this Regulation;
l)organise quarterly consultations
with the advisory forum, and, where
appropriate, public consultations
with other stakeholders, and to
make the results of those
consultations public on its website;
m) promote public awareness and
understanding of the benefits, risks,
safeguards and rights and
obligations in relation to the use of
AI systems;
n) 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;
o) provide monitoring of
foundation models and to organise
a regular dialogue with the
developers of foundation models
with regard to their compliance as
well as AI systems that make use of
such AI models
p) provide interpretive guidance
on how the AI Act applies to the
ever evolving typology of AI value
chains, and what the resulting
implications in terms of
accountability of all the entities
involved will be under the different
scenarios based on the generally
including as reflected in relevant
harmonized standards;
q) provide particular oversight
and monitoring and institutionalize
regular dialogue with the providers
of foundation models about the
compliance of foundation models as
well as AI systems that make use of
such AI models with Article 28b of
this Regulation, and about industry
best practices for self-governance.
Any such meeting shall be open to
national supervisory authorities,
notified bodies and market
surveillance authorities to attend
and contribute
r) issue and periodically update
guidelines on the thresholds that
qualify training a foundation model
as a large training run, record and
monitor known instances of large
training runs, and issue an annual
report on the state of play in the
development, proliferation, and use
of foundation models alongside
policy options to address risks and
opportunities specific to foundation
models.
s) promote AI literacy pursuant to
Article 4b.
Article 56(c) new
56 c Article 56 c
Accountability, independence,
and transparency
1. The AI Office shall:
a. be accountable to the European
Parliament and to the Council in
accordance with this Regulation;
b. act independently when
G 552c G
carrying out its tasks or exercising
its powers; and
c. ensure a high level of
transparency concerning its
activities and develop good
administrative practices in that
regard.
Regulation (EC) No 1049/2001
shall apply to documents held by
the AI Office.
(a) contribute to the effective

cooperation of the national deleted
G 553 supervisory authorities and the G
Commission with regard to matters

covered by this Regulation;
(b) coordinate and contribute to

guidance and analysis by the deleted
Commission and the national
supervisory authorities and other
G 554 G
competent authorities on emerging
issues across the internal market
with regard to matters covered by
this Regulation;
(c) assist the national supervisory

authorities and the Commission in deleted
G 555 G
ensuring the consistent application
of this Regulation.
Article 56(2a)
2a. The Board shall be composed 2. The Board shall be composed of

G 555a G
of one representative per Member one representative per Member
State. The European Data State. The European Data
Protection Supervisor shall Protection Supervisor, shall
participate as an observer. The participate as observer. The AI
Commission shall also attend the Office shall also attend the Board’s
Board’s meetings without taking meetings without taking part in the
part in the votes. 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.
Other national and Union

authorities, bodies or experts may
be invited to the meetings by the
G 555b G
Board on a case by case basis,
where the issues discussed are of
relevance for them.
Article 56a new
56 a Article 56 a
Structure
The administrative and
management structure of the AI
Office shall comprise:
G 555c G
(a) a management board,
including a chair
(b) a secretariat managed by an
executive director;
(c) an advisory forum.
Article 56(2b)
2b. Each representative shall be 2a. Each representative shall be

designated by their Member State designated by their Member State
G 555d G
for a period of 3 years, renewable for a period of 3 years, renewable
once. once.
Article 56(2c), first subparagraph
2c. Member States shall ensure 2b. Member States shall ensure
G 555e that their representatives in the that their representatives in the G
Board: Board:
Article 56(2c), second subparagraph
(i) have the relevant competences (a) have the relevant competences
and powers in their Member State and powers in their Member State
so as to contribute actively to the so as to contribute actively to the
achievement of the board’s tasks achievement of the Board’s tasks
referred to in Article 58; referred to in Article 58;
(ii) are designated as a single (b) are designated as a single
contact point vis-à-vis the Board contact point vis-à-vis the Board
and, where appropriate, taking into and, where appropriate, taking into
account Member States’ needs, as a account Member States’ needs, as a
single contact point for single contact point for
G 555f G
stakeholders; stakeholders;
(iii) are empowered to facilitate (c) are empowered to facilitate
consistency and coordination consistency and coordination
between national competent between national competent
authorities in their Member State as authorities in their Member State as
regards the implementation of this regards the implementation of this
Regulation, including through the Regulation, including through the
collection of relevant data and collection of relevant data and
information for the purpose of information for the purpose of
fulfilling their tasks on the Board. fulfilling their tasks on the Board.
Article 56(2d), first subparagraph
2d. The designated representatives 3. The designated representatives

of the Member States shall adopt of the Member States shall adopt
the Board’s rules of procedure by a the Board’s rules of procedure by a
two-thirds majority. two-thirds majority. The rules of
procedure shall, in particular, lay
G 555g down procedures for the selection G
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.
The rules of procedure shall, in

particular, lay down procedures for
the selection process, duration of
mandate and specifications of the
G 555h G
tasks of the Chair, the voting
modalities, and the organisation of
the Board’s activities and its sub-
groups.
Article 56(2d), third subparagraph
The Board shall establish a 3a. The Board shall establish two
standing subgroup serving as a standing sub-groups to provide a
platform for stakeholders to advise platform for cooperation and
G 555i the Board on all issues related to exchange among market G
the implementation of this surveillance authorities and

Regulation, including on the notifying authorities on issues
preparation of implementing and related to market surveillance and
delegated acts. To this purpose, notified bodies respectively.
organisations representing the
interests of the providers and users The standing sub-group for market
of AI systems, including SMEs and surveillance should act as the
start-ups, as well as civil society Administrative Cooperation Group
organisations, representatives of (ADCO) for this Regulation in the
affected persons, researchers, meaning of Article 30 of Regulation
standardisation organisations, (EU) 2019/1020.
notified bodies, laboratories and
testing and experimentation The Board may establish other
facilities shall be invited to standing or temporary sub-groups
participate to this sub-group. The as appropriate for the purpose of
Board shall establish two standing examining specific issues. Where
sub-groups to provide a platform appropriate, representatives of the
for cooperation and exchange advisory forum as referred to in
among market surveillance Article [XX] may be invited to such
authorities and notifying sub-groups or to specific meetings
authorities on issues related to of those subgroups in the capacity
market surveillance and notified of observers.
bodies respectively.
Article 56(2d), fourth subparagraph
The Board may establish other

standing or temporary sub-groups
as appropriate for the purpose of
examining specific issues. Where
appropriate, stakeholders referred
G 555j G
to in the previous subparagraph
may be invited to such sub-groups
or to specific meetings of those
subgroups in the capacity of
observers.
Article 56(2e)
G 555k G
2e. The Board shall be organised 3b. The Board shall be organised
and operated so as to safeguard the and operated so as to safeguard the
objectivity and impartiality of its objectivity and impartiality of its
activities. activities.
Article 56(2f)
2f. The Board shall be chaired by 4 The Board shall be chaired by

one of the representatives of the one of the representatives of the
Member States. Upon request of the Member States. The European AI
Chair, the Commission shall Office shall provide the Secretariat
convene the meetings and prepare for the Board. convene the meetings
the agenda in accordance with the upon request of the Chair and
G 555l tasks of the Board pursuant to this prepare the agenda in accordance G
Regulation and its rules of with the tasks of the Board

procedure. The Commission shall pursuant to this Regulation and its
provide administrative and rules of procedure.
analytical support for the activities
of the Board pursuant to this
Regulation.
Article 56a
Article 57 Article 5756a

Structure of the Board Structure of the BoardSecretariat
G 555m G
Moved reference text Moved from row 556 [556 - 555m]
Article 57
Article 57
G 556 G
Structure of the Board Moved to row 555m [556 - 555m] deleted
Article 57(1)
1. The Board shall be composed of 1. The Boardactivities of the

the national supervisory authorities, secretariat shall be composed of the deleted
who shall be represented by the head national supervisory authorities,
or equivalent high-level official of whomanaged by an executive
that authority, and the European director. The executive director
Data Protection Supervisor. Other shall be represented by the head or
national authorities may be invited equivalent high-level official of that
to the meetings, where the issues authority, and the European Data
discussed are of relevance for them. Protection Supervisor. Other
national authorities may be invited
G 557 G
to the meetings, where the issues
discussed are of relevance for
them.accountable to the
management board. Without
prejudice to the respective powers
of the management board and the
Union institutions, the executive
director shall neither seek nor take
instructions from any government
or from any other body
Article 57(2)
2. The Board shall adopt its rules of 2. The Board shall adopt its rules of
procedure by a simple majority of its procedure by a simple majority of its deleted
members, following the consent of members, following the consent of
the Commission. The rules of the Commission. The rules of
procedure shall also contain the procedureexecutive director shall
G 558 operational aspects related to the attend hearings on any matter G
execution of the Board’s tasks as linked to the AI Office's activities

listed in Article 58. The Board may and shall also contain the
establish sub-groups as appropriate operational aspects related to the
for the purpose of examining executionreport on the performance
specific questions. of the Board’s tasks as listed in
Article 58. The Board may establish
sub-groups as appropriate for the
purpose of examining specific
questionsexecutive director’s duties
when invited to do so by the
European Parliament or the
Council.
Article 57(3)
3. The Board shall be chaired by the 3. The Board shall be chaired by

Commission. The Commission shall the Commission. The deleted
convene the meetings and prepare Commissionexecutive director shall
the agenda in accordance with the convene the meetings and prepare
tasks of the Board pursuant to this the agenda in accordance with the
Regulation and with its rules of tasks of the Board pursuant to this
procedure. The Commission shall Regulation and with its rules of
G 559 provide administrative and analytical procedure. The Commission shall G
support for the activities of the provide administrative and

Board pursuant to this Regulation. analytical support for the activities
of the Board pursuant to this
Regulation.represent the AI Office,
including in international for a for
cooperation with regard to artificial
intelligence;
Article 57(4)
4. The Board may invite external 4. The secretariat shall provide the
experts and observers to attend its management board may invite deleted
meetings and may hold exchanges external experts and observers to
G 560 with interested third parties to attend its meetings and may hold G
inform its activities to an appropriate exchanges with interested third

extent. To that end the Commission parties to inform itsand the advisory
may facilitate exchanges between forum with the analytical,
the Board and other Union bodies, administrative and logistical
offices, agencies and advisory support necessary to fulfil the tasks
groups. of the AI Office, including by:
(a) Implementing the decisions,
programmes and activities to an
appropriate extent. To that end the
Commission may facilitate
exchanges between the Board and
other Union bodies, offices, agencies
and advisory groups.adopted by the
management board;
(b) preparing each year the draft
single programming document, the
draft budget, the annual activity
report on the AI Office, the draft
opinions and the draft positions of
the AI Office, and submit them to
the management board
(c) Coordinating with
international fora for cooperation
on artificial intelligence;
Article - 57(a) new - SECTION 2 - title
Article - 57a
G 560a Title G
SECTION 2: Management Board
Article - 57a
Article - 57a
Composition of the management
G 560b board G
1. The management board shall

be composed of the following
members:
(a) one representative of each
Member State’s national
supervisory authority;
(b) one representative from the
Commission;
(c) one representative from the
European Data Protection
Supervisor (EDPS);
(d) one representative from the
Cybersecurity (ENISA);
(e) one representative from the
Fundamental Rights Agency (FRA)
Each representative of a national
supervisory authority shall have
one vote. The representatives of the
Commission, the EDPS, the ENISA
and the FRA shall not have voting
rights. Each member shall have a
substitute. The appointment of
members and substitute members of
the management board shall take
into account the need to gender
balance. The members of the
management board and their
substitute members shall be made
public.
2. The members and substitutes
members of the management board
shall not hold conflicting positions
or commercial interests with regard
to any topic related to the
application of this Regulation.
3. The rules for the meetings and
voting of the management board
and the appointment and removal
of the Executive Director shall be
laid down in the rules of procedure
referred to in Article – 57 b, point
(a).
Article - 57b new
Article - 57b
Functions of the management
board
have the following tasks:
(a) to make strategic decisions on
the activities of the AI Office and to
adopt its rules of procedure by a
two-thirds majority of its members;
(b) to implement its rules of
procedure;
(c) to adopt the AI Office’s single
programming document as well as
it annual public report and transmit
G 560c both to the European Parliament, to G
the Council, to the Commission,

and to the Court of Auditors;
(d) to adopt the AI Office’s
budget;
(e) to appoint the executive
director and, where relevant, to
extend or curtail the executive
director’s term of office or remove
him or her from office;
(f) to decide on the establishment
of the AI Office’s internal
structures and, where necessary,
the modification of those internal
structures necessary for the
fulfilment of the AI Office tasks;
Article - 57c - new
Article - 57c
Chair of the management board
elect a Chair and two deputy Chairs
from among its voting members, by
G 560d simple majority. G
2. The term of office of the Chair

and of the deputy Chairs shall be
four years. The terms of the Chair
and of the deputy Chairs renewable
once.
Article 58

Tasks of the Board Tasks of the BoardAdvisory Forum Tasks of the Board Tasks of the Board
G 561 G

Proposal
When providing advice and When providing advice and When providingThe Board shall When providing advice and
assistance to the Commission in the assistance to the Commission in the advice and assistance to the assistance to the Commission in the
context of Article 56(2), the Board context of Article 56(2), the Board Commission in the context of Article context of Article 56(2),The Board
shall in particular: shall in particular:The advisory 56(2),assist the Commission and the shall advise and assist the
G 562 G
forum shall provide the AI Office Member States in order to facilitate Commission and the Member States
with stakeholder input in matters the consistent and effective in order to facilitate the consistent
relating to this Regulation, in application of this Regulation. For and effective application of this
particular with regard to the tasks this purpose the Board shallmay in Regulation. For this purpose the
set out in Article 56b point (l). particular: Board shallmay in particular:
(a) collect and share expertise and (a) collect and share technical and (a) collect and share expertise and
best practices among Member regulatory expertise and best best practices among Member
States; practices among Member States; Statescontribute to the coordination
among national competent
authorities responsible for the
application of this Regulation and,
G 563 G
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) contribute to uniform (b) contribute to uniformthe (b) contribute to uniform

administrative practices in the harmonisation of administrative administrative practices in the
Member States, including for the practices in the Member States, Member States, including for the
functioning of regulatory sandboxes including forin relation to the functioning ofcollect and share
referred to in Article 53; derogation from the conformity technical and regulatory sandboxes
G 564 G
assessment procedures referred to referred to in Article 53expertise
in Article 47, the functioning of and best practices among Member
regulatory sandboxes and testing in States;
real world conditions referred to in
Article 53, 54 and 54a;
Article 58, first paragraph, point (ba)
(c) provide advice in the

G 564a G
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
Article 53, 54 and 54a;
Article 58, first paragraph(e)
(c) issue opinions, (c) issue opinions, upon the request (c)(e) issue opinions, upon the
recommendations or written of the Commission or on its own request of the Commission or on its
contributions on matters related to initiative, issue recommendations own initiative, issue
the implementation of this orand written contributions on recommendations orand written
Regulation, in particular opinions on any relevant matters contributions onopinions on any
G 565 G
related to the implementation of this relevant matters related to the
Regulation, in particular and to its implementation of this Regulation
consistent and effective application, and to its consistent and effective
including: application, including: , in
particular
Article 58, first paragraph(e), point (i)
(i) on technical specifications or (i) on technical specifications or (i) (i) on the development and
existing standards regarding the existing standards regarding the application of codes of conduct and
G 566 requirements set out in Title III, requirements set out in Title III, code of practice pursuant to this G
Chapter 2, Chapter 2, 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
Chapter 2,
Article 58, first paragraph(e), point (ii)
(ii) on the use of harmonised (ii) on the use of harmonised (iiiv) on the use of harmonised
G 567 standards or common specifications standards or common specifications standards or common specifications G
referred to in Articles 40 and 41, referred to in Articles 40 and 41, referred to in Articles 40 and 41,
Article 58, first paragraph(e), point (iii)
(iii) on the preparation of guidance (iii) on the preparation of guidance (iii)(v) trends, such as European
documents, including the guidelines documents, including the guidelines global competitiveness in artificial
concerning the setting of concerning the setting of intelligence, the uptake of artificial
administrative fines referred to in administrative fines referred to in intelligence in the Union and the
Article 71. Article 71.; development of digital skills;
G 568 G
(via) trends on the preparation of
guidance documents, including the
guidelines concerning the setting of
administrative fines referred to in
Article 71.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;
Article 58, second paragraph, (new)
2. The membership of the advisory

forum shall represent a balanced
selection of stakeholders, including
industry, start-ups, SMEs, civil
society, the social partners and
academia. The membership of the
G 568a G
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.
Article 58, third paragraph, (new)

appoint the members of the
G 568b advisory forum in accordance with G
the selection procedure established

in the AI Office’s rules of
procedure and taking into account
the need for transparency and in
accordance with the criteria set out
in paragraph 2;
Article 58, fourth paragraph, (new)
4. The term of office of the

members of the advisory forum
G 568c shall be two years, which may be G
extended by up to no more than

four years.
Article 58, fifth paragraph, (new)
5. The European Committee for

Standardization (CEN), the
European Committee for
Electrotechnical Standardization
(CENELEC), and the European
G 568d Telecommunications Standards G
Institute (ETSI) shall be permanent

members of the Advisory Forum.
The Joint Research Centre shall be
permanent member, without voting
rights.
Article 58, sixth paragraph , (new)
6. The advisory forum shall draw

up its rules of procedure. It shall
G 568e elect two co-Chairs from among its G
members, in accordance with

criteria set out in paragraph 2. The
term of office of the co-Chairs shall
be two years, renewable once.
Article 58, seventh paragraph, (new)
7. The advisory forum shall hold

meetings at least four times a year.
The advisory forum may invite
G 568f experts and other stakeholders to its G
meetings. The executive director

may attend, ex officio, the meetings
of the advisory forum.
Article 58, eigth paragraph, (new)
8. In fulfilling its role as set out in

paragraph 1, the advisory forum
G 568g may prepare opinions, G
recommendations and written

contributions.
Article 58, tenth paragraph, (new)
(10) The advisory forum shall

prepare an annual report of its
G 568h G
activities. That report shall be made
publicly available.
Article 58 a (new)
58 a Article 58 a
G 568i Benchmarking G
The European authorities on

benchmarking referred to in Article
15 (1a) and the AI Office shall, in
close cooperation with international
partners, jointly develop cost-
effective guidance and capabilities
to measure and benchmark aspects
of AI systems and AI components,
and in particular of foundation
models relevant to the compliance
and enforcement of this Regulation
based on the generally
including as reflected in relevant
harmonized standards.
Article 58a, SECTION 5 - title
(title) European Authorities on

G 568j G
benchmarking
Article 58, nineth paragraph, (new)
9. The advisory forum may

establish standing or temporary
subgroups as appropriate for the
G 568k G
questions related to the objectives of
this Regulation.
Article 58, first paragraph(e), point (iiia)
G 568l G

G 568m G
(ca) advise the Commission on the (f) support the Commission in
potential need for amendment of promoting AI literacy, public
Annex III in accordance with awareness and understanding of
Articles 4 and 7, taking into the benefits, risks, safeguards and
account relevant available evidence rights and obligations in relation to
and the latest develoments in the use of AI systems;
technology;
(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
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.
(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 58, first paragraph, point (cb)

(cb) advise the Commission during

the preparation of delegated or
G 568n G
implementing act pursuant to this
Regulation;
Article 58, first paragraph, point (cc)
(cc) cooperate, as appropriate, with

relevant EU bodies, experts groups
and networks in particular in the
fields of product safety,
G 568o cybersecurity, competition, digital G
and media services, financial

services, cryptocurrencies,
consumer protection, data and
fundamental rights protection;
Article 58, first paragraph, point (cd)
(cd) contribute and provide

relevant advice to the Commission
G 568p in the development of the guidance G
referred to in Article 58a or request

the development of such guidance;
Article 58, first paragraph, point (ce)
(ce) assist the work of market

surveillance authorities and, in
G 568q cooperation and subject to G
agreement of the concerned market

surveillance authorities, promote
and support cross-border market
surveillance investigations,
including with respect to the
emergence of risks of systemic
nature that may stem from AI
systems;
Article 58, first paragraph, point (cf)
(cf) contribute to the assessment of

training needs for staff of Member
G 568r G
States involved in implementing this
Regulation;
Article 58, first paragraph, point (cg)
(cg) advise the Commission in

G 568s relation to international matters on G
artificial intelligence.
Chapter 1a
Chapter 1a
G 568t GUIDELINES FROM THE G
COMMISSION
Article 58a
Article 58a
Guidelines from the Commission on Text Origin: Council Mandate
G 568u G
Regulation
Article 58a, first paragraph

Upon the request of the Member

States or the Board, or on its own
initiative, the Commission shall
G 568v G
issue guidelines on the practical
and in particular on:
Article 58a, second paragraph
(i) the application of the

requirements referred to in Articles
8 - 15;
(ii) the prohibited practices
referred to in Article 5;
(iii) the practical implementation
of the provisions related to
substantial modification;
(iv) the practical implementation
of uniform conditions referred to in
G 568w Article 6, paragraph 3, including G
examples in relation to high risk AI

systems referred to in Annex III;
(v) the practical implementation
of transparency obligations laid
down in Article 52;
(vi) the relationship of this
Regulation with other relevant
Union legislation, including as
regards consistency in their
enforcement.
Article 58a, third paragraph
G 568x G
When issuing such guidelines, the
Commission shall pay particular Text Origin: Council Mandate
attention to the needs of SMEs
including start-ups, local public
authorities and sectors most likely
to be affected by this Regulation.
Article 58b
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.
G 568y The membership of the advisory G
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.
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.
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
questions related to the objectives of
this Regulation.
prepare an annual report of its
activities. That report shall be made
publicly available.
Chapter 1a
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
G 568z G
panel of independent experts (the
‘scientific panel’) intended to
support the enforcement activities
under this Regulation. Those
implementing acts shall be adopted
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;
(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 [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 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
cost-effectiveness and the necessity
to ensure an effective access to
experts by all Member States.
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.
CHAPTER 2
CHAPTER 2 CHAPTER 2 CHAPTER 2 CHAPTER 2

national competent authorities national competentsupervisory National competent authorities national competent authorities
G 569 authorities
G

Proposal
Article 59

Designation of national competent Designation of national Designation of national competent Designation of national competent
authorities competentsupervisory authorities authorities authorities and single point of
G 570 contact
G

Proposal
Article 59(1)
1. National competent authorities 1. National competent 1. National competent authorities

shall be established or designated by authoritiesEach Member State shall deleted shall be established or designated by
each Member State for the purpose be established or designated by each each Member State for the purpose
G 571 of ensuring the application and Member State for the purpose of of ensuring the application and G
implementation of this Regulation. ensuring the application and implementation of this Regulation.
National competent authorities shall implementation of this Regulation. National competent authorities shall
be organised so as to safeguard the National competent authorities shall be organised so as to safeguard the
objectivity and impartiality of their be organised so as to safeguard the objectivity and impartiality of their
activities and tasks. objectivity and impartiality of their activities and tasks.deleted
activities and tasksdesignate one
national supervisory authority,
which shall be organised so as to
safeguard the objectivity and
impartiality of its activities and
tasks by ...[three months after the
date of entry into force of this
Regulation].
Article 59(2)
2. Each Member State shall 2. Each Member StateThe national 2. Each Member State shall 2. 2. Each Member State shall
designate a national supervisory supervisory authority shall establish or designate a national establish or designate a national
authority among the national designate a national supervisory supervisoryat least one notifying supervisoryat least one notifying
competent authorities. The national authority among the nationalensure authority among the and at least one authority and at least one market
supervisory authority shall act as the application and implementation market surveillance authority for surveillance authority among the for
notifying authority and market of this Regulation. With regard to the purpose of this Regulation as the purpose of this Regulation as
surveillance authority unless a high-risk AI systems, related to national competent authorities. national competent authorities.
Member State has organisational and products to which legal acts listed TheThese national supervisory TheThese national supervisory
administrative reasons to designate in Annex II apply, the competent authoritycompetent authorities shall authoritycompetent authorities shall
more than one authority. authorities. The national supervisory act as notifying authority and market act as notifying authority and market
authority designated under those surveillance authority unless a surveillance authority unless a
G 572 legal acts shall act as notifying Member State has organisational Member State has organisational G
authority and market surveillance and administrative reasons to and administrative reasons to
authority unless a Member State has designate more than one authoritybe designate more than one
organisational and administrative organised so as to safeguard the authorityexercise their powers
reasons to designate more than priniciples of objectivity and independently, impartially and
onecontinue to lead the impartiality of their activities and without bias so as to safeguard the
administrative procedures. tasks. Provided that those prinicples principles of objectivity of their
However, to the extent a case are respected, such activities and activities and tasks and to ensure
involves aspects exclusively covered tasks may be performed by one or the application and implementation
by this Regulation, those competent several designated authorities, in of this Regulation. The members of
authorities shall be bound by the accordance with the organisational these authorities shall refrain from
measures related to those aspects needs of the Member State. any action incompatible with their
issued by the national supervisory duties. Provided that those
authority designated under this prinicples are respected, such
Regulation. The national activities and tasks may be
supervisory authority shall act as performed by one or several
market surveillance authority. designated authorities, in
accordance with the organisational
needs of the Member State.
Article 59(3)
3. Member States shall inform the 3. Member States shall inform the 3. Member States shall inform the 3. Member States shall
Commission of their designation or Commission of their designation or Commission of their designation or informcommunicate to the
designations and, where applicable, designations and, where applicable, designations and, where applicable, Commission the identity of the
the reasons for designating more the reasons for designating more the reasons for designating more notifying authorities and the market
than one authority. than one authoritymake publicly than one authority. surveillance authorities and the
available and communicate to the tasks of those authorities and as
AI Office and the Commission the well as any subsequent changes
national supervisory authority and thereto. Member States shall make
information on how it can be publicly available information on
contacted, by… [three months after how competent authorities and
the date of entry into force of this single point of contact can be
Regulation]. The national contactedof their designation or
supervisory authority shall act as designations and, where applicable,
G 573 G
single point of contact for this through electronic communication
Regulation and should be means by… [12 months after the
contactable though electronic date of entry into force of this
communications means. 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 the
reasons for designating more than
one authority.
Article 59(4)
4. Member States shall ensure that 4. Member States shall ensure that 4. Member States shall ensure that 4. Member States shall ensure that
national competent authorities are the national competent authorities national competent authorities are the national competent authorities
provided with adequate financial and aresupervisory authority is provided provided with adequate financial areauthority is provided with
human resources to fulfil their tasks with adequate technical, financial resources, technical equipment and adequate technical, financial and
under this Regulation. In particular, and human resources, and well qualified and human resources human resources, and infrastructure
national competent authorities shall infrastructure to fulfil their tasks to effectively fulfil their tasks under to fulfil their tasks effectively under
have a sufficient number of effectively under this Regulation. In this Regulation. In particular, this Regulation. In particular, the
personnel permanently available particular, the national competent national competent authorities shall national competent
whose competences and expertise authoritiessupervisory authority have a sufficient number of authoritiesauthority shall have a
shall include an in-depth shall have a sufficient number of personnel permanently available sufficient number of personnel
understanding of artificial personnel permanently available whose competences and expertise permanently available whose
intelligence technologies, data and whose competences and expertise shall include an in-depth competences and expertise shall
data computing, fundamental rights, shall include an in-depth understanding of artificial include an in-depth understanding of
G 574 G
health and safety risks and understanding of artificial intelligence technologies, data and artificial intelligence technologies,
knowledge of existing standards and intelligence technologies, data and data computing, fundamental rights, data and data computing, personal
legal requirements. data computing, personal data health and safety risks and data protection, cybersecurity,
protection, cybersecurity, knowledge of existing standards and fundamental rights, health and safety
competition law, fundamental rights, legal requirements. risks and knowledge of existing
health and safety risks and standards and legal requirements.
knowledge of existing standards and Member States shall assess and, if
legal requirements. Member States deemed necessary, update
shall assess and, if deemed competence and resource
necessary, update competence and requirements referred to in this
resource requirements referred to paragraph on an annual basis.
in this paragraph on an annual
basis.
Article 59(4a)
4a. Each national supervisory

G 574a G
authority shall exercise their
powers and carry out their duties
independently, impartially and
without bias. The members of each
national supervisory authority, in
the performance of their tasks and
exercise of their powers under this
Regulation, shall neither seek nor
take instructions from any body and
shall refrain from any action
incompatible with their duties.
Article 59(4a)
4b. National supervisory 4a. National competent authorities

authorities shall satisfy the shall satisfy an adequate level of
minimum cybersecurity cybersecurity measures.
requirements set out for public
G 574b G
administration entities identified as
operators of essential services
pursuant to Directive (EU)
2022/2555.
Article 59(4b)
4c. When performing their tasks, 4c. When performing their tasks,
the national supervisory authority the national competent authorities
shall act in compliance with the shall act in compliance with the
G 574c confidentiality obligations set out in confidentiality obligations set out in G
Article 70. Article 70.

Article 59(5)
G 575 G
5. Member States shall report to the 5. Member States shall report to the 5. Member States shall report to the 5. By one year after entry into
Commission on an annual basis on Commission on an annual basis on Commission on an annual basisBy force of this Regulation and once
the status of the financial and human the status of the financial and human [one year after entry into force of every two years thereafter Member
resources of the national competent resources of the national competent this Regulation] and afterwards six States shall report to the
authorities with an assessment of authoritiessupervisory authority months before the deadline referred Commission on an annual basis on
their adequacy. The Commission with an assessment of their to in Article 84(2) Member States the status of the financial and human
shall transmit that information to the adequacy. The Commission shall shall inform the Commission on the resources of the national competent
Board for discussion and possible transmit that information to the status of the financial resources, authorities with an assessment of
recommendations. BoardAI Office for discussion and technical equipment and human their adequacy. The Commission
possible recommendations. resources of the national competent shall transmit that information to the
authorities with an assessment of Board for discussion and possible
their adequacy. The Commission recommendations.
shall transmit that information to the
Board for discussion and possible
recommendations.
Article 59(6)
6. The Commission shall facilitate 6. The Commission shall facilitate 6. The Commission shall facilitate
the exchange of experience between deleted the exchange of experience between the exchange of experience between
G 576 national competent authorities. national competent authorities. national competent authorities. G
Article 59(7)
7. National competent authorities 7. National competentsupervisory 7. National competent authorities 7. 7. National competent authorities
may provide guidance and advice on authorities may provide guidance may provide guidance and advice on may provide guidance and advice on
the implementation of this and advice on the implementation of the implementation of this the implementation of this
Regulation, including to small-scale this Regulation, including to small- Regulation, including tailored to Regulation, including to small-scale
G 577 providers. Whenever national scale providersSMEs and start-ups, SMEto small-scale providers, providersin particular to SMEs G
competent authorities intend to taking into account the AI Office or including start-ups. Whenever including start-ups, taking into
provide guidance and advice with the Commission’s guidance and national competent authorities intend account the Board's and the
regard to an AI system in areas advice. Whenever the national to provide guidance and advice with Commission’s guidance and advice,
covered by other Union legislation, competent authoritiessupervisory regard to an AI system in areas as appropriate. Whenever national
the competent national authorities authority intend to provide guidance covered by other Union legislation, competent authorities intend to
under that Union legislation shall be and advice with regard to an AI the competent national authorities provide guidance and advice with
consulted, as appropriate. Member system in areas covered by other under that Union legislation shall be regard to an AI system in areas
States may also establish one central Union legislation, the competent consulted, as appropriate. Member covered by other Union legislation,
contact point for communication national authorities under that States may also establish one central the competent national authorities
with operators. Union legislationlaw, the guidance contact point for communication under that Union legislation shall be
shall be consulted, as appropriate. with operators. consulted, as appropriate. Member
Member States may also establish States may also establish one central
one central contact point for contact point for communication
communication with with operators.
operatorsdrafted in consultation
with the competent national
authorities under that Union law,
as appropriate.
Article 59(8)
8. When Union institutions, 8. When Union institutions, 8. When Union institutions, 8. When Union institutions,
agencies and bodies fall within the agencies and bodies fall within the agencies and bodies fall within the agencies and bodies fall within the
scope of this Regulation, the scope of this Regulation, the scope of this Regulation, the scope of this Regulation, the
G 578 European Data Protection European Data Protection European Data Protection European Data Protection G
Supervisor shall act as the competent Supervisor shall act as the competent Supervisor shall act as the competent Supervisor shall act as the competent
authority for their supervision. authority for their supervision and authority for their supervision. authority for their supervision.
coordination.
Article 59a
59 a. Cooperation mechanism
between national supervisory
authorities in cases involving two or
G 578a more Member States G
1. Each national supervisory

authority shall perform its tasks
and powers conferred on in
accordance with this Regulation on
the territory of its own Member
State.
2. In the event of a case involving
two or more national supervisory
authorities, the national supervisory
authority of the Member State
where the infringement took place
shall be considered the lead
supervisory authority.
3. In the cases referred to in
paragraph 2, the relevant
supervisory authorities shall
cooperate and exchange all relevant
information in due time. National
supervisory authorities shall
cooperate in order to reach a
consensus.
TITLE VII
TITLE VII TITLE VII TITLE VII TITLE VII

EU DATABASE FOR STAND- EU DATABASE FOR STAND- EU DATABASE FOR STAND- EU DATABASE FOR STAND-
G 579 ALONE HIGH-RISK AI SYSTEMS ALONE HIGH-RISK AI SYSTEMS ALONE HIGH-RISK AI SYSTEMS ALONE HIGH-RISK AI SYSTEMS G
LISTED IN ANNEX III LISTED IN ANNEX III

Article 60

EU database for stand-alone high- EU database for stand-alone high- EU database for high-risk AI EU database for high-risk AI
G 580 risk AI systems risk AI systems systems listed in Annex IIIEU systems listed in Annex IIIEU G
database for stand-alone high-risk database for stand-alone high-risk

AI systems AI systems
Article 60(1)
1. The Commission shall, in 1. The Commission shall, in 1. The Commission shall, in 1. The Commission shall, in
collaboration with the Member collaboration with the Member collaboration with the Member collaboration with the Member
States, set up and maintain a EU States, set up and maintain a public States, set up and maintain a EU States, set up and maintain a EU
database containing information EU database containing information database containing information database containing information
referred to in paragraph 2 referred to in paragraph 2 referred to in paragraph 2 referred to in paragraph 2
concerning high-risk AI systems paragraphs 2 and 2a concerning concerning relevant operators and paragraphs 2 and 2a concerning
referred to in Article 6(2) which are high-risk AI systems referred to in high-risk AI systems referred to in high-risk AI systems referred to in
registered in accordance with Article Article 6(2)6 (2) which are Article 6(2)listed in Annex III Article 6(2) which are registered in
G 581 51. registered in accordance with Article which are registered in accordance accordance with Article 51Articles G
51. with Article 51Articles 51 and 54a. 51 and 54a. When setting the
When setting the fuctional functional specifications of such
specifications of such database, the database, the Commission shall
Commission shall consult the AI consult the relevant experts, and
Board. when updating the functional
specifications of such database, the
Commission shall consult the AI
Board.
Article 60(2)
2. The data listed in Annex VIII 2. The data listed in Annex VIII, 2. The data listed in Annex VIII, 2. The data listed in Annex VIII,
shall be entered into the EU database Section A, shall be entered into the Part I, shall be entered into the EU Section A, shall be entered into the
by the providers. The Commission EU database by the providers. The database by the providers, EU database by the providers. The
shall provide them with technical Commission shall provide them with authorised representatives and Commission shall provide them with
and administrative support. technical and administrative relevant users, as applicable, upon technical and administrative
G 582 support. their registration. The Commission supportprovider or where applicable G
The data listed in Annex VIII, Part the authorised representative.

II, 1 to 11, shall provide them with
technical and administrative
supportbe entered into the EU
database by the providers, or where
applicable by the authorised
representative, in accordance with
Article 51. The data referred in
Annex VIII, Part II, 12 shall be
automatically generated by the
database based on the information
provided by relevant users pursuant
to Article 51(2). The data listed in
Annex VIIIa shall be entered into
the database by the prospective
providers or providers in
accordance with Article 54a.
Article 60(2a)
2a. The data listed in Annex VIII, 2a. The data listed in Annex VIII,
Section B, shall be entered into the Section B, shall be entered into the
EU database by the deployers who EU database by the deployer who is
are or who act on behalf of public or who acts on behalf of public
G 582a authorities or Union institutions, authorities, agencies or bodies, G
bodies, offices or agencies and by according to articles 51(1a) and

deployers who are undertakings (1b).
referred to in Article 51(1a) and
(1b).
Article 60(3)
3. Information contained in the EU 3. Information contained in the EU 3. With the exception of the section
database shall be accessible to the database shall be accessiblefreely deleted referred to in Article 51(1c) and
public. available to the public, user-friendly Article 54a(5), the information
and accessible, easily navigable and contained in the EU database
G 583 G
machine-readable containing registered in accordance with
structured digital data based on a Article 51 shall be accessible and
standardised protocol. 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 to the
public.
Article 60(4)
4. The EU database shall contain 4. The EU database shall contain 4. The EU database shall contain no 4. The EU database shall contain
personal data only insofar as personal data only insofar as personal data only insofar as personal data only insofar as
necessary for collecting and necessary for collecting and necessary for collecting and necessary for collecting and
processing information in processing information in processing, except for the processing information in
accordance with this Regulation. accordance with this Regulation. information listed in Annex VIII, accordance with this Regulation.
That information shall include the That information shall include the and in accordance with this That information shall include the
names and contact details of natural names and contact details of natural Regulation. That information shall names and contact details of natural
persons who are responsible for persons who are responsible for include the names and contact persons who are responsible for
G 584 registering the system and have the registering the system and have the details of natural persons who are registering the system and have the G
legal authority to represent the legal authority to represent the responsible for registering the legal authority to represent the
provider. provider or the deployer which is a system and have the legal authority provider or the deployer, as
public authority or Union to represent the providerbe without applicable.
institution, body, office or agency prejudice to Article 70.
or a deployer acting on their behalf
or a deployer which is an
undertaking referred to in Article
51(1a)(b) and (1b).
Article 60(5)
G 585 5. The Commission shall be the 5. The Commission shall be the 5. The Commission shall be the 5. The Commission shall be the G
controller of the EU database. It controller of the EU database. It controller of the EU database. It controller of the EU database. It
shall also ensure to providers shall also ensure to providers and shall also ensuremake available to shall also ensure tomake available
adequate technical and deployers adequate technical and providers, prospective providers and to providers, prospective providers
administrative support. administrative support. users adequate technical and and deployers adequate technical
The database shall comply with administrative support. and administrative support. The
the accessibility requirements of database shall comply with the
Annex I to Directive (EU) applicable accessibility
2019/882. requirements.
Article 60(5a)
5a. Information contained in the

EU database registered in
accordance with Article 51 shall be
accessible to the public. The
information registered in
accordance with Article 54a shall
G 585a be accessible only to market G
surveillance authorities and the

Commission, unless the prospective
provider or provider has given
consent for making this
information also accessible the
public.
TITLE VIII
TITLE VIII TITLE VIII TITLE VIII TITLE VIII

POST-MARKET MONITORING, POST-MARKET MONITORING, POST-MARKET MONITORING, POST-MARKET MONITORING,
INFORMATION SHARING, INFORMATION SHARING, INFORMATION SHARING, INFORMATION SHARING,
G 586 MARKET SURVEILLANCE MARKET SURVEILLANCE MARKET SURVEILLANCE MARKET SURVEILLANCE
G

Proposal
Chapter 1

Post-market monitoring Post-market monitoring Post-market monitoring Post-market monitoring
G 587 G

Proposal
Article 61

Post-market monitoring by providers Post-market monitoring by providers Post-market monitoring by providers Post-market monitoring by providers
and post-market monitoring plan for and post-market monitoring plan for and post-market monitoring plan for and post-market monitoring plan for
G 588 high-risk AI systems high-risk AI systems high-risk AI systems high-risk AI systems
G

Proposal
Article 61(1)
1. Providers shall establish and 1. Providers shall establish and 1. Providers shall establish and 1. Providers shall establish and
document a post-market monitoring document a post-market monitoring document a post-market monitoring document a post-market monitoring
system in a manner that is system in a manner that is system in a manner that is system in a manner that is
proportionate to the nature of the proportionate to the nature of the proportionate to the nature of the proportionate to the nature of the
G 589 artificial intelligence technologies artificial intelligence technologies artificial intelligence technologies artificial intelligence technologies G
and the risks of the high-risk AI and the risks of the high-risk AI and the risks of the high-risk AI and the risks of the high-risk AI
Proposal
Article 61(2)
2. The post-market monitoring 2. The post-market monitoring 2. In order to allow the provider to 2. The post-market monitoring
G 590 system shall actively and system shall actively and evaluate the compliance of AI system shall actively and G
systematically collect, document and systematically collect, document and systems with the requirements set systematically collect, document and
analyse relevant data provided by analyse relevant data provided by out in Title III, Chapter 2 analyse relevant data which may be
users or collected through other usersdeployers or collected through throughout their life cycle, the post- provided by users or deployers or
sources on the performance of high- other sources on the performance of market monitoring system shall which may be collected through
risk AI systems throughout their high-risk AI systems throughout actively and systematically collect, other sources on the performance of
lifetime, and allow the provider to their lifetime, and allow the provider document and analyse relevant data, high-risk AI systems throughout
evaluate the continuous compliance to evaluate the continuous which may be provided by users or their lifetime, and allow the provider
of AI systems with the requirements compliance of AI systems with the which may be collected through to evaluate the continuous
set out in Title III, Chapter 2. requirements set out in Title III, other sources on the performance of compliance of AI systems with the
Chapter 2. Where relevant, post- high-risk AI systems. This requirements set out in Title III,
market monitoring shall include an obligation shall not cover sensitive Chapter 2. Where relevant, post-
analysis of the interaction with operational data of users market monitoring shall include an
other AI systems environment, throughout their lifetime, and allow analysis of the interaction with
including other devices and the provider to evaluate the other AI systems.
software taking into account the continuous compliance of AI This obligation shall not cover
rules applicable from areas such as systems with the requirements set sensitive operational data of
data protection, intellectual out in Title III, Chapter 2which are deployers which are law
property rights and competition law enforcement authorities. enforcement authorities.
law.
Article 61(3)
3. The post-market monitoring 3. The post-market monitoring 3. The post-market monitoring 3. The post-market monitoring
system shall be based on a post- system shall be based on a post- system shall be based on a post- system shall be based on a post-
market monitoring plan. The post- market monitoring plan. The post- market monitoring plan. The post- market monitoring plan. The post-
market monitoring plan shall be part market monitoring plan shall be part market monitoring plan shall be part market monitoring plan shall be part
of the technical documentation of the technical documentation of the technical documentation of the technical documentation
referred to in Annex IV. The referred to in Annex IV. The referred to in Annex IV. The referred to in Annex IV. The
Commission shall adopt an Commission shall adopt an Commission shall adopt an Commission shall adopt an
G 591 G
implementing act laying down implementing act laying down implementing act laying down implementing act laying down
detailed provisions establishing a detailed provisions establishing a detailed provisions establishing a detailed provisions establishing a
template for the post-market template for the post-market template for the post-market template for the post-market
monitoring plan and the list of monitoring plan and the list of monitoring plan and the list of monitoring plan and the list of
elements to be included in the plan. elements to be included in the plan elements to be included in the plan. elements to be included in the plan
by [twelve months after the date of by six months before the entry into
entry into force of this Regulation]. application of this Regulation.

4. For high-risk AI systems covered 4. For high-risk AI systems covered 4. For high-risk AI systems covered 4. 4. For high-risk AI systems
by the legal acts referred to in Annex by the legal acts referred to in Annex by the legal acts referred to in Annex covered by the legal acts referred to
II, where a post-market monitoring II, where a post-market monitoring II, Section A, where a post-market in Annex II, Section A, where a
system and plan is already system and plan is already monitoring system and plan is post-market monitoring system and
established under that legislation, the established under that legislation, the already established under that plan is already established under that
elements described in paragraphs 1, elements described in paragraphs 1, legislation, the elements described in legislation, in order to ensure
2 and 3 shall be integrated into that 2 and 3 shall be integrated into that paragraphs 1, 2 and 3post-market consistency, avoid duplications and
system and plan as appropriate. system and plan as appropriate. monitoring documentation as minimise additional burdens,
prepared under that legislation shall providers shall have a choice to
be integrated into that system and integrate, as appropriate, the
G 592 G
plan as appropriatedeemed necessary the elements described in
sufficient, provided that the paragraphs 1, 2 and 3 shall be
template referred to paragraph 3 is integrated into thatusing the
used. template referred in paragraph 3
into already existing system and
plan as appropriateunder the Union
Annex II, Section A, provided it
achieves an equivalent level of
protection.
The first subparagraph shall also The first subparagraph shall also The first subparagraph shall also The first subparagraph shall also
apply to high-risk AI systems apply to high-risk AI systems apply to high-risk AI systems apply to high-risk AI systems
referred to in point 5(b) of Annex III referred to in point 5(b) of Annex III referred to in point 5(b)5 of Annex referred to in point 5(b)5 of Annex
placed on the market or put into placed on the market or put into III placed on the market or put into III placed on the market or put into
service by credit institutions service by credit institutions service by creditfinancial service by creditfinancial
G 593 regulated by Directive 2013/36/EU. regulated by Directive 2013/36/EU. institutions regulated by Directive institutions regulated by Directive G
2013/36/EUthat are subject to 2013/36/EUthat are subject to

requirements regarding their requirements regarding their
internal governance, arrangements internal governance, arrangements
or processes under Union financial or processes under Union financial
services legislation. services legislation.
Chapter 2

Sharing of information on incidents Sharing of information on incidents Sharing of information on incidents Sharing of information on incidents
and malfunctioning and malfunctioning and malfunctioningSHARING OF and malfunctioningSHARING OF
G 594 INFORMATION ON SERIOUS INFORMATION ON SERIOUS G
INCIDENTS INCIDENTS
Article 62

Reporting of serious incidents and of Reporting of serious incidents and Reporting of serious incidents Reporting of serious incidents
G 595 malfunctioning of malfunctioning Reporting of serious incidents and of Reporting of serious incidents and of G
malfunctioning malfunctioning
1. Providers of high-risk AI systems 1. Providers and, where deployers 1. Providers of high-risk AI systems 1. Providers of high-risk AI systems
placed on the Union market shall have identified a serious incident, placed on the Union market shall placed on the Union market shall
report any serious incident or any deployers of high-risk AI systems report any serious incident or any report any serious incident or any
malfunctioning of those systems placed on the Union market shall malfunctioning of those systems malfunctioning of those systems
which constitutes a breach of report any serious incident or any which constitutes a breach of which constitutes a breach of
obligations under Union law malfunctioning of those systems obligations under Union law obligations under Union law
G 596 intended to protect fundamental which constitutes a breach of intended to protect fundamental intended to protect fundamental G
rights to the market surveillance obligations under Union law rights to the market surveillance rights to the market surveillance
authorities of the Member States intended to protect fundamental authorities of the Member States authoritiesto the market
where that incident or breach rights to the market surveillance where that incident or breach surveillance authorities of the
occurred. authoritiesnational supervisory occurred. Member States where that incident
authority of the Member States occurred.
where that incident or breach
occurred. 1a. As a general rule, the period for
the reporting referred to in
paragraph 1 shall take account of
the Member States where
thatseverity of the serious incident
or breach occurred.
Such notification shall be made Such notification shall be made Such notification shall be made Such1b. The notification referred to
immediately after the provider has immediatelywithout undue delay immediately after the provider has in paragraph 1 shall be made
established a causal link between the after the provider, or, where established a causal link between the immediately after the provider has
AI system and the incident or applicable the deployer, has AI system and the serious incident established a causal link between the
malfunctioning or the reasonable established a causal link between the or malfunctioning or the reasonable AI system and the serious incident
likelihood of such a link, and, in any AI system and the incident or likelihood of such a link, and, in any or malfunctioning or the reasonable
event, not later than 15 days after the malfunctioning or the reasonable event, not later than 15 days after the likelihood of such a link, and, in any
providers becomes aware of the likelihood of such a link, and, in any providers becomes aware of the event, not later than 15 days after the
serious incident or of the event, not later than 15 days72 serious incident or of the providersprovider or, where
malfunctioning. hours after the providers becomes malfunctioning. applicable, the deployer, becomes
aware of the serious incident aware of the serious incident.
orprovider or, where applicable, the
deployer becomes aware of the 1c. Notwithstanding paragraph 1b,
G 597 malfunctioningserious incident. in the event of a widespread G
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 or of the
malfunctioning.
Article 62(1a)
Upon establishing a causal link 1a. Following the reporting of a

between the AI system and the serious incident pursuant to the
serious incident or the reasonable first subparagraph, the provider
likelihood of such a link, providers shall, without delay, perform the
shall take appropriate corrective necessary investigations in relation
actions pursuant to Article 21. to the serious incident and the AI
system concerned. This shall
include a risk assessment of the
G 597a G
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.
Article 62(2)
2. Upon receiving a notification 2. Upon receiving a notification 2. Upon receiving a notification 2. Upon receiving a notification
related to a breach of obligations related to a breach of obligations related to a breach of obligations related to a breach of obligations
under Union law intended to protect under Union law intended to protect under Union law intended to protect under Union law intended to protect
fundamental rights, the market fundamental rights, the market fundamental rights, theserious fundamental rights, the serious
surveillance authority shall inform surveillancenational supervisory incident referred to in Article incident referred to in Article
the national public authorities or authority shall inform the national 3(44)(c), the relevant market 3(44)(c), the relevant market
bodies referred to in Article 64(3). public authorities or bodies referred surveillance authority shall inform surveillance authority shall inform
The Commission shall develop to in Article 64(3). The Commission the national public authorities or the national public authorities or
G 598 dedicated guidance to facilitate shall develop dedicated guidance to bodies referred to in Article 64(3). bodies referred to in Article 64(3). G
compliance with the obligations set facilitate compliance with the The Commission shall develop The Commission shall develop
out in paragraph 1. That guidance obligations set out in paragraph 1. dedicated guidance to facilitate dedicated guidance to facilitate
shall be issued 12 months after the That guidance shall be issued 12 compliance with the obligations set compliance with the obligations set
entry into force of this Regulation, at months after by [the entry into force out in paragraph 1. That guidance out in paragraph 1. That guidance
the latest. of this Regulation, at the latest] and shall be issued 12 months after the shall be issued 12 months after the
shall be assessed regularly. entry into force of this Regulation, at entry into force of this Regulation, at
the latest. the latest, and shall be assessed
regularly.
Article 62(2a)
2a. The national supervisory 2a. “2a. The market surveillance

authority shall take appropriate authority shall take appropriate
G 598a G
measures within 7 days from the measures, as provided in Article 19
date it received the notification of the Regulation 2019/1020, within
referred to in paragraph 1. Where 7 days from the date it received the
the infringement takes place or is notification referred to in
likely to take place in other Member paragraph 1 and follow the
States, the national supervisory notification procedures as provided
authority shall notify the AI Office in the Regulation 2019/1020.
and the relevant national
supervisory authorities of these
Member States.
Article 62(3)
to in point 5(b) of Annex III which to in point 5(b) of Annex III to in point 5(b)5 of Annex III which to in point 5(b) of Annex III
are placed on the market or put into whichthat are placed on the market are placed on the market or put into whichthat are placed on the market
service by providers that are credit or put into service by providers that service by providers that are or put into service by providers that
institutions regulated by Directive are credit institutions regulated by creditfinancial institutions regulated are credit institutions regulated by
2013/36/EU and for high-risk AI Directive 2013/36/EU and for high- by Directive 2013/36/EU and for Directive 2013/36/EU and for high-
systems which are safety risk AI systems which are safety high-risk AI systems which are risk AI systems which are safety
components of devices, or are components of devices, or are safety components of devices, or are components of devices, or are
themselves devices, covered by themselves devices, covered themselves devices, covered by themselves devices, covered
Regulation (EU) 2017/745 and bysubject to Union legislative Regulation (EU) 2017/745 and bysubject to Union legislative
Regulation (EU) 2017/746, the instruments laying down reporting Regulation (EU) 2017/746that are instruments laying down reporting
G 599 notification of serious incidents or obligations equivalent to those set subject to requirements regarding obligations equivalent to those set G
malfunctioning shall be limited to out in this Regulation (EU) their internal governance, out in this Regulation (EU)
those that that constitute a breach of 2017/745 and Regulation (EU) arrangements or processes under 2017/745 and Regulation (EU)
obligations under Union law 2017/746, the notification of serious Union financial services legislation, 2017/746, the notification of serious
intended to protect fundamental incidents or malfunctioning shall be the notification of serious incidents incidents or malfunctioning shall be
rights. limited to those that that or malfunctioning shall be limited to limited to those that that constitute a
constituteconstituting a breach of those that that constitute a breach of breach of obligations under Union
obligationsfundamental rights obligations under Union law law intended to protect fundamental
under Union law intended to protect intended to protect fundamental rightsreferred to in Article 3(44) (c
fundamental rightsshall be rightsreferred to in Article 3(44)(c). ).
transferred to the national
supervisory authority.
Article 62(3a)
3a. For high-risk AI systems which 3a. For high-risk AI systems which
are safety components of devices, or are safety components of devices, or
are themselves devices, covered by are themselves devices, covered by
Regulation (EU) 2017/745 and Regulation (EU) 2017/745 and
Regulation (EU) 2017/746 the Regulation (EU) 2017/746 the
notification of serious incidents notification of serious incidents
G 599a shall be limited to those referred to shall be limited to those referred to G
in Article 3(44)(c) and be made to in Article 3(44)(c) and be made to

the national competent authority the national competent authority
chosen for this purpose by the chosen for this purpose by the
Member States where that incident Member States where that incident
occurred. occurred.
Article 62(3b)
3a. National supervisory 3a. National competent authorities

authorities shall on an annual basis shall immediately notify the
notify the AI Office of the serious Commission of any serious
incidents reported to them in incident, whether or not it has
G 599b accordance with this Article. taken action on it, in accordance G
with Article 20 of Regulation

2019/1020.
Chapter 3

Enforcement Enforcement Enforcement Enforcement
G 600 G

Proposal
Article 63

Market surveillance and control of Market surveillance and control of Market surveillance and control of Market surveillance and control of
G 601 AI systems in the Union market AI systems in the Union market AI systems in the Union market AI systems in the Union market G

Proposal
Article 63(1)
1. Regulation (EU) 2019/1020 shall 1. Regulation (EU) 2019/1020 shall 1. Regulation (EU) 2019/1020 shall 1. Regulation (EU) 2019/1020 shall
apply to AI systems covered by this apply to AI systems and foundation apply to AI systems covered by this apply to AI systems covered by this
Regulation. However, for the models covered by this Regulation. Regulation. However, for the Regulation. However, for the
G 602 purpose of the effective enforcement However, for the purpose of the purpose of the effective enforcement purpose of the effective enforcement G
of this Regulation: effective enforcement of this of this Regulation: of this Regulation:

Regulation:
(a) any reference to an economic (a) any reference to an economic (a) any reference to an economic (a) any reference to an economic
operator under Regulation (EU) operator under Regulation (EU) operator under Regulation (EU) operator under Regulation (EU)
2019/1020 shall be understood as 2019/1020 shall be understood as 2019/1020 shall be understood as 2019/1020 shall be understood as
G 603 including all operators identified in including all operators identified in including all operators identified in including all operators identified in G
Title III, Chapter 3 of this Title III, Chapter 3 of this Title III, Chapter 3 Article 2 of this Title III, Chapter 3 Article 2(1) of
Regulation; Regulation; Regulation; this Regulation;
(b) any reference to a product under (b) any reference to a product under (b) any reference to a product under (b) any reference to a product under
G 604 G
Regulation (EU) 2019/1020 shall be Regulation (EU) 2019/1020 shall be Regulation (EU) 2019/1020 shall be Regulation (EU) 2019/1020 shall be
understood as including all AI understood as including all AI understood as including all AI understood as including all AI
systems falling within the scope of systems falling within the scope of systems falling within the scope of systems falling within the scope of
this Regulation. this Regulation. this Regulation. this Regulation.
Proposal
(ba) the national supervisory

authorities shall act as market
surveillance authorities under this
G 604a Regulation and have the same G
powers and obligations as market

surveillance authorities under
Article 63(2)
2. The national supervisory 2. The national supervisory 2. The national supervisory 2. The national supervisory
authority shall report to the authority shall report to the authority shall report to the authority shall report to the
Commission on a regular basis the Commission on a regular basisand Commission on a regular basis the Commission on a regular basis the
outcomes of relevant market the AI Office annually the outcomes outcomes of relevant As part of their outcomes of relevant As part of their
surveillance activities. The national of relevant market surveillance reporting obligations under Article reporting obligations under Article
supervisory authority shall report, activities. The national supervisory 34(4) of Regulation (EU) 34(4) of Regulation (EU)
without delay, to the Commission authority shall report, without delay, 2019/1020, the market surveillance 2019/1020, the market surveillance
and relevant national competition to the Commission and relevant activities. The national supervisory activities. The national supervisory
G 605 G
authorities any information national competition authorities any authorityauthorities shall report, authorityauthorities shall report,
identified in the course of market information identified in the course without delay, to the Commission without delay annually, to the
surveillance activities that may be of of market surveillance activities that and relevant national competition Commission and relevant national
potential interest for the application may be of potential interest for the authorities any information competition authorities any
of Union law on competition rules. application of Union law on identified in the course of about the information identified in the course
competition rules. outcomes of relevant market of market surveillance activities that
surveillance activities that may be of may be of potential interest for the
potential interest for the application application of Union law on
of Union law on competition competition rules. They shall also
rules.under this Regulation. annually report to the Commission
about the use of prohibited
practices that occurred during that
year and about the measures taken.
Article 63(3)
3. For high-risk AI systems, related 3. For high-risk AI systems, related 3. For high-risk AI systems, related 3. For high-risk AI systems, related
to products to which legal acts listed to products to which legal acts listed to products to which legal acts listed to products to which legal acts listed
in Annex II, section A apply, the in Annex II, section A apply, the in Annex II, section A apply, the in Annex II, section A apply, the
market surveillance authority for the market surveillance authority for the market surveillance authority for the market surveillance authority for the
purposes of this Regulation shall be purposes of this Regulation shall be purposes of this Regulation shall be purposes of this Regulation shall be
the authority responsible for market the authority responsible for market the authority responsible for market the authority responsible for market
surveillance activities designated surveillance activities designated surveillance activities designated surveillance activities designated
under those legal acts. under those legal acts. under those legal acts or, in justified under those legal acts. By
circumstances and provided that derogation from the previous
coordination is ensured, another paragraph in justified
G 606 relevant authority identified by the circumstances, Member States may G
Member State. 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.
Article 63(3a)
3a. The procedures referred to in 3a. The procedures referred to in

G 606a G
Articles 65, 66, 67 and 68 of this Articles 65, 66, 67 and 68 of this
Regulation shall not apply to AI Regulation shall not apply to AI
systems related to products, to systems related to products, to
which legal acts listed in Annex II, which legal acts listed in Annex II,
section A apply, when such legal section A apply, when such legal
acts already provide for procedures acts already provide for procedures
having the same objective. In such ensuring an equivalent level of
a case, these sectoral procedures protection and having the same
shall apply instead. objective. In such a case, these
sectoral procedures shall apply
instead
Article 63(3b)
3a. For the purpose of ensuring 3b. Without prejudice to the powers
the effective enforcement of this of market surveillance authorities
Regulation, national supervisory under Article 14 of Regulation
authorities may: 2019/1020, for the purpose of
(a) carry out unannounced on- ensuring the effective enforcement
site and remote inspections of high- of this Regulation, market
G 606b risk AI systems; surveillance authorities may G
(b) acquire samples related to exercise the powers referred to in

high-risk AI systems, including Article 14(4)(d) and (j) of
through remote inspections, to Regulation 2019/1020 remotely as
reverse-engineer the AI systems and appropriate.
to acquire evidence to identify non-
compliance.
Article 63(4)
4. For AI systems placed on the 4. For AI systems placed on the 4. For high-risk AI systems placed 4. For high-risk AI systems placed
market, put into service or used by market, put into service or used by on the market, put into service or on the market, put into service or
G 607 G
financial institutions regulated by financial institutions regulated by used by financial institutions used by financial institutions
Union legislation on financial Union legislation on financial regulated by Union legislation on regulated by Union legislation on
services, the market surveillance services, the market surveillance financial services, the market financial services, the market
authority for the purposes of this authority for the purposes of this surveillance authority for the surveillance authority for the
Regulation shall be the relevant Regulation shall be the relevant purposes of this Regulation shall be purposes of this Regulation shall be
authority responsible for the authority responsible for the the relevant national authority the relevant national authority
financial supervision of those financial supervision of those responsible for the financial responsible for the financial
institutions under that legislation. institutions under that legislation. supervision of those institutions supervision of those institutions
under that legislation in so far as the under that legislation in so far as the
placement on the market, putting placement on the market, putting
into service or the use of the AI into service or the use of the AI
system is in direct connection with system is in direct connection with
the provision of those financial the provision of those financial
services. services.
4a. By way of a derogation from 4a. By way of a derogation from

the previous subparagraph, in the previous subparagraph, in
justified circumstances and justified circumstances and
provided that coordination is provided that coordination is
ensured, another relevant authority ensured, another relevant authority
G 607a may be identified by the Member may be identified by the Member G
State as market surveillance State as market surveillance

authority for the purposes of this authority for the purposes of this
Regulation. Regulation.
National market surveillance National market surveillance

authorities supervising regulated authorities supervising regulated
G 607b credit institutions regulated under credit institutions regulated under G
Directive 2013/36/EU, which are Directive 2013/36/EU, which are

participating in the Single participating in the Single
Supervisory Mechanism (SSM) Supervisory Mechanism (SSM)
established by Council Regulation established by Council Regulation
No 1204/2013, should report, No 1204/2013, should report,
without delay, to the European without delay, to the European
Central Bank any information Central Bank any information
identified in the course of their identified in the course of their
market surveillance activities that market surveillance activities that
may be of potential interest for the may be of potential interest for the
European Central Bank’s European Central Bank’s
prudential supervisory tasks as prudential supervisory tasks as
specified in that Regulation. specified in that Regulation.
Article 63(5)
5. For AI systems listed in point 5. For AI systems listed in point 5. For high-risk AI systems listed in 5. For high-risk AI systems listed in
1(a) in so far as the systems are used 1(a) in so far as the systemsthat are point 1(a) in so far as the systems are point 1(a)1 in so far as the systems
for law enforcement purposes, points used for law enforcement purposes, used for law enforcement purposes, are used for law enforcement
6 and 7 of Annex III, Member States points 6 and 7 of Annex III, Member points 6, 7 and 8 and 7 of Annex III, purposes, and for purposes listed in
shall designate as market States shall designate as market Member States shall designate as points 6, 7 and 8 and 7 of Annex III,
surveillance authorities for the surveillance authorities for the market surveillance authorities for Member States shall designate as
purposes of this Regulation either purposes of this Regulation either the purposes of this Regulation market surveillance authorities for
the competent data protection the competent data protection either the national authorities the purposes of this Regulation
supervisory authorities under supervisory authorities under supervising the activities of the law either the competent data protection
Directive (EU) 2016/680, or Directive (EU) 2016/680, or enforcement, border control, supervisory authorities under
G 608 G
Regulation 2016/679 or the national Regulation 2016/679 or the national immigration, asylum or judicial Regulation 2016/679, or Directive
competent authorities supervising competent authorities supervising authorities, or the competent data (EU) 2016/680, or Regulation
the activities of the law enforcement, the activities of the law enforcement, protection supervisory authorities 2016/679 or the national competent
immigration or asylum authorities immigration or asylum authorities under Directive (EU) 2016/680, or authorities supervising the activities
putting into service or using those putting into service or using those Regulation 2016/679. Market of the law enforcement, immigration
systems. systems. surveillance activities shall in no or asylum authorities putting into
way affect the independence of service or using those systems. or
judicial authorities or otherwise any other authority designated
interfere with their activities when pursuant to the same condictions
acting in their judicial capacity or laid down in Articles 1 to 44 of
the national competent authorities Directive or Directive (EU)
supervising the activities of the law 2016/680. Market surveillance
enforcement, immigration or asylum activities shall in no way affect the
authorities putting into service or independence of judicial authorities
using those systems. or otherwise interfere with their
activities when acting in their
judicial capacity
Article 63(6)
6. Where Union institutions, 6. Where Union institutions, 6. Where Union institutions, 6. Where Union institutions,
agencies and bodies fall within the agencies and bodies fall within the agencies and bodies fall within the agencies and bodies fall within the
scope of this Regulation, the scope of this Regulation, the scope of this Regulation, the scope of this Regulation, the
European Data Protection European Data Protection European Data Protection European Data Protection
Supervisor shall act as their market Supervisor shall act as their market Supervisor shall act as their market Supervisor shall act as their market
G 609 surveillance authority. surveillance authority. surveillance authority. surveillance authority except in
G
relation to the Court of Justice

acting in its judicial capacity.
Proposal
Article 63(7)
7. Member States shall facilitate the 7. Member States shall facilitate the 7. Member States shall facilitate the 7. Member States shall facilitate the
coordination between market coordination between market coordination between market coordination between market
surveillance authorities designated surveillanceNational supervisory surveillance authorities designated surveillance authorities designated
under this Regulation and other authorities designated under this under this Regulation and other under this Regulation and other
relevant national authorities or Regulation andshall coordinate with relevant national authorities or relevant national authorities or
G 610 G
bodies which supervise the other relevant national authorities or bodies which supervise the bodies which supervise the
application of Union harmonisation bodies which supervise the application of Union harmonisation application of Union harmonisation
legislation listed in Annex II or other application of Union harmonisation legislation listed in Annex II or other legislation listed in Annex II or other
Union legislation that might be legislationlaw listed in Annex II or Union legislation that might be Union legislation that might be
relevant for the high-risk AI systems other Union legislationlaw that relevant for the high-risk AI systems relevant for the high-risk AI systems
referred to in Annex III. might be relevant for the high-risk referred to in Annex III. referred to in Annex III.
AI systems referred to in Annex III.
Proposal
Article 63(7a)
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
G 610a non-compliance, raising awareness G
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.
Article 63(7b)
7a. Without prejudice to powers 7a. Without prejudice to powers

provided under Regulation (EU) provided under Regulation (EU)
2019/1020, and where relevant and 2019/1020, and where relevant and
G 610b G
limited to what is necessary to fulfil limited to what is necessary to fulfil
their tasks, the market surveillance their tasks, the market surveillance
authorities shall be granted full authorities shall be granted full
access by the provider to the access by the provider to the
documentation as well as the documentation as well as the
training, validation and testing training, validation and testing
datasets used for the development datasets used for the development
of the high-risk AI system, of the high-risk AI system,
including, where appropriate and including, where appropriate and
subject to security safeguards, subject to security safeguards,
through application programming through application programming
interfaces (‘API’) or other relevant interfaces (‘API’) or other relevant
technical means and tools enabling technical means and tools enabling
remote access. remote access.
Article 63(7c)
7b. Market surveillance authorities 7b. Market surveillance authorities

shall be granted access to the shall be granted access to the
source code of the high-risk AI source code of the high-risk AI
G 610c system upon a reasoned request and system upon a reasoned request and G
only when the following cumulative only when the following cumulative
conditions are fulfilled: conditions are fulfilled:
Article 63(7c), point (a)
(a) access to source code is (a) access to source code is

necessary to assess the conformity necessary to assess the conformity
of a high-risk AI system with the of a high-risk AI system with the
G 610d requirements set out in Title III, requirements set out in Title III, G
Chapter 2, and Chapter 2, and

Article 63(7c), point (b)
(b) testing/auditing procedures and (b) testing/auditing procedures and

verifications based on the data and verifications based on the data and
documentation provided by the documentation provided by the
G 610e provider have been exhausted or provider have been exhausted or G
proved insufficient. proved insufficient.

Article 63(7d)
7c. Any information and 7c. Any information and

documentation obtained by market documentation obtained by market
surveillance authorities shall be surveillance authorities shall be
G 610f treated in compliance with the treated in compliance with the G
confidentiality obligations set out in confidentiality obligations set out in

Article 63(7e)
7d. Complaints to the relevant 7d.

market surveillance authority can
be submitted by any natural or legal Now in cell 649a
G 610g G
person having grounds to consider
that there has been an infringement
of the provisions of this Regulation.
In accordance with Article 11(3)(e)

G 610h and (7)(a) of Regulation (EU) G
2019/1020, complaints shall be as above.

taken into account for the purpose
of conducting the market Text Origin: Council Mandate
surveillance activities and be
handled in line with the dedicated
procedures established therefore by
the market surveillance authorities.
Article 63a
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
G 610i obligations of this Regulation. To G
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 AI model
despite having made all appropriate
efforts to obtain that 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
G 610j Article 63a Article 63b G
Supervision of testing in real world

conditions by market surveillance Supervision of testing in real world
authorities conditions by market surveillance
authorities
Article 63c(1)
1. Market surveillance authorities 1. Market surveillance authorities

shall have the competence and shall have the competence and
G 610k powers to ensure that testing in real powers to ensure that testing in real G
world conditions is in accordance world conditions is in accordance

with this Regulation. with this Regulation.
Article 63c(2)
2. Where testing in real world 2. Where testing in real world

conditions is conducted for AI conditions is conducted for AI
systems that are supervised within systems that are supervised within
an AI regulatory sandbox under an AI regulatory sandbox under
Article 54, the market surveillance Article 54, the market surveillance
authorities shall verify the authorities shall verify the
compliance with the provisions of compliance with the provisions of
Article 54a as part of their Article 54a as part of their
G 610l G
supervisory role for the AI supervisory role for the AI
regulatory sandbox. Those regulatory sandbox. Those
authorities may, as appropriate, authorities may, as appropriate,
allow the testing in real world allow the testing in real world
conditions to be conducted by the conditions to be conducted by the
provider or prospective provider in provider or prospective provider in
derogation to the conditions set out derogation to the conditions set out
in Article 54a(4) (f) and (g). in Article 54a(4) (f) and (g).
Article 63c(3)
G 610m G
3. Where a market surveillance 3. Where a market surveillance
authority has been informed by the authority has been informed by the
prospective provider, the provider prospective provider, the provider
or any third party of a serious or any third party of a serious
incident or has other grounds for incident or has other grounds for
considering that the conditions set considering that the conditions set
out in Articles 54a and 54b are not out in Articles 54a and 54b are not
met, it may take any of the met, it may take any of the
following decisions on its territory, following decisions on its territory,
as appropriate: as appropriate:
Article 63c(3), point (a)
(a) suspend or terminate the testing (a) suspend or terminate the testing
G 610n G
Article 63c(3), point (b)
(b) require the provider or (b) require the provider or

prospective provider and user(s) to prospective provider and user(s) to
G 610o G
modify any aspect of the testing in modify any aspect of the testing in
real world conditions. real world conditions.
Article 63c(4)
4. Where a market surveillance 4. Where a market surveillance

authority has taken a decision authority has taken a decision
referred to in paragraph 3 of this referred to in paragraph 3 of this
Article or has issued an objection Article or has issued an objection
G 610p within the meaning of Article within the meaning of Article G
54a(4)(b), the decision or the 54a(4)(b), the decision or the

objection shall indicate the grounds objection shall indicate the grounds
thereof and the modalities and thereof and the modalities and
conditions for the provider or conditions for the provider or
prospective provider to challenge prospective provider to challenge
the decision or objection. the decision or objection.
Article 63c(5)
5. Where applicable, where a 5. Where applicable, where a

market surveillance authority has market surveillance authority has
taken a decision referred to in taken a decision referred to in
paragraph 3 of this Article, it shall paragraph 3 of this Article, it shall
communicate the grounds therefor communicate the grounds therefor
G 610q G
to the market surveillance to the market surveillance
authorities of the other Member authorities of the other Member
States in which the AI system has States in which the AI system has
been tested in accordance with the been tested in accordance with the
testing plan. testing plan.
Article 64

Access to data and documentation Access to data and documentation Access to data and Access to data and
G 611 documentationPowers of authorities documentationPowers of authorities G
protecting fundamental rights protecting fundamental rights

Article 64(1)
1. Access to data and 1. Access to data and

documentation in the context of their documentation In the context of their deleted
activities, the market surveillance activities, and upon their reasoned
G 612 authorities shall be granted full request the national supervisory G
access to the training, validation and authoritythe market surveillance

testing datasets used by the provider, authorities shall be granted full
including through application access to the training, validation and
programming interfaces (‘API’) or testing datasets used by the provider,
other appropriate technical means including through application
and tools enabling remote access. programming interfaces (‘API’) or
otheror, where relevant, the
deployer, that are relevant and
strictly necessary for the purpose of
its request through appropriate
technical means and tools enabling
remote access.
Article 64(2)
2. Where necessary to assess the 2. Where necessary to assess the

conformity of the high-risk AI conformity of the high-risk AI deleted
system with the requirements set out system with the requirements set out
in Title III, Chapter 2 and upon a in Title III, Chapter 2, after all other
reasoned request, the market reasonable ways to verify
surveillance authorities shall be conformity including paragraph 1
granted access to the source code of have been exhausted and have
the AI system. proven to be insufficient, and upon
a reasoned request, the market
surveillance authoritiesnational
supervisory authority shall be
granted access to the source
G 613 G
codetraining and trained models of
the AI system, including its relevant
model parameters. All information
in line with Article 70 obtained
shall be treated as confidential
information and shall be subject to
existing Union law on the
protection of intellectual property
and trade secrets and shall be
deleted upon the completion of the
investigation for which the
information was requested.
Article 64(2a)
2a. Paragraphs 1 and 2 are without

prejudice to the procedural rights of
G 613a the concerned operator in G
accordance with Article 18 of

Article 64(3)
3. National public authorities or 3. National public authorities or 3. National public authorities or 3. National public authorities or
bodies which supervise or enforce bodies which supervise or enforce bodies which supervise or enforce bodies which supervise or enforce
the respect of obligations under the respect of obligations under the respect of obligations under the respect of obligations under
Union law protecting fundamental Union law protecting fundamental Union law protecting fundamental Union law protecting fundamental
rights in relation to the use of high- rights in relation to the use of high- rights, including the right to non- rights, including the right to non-
risk AI systems referred to in Annex risk AI systems referred to in Annex discrimination, in relation to the use discrimination, in relation to the use
III shall have the power to request III shall have the power to request of high-risk AI systems referred to in of high-risk AI systems referred to in
and access any documentation and access any documentation Annex III shall have the power to Annex III shall have the power to
created or maintained under this created or maintained under this request and access any request and access any
Regulation when access to that Regulation when access to that documentation created or maintained documentation created or maintained
documentation is necessary for the documentation is necessary for the under this Regulation when access to under this Regulation in accesible
G 614 fulfilment of the competences under fulfilment of the competences under that documentation is necessary for language and format when access G
their mandate within the limits of their mandate within the limits of the fulfilment of the competences to that documentation is necessary
their jurisdiction. The relevant their jurisdiction. The relevant under their mandate within the limits for the fulfilment of the competences
public authority or body shall inform public authority or body shall inform of their jurisdiction. The relevant undereffectively fulfilling their
the market surveillance authority of the market surveillancenational public authority or body shall inform mandate within the limits of their
the Member State concerned of any supervisory authority of the Member the market surveillance authority of jurisdiction. The relevant public
such request. State concerned of any such request. the Member State concerned of any authority or body shall inform the
such request. market surveillance authority of the
Member State concerned of any such
request.
Article 64(4)
4. By 3 months after the entering 4. By 3three months after the 4. By 3 months after the entering 4. By 3three months after the
into force of this Regulation, each entering into force of this into force of this Regulation, each entering into force of this
Member State shall identify the Regulation, each Member State shall Member State shall identify the Regulation, each Member State shall
public authorities or bodies referred identify the public authorities or public authorities or bodies referred identify the public authorities or
to in paragraph 3 and make a list bodies referred to in paragraph 3 and to in paragraph 3 and make athe list bodies referred to in paragraph 3 and
publicly available on the website of make a list publicly available on the publicly available on the website of make a list publicly available on the
the national supervisory authority. website of the national supervisory the national supervisory authority. website of the national supervisory
Member States shall notify the list to authority. Member StatesNational Member States shall notify the list to authority. Member States shall
the Commission and all other supervisory authorities shall notify the Commission and all other notify the list to the Commission and
G 615 G
Member States and keep the list up the list to the Commission, the AI Member States and keep the list up all other Member States and keep the
to date. Office, and all other Member to date. list up to date.
Statesnational supervisory
authorities and keep the list up to
date. The Commission shall publish
in a dedicated website the list of all
the competent authorities
designated by the Member States in
accordance with this Article.
Article 64(5)
5. Where the documentation 5. Where the documentation 5. Where the documentation 5. Where the documentation
referred to in paragraph 3 is referred to in paragraph 3 is referred to in paragraph 3 is referred to in paragraph 3 is
insufficient to ascertain whether a insufficient to ascertain whether a insufficient to ascertain whether a insufficient to ascertain whether a
breach of obligations under Union breach of obligations under Union breach of obligations under Union breach of obligations under Union
law intended to protect fundamental law intended to protect fundamental law intended to protect fundamental law intended to protect fundamental
rights has occurred, the public rights has occurred, the public rights has occurred, the public rights has occurred, the public
G 616 authority or body referred to authority or body referred to in authority or body referred to authority or body referred to in G
paragraph 3 may make a reasoned paragraph 3 may make a reasoned paragraph 3 may make a reasoned paragraph 3 may make a reasoned
request to the market surveillance request to the market request to the market surveillance request to the market surveillance
authority to organise testing of the surveillancenational supervisory authority to organise testing of the authority, to organise testing of the
high-risk AI system through authority, to organise testing of the high-risk AI system through high-risk AI system through
technical means. The market high-risk AI system through technical means. The market technical means. The market
surveillance authority shall organise technical means. The market surveillance authority shall organise surveillance authority shall organise
the testing with the close surveillancenational supervisory the testing with the close the testing with the close
involvement of the requesting public authority shall organise the testing involvement of the requesting public involvement of the requesting public
authority or body within reasonable with the close involvement of the authority or body within reasonable authority or body within reasonable
time following the request. requesting public authority or body time following the request. time following the request.
within reasonable time following the
request.
Article 64(6)
6. Any information and 6. Any information and 6. Any information and 6. Any information and
documentation obtained by the documentation obtained by the documentation obtained by the documentation obtained by the
national public authorities or bodies national public authorities or bodies national public authorities or bodies national public authorities or bodies
referred to in paragraph 3 pursuant referred to in paragraph 3 pursuant referred to in paragraph 3 pursuant referred to in paragraph 3 pursuant
to the provisions of this Article shall to the provisions of this Article shall to the provisions of this Article shall to the provisions of this Article shall
G 617 be treated in compliance with the be treated in compliance with the be treated in compliance with the be treated in compliance with the
G
confidentiality obligations set out in confidentiality obligations set out in confidentiality obligations set out in confidentiality obligations set out in
Article 70. Article 70. Article 70. Article 70.
Proposal
Article 65

Procedure for dealing with AI Procedure for dealing with AI Procedure for dealing with AI Procedure for dealing with AI
G 618 systems presenting a risk at national systems presenting a risk at national systems presenting a risk at national systems presenting a risk at national G
level level level level

Article 65(1)
1. AI systems presenting a risk shall 1. AI systems presenting a risk shall 1. AI systems presenting a risk shall 1. AI systems presenting a risk shall
G 619 be understood as a product be understood as a product be understood as a product be understood as a product G
presenting a risk defined in Article presenting a risk defined in Article presenting a risk defined in Article presenting a risk defined in Article
3, point 19 of Regulation (EU) 3, point 19 of Regulation (EU) 3, point 19 of Regulation (EU) 3, point 19 of Regulation (EU)
2019/1020 insofar as risks to the 2019/1020 insofar as risks to the 2019/1020 insofar as risks to the 2019/1020 insofar as risks to the
health or safety or to the protection health or safety or to the protection health or safety or to the protection health or safety or to the protection
of fundamental rights of persons are of fundamental rights of personsan of fundamental rights of persons are of fundamental rights of persons are
concerned. AI system having the potential to concerned. concerned.
affect adversely health and safety,
fundamental rights of persons in
general, including in the workplace,
protection of consumers, the
environment, public security, or
democracy or the rule of law and
other public interests, that are
protected by the applicable Union
harmonisation law, to a degree
which goes beyond that considered
reasonable and acceptable in
relation to its intended purpose or
under the normal or reasonably
foreseeable conditions of use of the
system are concerned, including the
duration of use and, where
applicable, its putting into service,
installation and maintenance
requirements.
2. Where the market surveillance 2. Where the market 2. Where the market surveillance 2. Where the market surveillance
authority of a Member State has surveillancenational supervisory authority of a Member State has authority of a Member State has
sufficient reasons to consider that an authority of a Member State has sufficient reasons to consider that an sufficient reasons to consider that an
AI system presents a risk as referred sufficient reasons to consider that an AI system presents a risk as referred AI system presents a risk as referred
G 620 to in paragraph 1, they shall carry AI system presents a risk as referred to in paragraph 1, they shall carry to in paragraph 1, theyit shall carry G
out an evaluation of the AI system to in paragraph 1, theyit shall carry out an evaluation of the AI system out an evaluation of the AI system
concerned in respect of its out an evaluation of the AI system concerned in respect of its concerned in respect of its
compliance with all the requirements concerned in respect of its compliance with all the requirements compliance with all the requirements
and obligations laid down in this compliance with all the requirements and obligations laid down in this and obligations laid down in this
Regulation. When risks to the and obligations laid down in this Regulation. When risks to the Regulation. When risks to the
protection of fundamental rights are Regulation. When risks to the protection of fundamental rights are protection ofParticular attention
present, the market surveillance protection of fundamental rights are presentidentified, the market shall be given to AI systems
authority shall also inform the present, the market surveillance authority shall also presenting a risk to vulnerable
relevant national public authorities surveillancenational supervisory inform the relevant national public groups (referred to in Article 5).
or bodies referred to in Article 64(3). authority shall also immediately authorities or bodies referred to in When risks to fundamental rights
The relevant operators shall inform and fully cooperate with the Article 64(3). The relevant operators are presentidentified, the market
cooperate as necessary with the relevant national public authorities shall cooperate as necessary with the surveillance authority shall also
market surveillance authorities and or bodies referred to in Article market surveillance authorities and inform and fully cooperate with the
the other national public authorities 64(3); Where there is sufficient the other national public authorities relevant national public authorities
or bodies referred to in Article 64(3). reason to consider that that an AI or bodies referred to in Article 64(3). or bodies referred to in Article 64(3).
system exploits the vulnerabilities of The relevant operators shall
vulnerable groups or violates their cooperate as necessary with the
rights intentionally or market surveillance
unintentionally, the national authoritiesauthority and the other
supervisory authority shall have the national public authorities or bodies
duty to investigate the design goals, referred to in Article 64(3).;
data inputs, model selection,
implementation and outcomes of
the AI system . The relevant
operators shall cooperate as
necessary with the market
surveillance authoritiesnational
supervisory authority and the other
national public authorities or bodies
referred to in Article 64(3).;
Where, in the course of that Where, in the course of that Where, in the course of that Where, in the course of that
evaluation, the market surveillance evaluation, the market evaluation, the market surveillance evaluation, the market surveillance
authority finds that the AI system surveillancenational supervisory authority finds that the AI system authority and where applicable in
G 621 does not comply with the authority or, where relevant, the does not comply with the cooperation with the national G
requirements and obligations laid national public authority referred to requirements and obligations laid public authority referred to in
down in this Regulation, it shall in Article 64(3) finds that the AI down in this Regulation, it shall Article 64(3) finds that the AI
without delay require the relevant system does not comply with the without undue delay require the system does not comply with the
operator to take all appropriate requirements and obligations laid relevant operator to take all requirements and obligations laid
corrective actions to bring the AI down in this Regulation, it shall appropriate corrective actions to down in this Regulation, it shall
system into compliance, to withdraw without delay require the relevant bring the AI system into compliance, without undue delay require the
the AI system from the market, or to operator to take all appropriate to withdraw the AI system from the relevant operator to take all
recall it within a reasonable period, corrective actions to bring the AI market, or to recall it, within a appropriate corrective actions to
commensurate with the nature of the system into compliance, to withdraw reasonable period, commensurate bring the AI system into compliance,
risk, as it may prescribe. the AI system from the market, or to with the nature of the risk, as it may to withdraw the AI system from the
recall it within a reasonable period, prescribe. market, or to recall it within a
commensurate with the nature of the reasonable period, commensurate
risk, as it may prescribe. and in any with the nature of the risk, as it may
event no later than fifteen working prescribe.period it may prescribe
days or as provided for in the and in any event no later than
relevant Union harmonisation law fifteen working days or as provided
as applicable for in the relevant Union
harmonisation law as applicable
The market surveillance authority The national supervisoryThe The market surveillance authority The market surveillance authority
shall inform the relevant notified market surveillance authority shall shall inform the relevant notified shall inform the relevant notified
body accordingly. Article 18 of inform the relevant notified body body accordingly. Article 18 of body accordingly. Article 18 of
G 622 Regulation (EU) 2019/1020 shall accordingly. Article 18 of Regulation (EU) 2019/1020 shall Regulation (EU) 2019/1020 shall G
apply to the measures referred to in Regulation (EU) 2019/1020 shall apply to the measures referred to in apply to the measures referred to in
the second subparagraph. apply to the measures referred to in the second subparagraph. the second subparagraph.
the second subparagraph.
Article 65(3)
authority considers that non- surveillancenational supervisory authority considers that non- authority considers that non-
G 623 compliance is not restricted to its authority considers that non- compliance is not restricted to its compliance is not restricted to its G
national territory, it shall inform the compliance is not restricted to its national territory, it shall inform the national territory, it shall inform the
Commission and the other Member national territory, it shall inform the Commission and the other Member Commission, and the other Member
States of the results of the evaluation Commission, the AI Office and the States without undue delay of the States without undue delay of the
and of the actions which it has national supervisory authority of results of the evaluation and of the results of the evaluation and of the
required the operator to take. the other Member States without actions which it has required the actions which it has required the
undue delay of the results of the operator to take. operator to take.
evaluation and of the actions which
it has required the operator to take.
Article 65(4)
4. The operator shall ensure that all 4. The operator shall ensure that all 4. The operator shall ensure that all
appropriate corrective action is taken appropriate corrective action is taken appropriate corrective action is taken
G 624 in respect of all the AI systems in respect of all the AI systems in respect of all the AI systems G
concerned that it has made available concerned that it has made available concerned that it has made available
on the market throughout the Union. on the market throughout the Union. on the market throughout the Union.
Article 65(5)
5. Where the operator of an AI 5. Where the operator of an AI 5. Where the operator of an AI 5. 5. Where the operator of an AI
system does not take adequate system does not take adequate system does not take adequate system does not take adequate
corrective action within the period corrective action within the period corrective action within the period corrective action within the period
referred to in paragraph 2, the referred to in paragraph 2, the referred to in paragraph 2, the referred to in paragraph 2, the
market surveillance authority shall market surveillancenational market surveillance authority shall market surveillance authority shall
take all appropriate provisional supervisory authority shall take all take all appropriate provisional take all appropriate provisional
measures to prohibit or restrict the appropriate provisional measures to measures to prohibit or restrict the measures to prohibit or restrict the
AI system's being made available on prohibit or restrict the AI system's AI system's being made available on AI system's being made available on
G 625 its national market, to withdraw the being made available on its national its national market, to withdraw the its national market or put into G
product from that market or to recall market or put into service, to product from that market or to recall service, to withdraw the product or
it. That authority shall inform the withdraw the productAI system from it. That authority shall informnotify the standalone AI system from that
Commission and the other Member that market or to recall it. That the Commission and the other market or to recall it. That authority
States, without delay, of those authority shall immediately inform Member States, without undue shall informwithout undue delay
measures. the Commission, the AI Office and delay, of those measures. notify the Commission and the other
the national supervisory authority Member States, without delay, of
of the other Member States, without those measures.
delay, of those measures.
Article 65(6)
6. The information referred to in 6. The information referred to in 6. The informationnotification 6. The informationnotification
paragraph 5 shall include all paragraph 5 shall include all referred to in paragraph 5 shall referred to in paragraph 5 shall
available details, in particular the available details, in particular the include all available details, in include all available details, in
data necessary for the identification data necessary for the identification particular the datainformation particular the datainformation
of the non-compliant AI system, the of the non-compliant AI system, the necessary for the identification of necessary for the identification of
origin of the AI system, the nature of origin of the AI system and the the non-compliant AI system, the the non-compliant AI system, the
the non-compliance alleged and the supply chain, the nature of the non- origin of the AI system, the nature of origin of the AI system and the
risk involved, the nature and compliance alleged and the risk the non-compliance alleged and the supply chain, the nature of the non-
duration of the national measures involved, the nature and duration of risk involved, the nature and compliance alleged and the risk
G 626 taken and the arguments put forward the national measures taken and the duration of the national measures involved, the nature and duration of G
by the relevant operator. In arguments put forward by the taken and the arguments put forward the national measures taken and the
particular, the market surveillance relevant operator. In particular, the by the relevant operator. In arguments put forward by the
authorities shall indicate whether the market surveillance particular, the market surveillance relevant operator. In particular, (the
non-compliance is due to one or authoritiesnational supervisory authorities shall indicate whether the market surveillance authorities) shall
more of the following: authority shall indicate whether the non-compliance is due to one or indicate whether the non-compliance
non-compliance is due to one or more of the following: is due to one or more of the
more of the following: following:
Article 65(6), point (-a)
(-a) non-compliance with the (-a) non-compliance with the

prohibition of the artificial prohibition of the artificial
G 626a intelligence practices referred to in intelligence practices referred to in G
Article 5; Article 5;
G 627 (a) a failure of the AI system to (a) a failure of the high-risk AI (a) a failure of thea high-risk AI (a) a failure of thea high-risk AI G
meet requirements set out in Title system to meet requirements set out system to meet requirements set out system to meet requirements set out
III, Chapter 2; in Title III, Chapter 2this in Title III, Chapter 2; in Title III, Chapter 2;
Regulation;
(b) shortcomings in the harmonised (b) shortcomings in the harmonised (b) shortcomings in the harmonised
standards or common specifications standards or common specifications standards or common specifications
G 628 referred to in Articles 40 and 41 referred to in Articles 40 and 41 referred to in Articles 40 and 41 G
conferring a presumption of conferring a presumption of conferring a presumption of

conformity. conformity. conformity.;
(ba) non-compliance with (ba) non-compliance with

G 628a provisions set out in Article 52; provisions set out in Article 52; G
(ba) non-compliance with the

prohibition of the artificial
G 628b G
intelligence practices referred to in
Article 5;
(bb) non-compliance of general (bb)

purpose AI systems with the
G 628c Text Origin: Council Mandate G
referred to in Article 4a.

(bb) non-compliance with

G 628d G
provisions set out in Article 52.
Article 65(7)
7. The market surveillance 7. The market surveillancenational 7. The market surveillance 7. The market surveillance
authorities of the Member States supervisory authorities of the authorities of the Member States authorities of the Member States
other than the market surveillance Member States other than the market other than the market surveillance other than the market surveillance
authority of the Member State surveillancenational supervisory authority of the Member State authority of the Member State
initiating the procedure shall without authority of the Member State initiating the procedure shall without initiating the procedure shall without
delay inform the Commission and initiating the procedure shall without undue delay inform the Commission undue delay inform the Commission
the other Member States of any delay inform the Commission, the and the other Member States of any and the other Member States of any
G 629 measures adopted and of any AI Office and the other Member measures adopted and of any measures adopted and of any G
additional information at their States of any measures adopted and additional information at their additional information at their
disposal relating to the non- of any additional information at their disposal relating to the non- disposal relating to the non-
compliance of the AI system disposal relating to the non- compliance of the AI system compliance of the AI system
concerned, and, in the event of compliance of the AI system concerned, and, in the event of concerned, and, in the event of
disagreement with the notified concerned, and, in the event of disagreement with the notified disagreement with the notified
national measure, of their objections. disagreement with the notified national measure, of their objections. national measure, of their objections.
national measure, of their objections.
Article 65(8)
8. Where, within three months of 8. Where, within three months of 8. Where, within three months of 8. Where, within three months of
receipt of the information referred to receipt of the information referred to receipt of the receipt of the
in paragraph 5, no objection has in paragraph 5, no objection has informationnotification referred to informationnotification referred to
been raised by either a Member State been raised by either a national in paragraph 5, no objection has in paragraph 5, no objection has
G 630 or the Commission in respect of a supervisory authority of a Member been raised by either a Member State been raised by either a market G
provisional measure taken by a State or the Commission in respect or the Commission in respect of a surveillance authority of a Member
Member State, that measure shall be of a provisional measure taken by a provisional measure taken by a State or the Commission in respect
deemed justified. This is without national supervisory authority of Member State, that measure shall be of a provisional measure taken by a
prejudice to the procedural rights of another Member State, that measure deemed justified. This is without market surveillance authority of
the concerned operator in shall be deemed justified. This is prejudice to the procedural rights of another Member State, that measure
accordance with Article 18 of without prejudice to the procedural the concerned operator in shall be deemed justified. This is
Regulation (EU) 2019/1020. rights of the concerned operator in accordance with Article 18 of without prejudice to the procedural
accordance with Article 18 of Regulation (EU) 2019/1020. The rights of the concerned operator in
Regulation (EU) 2019/1020. The period referred to in the first accordance with Article 18 of
period referred to in the first sentence of this paragraph shall be Regulation (EU) 2019/1020. The
sentence of this paragraph shall be reduced to 30 days in the case of period referred to in the first
reduced to thirty days in the event non-compliance with the sentence of this paragraph shall be
of non-compliance with the prohibition of the artificial reduced to thirty days in the event
prohibition of the artificial intelligence practices referred to in of non-compliance with the
intelligence practices referred to in Article 5. prohibition of the artificial
Article 5. intelligence practices referred to in
Article 5.
Article 65(9)
9. The market surveillance 9. The market surveillancenational 9. The market surveillance 9. The market surveillance
authorities of all Member States supervisory authorities of all authorities of all Member States authorities of all Member States
shall ensure that appropriate Member States shall ensure that shall then ensure that appropriate shall ensure that appropriate
restrictive measures are taken in appropriate restrictive measures are restrictive measures are taken in restrictive measures are taken in
respect of the product concerned, taken in respect of the productAI respect of the productAI system respect of the product or the AI
G 631 such as withdrawal of the product system concerned, such as concerned, such as withdrawal of the system concerned, such as G
from their market, without delay. withdrawal of the productAI system product from their market, without withdrawal of the product or the AI
from their market, without delay. undue delay. system from their market, without
undue delay.
Article 65(9a)
9a. National supervisory

authorities shall annually report to
G 631a G
the AI Office about the use of
prohibited practices that occurred
during that year and about the
measures taken to eliminate or
mitigate the risks in accordance
with this Article.
Article 65a
Article 65a
Procedure for dealing with AI
systems classified by the provider as
G 631b a not high-risk in application of G
Annex III
Article 65a(1)
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
G 631c out an evaluation of the AI system G
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.
Article 65a(2)
G 631d G
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.
Article 65a(3)
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
G 631e the other Member States without G
undue delay of the results of the

evaluation and of the actions which
it has required the provider to take.
Article 65a(4)
4. The provider shall ensure that

all necessary action is taken to
G 631f bring the AI system into compliance G
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.
Article 65a(5)
5. The provider shall ensure that

all appropriate corrective action is
taken in respect of all the AI
G 631g systems concerned that it has made G
available on the market throughout

the Union.
Article 65a(6)
6. Where the provider of the AI

system concerned does not take
adequate corrective action within
G 631h the period referred to in paragraph G
2, then the provisions of Article 65

paragraphs 5 to 9 apply.
Article 65a(7)
G 631i G
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.
Article 65a(8)
8. In exercising their power to

monitor the application of this
article and in accordance with
2019/1020, market surveillance
G 631j authorities may perform G
appropriate checks, taking into

account in particular information
stored in the EU database referred
to in Article 60.
Article 66

G 632 G
Union safeguard procedure Union safeguard procedure Union safeguard procedure
Article 66(1)
G 633 G
1. Where, within three months of 1. Where, within three months of 1. Where, within three months of 1. Where, within three months of
receipt of the notification referred to receipt of the notification referred to receipt of the notification referred to receipt of the notification referred to
in Article 65(5), objections are in Article 65(5), or 30 days in the in Article 65(5), or 30 days in the in Article 65(5), or 30 days in the
raised by a Member State against a case of non-compliance with the case of non-compliance with the case of non-compliance with the
measure taken by another Member prohibition of the artificial prohibition of the artificial prohibition of the artificial
State, or where the Commission intelligence practices referred to in intelligence practices referred to in intelligence practices referred to in
considers the measure to be contrary Article 5, objections are raised by Article 5, objections are raised by a Article 5, objections are raised by
to Union law, the Commission shall the national supervisory authority Member State against a measure the market surveillance authority of
without delay enter into consultation of a Member State against a measure taken by another Member State, or a Member State against a measure
with the relevant Member State and taken by another Member where the Commission considers the taken by another Member
operator or operators and shall Statenational supervisory authority, measure to be contrary to Union law, Statemarket surveillance authority,
evaluate the national measure. On or where the Commission considers the Commission shall without undue or where the Commission considers
the basis of the results of that the measure to be contrary to Union delay enter into consultation with the the measure to be contrary to Union
evaluation, the Commission shall law, the Commission shall without relevant Member State’s market law, the Commission shall without
decide whether the national measure delay enter into consultation with the surveillance authority and operator undue delay enter into consultation
is justified or not within 9 months national supervisory authority of or operators and shall evaluate the with the market surveillance
from the notification referred to in the relevant Member State and national measure. On the basis of the authority of the relevant Member
Article 65(5) and notify such operator or operators and shall results of that evaluation, the State and operator or operators and
decision to the Member State evaluate the national measure. On Commission shall decide whether shall evaluate the national measure.
concerned. the basis of the results of that the national measure is justified or On the basis of the results of that
evaluation, the Commission shall not within 9 months, or 60 days in evaluation, the Commission shall
decide whether the national measure the case of non-compliance with the decide whether the national measure
is justified or not within 9three prohibition of the artificial is justified or not within 9six
months, or 60 days in the case of intelligence practices referred to in months, or 60 days in the case of
non-compliance with the Article 5, starting from the non-compliance with the
prohibition of the artificial notification referred to in Article prohibition of the artificial
intelligence practices referred to in 65(5). It shall and notify such intelligence practices referred to in
Article 5, starting from the decision to the Member State Article 5, starting from the
notification referred to in Article concerned. The Commission shall notification referred to in Article
65(5) and notify such decision to the also inform all other Member States 65(5) and notify such decision to the
national supervisory authority of of such decision. market surveillance authority of the
the Member State concerned. The Member State concerned. The
Commission shall also inform all Commission shall also inform all
other national other market surveillance
authorities of such decision.
Article 66(2)
2. If the national measure is 2. If the national measure is 2. If the national measuremeasure 2. If the national measuremeasure
considered justified, all Member considered justified, all Member taken by the relevant Member taken by the relevant Member
States shall take the measures Statesnational supervisory State’s market surveillance States is considered justified by the
necessary to ensure that the non- authorities designated under this authority is considered justified by Commission, all Member States
compliant AI system is withdrawn Regulation shall take the measures the Commission, the market shall take theensure that
from their market, and shall inform necessary to ensure that the non- surveillance authorities of , all appropriate restrictive measures
the Commission accordingly. If the compliant AI system is withdrawn Member States shall take theensure necessary to ensure that the non-
national measure is considered from their market without delay, and that appropriate restrictive compliantare taken in respect of the
unjustified, the Member State shall inform the Commission and measures necessary to ensure that AI system is withdrawnconcerned,
concerned shall withdraw the the AI Office accordingly. If the the non-compliantare taken in such as withdrawal of the AI system
measure. national measure is considered respect of the AI system is from their market without undue
G 634 G
unjustified, the national supervisory withdrawnconcerned, such as delay, and shall inform the
authority of the Member State withdrawal of the AI system from Commission accordingly. If the
concerned shall withdraw the their market without undue delay, national measure is considered
measure. and shall inform the Commission unjustified by the Commission, the
accordingly. If the national measure Member State concerned shall
is considered unjustified by the withdraw the measure and inform
Commission, the market the Commission accordingly.
surveillance authority of the , the
Member State concerned shall
withdraw the measure and inform
the Commission accordingly.
Article 66(2a)
66 a Joint investigations 66 a
Where a national supervisory
authority has reasons to suspect
G 634a G
that the infringement by a provider
or a deployer of a high-risk AI
system or foundation model to this
Regulation amount to a widespread
infringement with a Union
dimension, or affects or is likely
affect at least 45 million
individuals, in more than one
Member State, that national
supervisory authority shall inform
the AI Office and may request the
national supervisory authorities of
the Member States where such
infringement took place to start a
joint investigation. The AI Office
shall provide central coordination
to the joint investigation.
Investigation powers shall remain
within the competence of the
national supervisory authorities.
Article 66(3)
3. Where the national measure is 3. Where the national measure is 3. Where the national measure is 3. Where the national measure is
considered justified and the non- considered justified and the non- considered justified and the non- considered justified and the non-
compliance of the AI system is compliance of the AI system is compliance of the AI system is compliance of the AI system is
attributed to shortcomings in the attributed to shortcomings in the attributed to shortcomings in the attributed to shortcomings in the
harmonised standards or common harmonised standards or common harmonised standards or common harmonised standards or common
specifications referred to in Articles specifications referred to in Articles specifications referred to in Articles specifications referred to in Articles
G 635 40 and 41 of this Regulation, the 40 and 41 of this Regulation, the 40 and 41 of this Regulation, the 40 and 41 of this Regulation, the
G
Commission shall apply the Commission shall apply the Commission shall apply the Commission shall apply the
procedure provided for in Article 11 procedure provided for in Article 11 procedure provided for in Article 11 procedure provided for in Article 11
of Regulation (EU) No 1025/2012. of Regulation (EU) No 1025/2012. of Regulation (EU) No 1025/2012. of Regulation (EU) No 1025/2012.
Proposal
Article 67
G 636 G
Compliant AI systems which present Compliant AI systems which present Compliant high-risk or general Compliant AI systems which present
a risk a risk purpose AI systems which present a a risk
riskCompliant AI systems which
present a risk Proposal
Article 67(1)
1. Where, having performed an 1. Where, having performed an 1. Where, having performed an 1. Where, having performed an
evaluation under Article 65, the evaluation under Article 65, in full evaluation under Article 65, the evaluation under Article 65, after
market surveillance authority of a cooperation with the relevant market surveillance authority of a consulting the relevant national
Member State finds that although an national public authority referred to Member State finds that although public authority referred to in
AI system is in compliance with this in Article 64(3), the national ana high-risk or general purpose AI Article 64(3), the market
Regulation, it presents a risk to the supervisorythe market surveillance system is in compliance with this surveillance authority of a Member
health or safety of persons, to the authority of a Member State finds Regulation, it presents a risk to the State finds that although ana high-
compliance with obligations under that although an AI system is in health or safety of persons, to the risk AI system is in compliance with
Union or national law intended to compliance with this Regulation, it compliance with obligations under this Regulation, it presents a risk to
protect fundamental rights or to presents a serious risk to the health Union or national law intended to the health or safety of persons, to the
other aspects of public interest or safety of persons, to the protect or to fundamental rights or compliance with obligations under
protection, it shall require the compliance with obligations under to other aspects of public interest Union or national law intended to
relevant operator to take all Union or national law intended to protection, it shall require the protect fundamental rights, or to
G 637 appropriate measures to ensure that protect fundamental rights, or the relevant operator to take all other aspects of public interest G
the AI system concerned, when environment or the democracy and appropriate measures to ensure that protection, it shall require the
placed on the market or put into rule of law or to other aspects of the AI system concerned, when relevant operator to take all
service, no longer presents that risk, public interest protection , it shall placed on the market or put into appropriate measures to ensure that
to withdraw the AI system from the require the relevant operator to take service, no longer presents that risk, the AI system concerned, when
market or to recall it within a all appropriate measures to ensure to withdraw the AI system from the placed on the market or put into
reasonable period, commensurate that the AI system concerned, when market or to recall it within a service, no longer presents that risk,
with the nature of the risk, as it may placed on the market or put into reasonable period, commensurate to withdraw the AI system from the
prescribe. service, no longer presents that risk, with the nature of the risk, aswithout market or to recall it without undue
to withdraw the AI system from the undue delay, within a period it may delay, within a reasonable period,
market or to recall it within a prescribe. commensurate with the nature of the
reasonable period, commensurate risk, as it may prescribe.
with the nature of the risk, as it may
prescribe.
Article 67(2)
2. The provider or other relevant 2. The provider or other relevant 2. The provider or other relevant 2. The provider or other relevant
operators shall ensure that corrective operators shall ensure that corrective operators shall ensure that corrective operators shall ensure that corrective
action is taken in respect of all the action is taken in respect of all the action is taken in respect of all the action is taken in respect of all the
AI systems concerned that they have AI systems concerned that they have AI systems concerned that they have AI systems concerned that they have
made available on the market made available on the market made available on the market made available on the market
G 638 throughout the Union within the throughout the Union within the throughout the Union within the throughout the Union within the G
timeline prescribed by the market timeline prescribed by the market timeline prescribed by the market timeline prescribed by the market
surveillance authority of the Member surveillancenational supervisory surveillance authority of the Member surveillance authority of the Member
State referred to in paragraph 1. authority authority of the Member State referred to in paragraph 1. State referred to in paragraph 1.
State referred to in paragraph 1.
Article 67(2a)
2a. Where the provider or other 2a.

relevant operators fail to take
corrective action as referred to in
paragraph 2 and the AI system
continues to present a risk as
referred to in paragraph 1, the
G 638a G
national supervisory authority may
require the relevant operator to
withdraw the AI system from the
market or to recall it within a
reasonable period, commensurate
with the nature of the risk.
Article 67(3)
G 639 3. The Member State shall 3. The Member Statenational 3. The Member State shall 3. The Member StateStates shall G
immediately inform the Commission supervisory authority shall immediately inform the Commission immediately inform the Commission
and the other Member States. That immediately inform the and the other Member States. That and the other Member States. That
information shall include all Commission, the AI Office and the information shall include all information shall include all
available details, in particular the other Member Statesnational available details, in particular the available details, in particular the
data necessary for the identification supervisory authorities. That data necessary for the identification data necessary for the identification
of the AI system concerned, the information shall include all of the AI system concerned, the of the AI system concerned, the
origin and the supply chain of the AI available details, in particular the origin and the supply chain of the AI origin and the supply chain of the AI
system, the nature of the risk data necessary for the identification system, the nature of the risk system, the nature of the risk
involved and the nature and duration of the AI system concerned, the involved and the nature and duration involved and the nature and duration
of the national measures taken. origin and the supply chain of the AI of the national measures taken. of the national measures taken.
system, the nature of the risk
involved and the nature and duration
of the national measures taken.
Article 67(4)
4. The Commission shall without 4. The Commission, in consultation 4. The Commission shall without 4. The Commission shall without
delay enter into consultation with the with the AI Office shall without undue delay enter into consultation undue delay enter into consultation
Member States and the relevant delay enter into consultation with the with the Member States concerned with the Member States concerned
operator and shall evaluate the Member Statesnational supervisory and the relevant operator and shall and the relevant operator and shall
national measures taken. On the authorities concerned and the evaluate the national measures evaluate the national measures
basis of the results of that relevant operator and shall evaluate taken. On the basis of the results of taken. On the basis of the results of
G 640 evaluation, the Commission shall the national measures taken. On the that evaluation, the Commission that evaluation, the Commission G
decide whether the measure is basis of the results of that shall decide whether the measure is shall decide whether the measure is
justified or not and, where evaluation, the CommissionAI justified or not and, where justified or not and, where
necessary, propose appropriate Office shall decide whether the necessary, propose appropriate necessary, propose appropriate
measures. measure is justified or not and, measures. measures.
where necessary, propose
appropriate measures.
Article 67(5)
5. The Commission shall address its 5. The Commission, in consultation 5. The Commission shall address its 5. The Commission shall
G 641 decision to the Member States. with the AI Office shall decision to the Member States addressimmediately communicate G
addressimmediately communicate concerned, and inform all other its decision to the Member States
its decision to the national Member States. concerned and to the relevant
supervisory authorities of the operators. It shall also inform of
Member States concerned and to the decision all other Member
the relevant operators. It shall also States.
inform the decision to all other
national supervisory authorities.
Article 67(5a)
5a. The Commission shall adopt 5a.

guidelines to help national
competent authorities to identify
G 641a G
and rectify, where necessary,
similar problems arising in other AI
systems.
Article 68

G 642 G
Formal non-compliance Formal non-compliance Formal non-compliance
Article 68(1)
authority of a Member State makes surveillancenational supervisory authority of a Member State makes authority of a Member State makes
one of the following findings, it shall authority of a Member State makes one of the following findings, it shall one of the following findings, it shall
require the relevant provider to put one of the following findings, it shall require the relevant provider to put require the relevant provider to put
G 643 an end to the non-compliance require the relevant provider to put an end to the non-compliance an end to the non-compliance G
concerned: an end to the non-compliance concerned, within a period it may concerned, within a period it may
concerned: prescribe: prescribe:
(a) the conformity marking has been (a) the conformityCE marking has (a) the conformity marking has been (a) the conformityCE marking has
affixed in violation of Article 49; been affixed in violation of Article affixed in violation of Article 49; been affixed in violation of Article
G 644 49; 49; G
(b) the conformity marking has not (b) the conformityCE marking has (b) the conformity marking has not (b) the conformityCE marking has
G 645 been affixed; not been affixed; been affixed; not been affixed; G
(c) the EU declaration of conformity (c) the EU declaration of conformity (c) the EU declaration of conformity
G 646 G
has not been drawn up; has not been drawn up; has not been drawn up;
(d) the EU declaration of (d) the EU declaration of (d) the EU declaration of

G 647 conformity has not been drawn up conformity has not been drawn up conformity has not been drawn up G
correctly; correctly; correctly;
(e) the identification number of the (e) the identification number of the (e) the identification number of the
notified body, which is involved in notified body, which is involved in notified body, which is involved in
G 648 the conformity assessment the conformity assessment the conformity assessment G
procedure, where applicable, has not procedure, where applicable, has not procedure, where applicable, has not
been affixed; been affixed; been affixed;.
Article 68(1), point (ea)

(ea) the registration in the EU (ea) the registration in the EU

G 648a database has not been carried out; database has not been carried out; G
Article 68(1), point (eb)
(eb) where applicable, the (eb) where applicable, the

authorised representative has not authorised representative has not
G 648b been appointed. been appointed. G
Article 68(1), point (ec)
(ec) the technical documentation is (ec) the technical documentation is

G 648c not available not available G
Article 68(2)
2. Where the non-compliance 2. Where the non-compliance 2. Where the non-compliance 2. Where the non-compliance
referred to in paragraph 1 persists, referred to in paragraph 1 persists, referred to in paragraph 1 persists, referred to in paragraph 1 persists,
the Member State concerned shall the national supervisory authority the Member State concerned shall the market surveillance authority of
take all appropriate measures to of the Member State concerned shall take all appropriate measures to the Member State concerned shall
restrict or prohibit the high-risk AI take all appropriate and restrict or prohibit the high-risk AI take all appropriateappropriate and
G 649 system being made available on the proportionate measures to restrict or system being made available on the proportionate measures to restrict or G
market or ensure that it is recalled or prohibit the high-risk AI system market or ensure that it is recalled or prohibit the high-risk AI system
withdrawn from the market. being made available on the market withdrawn from the market. being made available on the market
or ensure that it is recalled or or ensure that it is recalled or
withdrawn from the market without withdrawn from the market without
delay. The national supervisory delay.
authority of the Member State
concerned shall immediately inform
the AI Office of the non-
compliance and the measures
taken.
Article 68a

Union testing facilities in the area EU AI testing support structures in
G 649a of artificial intelligence the area of artificial intelligence G
Article 68a(1)
1. The Commission shall designate 1. The Commission shall designate

one or more Union testing facilities one or more EU AI testing support
pursuant to Article 21 of structures to perform the tasks
G 649b Regulation (EU) 1020/2019 in the listed under Article 21(6) of G
area of artificial intelligence. Regulation (EU) 1020/2019 in the

area of artificial intelligence.
Article 68a(2)
2. Without prejudice to the 2. Without prejudice to the tasks

activities of Union testing facilities referred to in paragraph 1, EU AI
referred to in Article 21(6) of testing support structure shall also
Regulation (EU) 1020/2019, Union provide independent technical or
G 649c G
testing facilities referred to in scientific advice at the request of
paragraph 1 shall also provide the Board, the Commission, or
independent technical or scientific market surveillance authorities.
advice at the request of the Board
or market surveillance authorities.
Article 68 – Chapter 3b (new)
Chapter 3a(new) Chapter 3b(new)

G 649d Remedies Remedies G
Article 68 – Chapter 3a (new)
Article 68 a Article 68 a
Right to lodge a complaint with a Right to lodge a complaint with a
national supervisory authority market surveillance authority
1. Without prejudice to any other
administrative or judicial remedy, 1. Without prejudice to other
every natural persons or groups of administrative or judicial remedies,
natural persons shall have the right complaints to the relevant market
to lodge a complaint with a national surveillance authority may be
supervisory authority, in particular submitted by any natural or legal
in the Member State of his or her person having grounds to consider
habitual residence, place of work or that there has been an infringement
G 649e place of the alleged infringement if of the provisions of this Regulation. G
they consider that the AI system

relating to him or her infringes this In accordance with Regulation
Regulation. (EU) 2019/1020, complaints shall
2. The national supervisory be taken into account for the
authority with which the complaint purpose of conducting the market
has been lodged shall inform the surveillance activities and be
complainant on the progress and handled in line with the dedicated
the outcome of the complaint procedures established therefore by
including the possibility of a the market surveillance authorities
judicial remedy pursuant to Article
78.
Chapter I
Chapter I
Supervision, investigation,
enforcement and monitoring in
respect of providers of general
purpose AI Models
Article A
Enforcement of obligations on
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 H. The
G 649f Commission shall entrust the G
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 B
Monitoring actions
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
compliance with this Regulation by
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;
(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 C
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 [Classification of general
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 [D-H].
3. A qualified alert shall be
duly reasoned and at least indicate:
(a) the point of contact of the
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 D
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 [Obligations for providers of
general purpose AI models] and
[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 [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
[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 E
Power to conduct evaluations
1. The AI Office, after
consulting the Board, may conduct
evaluations of the general purpose
AI model concerned
(a) to assess compliance of the
provider with the obligations under
this Regulation, where the
information gathered pursuant to
Article D [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
[Enforcement of obligations on
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 [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
xx(x).
7. Prior to requesting access
to the general purpose AI model
concerned, the AI Office may
initiate a structured dialogue with
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.
Article F
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/Chapter [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 [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
AI model.
3. If, during the structured
dialogue under paragraph 2, the
model with systemic risk offers
commitments to implement
mitigation meausres 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 H
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.
Article 68 b (new)
Article 68 b
Right to an effective judicial
remedy against a national
supervisory authority
administrative or non-judicial
remedy, each natural or legal
person shall have the right to an
effective judicial remedy against a
legally binding decision of a
concerning them.
G 649g administrative or non-judicial G
remedy, each natural or legal

person shall have the right to a an
effective judicial remedy where the
which is competent pursuant to
Articles 59 does not handle a
complaint or does not inform the
data subject within three months on
the progress or outcome of the
complaint lodged pursuant to
Article 68a.
3. Proceedings against a national
supervisory authority shall be
brought before the courts of the
Member State where the national
supervisory authority is established.
4. Where proceedings are brought
against a decision of a national
supervisory authority which was
preceded by an opinion or a
decision of the Commission in the
union safeguard procedure, the
supervisory authority shall forward
that opinion or decision to the
court.
Article 68b
Article 68b
G 649h G
Central pool of independent experts
Article 68b(1)
1. Upon request of the AI Board,

the Commission shall, by means of
an implementing act, make
provisions on the creation,
G 649i G
maintenance and financing of a
central pool of independent experts
to support the enforcement
activities under this Regulation.
Article 68b(2)
2. Experts shall be selected by the

G 649j Commission and included in the G
central pool on the basis of up-to-

date scientific or technical expertise
in the field of artificial intelligence,
having due regard to the technical
areas covered by the requirements
and obligations in this Regulation
and the activities of market
surveillance authorities pursuant to
1020/2019. The Commission shall
determine the number of experts in
the pool in accordance with the
required needs.
Article 68b(3)
3. Experts may have the following

G 649k G
tasks:
Article 68b(3), point (a)
(a) provide advice to and support

G 649l the work of market surveillance G
authorities, at their request;
Article 68b(3), point (b)
(b) support cross-border market

surveillance investigations as
G 649m referred to in Article 58(h), without G
prejudice of the powers of market

surveillance authorities;
Article 68b(3), point (c)

G 649n G
(c) advise and support the
Commission when carrying out its
duties in the context of the
safeguard clause pursuant to
Article 66.
Article 68b(4)
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. Each expert shall draw
G 649o G
up a declaration of interests, which
shall be made publicly available.
The Commission shall establish
systems and procedures to actively
manage and prevent potential
conflicts of interest.
Article 68b(5)
5. The Member States may be

required to pay fees for the advice
and support by the experts. The
structure and the level of fees as
well as the scale and structure of
G 649p recoverable costs shall be adopted G
by the Commission by means of the

implementing act referred to in
paragraph 1, taking into account
the objectives of the adequate
cost-effectiveness and the necessity
to ensure an effective access to
experts by all Member States.
Article 68b(6)
6. The Commission shall facilitate

timely access to the experts by the
Member States, as needed, and
ensure that the combination of
support activities carried out by
G 649q G
Union testing facilities pursuant to
Article 68a and experts pursuant to
this Article is efficiently organised
and provides the best possible added
value.
Article 68 c Article 68 c
A right to explanation of A right to explanation of individual
individual decision-making decision-making
1. Any affected person subject to a
decision which is taken by the 1. Any affected person subject to a
deployer on the basis of the output decision which is taken by the
from an high-risk AI system which deployer on the basis of the output
produces legal effects or similarly from an high-risk AI system listed
G 649r G
significantly affects him or her in a in Annex III, with the exception of
way that they consider to adversely systems listed under point 2, and
impact their health, safety, which produces legal effects or
fundamental rights, socio-economic similarly significantly affects him
well-being or any other of the rights or her in a way that they consider to
deriving from the obligations laid adversely impact their health, safety
down in this Regulation, shall have and fundamental rights shall have
the right to request from the the right to request from the
deployer clear and meaningful deployer clear and meaningful
explanation pursuant to Article explanations on the role of the AI
13(1) on the role of the AI system in system in the decision-making
the decision-making procedure, the procedure and the main elements of
main parameters of the decision the decision taken.
taken and the related input data. 2. Paragraph 1 shall not apply to
2. Paragraph 1 shall not apply to the use of AI systems for which
the use of AI systems for which exceptions from, or restrictions to,
exceptions from, or restrictions to, the obligation under paragraph 1
the obligation under paragraph 1 follow from Union or national law
follow from Union or national law in compliance with Union law.
are provided in so far as such 3. . This Article shall only apply to
exception or restrictions respect the the extent that the right referred to
essence of the fundamental rights in paragraph 1 is not already
and freedoms and is a necessary provided for under Union
and proportionate measure in a legislation.
democratic society.
3. This Article shall apply without
prejudice to Articles 13, 14, 15, and
22 of the Regulation 2016/679.
Article 68 d Article 68 d
Amendment to Directive (EU) Amendment to Directive (EU)
2020/1828 2020/1828
In Annex I to Directive (EU) In Annex I to Directive (EU)
2020/1828 of the European 2020/1828 of the European
Parliament and of the Council 1a, Parliament and of the Council 1a,
G 649s the following point is added: the following point is added: G
“(67a) Regulation xxxx/xxxx of “(67a) Regulation xxxx/xxxx of

the European Parliament and of the European Parliament and of
the Council [laying down the Council [laying down
harmonised rules on artificial harmonised rules on artificial
intelligence (Artificial Intelligence intelligence (Artificial Intelligence
Act) and amending certain Union Act) and amending certain Union
legislative acts (OJ L ...)]”. legislative acts (OJ L ...)]”.
_________________ _________________
1a 1a
Directive (EU) 2020/1828 of the Directive (EU) 2020/1828 of the
European Parliament and of the European Parliament and of the
Council of 25 November 2020 on Council of 25 November 2020 on
representative actions for the representative actions for the
protection of the collective interests protection of the collective interests
of consumers and repealing of consumers and repealing
Directive 2009/22/EC (OJ L 409, Directive 2009/22/EC (OJ L 409,
4.12.2020, p. 1). 4.12.2020, p. 1).
Article 68 e Article 68 e
Reporting of breaches and Reporting of breaches and
protection of reporting persons protection of reporting persons
Directive (EU) 2019/1937 of the Directive (EU) 2019/1937 of the
European Parliament and of the European Parliament and of the
G 649t Council shall apply to the reporting Council shall apply to the reporting G
of breaches of this Regulation and of breaches of this Regulation and

the protection of persons reporting the protection of persons reporting
such breaches. such breaches.
TITLE IX
TITLE IX TITLE IX TITLE IX TITLE IX

CODES OF CONDUCT CODES OF CONDUCT CODES OF CONDUCT CODES OF CONDUCT
G 650 G

Proposal
Article 69

Codes of conduct Codes of conduct Codes of conduct for voluntary Codes of conduct for voluntary
G 651 application of specific application of specific G
requirementsCodes of conduct requirementsCodes of conduct

Article 69(1)
1. The Commission and the 1. The Commission, the AI Office 1. The Commission, and the 1. The CommissionAI Office, and
Member States shall encourage and and the Member States shall Member States shall encourage and the Member States shall encourage
facilitate the drawing up of codes of encourage and facilitate the drawing facilitate the drawing up of codes of and facilitate the drawing up of
conduct intended to foster the up of codes of conduct intended, conduct intended to fosterencourage codes of conduct, including related
voluntary application to AI systems including where they are drawn up the voluntary application to AI governance mechanisms, intended
other than high-risk AI systems of in order to demonstrate how AI systems other than high-risk AI to foster the voluntary application to
the requirements set out in Title III, systems respect the principles set systems of one or more of the AI systems other than high-risk AI
Chapter 2 on the basis of technical out in Article 4a and can thereby be requirements set out in Title III, systems of some or all of the
specifications and solutions that are considered trustworthy, to foster the Chapter 2 on the basis of technical requirements set out in Title III,
G 652 appropriate means of ensuring voluntary application to AI systems specifications and solutions that are Chapter 2 on the basis of technical G
compliance with such requirements other than high-risk AI systems of appropriate means of ensuring specifications and solutions that are
in light of the intended purpose of the requirements set out in Title III, compliance with such requirements appropriate means of ensuring
the systems. Chapter 2 on the basis of technical in light of the intended purpose of compliance with such requirements
specifications and solutions that are the systemsof this Regulation to the in light of the intended purpose of
appropriate means of ensuring best extent possible, taking into the systemsof this Regulation taking
compliance with such requirements account the available, technical into account the available technical
in light of the intended purpose of solutions allowing for the solutions and industry best
the systems. application of such requirements. practices allowing for the
application of such requirements.
Article 69(2)
2. The Commission and the Board 2. Codes of conduct intended to 2. The Commission and the Board 2. The CommissionAI Office and
G 653 G
shall encourage and facilitate the foster the voluntary compliance shall encourage andMember States the BoardMember States shall
drawing up of codes of conduct with the principles underpinning shall facilitate the drawing up of encourage and facilitate the drawing
intended to foster the voluntary trustworthy AI systems,The codes of conduct intended to up of codes of conduct intended to
application to AI systems of Commission and the Board shall, in fosterencourage the voluntary fosterconcerning the voluntary
requirements related for example to particular: application to all AI systems of application, including by deployers,
environmental sustainability, (a) aim for a sufficient level of specific requirements related, for of specific requirements to all to AI
accessibility for persons with a AI literacy among their staff and example, to environmental systems, on the basis of clear
disability, stakeholders participation other persons dealing with the sustainability, including as regards objectives and key performance
in the design and development of the operation and use of AI systems in energy-efficient programming, indicators to measure the
AI systems and diversity of order to observe such principles; accessibility for persons with a achievement of those objectives,
development teams on the basis of (b) assess to what extent their disability, stakeholders participation including elements such as, but not
clear objectives and key encourage and facilitate the drawing in the design and development of the limited to:
performance indicators to measure up of codes of conduct intended to AI systems and diversity of
the achievement of those objectives. foster the voluntary application to development teams on the basis of (a) applicable elements foreseen in
AI systems of requirements related clear objectives and key European ethic guidelines for
for example to environmental performance indicators to measure trustworthy AI;
sustainability, accessibility formay the achievement of those objectives. (b) assessing and minimizing the
affect vulnerable persons or groups The Commission and the Member impact of AI systems on of
of persons, including children, the States shall also facilitate, where requirements related for example to
elderly, migrants and persons with a appropriate, the drawing of codes of environmental sustainability,
disability, stakeholders participation conduct applicable on a voluntary accessibility for persons with a
in the design and development of basis with regard to users' disability, stakeholders participation
thedisabilities or whether measures obligations in relation to AI in the design and development of
could be put in place in order to systems. theincluding as regards energy-
increase accessibility, or otherwise efficient programming and
support such persons or groups of techniques for efficient design,
persons; training and use of AI;
(c) consider the way in which (c) promoting AI literacy, in
the use of their AI systems may particular of persons dealing with
have an impact or can increase the development, operation and use
diversity, gender balance and of AI;
equality; (d) facilitating an inclusive and
(d) have regard to whether diverse design of AI systems,
their AI systems can be used in a including through the
way that, directly or indirectly, may establishment of inclusive and
residually or significantly reinforce diverse and diversity of
existing biases or inequalities; development teams on the basis of
(e) reflect on the need and clear objectives and key
relevance of having in place diverse performance indicators to measure
and diversity of development teams the achievement of those
on the basis of clear objectives and objectivesand the promotion of
key performance indicators to stakeholders’ participation in that
measure the achievement of those process;
objectivesin view of securing an (e) assessing and preventing the
inclusive design of their systems; negative impact of AI systems on
(f) give careful consideration vulnerable persons or groups of
to whether their systems can have a persons, including as regards
negative societal impact, notably accessibility for persons with a
concerning political institutions disability, as well as on gender
and democratic processes; equality.
(g) evaluate how AI systems
can contribute to environmental
sustainability and in particular to
the Union’s commitments under the
European Green Deal and the
European Declaration on Digital
Rights and Principles.
Article 69(3)
3. Codes of conduct may be drawn 3. Codes of conduct may be drawn 3. Codes of conduct applicable on a 3. Codes of conduct may be drawn
up by individual providers of AI up by individual providers of AI voluntary basis may be drawn up by up by individual providers or
systems or by organisations systems or by organisations individual providers of AI systems deployers of AI systems or by
representing them or by both, representing them or by both, or by organisations representing organisations representing them or
including with the involvement of including with the involvement of them or by both, including with the by both, including with the
users and any interested stakeholders users and any interested involvement of users and any involvement of usersdeployers and
and their representative stakeholders, including scientific interested stakeholders and their any interested stakeholders and their
G 654 G
organisations. Codes of conduct may researchers, and their representative representative organisations, or, representative organisations,
cover one or more AI systems taking organisations, in particular trade where appropriate, by users with including civil society organisations
into account the similarity of the unions, and consumer regard to their obligations. Codes of and academia. Codes of conduct
intended purpose of the relevant organisations. Codes of conduct conduct may cover one or more AI may cover one or more AI systems
systems. may cover one or more AI systems systems taking into account the taking into account the similarity of
taking into account the similarity of similarity of the intended purpose of the intended purpose of the relevant
the intended purpose of the relevant the relevant systems. systems.
systems. Providers adopting codes
of conduct will designate at least
one natural person responsible for
internal monitoring.
Article 69(4)
4. The Commission and the Board 4. The Commission and the 4. The Commission and the 4. The CommissionAI Office, and
shall take into account the specific BoardAI Office shall take into BoardMember States shall take into the BoardMember States shall take
interests and needs of the small-scale account the specific interests and account the specific interests and into account the specific interests
providers and start-ups when needs of the small-scale needs of the small-scaleSME and needs of the small-scale
G 655 G
encouraging and facilitating the providersSMEs and start-ups when providers, including and start-ups, providers andSMEs, including start-
drawing up of codes of conduct. encouraging and facilitating the when encouraging and facilitating ups, when encouraging and
drawing up of codes of conduct. the drawing up of codes of conduct facilitating the drawing up of codes
referred to in this Article. of conduct.
TITLE X
TITLE X TITLE X TITLE X TITLE X

CONFIDENTIALITY AND CONFIDENTIALITY AND CONFIDENTIALITY AND CONFIDENTIALITY AND
G 656 PENALTIES PENALTIES PENALTIES PENALTIES G

Proposal
Article 70

Confidentiality Confidentiality Confidentiality Confidentiality
G 657 G

Proposal
Article 70(1)
G 658 G
1. National competent authorities 1. The Commission, national 1. National competent authorities 1. National competentThe
and notified bodies involved in the competent authorities and notified and, notified bodies, the Commission, market surveillance
application of this Regulation shall bodies, the AI Office and any other Commission, the Board, and any authorities and notified bodies and
respect the confidentiality of natural or legal person involved in other natural or legal person any other natural or legal person
information and data obtained in the application of this Regulation involved in the application of this involved in the application of this
carrying out their tasks and activities shall respect the confidentiality of Regulation shall, in accordance with Regulation shall, in accordance
in such a manner as to protect, in information and data obtained in Union or national law, put with Union or national law, respect
particular: carrying out their tasks and activities appropriate technical and the confidentiality of information
in such a manner as to protect, in organisational measures in place to and data obtained in carrying out
particular:; ensure respect the confidentiality of their tasks and activities in such a
information and data obtained in manner as to protect, in particular:;
carrying out their tasks and activities
in such a manner as to protect, in
particular:
(a) intellectual property rights, and (a) intellectual property rights, and (a) intellectual property rights, and (a) intellectual property rights, and
confidential business information or confidential business information or confidential business information or confidential business information or
trade secrets of a natural or legal trade secrets of a natural or legal trade secrets of a natural or legal trade secrets of a natural or legal
person, including source code, person, in accordance with the person, including source code, person, including source code,
except the cases referred to in provisions of Directives 2004/48/EC except the cases referred to in except the cases referred to in
Article 5 of Directive 2016/943 on and 2016/943/EC, including source Article 5 of Directive 2016/943 on Article 5 of Directive 2016/943 on
G 659 the protection of undisclosed know- code, except the cases referred to in the protection of undisclosed know- the protection of undisclosed know- G
how and business information (trade Article 5 of Directive 2016/943 on how and business information (trade how and business information (trade
secrets) against their unlawful the protection of undisclosed know- secrets) against their unlawful secrets) against their unlawful
acquisition, use and disclosure how and business information (trade acquisition, use and disclosure acquisition, use and disclosure
apply. secrets) against their unlawful apply.; apply.;
acquisition, use and disclosure
apply.;
G 660 (b) the effective implementation of (b) the effective implementation of (b) the effective implementation of (b) the effective implementation of G
this Regulation, in particular for the this Regulation, in particular for the this Regulation, in particular for the this Regulation, in particular for the
purpose of inspections, purpose of inspections, purpose of inspections, purpose of inspections,
investigations or audits;(c) public investigations or audits;(c) public investigations or audits;(c) public investigations or audits;(c) public
and national security interests; and national security interests; and national security interests; and national security interests;
(ba) public and national security (ba) public and national security
G 660a G
interests interests
(c) integrity of criminal or (c) integrity of criminal or (c) integrity of criminal or (c) integrity of criminal or
G 661 administrative proceedings. administrative proceedings. administrative proceedings.public administrative proceedings. G
and national security interests;
(d) THIS POINT IS MISSING. (d) THIS POINT IS MISSING. (d) THIS POINT IS MISSING.
THANK YOU FOR USING THANK YOU FOR USING THANK YOU FOR USING
G 662 ANOTHER LANGUAGE. ANOTHER LANGUAGE. ANOTHER LANGUAGE.integrity of G
criminal or administrative
proceedings;
Article 70(1), point (da)
(da) the integrity of information (da) the integrity of information

G 662a classified in accordance with Union classified in accordance with Union G
or national law. or national law.
Article 70(1), point (db)
G 662b G
1a. The authorities involved in the (db) 1a. The authorities involved in
application of this Regulation the application of this Regulation
pursuant to paragraph 1 shall pursuant to paragraph 1 shall only
minimise the quantity of data request data that is strictly
requested for disclosure to the data necessary for the assessment of
that is strictly necessary for the the risk posed by the AI system and
perceived risk and the assessment for the exercise of their powers in
of that risk. They shall delete the compliance with this Regulation
data as soon as it is no longer and Regulation 2019/1020. They
needed for the purpose it was shall put in place adequate and
requested for. They shall put in effective cybersecurity measures to
place adequate and effective protect the security and
cybersecurity, technical and confidentiality of the information
organisational measures to protect and data obtained and shall delete
the security and confidentiality of the data collected as soon as it is no
the information and data obtained longer needed for the purpose it
in carrying out their tasks and was requested for, in accordance
activities; with applicable national or
European legislation .
2. Without prejudice to paragraph 1, 2. Without prejudice to paragraph 2. Without prejudice to paragraph 1, 2. Without prejudice to paragraph 1
information exchanged on a 1paragraphs 1 and 1a, information information exchanged on a and 1a, information exchanged on a
confidential basis between the exchanged on a confidential basis confidential basis between the confidential basis between the
national competent authorities and between the national competent national competent authorities and national competent authorities and
between national competent authorities and between national between national competent between national competent
authorities and the Commission shall competent authorities and the authorities and the Commission shall authorities and the Commission shall
not be disclosed without the prior Commission shall not be disclosed not be disclosed without the prior not be disclosed without the prior
G 663 G
consultation of the originating without the prior consultation of the consultation of the originating consultation of the originating
national competent authority and the originating national competent national competent authority and the national competent authority and the
user when high-risk AI systems authority and the userdeployer when user when high-risk AI systems userdeployer when high-risk AI
referred to in points 1, 6 and 7 of high-risk AI systems referred to in referred to in points 1, 6 and 7 of systems referred to in points 1, 6 and
Annex III are used by law points 1, 6 and 7 of Annex III are Annex III are used by law 7 of Annex III are used by law
enforcement, immigration or asylum used by law enforcement, enforcement, border control, enforcement, border control,
authorities, when such disclosure immigration or asylum authorities, immigration or asylum authorities, immigration or asylum authorities,
would jeopardise public and national when such disclosure would when such disclosure would when such disclosure would
security interests. jeopardise public andor national jeopardise public and national jeopardise public and national
security interests. security interests. This obligation to security interests. This exchange of
exchange information shall not information shall not cover
cover sensitive operational data in sensitive operational data in
relation to the activities of law relation to the activities of law
enforcement, border control, enforcement, border control,
immigration or asylum authorities. immigration or asylum authorities.
When the law enforcement, When the law enforcement, When the law enforcement, When the law enforcement,
immigration or asylum authorities immigration or asylum authorities immigration or asylum authorities immigration or asylum authorities
are providers of high-risk AI are providers of high-risk AI are providers of high-risk AI are providers of high-risk AI
systems referred to in points 1, 6 and systems referred to in points 1, 6 and systems referred to in points 1, 6 and systems referred to in points 1, 6 and
7 of Annex III, the technical 7 of Annex III, the technical 7 of Annex III, the technical 7 of Annex III, the technical
documentation referred to in Annex documentation referred to in Annex documentation referred to in Annex documentation referred to in Annex
IV shall remain within the premises IV shall remain within the premises IV shall remain within the premises IV shall remain within the premises
of those authorities. Those of those authorities. Those of those authorities. Those of those authorities. Those
authorities shall ensure that the authorities shall ensure that the authorities shall ensure that the authorities shall ensure that the
market surveillance authorities market surveillance authorities market surveillance authorities market surveillance authorities
referred to in Article 63(5) and (6), referred to in Article 63(5) and (6), referred to in Article 63(5) and (6), referred to in Article 63(5) and (6),
G 664 as applicable, can, upon request, as applicable, can, upon request, as applicable, can, upon request, as applicable, can, upon request,
G
immediately access the immediately access the immediately access the immediately access the
documentation or obtain a copy documentation or obtain a copy documentation or obtain a copy documentation or obtain a copy
thereof. Only staff of the market thereof. Only staff of the market thereof. Only staff of the market thereof. Only staff of the market
surveillance authority holding the surveillance authority holding the surveillance authority holding the surveillance authority holding the
appropriate level of security appropriate level of security appropriate level of security appropriate level of security
clearance shall be allowed to access clearance shall be allowed to access clearance shall be allowed to access clearance shall be allowed to access
that documentation or any copy that documentation or any copy that documentation or any copy that documentation or any copy
thereof. thereof. thereof. thereof.
Proposal
Article 70(3)
3. Paragraphs 1 and 2 shall not 3. Paragraphs 1, 1a and 2 shall not 3. Paragraphs 1 and 2 shall not 3. Paragraphs 1, [1a] and 2 shall not
affect the rights and obligations of affect the rights and obligations of affect the rights and obligations of affect the rights and obligations of
the Commission, Member States and the Commission, Member States and the Commission, Member States and the Commission, Member States and
notified bodies with regard to the notified bodies with regard to the their relevant authorities, as well as their relevant authorities, as well as
exchange of information and the exchange of information and the notified bodies, with regard to the notified bodies, with regard to the
dissemination of warnings, nor the dissemination of warnings, nor the exchange of information and the exchange of information and the
G 665 G
obligations of the parties concerned obligations of the parties concerned dissemination of warnings, dissemination of warnings,
to provide information under to provide information under including in the context of cross- including in the context of cross-
criminal law of the Member States. criminal law of the Member States.; border cooperation, nor the border cooperation, nor the
obligations of the parties concerned obligations of the parties concerned
to provide information under to provide information under
criminal law of the Member States. criminal law of the Member States.
Article 70(4)
4. The Commission and Member 4. The Commission and Member 4. The Commission and Member 4. The Commission and Member
States may exchange, where States may exchange, where strictly States may exchange, where States may exchange, where
necessary, confidential information necessary and in accordance with necessary, confidential information necessary and in accordance with
with regulatory authorities of third relevant provisions of international with regulatory authorities of third relevant provisions of international
countries with which they have and trade agreements, confidential countries with which they have and trade agreements, confidential
G 666 concluded bilateral or multilateral information with regulatory concluded bilateral or multilateral information with regulatory G
confidentiality arrangements authorities of third countries with confidentiality arrangements authorities of third countries with
guaranteeing an adequate level of which they have concluded bilateral guaranteeing an adequate level of which they have concluded bilateral
confidentiality. or multilateral confidentiality confidentiality. or multilateral confidentiality
arrangements guaranteeing an arrangements guaranteeing an
adequate level of confidentiality. adequate level of confidentiality.
Article 71

G 667 Penalties Penalties Penalties Penalties G

Proposal
Article 71(1)
1. In compliance with the terms and 1. In compliance with the terms and 1. In compliance with the terms and 1. In compliance with the terms and
conditions laid down in this conditions laid down in this conditions laid down in this conditions laid down in this
Regulation, Member States shall lay Regulation, Member States shall lay Regulation, Member States shall lay Regulation, Member States shall lay
down the rules on penalties, down the rules on penalties, down the rules on penalties, down the rules on penalties and
including administrative fines, including administrative fines, including administrative fines, other enforcement measures, which
applicable to infringements of this applicable to infringements of this applicable to infringements of this may also include warnings and
Regulation and shall take all Regulation by any operator, and Regulation and shall take all non-monetary measures, including
measures necessary to ensure that shall take all measures necessary to measures necessary to ensure that administrative fines, applicable to
they are properly and effectively ensure that they are properly and they are properly and effectively infringements of this Regulation by
implemented. The penalties provided effectively implemented and aligned implemented. The penalties provided operators, and shall take all
for shall be effective, proportionate, with the guidelines issued by the for shall be effective, proportionate, measures necessary to ensure that
G 668 G
and dissuasive. They shall take into Commission and the AI Office and dissuasive. They shall take into they are properly and effectively
particular account the interests of pursuant to Article 82b. The particular account the size and implemented and taking into
small-scale providers and start-up penalties provided for shall be interests of small-scaleSME account the guidelines issued by the
and their economic viability. effective, proportionate, and providers, including start-ups, and Commission pursuant to Article
dissuasive. They shall take into start-up and their economic 82b. The penalties provided for shall
particular account the interests of viability. They shall also take into be effective, proportionate, and
small-scale providers and start- account whether the use of the AI dissuasive. They shall take into
upSMEs and start-ups and their system is in the context of personal particular account the interests of
economic viability.; non-professional activity. small-scale providers and start-
upSMEs including start-ups and
their economic viability.
Article 71(2)
2. The Member States shall notify 2. The Member States shall notify 2. The Member States shall without 2. The Member States shall without
the Commission of those rules and the Commission and the Office by [ delay notify the Commission of delay notify the Commission and at
of those measures and shall notify it, 12 months after the date of entry those rules and of those measures the latest by the date of entry into
G 669 G
without delay, of any subsequent into force of this Regulation] of and shall notify it, without delay, of application of those respective rules
amendment affecting them. those rules and of those measures any subsequent amendment affecting and of those respective measures and
and shall notify itthem, without them. shall notify itthem, without delay, of
delay, of any subsequent amendment any subsequent amendment affecting
affecting them. them.
Article 71(3)
3. The following infringements shall 3. Non compliance with the 3. Non-compliance with any of the 3. Non compliance with the
be subject to administrative fines of prohibition of the artificial prohibitions of the artificial prohibition of the artificial
up to 30 000 000 EUR or, if the intelligence practices referred to in intelligence practices referred to in intelligence practices referred to in
offender is company, up to 6 % of its Article 5The following infringements Article 5The following infringements Article 5The following infringements
total worldwide annual turnover for shall be subject to administrative shall be subject to administrative shall be subject to administrative
the preceding financial year, fines of up to 30 000 00040 000 000 fines of up to 30 000 000 EUR or, if fines of up to 30 000 00035 000 000
whichever is higher: EUR or, if the offender is a the offender is company, up to 6 % EUR or, if the offender is a
G 670 G
company, up to 67 % of its total of its total worldwide annual company, up to 67 % of its total
worldwide annual turnover for the turnover for the preceding financial worldwide annual turnover for the
preceding financial year, whichever year, whichever is higher:. In case preceding financial year, whichever
is higher: of SMEs, including start-ups, these is higher:
fines shall be up to 3% of their
worldwide annual turnover for the
preceding financial year.
(a) non-compliance with the

prohibition of the artificial deleted deleted
G 671 G
intelligence practices referred to in
Article 5;
(b) non-compliance of the AI

G 672 system with the requirements laid deleted deleted G
down in Article 10.
Article 71(3a)
3a. Non-compliance of the AI

system with the requirements laid
down in Article 10 and 13 shall be
subject to administrative fines of up
G 672a to EUR 20 000 000 or, if the G
offender is a company, up to 4% of
its total worldwide annual turnover
for the preceding financial year,
whichever is the higher.
Article 71(4)
4. The non-compliance of the AI 4. The Non-compliance of the AI 4. The non- 4. The Non-compliance of thean AI
system with any requirements or system or foundation model with complianceInfringements of the AI system with any requirements or
obligations under this Regulation, any requirements or obligations system with any requirements or obligations under this Regulationof
other than those laid down in under this Regulation, other than obligations under this Regulation, the following provisions related to
Articles 5 and 10, shall be subject to those laid down in Articles 5, 10 and other than those laid down in operators or notified bodies, other
administrative fines of up to 20 000 13 and 10, shall be subject to Articles 5 and 10following than those laid down in Articles 5
000 EUR or, if the offender is a administrative fines of up to 20 000 provisions related to operators or and 10, shall be subject to
G 673 company, up to 4 % of its total 000 EUR 10 000 000 or, if the notified bodies, shall be subject to administrative fines of up to 20 000 G
worldwide annual turnover for the offender is a company, up to 4 %2% administrative fines of up to 20 000 00015 000 000 EUR or, if the
preceding financial year, whichever of its total worldwide annual 000 EUR or, if the offender is a offender is a company, up to 4 %3%
is higher. turnover for the preceding financial company, up to 4 % of its total of its total worldwide annual
year, whichever is higher.; worldwide annual turnover for the turnover for the preceding financial
preceding financial year, whichever year, whichever is higher.:
is higher.:
(a) obligations of providers (a)

G 673a pursuant to Articles 4b and 4c; G
(b) obligations of providers (b) obligations of providers

G 673b pursuant to Article 16; pursuant to Article 16; G
(c) obligations for certain other (c)

G 673c persons pursuant to Article 23a; G
(d) obligations of authorised (d) obligations of authorised

representatives pursuant to Article representatives pursuant to Article
G 673d 25; 25; G
(e) obligations of importers (e) obligations of importers

G 673e pursuant to Article 26; pursuant to Article 26; G
(f) obligations of distributors (f) obligations of distributors

G 673f pursuant to Article 27; pursuant to Article 27; G
(g) obligations of users pursuant to (g) obligations of deployers

Article 29, paragraphs 1 to 6a; pursuant to Article 29, paragraphs
G 673g 1 to 6a; G
(h) requirements and obligations of (h) requirements and obligations of

notified bodies pursuant to Article notified bodies pursuant to Article
G 673h 33, 34(1), 34(3), 34(4), 34a; 33, 34(1), 34(3), 34(4), 34a; G
(i) transparency obligations for (i) transparency obligations for

providers and users pursuant to providers and users pursuant to
G 673i Article 52. Article 52. G
Article 71(4a)
4a. In case of SMEs, including 4a.

start-ups, these fines shall be up to
G 673j 2% of their worldwide annual G
turnover for the preceding financial

year.
Article 71(5)
G 674 G
5. The supply of incorrect, 5. The supply of incorrect, 5. The supply of incorrect, 5. The supply of incorrect,
incomplete or misleading incomplete or misleading incomplete or misleading incomplete or misleading
information to notified bodies and information to notified bodies and information to notified bodies and information to notified bodies and
national competent authorities in national competent authorities in national competent authorities in national competent authorities in
reply to a request shall be subject to reply to a request shall be subject to reply to a request shall be subject to reply to a request shall be subject to
administrative fines of up to 10 000 administrative fines of up to 10 000 administrative fines of up to 10 000 administrative fines of up to 10 000
000 EUR or, if the offender is a 0005 000 000 EUR or, if the 000 EUR or, if the offender is a 0007 500 000 EUR or, if the
company, up to 2 % of its total offender is a company, up to 21 % of company, up to 2 % of its total offender is a company, up to 21 % of
worldwide annual turnover for the its total worldwide annual turnover worldwide annual turnover for the its total worldwide annual turnover
preceding financial year, whichever for the preceding financial year, preceding financial year, whichever for the preceding financial year,
is higher. whichever is higher. is higher. In case of SMEs, whichever is higher.
including start-ups, these fines
shall be up to 1% of their worldwide 5a. In case of SMEs, including
annual turnover for the preceding start-ups, each fine referred to in
financial year. this Article shall be up to the
percentages or amount referred to
paragraphs 3, 4 and 5, whichever of
the two is lower.
Article 71(6)
6. When deciding on the amount of 6. Fines may be imposed in 6. When deciding on the amount of 6. When deciding whether to
the administrative fine in each addition to or instead of non- the administrative fine in each impose an administrative fine and
individual case, all relevant monetary measures such as orders individual case, all relevant on the amount of the administrative
circumstances of the specific or warnings. When deciding on the circumstances of the specific fine in each individual case, all
situation shall be taken into account amount of the administrative fine in situation shall be taken into account relevant circumstances of the
G 675 G
and due regard shall be given to the each individual case, all relevant and due regard shall be given to the specific situation shall be taken into
following: circumstances of the specific following: account and, as appropriate, due
situation shall be taken into account regard shall be given to the
and due regard shall be given to the following:
following:;
G 676 G
(a) the nature, gravity and duration (a) the nature, gravity and duration (a) the nature, gravity and duration (a) the nature, gravity and duration
of the infringement and of its of the infringement and of its of the infringement and of its of the infringement and of its
consequences; consequences, taking into account consequences; consequences, taking into account
the purpose of the AI system, as the purpose of the AI system, as
well as, where appropriate, the well as, where appropriate, the
number of affected persons and the number of affected persons and the
level of damage suffered by them; level of damage suffered by them;
(aa) the intentional or negligent (aa)

G 676a G
character of the infringement;
Article 71(6), point (ab)
(ab) any action taken by the (ab)

operator in order to remedy the
G 676b infringement and mitigate the G
possible adverse effects of the

infringement;
(b) whether administrative fines (b) whether administrative fines (b) whether administrative fines (b) whether administrative fines
have been already applied by other have been already applied by other have been already applied by other have been already applied by other
market surveillance authorities to the market surveillancenational market surveillance authorities in market surveillance authorities of
G 677 same operator for the same supervisory authorities of one or other Member States to the same one or more Member States to the G
infringement. more Member States to the same operator for the same infringement.; same operator for the same
operator for the same infringement.; infringement.;

G 677a G
(ba) whether administrative fines (ba) whether administrative fines
have been already applied by other have been already applied by other
authorities to the same operator for authorities to the same operator for
infringements of other Union or infringements of other Union or
national law, when such national law, when such
infringements result from the same infringements result from the same
activity or omission constituting a activity or omission constituting a
relevant infringement of this Act; relevant infringement of this Act;
(c) the size and market share of the (c) the size and market shareannual (c) the size, the annual turnover (c) the size, the annual turnover
operator committing the turnover of the operator committing and market share of the operator and market share of the operator
G 678 infringement; the infringement; committing the infringement; committing the infringement; G
(ca) any other aggravating or (ca) any other aggravating or

mitigating factor applicable to the mitigating factor applicable to the
circumstances of the case, such as circumstances of the case, such as
G 678a financial benefits gained, or losses financial benefits gained, or losses G
avoided, directly or indirectly, from avoided, directly or indirectly, from

the infringement. the infringement.
(ca) the degree of cooperation with (ca) the degree of cooperation with
G 678b G
the national competent authorities, the national competent authorities,
in order to remedy the infringement in order to remedy the infringement
and mitigate the possible adverse and mitigate the possible adverse
effects of the infringement; effects of the infringement;
Article 71(6), point (cc)
(cb) the degree of responsibility of (cb) the degree of responsibility of

the operator taking into account the the operator taking into account the
G 678c technical and organisational technical and organisational G
measures implemented by them; measures implemented by them;

(cc) adherence to approved codes (cc)

G 678d of conduct or approved certification G
mechanisms;
(cd) any relevant previous

G 678e G
infringements by the operator;
Article 71(6), point (ce)
(ce) the manner in which the (ce) the manner in which the
infringement became known to the infringement became known to the
national competent authorities, in national competent authorities, in
G 678f G
particular whether, and if so to particular whether, and if so to
what extent, the operator notified what extent, the operator notified
the infringement; the infringement;
Article 71(6), point (cf)
(cf) the intentional or negligent (cf) the intentional or negligent

G 678g character of the infringement; character of the infringement; G
Article 71(6), point (cg)
(cg) any action taken by the (cg) any action taken by the
operator to mitigate the harm of operator to mitigate the harm of
G 678h damage suffered by the affected damage suffered by the affected G
persons; persons;
Article 71(7)
7. Each Member State shall lay 7. each Member State shall lay 7. Each Member State shall lay 7. Each Member State shall lay
down rules on whether and to what down rules on whether and to what down rules on whether and to what down rules on whether and to what
extent administrative fines may be extent administrative fines mayto be extent administrative fines may be extent administrative fines may be
G 679 imposed on public authorities and imposed on public authorities and imposed on public authorities and imposed on public authorities and G
bodies established in that Member bodies established in that Member bodies established in that Member bodies established in that Member
State. State.; State. State.
Article 71(8)
8. Depending on the legal system of 8. Depending on the legal system of 8. Depending on the legal system of 8. Depending on the legal system of
G 680 G
the Member States, the rules on the Member States, the rules on the Member States, the rules on the Member States, the rules on
administrative fines may be applied administrative fines may be applied administrative fines may be applied administrative fines may be applied
in such a manner that the fines are in such a manner that the fines are in such a manner that the fines are in such a manner that the fines are
imposed by competent national imposed by competent national imposed by competent national imposed by competent national
courts of other bodies as applicable courts of other bodies as applicable courts ofor other bodies as courts ofor other bodies as
in those Member States. The in those Member States. The applicable in those Member States. applicable in those Member States.
application of such rules in those application of such rules in those The application of such rules in The application of such rules in
Member States shall have an Member States shall have an those Member States shall have an those Member States shall have an
equivalent effect. equivalent effect. equivalent effect. equivalent effect.
Article 71(8a)
8a. The exercise by the market 8a. The exercise by the market
surveillance authority of its powers surveillance authority of its powers
under this Article shall be subject to under this Article shall be subject to
appropriate procedural safeguards appropriate procedural safeguards
G 680a in accordance with Union and in accordance with Union and G
Member State law, including Member State law, including

effective judicial remedy and due effective judicial remedy and due
process. process.
Article 71(8a)
8a. The penalties referred to in this

article as well as the associated
litigation costs and indemnification
claims may not be the subject of
G 680b contractual clauses or other form of G
burden-sharing agreements
between providers and distributors,
importers, deployers, or any other
third parties;
Article 71(8b)
8b. National supervisory 8b. Member States shall, on an

authorities shall, on an annual annual basis, report to the
basis, report to the AI Office about Commission about the
the fines they have issued during administrative fines they have
G 680c that year, in accordance with this issued during that year, in G
Article; accordance with this Article, and

any related litigation or judicial
proceedings;
Article 71(8c)
8c. The exercise by competent

authorities of their powers under
this Article shall be subject to
G 680d appropriate procedural safeguards G
in accordance with Union and

national law, including judicial
remedy and due process;
Article 72

Administrative fines on Union Administrative fines on Union Administrative fines on Union Administrative fines on Union
G 681 institutions, agencies and bodies institutions, agencies and bodies institutions, agencies and bodies institutions, agencies and bodies G

Proposal
Article 72(1)
G 682 G
1. The European Data Protection 1. The European Data Protection 1. The European Data Protection 1. The European Data Protection
Supervisor may impose Supervisor may impose Supervisor may impose Supervisor may impose
administrative fines on Union administrative fines on Union administrative fines on Union administrative fines on Union
institutions, agencies and bodies institutions, agencies and bodies institutions, agencies and bodies institutions, agencies and bodies
falling within the scope of this falling within the scope of this falling within the scope of this falling within the scope of this
Regulation. When deciding whether Regulation. When deciding whether Regulation. When deciding whether Regulation. When deciding whether
to impose an administrative fine and to impose an administrative fine and to impose an administrative fine and to impose an administrative fine and
deciding on the amount of the deciding on the amount of the deciding on the amount of the deciding on the amount of the
administrative fine in each administrative fine in each administrative fine in each administrative fine in each
individual case, all relevant individual case, all relevant individual case, all relevant individual case, all relevant
circumstances of the specific circumstances of the specific circumstances of the specific circumstances of the specific
situation shall be taken into account situation shall be taken into account situation shall be taken into account situation shall be taken into account
and due regard shall be given to the and due regard shall be given to the and due regard shall be given to the and due regard shall be given to the
following: following: following: following:
Proposal
(a) the nature, gravity and duration (a) the nature, gravity and duration (a) the nature, gravity and duration (a) the nature, gravity and duration
of the infringement and of its of the infringement and of its of the infringement and of its of the infringement and of its
consequences; consequences;, taking into account consequences; consequences;, taking into account
the purpose of the AI system the purpose of the AI system
G 683 concerned as well as the number of concerned as well as the number of G
affected persons and the level of affected persons and the level of
damage suffered by them, and any damage suffered by them, and any
relevant previous infringement; relevant previous infringement;
(aa) the degree of responsibility of (aa) the degree of responsibility of

G 683a the Union institution, agency or the Union institution, agency or G
body, taking into account technical body, taking into account technical
and organisational measures and organisational measures
implemented by them; implemented by them;
Article 72(1), point (ab)
(ab) any action taken by the Union (ab) any action taken by the Union
institution, agency or body to institution, agency or body to
G 683b mitigate the damage suffered by mitigate the damage suffered by G
affected persons; affected persons;

(b) the cooperation with the (b) the degree of cooperation with (b) the cooperation with the (b) the degree of cooperation with
European Data Protection the European Data Protection European Data Protection the European Data Protection
Supervisor in order to remedy the Supervisor in order to remedy the Supervisor in order to remedy the Supervisor in order to remedy the
infringement and mitigate the infringement and mitigate the infringement and mitigate the infringement and mitigate the
possible adverse effects of the possible adverse effects of the possible adverse effects of the possible adverse effects of the
infringement, including compliance infringement, including compliance infringement, including compliance infringement, including compliance
G 684 with any of the measures previously with any of the measures previously with any of the measures previously with any of the measures previously G
ordered by the European Data ordered by the European Data ordered by the European Data ordered by the European Data
Protection Supervisor against the Protection Supervisor against the Protection Supervisor against the Protection Supervisor against the
Union institution or agency or body Union institution or agency or body Union institution or agency or body Union institution or agency or body
concerned with regard to the same concerned with regard to the same concerned with regard to the same concerned with regard to the same
subject matter; subject matter; subject matter; subject matter;
(c) any similar previous (c) any similar previous (c) any similar previous (c) any similar previous
G 685 G
infringements by the Union infringements by the Union infringements by the Union infringements by the Union
institution, agency or body; institution, agency or body; institution, agency or body;. institution, agency or body;

Proposal
(ca) the manner in which the (ca) the manner in which the
infringement became known to the infringement became known to the
European Data Protection European Data Protection
Supervisor, in particular whether, Supervisor, in particular whether,
G 685a and if so to what extent, the Union and if so to what extent, the Union G
institution or body notified the institution or body notified the

infringement; infringement;
(cb) the annual budget of the body; (cb) the annual budget of the body;
G 685b G
Article 72(2)
2. The following infringements shall 2. Non compliance with the 2. Non-compliance with any of the 2. Non compliance with the
be subject to administrative fines of prohibition of the artificial prohibitions of the artificial prohibition of the artificial
up to 500 000 EUR: intelligence practices referred to in intelligence practices referred to in intelligence practices referred to in
Article 5The following infringements Article 5The following infringements Article 5The following infringements
G 686 shall be subject to administrative shall be subject to administrative shall be subject to administrative G
fines of up to 500 000 EUR: EUR 1 fines of up to 500 000 EUR:. fines of up to 500 000 EUR: EUR 1
500 000. 500 000.
Article 72(2), point (-a)
G 686a G
(a) non-compliance with the (a) non-compliance with the

prohibition of the artificial deleted deleted prohibition of the artificial
G 687 G
intelligence practices referred to in intelligence practices referred to in
Article 5; Article 5;deleted
2 a non-compliance of the AI (aa) deleted

system with the requirements laid
G 687a down in Article 10 shall be subject G
to administrative fines of up to 1
000 000 EUR.
(b) non-compliance of the AI (b) non-compliance of the AI (b) non-compliance of the AI system
system with the requirements laid system with the requirements laid deleted with the requirements laid down in
G 688 down in Article 10. down in Article 10. Article 10.deleted G
Article 72(3)
3. The non-compliance of the AI 3. the non-compliance of the AI 3. The Non-compliance of the AI 3. the non-compliance of the AI
system with any requirements or system with any requirements or system with any requirements or system with any requirements or
G 689 obligations under this Regulation, obligations under this Regulation, obligations under this Regulation, obligations under this Regulation, G
other than those laid down in other than those laid down in other than those laid down in other than those laid down in
Articles 5 and 10, shall be subject to Articles 5 and 10, shall be subject to Articles 5 and 10, shall be subject to Articles 5 and 10, shall be subject to
administrative fines of up to 250 000 administrative fines of up to 250 000 administrative fines of up to 250 000 administrative fines of up to 250 000
EUR. EUR 750 000. EUR. EUR 750 000.
Article 72(4)
4. Before taking decisions pursuant 4. Before taking decisions pursuant 4. Before taking decisions pursuant 4. Before taking decisions pursuant
to this Article, the European Data to this Article, the European Data to this Article, the European Data to this Article, the European Data
Protection Supervisor shall give the Protection Supervisor shall give the Protection Supervisor shall give the Protection Supervisor shall give the
Union institution, agency or body Union institution, agency or body Union institution, agency or body Union institution, agency or body
which is the subject of the which is the subject of the which is the subject of the which is the subject of the
proceedings conducted by the proceedings conducted by the proceedings conducted by the proceedings conducted by the
Supervisor the opportunity of being Supervisor the opportunity of being Supervisor the opportunity of being Supervisor the opportunity of being
heard on the matter regarding the heard on the matter regarding the heard on the matter regarding the heard on the matter regarding the
possible infringement. The European possible infringement. The European possible infringement. The European possible infringement. The European
G 690 Data Protection Supervisor shall Data Protection Supervisor shall Data Protection Supervisor shall Data Protection Supervisor shall
G
base his or her decisions only on base his or her decisions only on base his or her decisions only on base his or her decisions only on
elements and circumstances on elements and circumstances on elements and circumstances on elements and circumstances on
which the parties concerned have which the parties concerned have which the parties concerned have which the parties concerned have
been able to comment. been able to comment. been able to comment. been able to comment.
Complainants, if any, shall be Complainants, if any, shall be Complainants, if any, shall be Complainants, if any, shall be
associated closely with the associated closely with the associated closely with the associated closely with the
proceedings. proceedings. proceedings. proceedings.
Proposal
Article 72(5)
5. The rights of defense of the 5. The rights of defense of the 5. The rights of defense of the 5. The rights of defense of the
parties concerned shall be fully parties concerned shall be fully parties concerned shall be fully parties concerned shall be fully
G 691 respected in the proceedings. They respected in the proceedings. They respected in the proceedings. They respected in the proceedings. They G
shall be entitled to have access to the shall be entitled to have access to the shall be entitled to have access to the shall be entitled to have access to the
Supervisor’s file, subject to the Supervisor’s file, subject to the Supervisor’s file, subject to the Supervisor’s file, subject to the
legitimate interest of individuals or legitimate interest of individuals or legitimate interest of individuals or legitimate interest of individuals or
undertakings in the protection of undertakings in the protection of undertakings in the protection of undertakings in the protection of
their personal data or business their personal data or business their personal data or business their personal data or business
secrets. secrets. secrets. secrets.
Proposal
Article 72(6)
6. Funds collected by imposition of 6. Funds collected by imposition of 6. Funds collected by imposition of 6. Funds collected by imposition of
fines in this Article shall be the fines in this Article shall be the fines in this Article shall be the fines in this Article shall be the
income of the general budget of the incomecontribute to the general income of the general budget of the incomecontribute to the general
Union. budget of the general budgetUnion. Union. budget of the general budgetUnion.
G 692 The fines shall not affect the The fines shall not affect the G
effective operation of the Union effective operation of the Union

institution, body or agency fined. institution, body or agency fined.
Article 72(6a)
6a. the European Data Protection 6a. the European Data Protection
Supervisor shall, on an annual Supervisor shall, on an annual
basis, notify the AI Office of the basis, notify the Commission of the
fines it has imposed pursuant to this administrative fines it has imposed
Article. pursuant to this Article and any
litigation or judicial proceedings;
G 692a G
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 Article [Power to
request documentation and
information], or supply of incorrect,
incomplete or misleading
information;
(b) fails to comply with a measure

requested under Article [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
[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 F(3) or in relevant
codes of practice in accordance
with Article [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
in accordance with the
examination procedure referred to
in Article xx(x).
TITLE XI
TITLE XI TITLE XI TITLE XI TITLE XI

DELEGATION OF POWER AND DELEGATION OF POWER AND DELEGATION OF POWER AND DELEGATION OF POWER AND
G 693 COMMITTEE PROCEDURE COMMITTEE PROCEDURE COMMITTEE PROCEDURE COMMITTEE PROCEDURE G

Proposal
Article 73

Exercise of the delegation Exercise of the delegation Exercise of the delegation Exercise of the delegation
G 694 G

Proposal
Article 73(1)
1. The power to adopt delegated 1. The power to adopt delegated 1. The power to adopt delegated 1. The power to adopt delegated
acts is conferred on the Commission acts is conferred on the Commission acts is conferred on the Commission acts is conferred on the Commission
subject to the conditions laid down subject to the conditions laid down subject to the conditions laid down subject to the conditions laid down
G 695 in this Article. in this Article. in this Article. in this Article.
G

Proposal
Article 73(2)
2. The delegation of power referred 2. The delegation of powerpower to 2. The delegation of power referred 2. The delegation of powerpower to
to in Article 4, Article 7(1), Article adopt delegated acts referred to in to in Article 47(1), Article 7(1)7(3), adopt delegated acts referred to in
11(3), Article 43(5) and (6) and Article 4, Article 7(1), Article 11(3), Article 11(3), Article 43(5) and (6) [Article 4, Article 7(1), Article
Article 48(5) shall be conferred on Article 43(5) and (6) and Article and Article 48(5) shall be conferred 11(3), Article 43(5) and (6) and
the Commission for an indeterminate 48(5) shall be conferred on the on the Commission for an Article 48(5)] shall be conferred on
period of time from [entering into Commission for an indeterminatea indeterminatea period of timefive the Commission for an
force of the Regulation]. period of time from five years from years from [entering into force of indeterminatea period of time from
… [enteringthe date of entry into the Regulationentering into force of five years from … [enteringthe date
force of the Regulation].The the Regulation]. of entry into force of the
Commission shall draw up a report Regulation].The Commission shall
G 696 in respect of the delegation of draw up a report in respect of the G
power not later than 9 months delegation of power not later than 9
before the end of the five-year months before the end of the five-
period. The delegation of power year period. The delegation of
shall be tacitly extended for periods power shall be tacitly extended for
of an identical duration, unless the periods of an identical duration,
European Parliament or the unless the European Parliament or
Council opposes such extension not the Council opposes such extension
later than three months before the not later than three months before
end of each period. the end of each period.
Article 73(2a)
G 696a G
2a. The Commission shall draw up
a report in respect of the delegation covered above.
of power not later than nine months
before the end of the 5 year period.
The delegation of power shall be
tacitly extended for periods of an
identical duration, unless the
European Parliament or the
Council opposes such extension not
later than three months before the
end of each period.
Article 73(3)
3. The delegation of power referred 3. The delegation of power referred 3. The delegation of power referred 3. The delegation of power referred
to in Article 4, Article 7(1), Article to in Article 4, Article 7(1), Article to in Article 47(1), Article 7(1)7(3), to in {Article 47(1), Article 7(1)7(3),
11(3), Article 43(5) and (6) and 11(3), Article 43(5) and (6) and Article 11(3), Article 43(5) and (6) Article 11(3), Article 43(5) and (6)
Article 48(5) may be revoked at any Article 48(5) may be revoked at any and Article 48(5) may be revoked at and Article 48(5)] may be revoked at
time by the European Parliament or time by the European Parliament or any time by the European Parliament any time by the European Parliament
by the Council. A decision of by the Council. A decision of or by the Council. A decision of or by the Council. A decision of
revocation shall put an end to the revocation shall put an end to the revocation shall put an end to the revocation shall put an end to the
delegation of power specified in that delegation of power specified in that delegation of power specified in that delegation of power specified in that
G 697 decision. It shall take effect the day decision. It shall take effect the day decision. It shall take effect the day decision. It shall take effect the day G
following that of its publication in following that of its publication in following that of its publication in following that of its publication in
the Official Journal of the European the Official Journal of the European the Official Journal of the the Official Journal of the
Union or at a later date specified Union or at a later date specified European UnionOfficial Journal of European UnionOfficial Journal of
therein. It shall not affect the validity therein. It shall not affect the validity the European Union or at a later date the European Union or at a later date
of any delegated acts already in of any delegated acts already in specified therein. It shall not affect specified therein. It shall not affect
force. force. the validity of any delegated acts the validity of any delegated acts
already in force. already in force.
Article 73(3a)
G 697a G
3a. Before adopting a delegated
act, the Commission shall consult
with the relevant institutions, the
Office, the Advisory Forum and
other relevant stakeholders in
accordance with the principles laid
down in the Interinstitutional
Agreement of 13 April 2016 on
Better Law-Making.
Once the Commission decides to
draft a delegated act, it shall notify
the European Parliament of this
fact. This notification does not
place an obligation on the
Commission to adopt the said act.
Article 73(4)
4. As soon as it adopts a delegated 4. As soon as it adopts a delegated 4. As soon as it adopts a delegated 4. As soon as it adopts a delegated
act, the Commission shall notify it act, the Commission shall notify it act, the Commission shall notify it act, the Commission shall notify it
simultaneously to the European simultaneously to the European simultaneously to the European simultaneously to the European
G 698 Parliament and to the Council. Parliament and to the Council. Parliament and to the Council. Parliament and to the Council.
G

Proposal
Article 73(5)
5. Any delegated act adopted 5. Any delegated act adopted 5. Any delegated act adopted 5. Any delegated act adopted
pursuant to Article 4, Article 7(1), pursuant to Article 4, Article 7(1), pursuant to Article 47(1), Article pursuant to [Article 4], Article 7(1),
Article 11(3), Article 43(5) and (6) Article 11(3), Article 43(5) and (6) 7(1)7(3), Article 11(3), Article 43(5) Article 11(3), Article 43(5) and (6)
G 699 G
and Article 48(5) shall enter into and Article 48(5) shall enter into and (6) and Article 48(5) shall enter and Article 48(5) shall enter into
force only if no objection has been force only if no objection has been into force only if no objection has force only if no objection has been
expressed by either the European expressed by either the European been expressed by either the expressed by either the European
Parliament or the Council within a Parliament or the Council within a European Parliament or the Council Parliament or the Council within a
period of three months of period of three months of within a period of three months of period of three months of
notification of that act to the notification of that act to the notification of that act to the notification of that act to the
European Parliament and the European Parliament and the European Parliament and the European Parliament and the
Council or if, before the expiry of Council or if, before the expiry of Council or if, before the expiry of Council or if, before the expiry of
that period, the European Parliament that period, the European Parliament that period, the European Parliament that period, the European Parliament
and the Council have both informed and the Council have both informed and the Council have both informed and the Council have both informed
the Commission that they will not the Commission that they will not the Commission that they will not the Commission that they will not
object. That period shall be extended object. That period shall be extended object. That period shall be extended object. That period shall be extended
by three months at the initiative of by three months at the initiative of by three months at the initiative of by three months at the initiative of
the European Parliament or of the the European Parliament or of the the European Parliament or of the the European Parliament or of the
Council. Council. Council. Council.
Proposal
Article 74

Committee procedure Committee procedure Committee procedure Committee procedure
G 700 G

Proposal
Article 74(1)
1. The Commission shall be assisted 1. The Commission shall be assisted 1. The Commission shall be assisted 1. The Commission shall be assisted
by a committee. That committee by a committee. That committee by a committee. That committee by a committee. That committee
shall be a committee within the shall be a committee within the shall be a committee within the shall be a committee within the
G 701 meaning of Regulation (EU) No meaning of Regulation (EU) No meaning of Regulation (EU) No meaning of Regulation (EU) No G
182/2011. 182/2011. 182/2011. 182/2011.

Proposal
Article 74(2)
G 702 G
2. Where reference is made to this 2. Where reference is made to this 2. Where reference is made to this 2. Where reference is made to this
paragraph, Article 5 of Regulation paragraph, Article 5 of Regulation paragraph, Article 5 of Regulation paragraph, Article 5 of Regulation
(EU) No 182/2011 shall apply. (EU) No 182/2011 shall apply. (EU) No 182/2011 shall apply. (EU) No 182/2011 shall apply.
Proposal
TITLE XII
TITLE XII TITLE XII TITLE XII TITLE XII

FINAL PROVISIONS FINAL PROVISIONS FINAL PROVISIONS FINAL PROVISIONS
G 703 G

Proposal
Article 75

Amendment to Regulation (EC) No Amendment to Regulation (EC) No Amendment to Regulation (EC) No Amendment to Regulation (EC) No
G 704 300/2008 300/2008 300/2008 300/2008 G

Proposal
In Article 4(3) of Regulation (EC) In Article 4(3) of Regulation (EC) In Article 4(3) of Regulation (EC) In Article 4(3) of Regulation (EC)
No 300/2008, the following No 300/2008, the following No 300/2008, the following No 300/2008, the following
G 705 subparagraph is added: subparagraph is added: subparagraph is added: subparagraph is added: G

Proposal
Article 75, first paragraph, amending provision, first paragraph

G 706 G
“ “ “ “
When adopting detailed measures When adopting detailed measures “When adopting detailed measures When adopting detailed measures
related to technical specifications related to technical specifications related to technical specifications related to technical specifications
and procedures for approval and use and procedures for approval and use and procedures for approval and use and procedures for approval and use
of security equipment concerning of security equipment concerning of security equipment concerning of security equipment concerning
Artificial Intelligence systems in the Artificial Intelligence systems in the Artificial Intelligence systems in the Artificial Intelligence systems in the
meaning of Regulation (EU) meaning of Regulation (EU) meaning of Regulation (EU) meaning of Regulation (EU)
YYY/XX [on Artificial Intelligence] YYY/XX [on Artificial Intelligence] YYY/XX [on Artificial Intelligence] YYY/XX [on Artificial Intelligence]
the Council*, the requirements set the Council*, the requirements set the Council*, the requirements set the Council*, the requirements set
out in Chapter 2, Title III of that out in Chapter 2, Title III of that out in Chapter 2, Title III of that out in Chapter 2, Title III of that
Regulation shall be taken into Regulation shall be taken into Regulation shall be taken into Regulation shall be taken into
account.” account.” account.” account.”
Proposal
Article 75, first paragraph, amending provision, second paragraph
__________ __________ __________ __________

G
Proposal
Article 75, first paragraph, amending provision, third paragraph
* Regulation (EU) YYY/XX [on * Regulation (EU) YYY/XX [on * Regulation (EU) YYY/XX [on * Regulation (EU) YYY/XX [on
Artificial Intelligence] (OJ …).” Artificial Intelligence] (OJ …).” Artificial Intelligence] (OJ …).” Artificial Intelligence] (OJ …).”
G 708 “ “ “ “ G

Proposal
Article 76
G 709 G
Amendment to Regulation (EU) No Amendment to Regulation (EU) No Amendment to Regulation (EU) No Amendment to Regulation (EU) No
167/2013 167/2013 167/2013 167/2013
Proposal
In Article 17(5) of Regulation (EU) In Article 17(5) of Regulation (EU) In Article 17(5) of Regulation (EU) In Article 17(5) of Regulation (EU)

Proposal
“ “ “ “
When adopting delegated acts When adopting delegated acts “When adopting delegated acts When adopting delegated acts
pursuant to the first subparagraph pursuant to the first subparagraph pursuant to the first subparagraph pursuant to the first subparagraph
concerning artificial intelligence concerning artificial intelligence concerning artificial intelligence concerning artificial intelligence
systems which are safety systems which are safety systems which are safety systems which are safety
components in the meaning of components in the meaning of components in the meaning of components in the meaning of
Regulation (EU) YYY/XX [on Regulation (EU) YYY/XX [on Regulation (EU) YYY/XX [on Regulation (EU) YYY/XX [on
G 711 Artificial Intelligence] of the Artificial Intelligence] of the Artificial Intelligence] of the Artificial Intelligence] of the G
Council*, the requirements set out in Council*, the requirements set out in Council*, the requirements set out in Council*, the requirements set out in
Title III, Chapter 2 of that Title III, Chapter 2 of that Title III, Chapter 2 of that Title III, Chapter 2 of that
account. account. account. account.
Proposal

G 712 G
__________ __________ __________ __________
Proposal
Artificial Intelligence] (OJ …). Artificial Intelligence] (OJ …). Artificial Intelligence] (OJ …).” Artificial Intelligence] (OJ …).
G 713 ” ” ” ” G

Proposal
Article 77

Amendment to Regulation (EU) No Amendment to Regulation (EU) No Amendment to Regulation (EU) No Amendment to Regulation (EU) No
G 714 168/2013 168/2013 168/2013 168/2013 G

Proposal
In Article 22(5) of Regulation (EU) In Article 22(5) of Regulation (EU) In Article 22(5) of Regulation (EU) In Article 22(5) of Regulation (EU)

Proposal
G 716 G
“ “ “ “
When adopting delegated acts When adopting delegated acts “When adopting delegated acts When adopting delegated acts
pursuant to the first subparagraph pursuant to the first subparagraph pursuant to the first subparagraph pursuant to the first subparagraph
concerning Artificial Intelligence concerning Artificial Intelligence concerning Artificial Intelligence concerning Artificial Intelligence
Regulation (EU) YYY/XX on Regulation (EU) YYY/XX on Regulation (EU) YYY/XX on Regulation (EU) YYY/XX on
[Artificial Intelligence] of the [Artificial Intelligence] of the [Artificial Intelligence] of the [Artificial Intelligence] of the
Proposal
__________ __________ __________ __________

G
Proposal
Artificial Intelligence] (OJ …). Artificial Intelligence] (OJ …). Artificial Intelligence] (OJ …).” Artificial Intelligence] (OJ …).
G 718 ” ” ” ” G

Proposal
Article 78
Amendment to Directive Amendment to Directive Amendment to Directive Amendment to Directive

2014/90/EU 2014/90/EU 2014/90/EU 2014/90/EU
Proposal
In Article 8 of Directive In Article 8 of Directive In Article 8 of Directive In Article 8 of Directive

2014/90/EU, the following 2014/90/EU, the following 2014/90/EU, the following 2014/90/EU, the following
G 720 paragraph is added: paragraph is added: paragraph is added: paragraph is added: G

Proposal
Article 78, first paragraph, amending provision, first subparagraph
" " " "

4. “For Artificial Intelligence 4. “For Artificial Intelligence 4. “4. For Artificial Intelligence 4. “For Artificial Intelligence
Artificial Intelligence] of the Artificial Intelligence] of the Artificial Intelligence] of the Artificial Intelligence] of the
Council*, when carrying out its Council*, when carrying out its Council*, when carrying out its Council*, when carrying out its
activities pursuant to paragraph 1 activities pursuant to paragraph 1 activities pursuant to paragraph 1 activities pursuant to paragraph 1
G 721 and when adopting technical and when adopting technical and when adopting technical and when adopting technical
G
specifications and testing standards specifications and testing standards specifications and testing standards specifications and testing standards
in accordance with paragraphs 2 and in accordance with paragraphs 2 and in accordance with paragraphs 2 and in accordance with paragraphs 2 and
3, the Commission shall take into 3, the Commission shall take into 3, the Commission shall take into 3, the Commission shall take into
account the requirements set out in account the requirements set out in account the requirements set out in account the requirements set out in
Regulation. Regulation. Regulation. Regulation.
Proposal
Article 78, first paragraph, amending provision, first subparagraph, first paragraph
__________ __________ __________ __________

G
Proposal
Article 78, first paragraph, amending provision, first subparagraph, second paragraph
Artificial Intelligence] (OJ …).”. Artificial Intelligence] (OJ …).”. Artificial Intelligence] (OJ …).”. Artificial Intelligence] (OJ …).”.
G 723 " " " " G

Proposal
Article 79

Amendment to Directive (EU) Amendment to Directive (EU) Amendment to Directive (EU) Amendment to Directive (EU)
G 724 2016/797 2016/797 2016/797 2016/797 G

Proposal
In Article 5 of Directive (EU) In Article 5 of Directive (EU) In Article 5 of Directive (EU) In Article 5 of Directive (EU)
2016/797, the following paragraph is 2016/797, the following paragraph is 2016/797, the following paragraph is 2016/797, the following paragraph is
G 725 added: added: added: added: G

Proposal
" " " "

12. “When adopting delegated acts 12. “When adopting delegated acts 12. “12. When adopting delegated 12. “When adopting delegated acts
pursuant to paragraph 1 and pursuant to paragraph 1 and acts pursuant to paragraph 1 and pursuant to paragraph 1 and
implementing acts pursuant to implementing acts pursuant to implementing acts pursuant to implementing acts pursuant to
paragraph 11 concerning Artificial paragraph 11 concerning Artificial paragraph 11 concerning Artificial paragraph 11 concerning Artificial
Intelligence systems which are Intelligence systems which are Intelligence systems which are Intelligence systems which are
safety components in the meaning of safety components in the meaning of safety components in the meaning of safety components in the meaning of
G 726 Artificial Intelligence] of the Artificial Intelligence] of the Artificial Intelligence] of the Artificial Intelligence] of the
G
Proposal
__________ __________ __________ __________

G
Proposal
G 728 " " " " G

Proposal
Article 80

Amendment to Regulation (EU) Amendment to Regulation (EU) Amendment to Regulation (EU) Amendment to Regulation (EU)
G 729 2018/858 2018/858 2018/858 2018/858 G

Proposal
In Article 5 of Regulation (EU) In Article 5 of Regulation (EU) In Article 5 of Regulation (EU) In Article 5 of Regulation (EU)
2018/858 the following paragraph is 2018/858 the following paragraph is 2018/858 the following paragraph is 2018/858 the following paragraph is
G 730 added: added: added: added: G

Proposal
" " " "

4. “When adopting delegated acts 4. “When adopting delegated acts 4. “4. When adopting delegated acts 4. “When adopting delegated acts
pursuant to paragraph 3 concerning pursuant to paragraph 3 concerning pursuant to paragraph 3 concerning pursuant to paragraph 3 concerning
Artificial Intelligence systems which Artificial Intelligence systems which Artificial Intelligence systems which Artificial Intelligence systems which
are safety components in the are safety components in the are safety components in the are safety components in the
YYY/XX [on Artificial Intelligence] YYY/XX [on Artificial Intelligence] YYY/XX [on Artificial Intelligence] YYY/XX [on Artificial Intelligence]
G 731 of the European Parliament and of of the European Parliament and of of the European Parliament and of of the European Parliament and of
G
the Council *, the requirements set the Council *, the requirements set the Council *, the requirements set the Council *, the requirements set
out in Title III, Chapter 2 of that out in Title III, Chapter 2 of that out in Title III, Chapter 2 of that out in Title III, Chapter 2 of that
Proposal
__________ __________ __________

G
Proposal
G 733 " " " " G

Proposal
Article 81

G 734 2018/1139 2018/1139 2018/1139 2018/1139 G

Proposal
Regulation (EU) 2018/1139 is Regulation (EU) 2018/1139 is Regulation (EU) 2018/1139 is Regulation (EU) 2018/1139 is
amended as follows: amended as follows: amended as follows: amended as follows:
G 735 G

Proposal
G 736 G
(1) In Article 17, the following (1) In Article 17, the following (1) In Article 17, the following (1) In Article 17, the following
paragraph is added: paragraph is added: paragraph is added: paragraph is added:
Proposal
Article 81, first paragraph, point (1), amending provision, first subparagraph
" " " "

3. “Without prejudice to paragraph 3. “Without prejudice to paragraph 3. “Without prejudice to paragraph 3. “Without prejudice to paragraph
2, when adopting implementing acts 2, when adopting implementing acts 2, when adopting implementing acts 2, when adopting implementing acts
pursuant to paragraph 1 concerning pursuant to paragraph 1 concerning pursuant to paragraph 1 concerning pursuant to paragraph 1 concerning
Artificial Intelligence systems which Artificial Intelligence systems which Artificial Intelligence systems which Artificial Intelligence systems which
are safety components in the are safety components in the are safety components in the are safety components in the
G 737 YYY/XX [on Artificial Intelligence] YYY/XX [on Artificial Intelligence] YYY/XX [on Artificial YYY/XX [on Artificial Intelligence] G
of the European Parliament and of of the European Parliament and of Intelligenceon Artificial of the European Parliament and of
the Council*, the requirements set the Council*, the requirements set Intelligence] of the European the Council*, the requirements set
out in Title III, Chapter 2 of that out in Title III, Chapter 2 of that Parliament and of the Council*, the out in Title III, Chapter 2 of that
Regulation shall be taken into Regulation shall be taken into requirements set out in Title III, Regulation shall be taken into
account. account. Chapter 2 of that Regulation shall be account.
taken into account.
Proposal
Article 81, first paragraph, point (1), amending provision, first subparagraph, first paragraph
__________ __________ __________

G
Proposal
Article 81, first paragraph, point (1), amending provision, first subparagraph, second paragraph
G 739 G
Artificial Intelligence] (OJ …).” Artificial Intelligence] (OJ …).” Artificial Intelligence] (OJ …).” Artificial Intelligence] (OJ …).”
" " " "

Proposal
G 740 G

Proposal
Article 81, first paragraph, point (2), amending provision, numbered paragraph (4)
“ “ “ “
4. When adopting delegated acts 4. When adopting delegated acts 4. When adopting delegated acts 4. When adopting delegated acts
pursuant to paragraphs 1 and 2 pursuant to paragraphs 1 and 2 pursuant to paragraphs 1 and 2 pursuant to paragraphs 1 and 2
G 741 Artificial Intelligence], the Artificial Intelligence], the Artificial Intelligence], the Artificial Intelligence], the
G
requirements set out in Title III, requirements set out in Title III, requirements set out in Title III, requirements set out in Title III,
Chapter 2 of that Regulation shall be Chapter 2 of that Regulation shall be Chapter 2 of that Regulation shall be Chapter 2 of that Regulation shall be
taken into account. taken into account. taken into account.” taken into account.
” ” ” ”
Proposal
G 742 paragraph is added: paragraph is added: paragraph is added: paragraph is added: G
Proposal
“ “ “ “
4. When adopting implementing 4. When adopting implementing 4. When adopting implementing 4. When adopting implementing
acts pursuant to paragraph 1 acts pursuant to paragraph 1 acts pursuant to paragraph 1 acts pursuant to paragraph 1
G 743 Artificial Intelligence], the Artificial Intelligence], the Artificial Intelligence], the Artificial Intelligence], the
G
” ” ” ”
Proposal
G 744 G

Proposal
“ “ “ “
G 745 G
Artificial Intelligence], the Artificial Intelligence], the Artificial Intelligence], the Artificial Intelligence], the
” ” ” ”
Proposal
G 746 G

Proposal
Article 81, first paragraph, point (5), amending provision, first paragraph
“ “ “ “
When adopting those implementing When adopting those implementing When adopting those implementing When adopting those implementing
acts concerning Artificial acts concerning Artificial acts concerning Artificial acts concerning Artificial
Intelligence systems which are Intelligence systems which are Intelligence systems which are Intelligence systems which are
safety components in the meaning of safety components in the meaning of safety components in the meaning of safety components in the meaning of
G 747 Artificial Intelligence], the Artificial Intelligence], the Artificial Intelligence], the Artificial Intelligence], the G
” ” ” ”
Proposal
G 748 G

Proposal
“ “ “ “
G 749 Artificial Intelligence] , the Artificial Intelligence] , the Artificial Intelligence] , the Artificial Intelligence] , the
G
taken into account.. taken into account.. taken into account.”. taken into account..
” ” ” ”
Proposal
Article 81a (new)
Article 81a
Amendment to Regulation (EU)
2019/1020
G 749a G
Regulation (EU) 2019/1020 is

amended as follows:
in Article 14(4), the following
paragraph is added:
“(l). the power to implement the
powers provided for in this Article
remotely, where applicable;”
Article 82

G 750 2019/2144 2019/2144 2019/2144 2019/2144 G

Proposal
Article 82a (new)
Article 82a
Better Regulation
in taking into account the

requirements of this Regulation
pursuant to the Amendments in
Articles 75, 76, 77, 78, 79, 80, 81,
G 750a G
and 82, the Commission shall
conduct an analysis and consult
relevant stakeholders to determine
potential gaps as well as overlaps
between existing sectoral legislation
and the provisions of this
Regulation.
Article 82b (new)
G 750b Article 82b G
Guidelines from the Commission
on the implementation of this
Regulation
1. The Commission shall develop,

in consultation with the AI office,
guidelines on the practical
(a) the application of the
requirements referred to in Articles
8 - 15 and Article 28 to 28b;
(b) the prohibited practices
(c) the practical implementation
of the provisions related to
substantial modification;
(d) the practical circumstances
where the output of an AI system
referred to in Annex III would pose
a significant risk of harm to the
of natural persons as referred to in
Article 6, paragraph 2, including
examples in relation to high risk AI
systems referred to in Annex III;
(e) the practical implementation
of transparency obligations laid
down in Article 52;
(f) the development of codes of
conduct referred to in Article 69;
(g) the relationship of this
Regulation with other relevant
Union law, including as regards
consistency in their enforcement.
(h) the practical implementation
of Article 12, Article 28b on
environmental impact of
foundation models and Annex IV
3(b), particularly the measurement
and logging methods to enable
calculations and reporting of the
environmental impact of systems to
comply with the obligations in this
Regulation, including carbon
footprint and energy efficiency,
taking into account state-of-the-art
methods and economies of scale.
Commission shall pay particular
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.
In Article 11 of Regulation (EU) In Article 11 of Regulation (EU) In Article 11 of Regulation (EU) In Article 11 of Regulation (EU)
2019/2144, the following paragraph 2019/2144, the following paragraph 2019/2144, the following paragraph 2019/2144, the following paragraph
G 751 is added: is added: is added: is added: G

Proposal
G 752 ” ” ” ” G
3. “When adopting the 3. “When adopting the 3. “When adopting the 3. “When adopting the
implementing acts pursuant to implementing acts pursuant to implementing acts pursuant to implementing acts pursuant to
paragraph 2, concerning artificial paragraph 2, concerning artificial paragraph 2, concerning artificial paragraph 2, concerning artificial
intelligence systems which are safety intelligence systems which are safety intelligence systems which are safety intelligence systems which are safety
Artificial Intelligence] of the Artificial Intelligence] of the Artificial Intelligence] of the Artificial Intelligence] of the
Proposal
__________ __________ __________ __________

G
Proposal
Artificial Intelligence] (OJ …).. Artificial Intelligence] (OJ …).. Artificial Intelligence] (OJ …).”. Artificial Intelligence] (OJ …)..
G 754 ” ” ” ” G

Proposal
Article 82a
Article 82a
754a
Guidelines from the Commission on
Regulation
1. The Commission shall develop

guidelines on the practical
754b
Article 82a(1), first subparagraph, point (a)
(a) the application of the

754c
referred to in Articles 8 - 15 and
Article 28;
Article 82a(1), first subparagraph, point (b)
(b) the prohibited practices

754d
Article 82a(1), first subparagraph, point (c)
(c) the practical implementation of

754e the provisions related to substantial
modification;
Article 82a(1), first subparagraph, point (d)
(d) the practical implementation of

754f
transparency obligations laid down
in Article 52;
Article 82a(1), first subparagraph, point (e)
(e) detailed information on the

relationship of this Regulation with
the legislation referred to in Annex
754g II of this Regulation as well as
other relevant Union law, including
as regards consistency in their
enforcement;
Article 82a(1), first subparagraph, point (f)
(f) the application of the definition

754h of an AI system as set out in Article
3(1).

Commission shall pay particular
754i
Article 82a(1), third subparagraph
The guidelines referred to in the

first subparagraph shall take due
754j
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.
Article 82a(2)
2. Upon request of the Member

States or the AI Office, or on its
754k own initiative, the Commission
shall update already adopted
guidelines when deemed necessary.
Article 83

AI systems already placed on the AI systems already placed on the AI systems already placed on the AI systems already placed on the
G 755 market or put into service market or put into service market or put into service market or put into service G

Proposal
1. This Regulation shall not apply to 1. This Regulation shall not apply 1. This Regulation shall not apply to 1. This Regulation shall not apply to
the AI systems which are toOperators of the AI systems which the AI systems which are the Without prejudice to the
components of the large-scale IT are components of the large-scale IT components of the large-scale IT application of Article 5 as referred
G 756 G
systems established by the legal acts systems established by the legal acts systems established by the legal acts in Article 85 (3) (-aa) AI systems
listed in Annex IX that have been listed in Annex IX that have been listed in Annex IX that have been which are components of the large-
placed on the market or put into placed on the market or put into placed on the market or put into scale IT systems established by the
service before [12 months after the service before [12 months after prior service before [12 months after the legal acts listed in Annex IX that
date of application of this Regulation to ... [the date of applicationentry date of application of this have been placed on the market or
referred to in Article 85(2)], unless into force of this Regulation] shall Regulation referred to in Article put into service before [12 months
the replacement or amendment of take the necessary steps to comply 85(2)][12 months after the date of after the date of application of this
those legal acts leads to a significant with the requirements laid down in application of this Regulation Regulation referred to in Article
change in the design or intended this Regulation by … [four years referred to in Article 85(2)], unless 85(2)], unless the replacement or
purpose of the AI system or AI after the date of entry into force of the replacement or amendment of amendment of those legal acts leads
systems concerned. this Regulation] referred to in those legal acts leads to a significant to a significant change in the design
Article 85(2)], unless the change in the design or intended or intended purpose of the AI system
replacement or amendment of those purpose of the AI system or AI or AI systems concerned shall be
legal acts leads to a significant systems concerned. brought into compliance with this
change in the design or intended Regulation by end of 2030.
purpose of the AI system or AI
systems concerned.
The requirements laid down in this The requirements laid down in this The requirements laid down in this The requirements laid down in this
account, where applicable, in the account, where applicable, in the account, where applicable, in the account, where applicable, in the
evaluation of each large-scale IT evaluation of each large-scale IT evaluation of each large-scale IT evaluation of each large-scale IT
systems established by the legal acts systems established by the legal acts systems established by the legal acts systems established by the legal acts
G 757 listed in Annex IX to be undertaken listed in Annex IX to be undertaken listed in Annex IX to be undertaken listed in Annex IX to be undertaken G
as provided for in those respective as provided for in those respective as provided for in those respective as provided for in those respective
acts. acts and whenever those legal acts acts. acts and whenever those legal acts
are replaced or amended. are replaced or amended.
Article 83(2)
2. This Regulation shall apply to the 2. This Regulation shall apply to 2. This Regulation shall apply to the 2. Without prejudice to the
high-risk AI systems, other than the theoperators of high-risk AI high-risk AI systems, other than the application of Article 5 as referred
G 758 G
ones referred to in paragraph 1, that systems, other than the ones referred ones referred to in paragraph 1, that in Article 85 (3) (-aa ) this
have been placed on the market or to in paragraph 1, that have been have been placed on the market or Regulation shall apply to
put into service before [date of placed on the market or put into put into service before [date of theoperators of high-risk AI
application of this Regulation service before [date of application of application of this Regulation systems, other than the ones referred
referred to in Article 85(2)], only if, this Regulation referred to in Article referred to in Article 85(2)date of to in paragraph 1, that have been
from that date, those systems are 85(2)], only if, from that date, those application of this Regulation placed on the market or put into
subject to significant changes in systems are subject to significant referred to in Article 85(2)], only if, service before [date of application of
their design or intended purpose. changes in their design from that date, those systems are this Regulation referred to in Article
orsubstantial modifications as subject to significant changes in 85(2)], only if, from that date, those
defined in Article 3(23). In the case their design or intended purpose. systems are subject to significant
of high-risk AI systems intended changes in their design ordesigns. In
purposeto be used by public the case of high-risk AI systems
authorities, providers and deployers intended purposeto be used by
of such systems shall take the public authorities, providers and
necessary steps to comply with the deployers of such systems shall take
requirements of the present the necessary steps to comply with
Regulation [two years after the date the requirements of the present
of entry into force of this Regulation four years after the date
Regulation]. 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 Evaluation and review Evaluation and review Evaluation and review

Proposal
Article 84(1)
1. The Commission shall assess the 1. After consulting the AI Office, 1. The Commission shall assess the 1. The Commission shall assess the
need for amendment of the list in the Commission shall assess the need for amendment of the list in need for amendment of the list in
Annex III once a year following the need for amendment of the list in Annex III once a yearevery 24 Annex III, the list of prohibited AI
entry into force of this Regulation. Annex III, including the extension months following the entry into practices in Article 5, once a year
of existing area headings or force of this Regulation and until following the entry into force of this
addition of new area headings in the end of the period of the Regulation, and until the end of the
that Annex, the list of prohibited AI delegation of power. The findings period of the delegation of power.
practices in Article 5, and the list of of that assessment shall be The Commission shall submit the
AI systems requiring additional presented to the European findings of that assessment to the
G 760 G
transparency measures in Article 52 Parliament and the Council. European Parliament and the
once a year following the entry into Council.
force of this Regulation and
following a recommendation of the
Office.
The Commission shall submit the
findings of that assessment to the
European Parliament and the
Council.
Article 84(2)
2. By [three years after the date of 2. By … [threetwo years after the 2. By [three years after the date of 2. By [two years after the date of
application of this Regulation date of application of this Regulation application of this Regulation application of this Regulation
referred to in Article 85(2)] and referred to in Article 85(2)] and referred to in Article 85(2)three referred to in Article 85(2) and
G 761 every four years thereafter, the every fourtwo years thereafter, the years after the date of application of every four years thereafter, the G
Commission shall submit a report on Commission, together with the AI this Regulation referred to in Article Commission shall evaluate and
the evaluation and review of this office, shall submit a report on the 85(2)] and every four years report to the European Parliament
Regulation to the European evaluation and review of this thereafter, the Commission shall and to the Council on the need for
Parliament and to the Council. The Regulation to the European submit a report on the evaluation and amendment of the following:
reports shall be made public. Parliament and to the Council. The review of this Regulation to the - the need for extension of existing
reports shall be made public. European Parliament and to the area headings or addition of new
Council. The reports shall be made area headings in Annex III,
public. - the list of AI systems requiring
additional transparency measures
in Article 52
- effectiveness of the supervision
and governance system
2a. By three years after the date of

application of this Regulation
referred to in Article 85(2)]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.
Article 84(3)
3. The reports referred to in 3. The reports referred to in 3. The reports referred to in 3. The reports referred to in
G 762 paragraph 2 shall devote specific paragraph 2 shall devote specific paragraph 2 shall devote specific paragraph 2 shall devote specific G
attention to the following: attention to the following: attention to the following: attention to the following:
Proposal
(a) the status of the financial and (a) the status of the financial, (a) the status of the financial (a) the status of the financial,
human resources of the national technical and human resources of resources, technical equipment and technical and human resources of
competent authorities in order to the national competent authorities in human resources of the national the national competent authorities in
G 763 effectively perform the tasks order to effectively perform the tasks competent authorities in order to order to effectively perform the tasks G
assigned to them under this assigned to them under this effectively perform the tasks assigned to them under this
Regulation; Regulation; assigned to them under this Regulation;
Regulation;
(b) the state of penalties, and (b) the state of penalties, and (b) the state of penalties, and (b) the state of penalties, and
notably administrative fines as notably administrative fines as notably administrative fines as notably administrative fines as
referred to in Article 71(1), applied referred to in Article 71(1), applied referred to in Article 71(1), applied referred to in Article 71(1), applied
G 764 by Member States to infringements by Member States to infringements by Member States to infringements by Member States to infringements G
of the provisions of this Regulation. of the provisions of this Regulation. of the provisions of this Regulation. of the provisions of this Regulation.
Proposal
(ba) the level of the development of (ba) ba) adopted harmonised

harmonised standards and common standards and common
specifications for Artificial specifications developed to support
G 764a Intelligence; this Regulation. G
bb) the number of companies that

enter the market after the enter into
application of the regulation and
how many of them are SMEs.
(bb) the levels of investments in

G 764b G
application of AI systems
throughout the Union;
Article 84(3), point (bc)
(bc) the competitiveness of the

aggregated European AI sector
G 764c G
compared to AI sectors in third
countries;
Article 84(3), point (bd)
(bd) the impact of the Regulation

with regards to the resource and
G 764d energy use, as well as waste G
production and other

environmental impact;
Article 84(3), point (be)
(be) the implementation of the

G 764e coordinated plan on AI, taking into G
account the different level of

progress among Member States and
identifying existing barriers to
innovation in AI;
Article 84(3), point (bf)
(bf) the update of the specific

requirements regarding the
sustainability of AI systems and
G 764f foundation models, building on the G
reporting and documentation

requirement in Annex IV and in
Article 28b;
Article 84(3), point (bg)
(bg) the legal regime governing

G 764g G
foundation models;
Article 84(3), point (bh)
(bh) the list of unfair contractual

terms within Article 28a taking into
G 764h G
account new business practices if
necessary;
3a. By ... [two years after the date (bb) By ... [two years after the date
of entry into application of this of entry into application of this
G 764i Regulation referred to in Article Regulation referred to in Article G
85(2)] the Commission shall 85(2)] the Commission shall

evaluate the functioning of the AI evaluate the functioning of the AI
office, whether the office has been office, whether the office has been
given sufficient powers and given sufficient powers and
competences to fulfil its tasks and competences to fulfil its tasks and
whether it would be relevant and whether it would be relevant and
needed for the proper needed for the proper
implementation and enforcement of implementation and enforcement of
this Regulation to upgrade the this Regulation to upgrade the
Office and its enforcement Office and its enforcement
competences and to increase its competences and to increase its
resources. The Commission shall resources. The Commission shall
submit this evaluation report to the submit this evaluation report to the
European Parliament and to the European Parliament and to the
Council. Council.
Article 84(3a)
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
G 764j G
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.
Article 84(4)
G 765 G
4. Within [three years after the date 4. Within … [three yearsone year 4. Within [three years after the date 4. Within … [three yearstwo year
of application of this Regulation after the date of application of this of application of this Regulation after the date of application of this
referred to in Article 85(2)] and Regulation referred to in Article referred to in Article 85(2)three Regulation referred to in Article
every four years thereafter, the 85(2)] and every fourtwo years years after the date of application of 85(2)] and every fourthree years
Commission shall evaluate the thereafter, the Commission shall this Regulation referred to in Article thereafter, the Commission shall
impact and effectiveness of codes of evaluate the impact and 85(2)] and every four years evaluate the impact and
conduct to foster the application of effectiveness of codes of conduct to thereafter, where appropriate, the effectiveness of voluntary codes of
the requirements set out in Title III, foster the application of the Commission shall evaluate the conduct to foster the application of
Chapter 2 and possibly other requirements set out in Title III, impact and effectiveness of the requirements set out in Title III,
additional requirements for AI Chapter 2 and possibly other voluntary codes of conduct to foster Chapter 2 for AI systems other than
systems other than high-risk AI additional requirements for AI the application of the requirements high-risk AI systems and possibly
systems. systems other than high-risk AI set out in Title III, Chapter 2 for AI other additional requirements for AI
systems.; systems other than high-risk AI systems other than high-risk AI
systems and possibly other systems., including as regards
additional requirements for AI environmental sustainability;
systems, including as regards
environmental sustainability other
than high-risk AI systems.
Article 84(5)
5. For the purpose of paragraphs 1 5. For the purpose of paragraphs 1 5. For the purpose of paragraphs 5. 5. For the purpose of paragraphs
to 4 the Board, the Member States to 4 the BoardAI Office, the 11a to 4 the Board, the Member 1 to 4 the Board, the Member States
and national competent authorities Member States and national States and national competent and national competent authorities
G 766 shall provide the Commission with competent authorities shall provide authorities shall provide the shall provide the Commission with G
information on its request. the Commission with information on Commission with information on its information on its request., without
its request without undue delay. request. undue delay
Article 84(6)
6. In carrying out the evaluations 6. in carrying out the evaluations 6. In carrying out the evaluations 6. 6. In carrying out the evaluations
G 767 and reviews referred to in and reviews referred to in and reviews referred to in and reviews referred to in G
paragraphs 1 to 4 the Commission paragraphs 1 to 4 the Commission paragraphs 11a to 4 the Commission paragraphs 1 to 4 the Commission
shall take into account the positions shall take into account the positions shall take into account the positions shall take into account the positions
and findings of the Board, of the and findings of the Board,-AI Office and findings of the Board, of the and findings of the Board, of the
European Parliament, of the Council, of the European Parliament, of the European Parliament, of the Council, European Parliament, of the Council,
and of other relevant bodies or Council, and of other relevant bodies and of other relevant bodies or and of other relevant bodies or
sources. or sources and shall consult sources. sources.
relevant stakeholders. The result of
such consultation shall be attached
to the report;
Article 84(7)
7. The Commission shall, if 7. the Commission shall, if 7. The Commission shall, if 7. The Commission shall, if
necessary, submit appropriate necessary, submit appropriate necessary, submit appropriate necessary, submit appropriate
proposals to amend this Regulation, proposals to amend this Regulation, proposals to amend this Regulation, proposals to amend this Regulation,
in particular taking into account in particular taking into account in particular taking into account in particular taking into account
developments in technology and in developments in technology, the developments in technology and in developments in technology, the
the light of the state of progress in effect of AI systems on health and the light of the state of progress in effect of AI systems on health and
G 768 G
the information society. safety, fundamental rights, the the information society. safety, fundamental rights and in
environment, equality, and the light of the state of progress in
accessibility for persons with the information society.
disabilities, democracy and rule of
law and in the light of the state of
progress in the information society.
Article 84(7a)
7a. To guide the evaluations and 7a. To guide the evaluations and
reviews referred to in paragraphs 1 reviews referred to in paragraphs 1
to 4 of this Article, the Office shall to 4 of this Article, the Office shall
undertake to develop an objective undertake to develop an objective
G 768a and participative methodology for and participative methodology for G
the evaluation of risk level based on the evaluation of risk level based on
the criteria outlined in the relevant the criteria outlined in the relevant
articles and inclusion of new articles and inclusion of new
systems in: the list in Annex III, systems in: the list in Annex III,
including the extension of existing including the extension of existing
area headings or addition of new area headings or addition of new
area headings in that Annex; the area headings in that Annex; the
list of prohibited practices laid list of prohibited practices laid
down in Article 5; and the list of AI down in Article 5; and the list of AI
systems requiring additional systems requiring additional
transparency measures pursuant to transparency measures pursuant to
Article 84(7b)
7b. Any amendment to this 7b. Any amendment to this

Regulation pursuant to paragraph 7 Regulation pursuant to paragraph 7
of this Article, or relevant future of this Article, or relevant future
delegated or implementing acts, delegated or implementing acts,
which concern sectoral legislation which concern sectoral legislation
listed in Annex II Ssection B, shall listed in Annex II Section B, shall
G 768b take into account the regulatory take into account the regulatory G
specificities of each sector, and specificities of each sector, and

existing governance, conformity existing governance, conformity
assessment and enforcement assessment and enforcement
mechanisms and authorities mechanisms and authorities
established therein. established therein.
Article 84(7c)
7c. By … [five years from the date 7c. By … [five years from the date
of application of this Regulation], of application of this Regulation],
the Commission shall carry out an the Commission shall carry out an
G 768c G
assessment of the enforcement of assessment of the enforcement of
this Regulation and shall report it this Regulation and shall report it
to the European Parliament, the to the European Parliament, the
Council and the European Council and the European
Economic and Social Committee, Economic and Social Committee,
taking into account the first years taking into account the first years
of application of the Regulation. On of application of the Regulation. On
the basis of the findings that report the basis of the findings that report
shall, where appropriate, be shall, where appropriate, be
accompanied by a proposal for accompanied by a proposal for
amendment of this Regulation with amendment of this Regulation with
regard to the structure of regard to the structure of
enforcement and the need for an enforcement and the need for an
Union agency to resolve any Union agency to resolve any
identified shortcomings. identified shortcomings.
Article 85

Entry into force and application Entry into force and application Entry into force and application Entry into force and application
G 769 G

Proposal
Article 85(1)
1. This Regulation shall enter into 1. This Regulation shall enter into 1. This Regulation shall enter into 1. This Regulation shall enter into
force on the twentieth day following force on the twentieth day following force on the twentieth day following force on the twentieth day following
that of its publication in the Official that of its publication in the Official that of its publication in the Official that of its publication in the Official
G 770 Journal of the European Union. Journal of the European Union. Journal of the European Journal of the European Union.
G
UnionOfficial Journal of the

European Union. Proposal
Article 85(2)
G 771 G
2. This Regulation shall apply from 2. This Regulation shall apply from 2. This Regulation shall apply from 2. This Regulation shall apply from
[24 months following the entering [24 months following the entering [2436 months following the entering [24 months following the entering
into force of the Regulation]. into force of the Regulation]. into force of the Regulation]. 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 *
Article 85(3)
3. By way of derogation from 3. By way of derogation from 3. By way of derogation from 3. By way of derogation from
paragraph 2: paragraph 2: paragraph 2: paragraph 2:
G 772 G

Proposal
Article 85(3),
(a) Title III, Chapter 4 and Title VI (a) Title III, Chapter 4 and Title VI (a) Title III, Chapter 4 and Title VI (a) (-a) Title I and II [Prohibitions]
shall apply from [three months shall apply from [three months shall apply from [threetwelve shall apply from [six months
following the entry into force of this following the entry into force of this months following the entry into following the entry into force of this
Regulation]; Regulation]; force of this Regulation]; Regulation];
G 773 G
(a) Title III, Chapter 4 and, Title VI
, Title VIIIa [GPAI], Title X
[Penalties] shall apply from
[threetwelve months following the
entry into force of this Regulation];

G 774 G
(b) Article 71 shall apply from (b) Article 71 shall apply from (b) Article 71 shall apply from (b) Article 716(1) and the
[twelve months following the entry [twelve months following the entry [twelve months following the entry corresponding obligations in this
into force of this Regulation]. into force of this Regulation]. into force of this Regulation]. Regulation shall apply from
[twelve36 months following the
entry into force of this Regulation].
Proposal
Article 85, fourth paragraph -a
Codes of practices shall be ready at

the latest nine months after the
entry into force of this Regulation.
G 774a The AI Office shall take the G
necessary steps, including inviting

providers pursuant to Article 52e
paragraph 5.
This Regulation shall be binding in This Regulation shall be binding in This Regulation shall be binding in This Regulation shall be binding in
its entirety and directly applicable in its entirety and directly applicable in its entirety and directly applicable in its entirety and directly applicable in
G 775 all Member States. all Member States. all Member States. all Member States. G

Proposal
Formula
Done at Brussels, Done at Brussels, Done at Brussels, Done at Brussels,

G
Proposal
Formula
For the European Parliament For the European Parliament For the European Parliament For the European Parliament
G
Proposal
Formula
The President The President The President The President

G
Proposal
Formula
For the Council For the Council For the Council For the Council
G
Proposal
Formula
The President The President The President The President

G
Proposal
Annex I
Annex I ARTIFICIAL
INTELLIGENCE TECHNIQUES deleted deleted
G 781 G
AND APPROACHESreferred to in
Article 3, point 1
Annex I, first paragraph
(a) Machine learning approaches,

including supervised, unsupervised deleted deleted
G 782 and reinforcement learning, using a G
wide variety of methods including

deep learning;
Annex I, second paragraph
(b) Logic- and knowledge-based

approaches, including knowledge deleted deleted
representation, inductive (logic)
G 783 programming, knowledge bases, G
inference and deductive engines,

(symbolic) reasoning and expert
systems;
Annex I, third paragraph
(c) Statistical approaches, Bayesian

G 784 estimation, search and optimization deleted deleted G
methods.
Annex II
Annex II LIST OF UNION Annex II LIST OF UNION Annex II LIST OF UNION Annex II LIST OF UNION
HARMONISATION HARMONISATION HARMONISATION HARMONISATION
G 785 LEGISLATION LEGISLATION LEGISLATION LEGISLATION G

Proposal
Annex II, Part I

Part I Section A. List of Union Part I Section A. List of Union Part I Section A. – List of Union Part I Section A. List of Union
harmonisation legislation based on harmonisation legislation based on harmonisation legislation based on harmonisation legislation based on
G 786 the New Legislative Framework the New Legislative Framework the New Legislative Framework the New Legislative Framework G

Proposal
Annex II, point 1.
1. Directive 2006/42/EC of the 1. Directive 2006/42/EC of the 1. Directive 2006/42/EC of the 1. Directive 2006/42/EC of the
Council of 17 May 2006 on Council of 17 May 2006 on Council of 17 May 2006 on Council of 17 May 2006 on
machinery, and amending Directive machinery, and amending Directive machinery, and amending Directive machinery, and amending Directive
G 787 95/16/EC (OJ L 157, 9.6.2006, p. 95/16/EC (OJ L 157, 9.6.2006, p. 95/16/EC (OJ L 157, 9.6.2006, p. 95/16/EC (OJ L 157, 9.6.2006, p. G
24) [as repealed by the Machinery 24) [as repealed by the Machinery 24) [as repealed by the Machinery 24) [as repealed by the Machinery
Regulation]; Regulation]; Regulation]; Regulation];
Proposal
Annex II, point 2.
2. Directive 2009/48/EC of the 2. Directive 2009/48/EC of the 2. Directive 2009/48/EC of the 2. Directive 2009/48/EC of the
Council of 18 June 2009 on the Council of 18 June 2009 on the Council of 18 June 2009 on the Council of 18 June 2009 on the
G 788 safety of toys (OJ L 170, 30.6.2009, safety of toys (OJ L 170, 30.6.2009, safety of toys (OJ L 170, 30.6.2009, safety of toys (OJ L 170, 30.6.2009, G
p. 1); p. 1); p. 1); p. 1);

Proposal
Annex II, point 3.
G 789 3. Directive 2013/53/EU of the 3. Directive 2013/53/EU of the 3. Directive 2013/53/EU of the 3. Directive 2013/53/EU of the G
Council of 20 November 2013 on Council of 20 November 2013 on Council of 20 November 2013 on Council of 20 November 2013 on
recreational craft and personal recreational craft and personal recreational craft and personal recreational craft and personal
watercraft and repealing Directive watercraft and repealing Directive watercraft and repealing Directive watercraft and repealing Directive
94/25/EC (OJ L 354, 28.12.2013, p. 94/25/EC (OJ L 354, 28.12.2013, p. 94/25/EC (OJ L 354, 28.12.2013, p. 94/25/EC (OJ L 354, 28.12.2013, p.
90); 90); 90); 90);
Proposal
Annex II, point 4.
4. Directive 2014/33/EU of the 4. Directive 2014/33/EU of the 4. Directive 2014/33/EU of the 4. Directive 2014/33/EU of the
Council of 26 February 2014 on the Council of 26 February 2014 on the Council of 26 February 2014 on the Council of 26 February 2014 on the
harmonisation of the laws of the harmonisation of the laws of the harmonisation of the laws of the harmonisation of the laws of the
G 790 Member States relating to lifts and Member States relating to lifts and Member States relating to lifts and Member States relating to lifts and G
safety components for lifts (OJ L 96, safety components for lifts (OJ L 96, safety components for lifts (OJ L 96, safety components for lifts (OJ L 96,
29.3.2014, p. 251); 29.3.2014, p. 251); 29.3.2014, p. 251); 29.3.2014, p. 251);
Proposal
Annex II, point 5.
Council of 26 February 2014 on the Council of 26 February 2014 on the Council of 26 February 2014 on the Council of 26 February 2014 on the
Member States relating to equipment Member States relating to equipment Member States relating to equipment Member States relating to equipment
G 791 and protective systems intended for and protective systems intended for and protective systems intended for and protective systems intended for G
use in potentially explosive use in potentially explosive use in potentially explosive use in potentially explosive
atmospheres (OJ L 96, 29.3.2014, p. atmospheres (OJ L 96, 29.3.2014, p. atmospheres (OJ L 96, 29.3.2014, p. atmospheres (OJ L 96, 29.3.2014, p.
309); 309); 309); 309);
Proposal
Annex II, point 6.
Council of 16 April 2014 on the Council of 16 April 2014 on the Council of 16 April 2014 on the Council of 16 April 2014 on the
Member States relating to the Member States relating to the Member States relating to the Member States relating to the
G 792 making available on the market of making available on the market of making available on the market of making available on the market of G
radio equipment and repealing radio equipment and repealing radio equipment and repealing radio equipment and repealing
Directive 1999/5/EC (OJ L 153, Directive 1999/5/EC (OJ L 153, Directive 1999/5/EC (OJ L 153, Directive 1999/5/EC (OJ L 153,
22.5.2014, p. 62); 22.5.2014, p. 62); 22.5.2014, p. 62); 22.5.2014, p. 62);
Proposal
Annex II, point 7.
Council of 15 May 2014 on the Council of 15 May 2014 on the Council of 15 May 2014 on the Council of 15 May 2014 on the
Member States relating to the Member States relating to the Member States relating to the Member States relating to the
G 793 making available on the market of making available on the market of making available on the market of making available on the market of
G
pressure equipment (OJ L 189, pressure equipment (OJ L 189, pressure equipment (OJ L 189, pressure equipment (OJ L 189,
27.6.2014, p. 164); 27.6.2014, p. 164); 27.6.2014, p. 164); 27.6.2014, p. 164);
Proposal
Annex II, point 8.
8. Regulation (EU) 2016/424 of the 8. Regulation (EU) 2016/424 of the 8. Regulation (EU) 2016/424 of the 8. Regulation (EU) 2016/424 of the
G 794 G
Council of 9 March 2016 on Council of 9 March 2016 on Council of 9 March 2016 on Council of 9 March 2016 on
cableway installations and repealing cableway installations and repealing cableway installations and repealing cableway installations and repealing
31.3.2016, p. 1); 31.3.2016, p. 1); 31.3.2016, p. 1); 31.3.2016, p. 1);
Proposal
Annex II, point 9.
9. Regulation (EU) 2016/425 of the 9. Regulation (EU) 2016/425 of the 9. Regulation (EU) 2016/425 of the 9. Regulation (EU) 2016/425 of the
personal protective equipment and personal protective equipment and personal protective equipment and personal protective equipment and
G 795 repealing Council Directive repealing Council Directive repealing Council Directive repealing Council Directive G
89/686/EEC (OJ L 81, 31.3.2016, p. 89/686/EEC (OJ L 81, 31.3.2016, p. 89/686/EEC (OJ L 81, 31.3.2016, p. 89/686/EEC (OJ L 81, 31.3.2016, p.
51); 51); 51); 51);
Proposal
Annex II, point 10.
10. Regulation (EU) 2016/426 of 10. Regulation (EU) 2016/426 of 10. Regulation (EU) 2016/426 of 10. Regulation (EU) 2016/426 of
appliances burning gaseous fuels and appliances burning gaseous fuels and appliances burning gaseous fuels and appliances burning gaseous fuels and
G 796 repealing Directive 2009/142/EC repealing Directive 2009/142/EC repealing Directive 2009/142/EC repealing Directive 2009/142/EC
G
(OJ L 81, 31.3.2016, p. 99); (OJ L 81, 31.3.2016, p. 99); (OJ L 81, 31.3.2016, p. 99); (OJ L 81, 31.3.2016, p. 99);
Proposal
Annex II, point 11.
G 797 the European Parliament and of the the European Parliament and of the the European Parliament and of the the European Parliament and of the G
Council of 5 April 2017 on medical Council of 5 April 2017 on medical Council of 5 April 2017 on medical Council of 5 April 2017 on medical
devices, amending Directive devices, amending Directive devices, amending Directive devices, amending Directive
2001/83/EC, Regulation (EC) No 2001/83/EC, Regulation (EC) No 2001/83/EC, Regulation (EC) No 2001/83/EC, Regulation (EC) No
178/2002 and Regulation (EC) No 178/2002 and Regulation (EC) No 178/2002 and Regulation (EC) No 178/2002 and Regulation (EC) No
1223/2009 and repealing Council 1223/2009 and repealing Council 1223/2009 and repealing Council 1223/2009 and repealing Council
Directives 90/385/EEC and Directives 90/385/EEC and Directives 90/385/EEC and Directives 90/385/EEC and
93/42/EEC (OJ L 117, 5.5.2017, p. 93/42/EEC (OJ L 117, 5.5.2017, p. 93/42/EEC (OJ L 117, 5.5.2017, p. 93/42/EEC (OJ L 117, 5.5.2017, p.
1; 1; 1; 1;
Proposal
Annex II, point 12.
Council of 5 April 2017 on in vitro Council of 5 April 2017 on in vitro Council of 5 April 2017 on in vitro Council of 5 April 2017 on in vitro
diagnostic medical devices and diagnostic medical devices and diagnostic medical devices and diagnostic medical devices and
G 798 repealing Directive 98/79/EC and repealing Directive 98/79/EC and repealing Directive 98/79/EC and repealing Directive 98/79/EC and G
Commission Decision 2010/227/EU Commission Decision 2010/227/EU Commission Decision 2010/227/EU Commission Decision 2010/227/EU
(OJ L 117, 5.5.2017, p. 176). (OJ L 117, 5.5.2017, p. 176). (OJ L 117, 5.5.2017, p. 176). (OJ L 117, 5.5.2017, p. 176).
Proposal
Annex II, Part II
Part II Section B. List of other Part II Section B. List of other Part II Section B. List of other Part II Section B. List of other
Union harmonisation legislation Union harmonisation legislation Union harmonisation legislation Union harmonisation legislation
G 799 G

Proposal
Annex II, point 13.
13. Regulation (EC) No 300/2008 13. Regulation (EC) No 300/2008 13. Regulation (EC) No 300/2008 13. Regulation (EC) No 300/2008
G 800 G
the Council of 11 March 2008 on the Council of 11 March 2008 on the Council of 11 March 2008 on the Council of 11 March 2008 on
common rules in the field of civil common rules in the field of civil common rules in the field of civil common rules in the field of civil
aviation security and repealing aviation security and repealing aviation security and repealing aviation security and repealing
Regulation (EC) No 2320/2002 (OJ Regulation (EC) No 2320/2002 (OJ Regulation (EC) No 2320/2002 (OJ Regulation (EC) No 2320/2002 (OJ
L 97, 9.4.2008, p. 72). L 97, 9.4.2008, p. 72). L 97, 9.4.2008, p. 72). L 97, 9.4.2008, p. 72).
Proposal
Annex II, point 14.
14. Regulation (EU) No 168/2013 14. Regulation (EU) No 168/2013 14. Regulation (EU) No 168/2013 14. Regulation (EU) No 168/2013
the Council of 15 January 2013 on the Council of 15 January 2013 on the Council of 15 January 2013 on the Council of 15 January 2013 on
the approval and market surveillance the approval and market surveillance the approval and market surveillance the approval and market surveillance
G 801 of two- or three-wheel vehicles and of two- or three-wheel vehicles and of two- or three-wheel vehicles and of two- or three-wheel vehicles and G
quadricycles (OJ L 60, 2.3.2013, p. quadricycles (OJ L 60, 2.3.2013, p. quadricycles (OJ L 60, 2.3.2013, p. quadricycles (OJ L 60, 2.3.2013, p.
52); 52); 52); 52);
Proposal
Annex II, point 15.
15. Regulation (EU) No 167/2013 15. Regulation (EU) No 167/2013 15. Regulation (EU) No 167/2013 15. Regulation (EU) No 167/2013
the Council of 5 February 2013 on the Council of 5 February 2013 on the Council of 5 February 2013 on the Council of 5 February 2013 on
the approval and market surveillance the approval and market surveillance the approval and market surveillance the approval and market surveillance
G 802 of agricultural and forestry vehicles of agricultural and forestry vehicles of agricultural and forestry vehicles of agricultural and forestry vehicles
G
(OJ L 60, 2.3.2013, p. 1); (OJ L 60, 2.3.2013, p. 1); (OJ L 60, 2.3.2013, p. 1); (OJ L 60, 2.3.2013, p. 1);
Proposal
Annex II, point 16.
G 803 G
Council of 23 July 2014 on marine Council of 23 July 2014 on marine Council of 23 July 2014 on marine Council of 23 July 2014 on marine
equipment and repealing Council equipment and repealing Council equipment and repealing Council equipment and repealing Council
28.8.2014, p. 146); 28.8.2014, p. 146); 28.8.2014, p. 146); 28.8.2014, p. 146);
Proposal
Annex II, point 17.
17. Directive (EU) 2016/797 of the 17. Directive (EU) 2016/797 of the 17. Directive (EU) 2016/797 of the 17. Directive (EU) 2016/797 of the
interoperability of the rail system interoperability of the rail system interoperability of the rail system interoperability of the rail system
G 804 within the European Union (OJ L within the European Union (OJ L within the European Union (OJ L within the European Union (OJ L
G
138, 26.5.2016, p. 44). 138, 26.5.2016, p. 44). 138, 26.5.2016, p. 44).; 138, 26.5.2016, p. 44).
Proposal
Annex II, point 18.
approval and market surveillance of approval and market surveillance of approval and market surveillance of approval and market surveillance of
motor vehicles and their trailers, and motor vehicles and their trailers, and motor vehicles and their trailers, and motor vehicles and their trailers, and
of systems, components and separate of systems, components and separate of systems, components and separate of systems, components and separate
G 805 G
technical units intended for such technical units intended for such technical units intended for such technical units intended for such
vehicles, amending Regulations vehicles, amending Regulations vehicles, amending Regulations vehicles, amending Regulations
(EC) No 715/2007 and (EC) No (EC) No 715/2007 and (EC) No (EC) No 715/2007 and (EC) No (EC) No 715/2007 and (EC) No
595/2009 and repealing Directive 595/2009 and repealing Directive 595/2009 and repealing Directive 595/2009 and repealing Directive
2007/46/EC (OJ L 151, 14.6.2018, p. 2007/46/EC (OJ L 151, 14.6.2018, p. 2007/46/EC (OJ L 151, 14.6.2018, p. 2007/46/EC (OJ L 151, 14.6.2018, p.
1); 3. Regulation (EU) 2019/2144 of 1); 3. Regulation (EU) 2019/2144 of 1); 3. 1); 3
the European Parliament and of the the European Parliament and of the Regulation (EU) 2019/2144 of the
Council of 27 November 2019 on Council of 27 November 2019 on European Parliament and of the
type-approval requirements for type-approval requirements for Council of 27 November 2019 on 18a. Regulation (EU) 2019/2144 of
motor vehicles and their trailers, and motor vehicles and their trailers, and type-approval requirements for the European Parliament and of the
systems, components and separate systems, components and separate motor vehicles and their trailers, and Council of 27 November 2019 on
technical units intended for such technical units intended for such systems, components and separate type-approval requirements for
vehicles, as regards their general vehicles, as regards their general technical units intended for such motor vehicles and their trailers, and
safety and the protection of vehicle safety and the protection of vehicle vehicles, as regards their general systems, components and separate
occupants and vulnerable road users, occupants and vulnerable road users, safety and the protection of vehicle technical units intended for such
amending Regulation (EU) 2018/858 amending Regulation (EU) 2018/858 occupants and vulnerable road users, vehicles, as regards their general
of the European Parliament and of of the European Parliament and of amending Regulation (EU) 2018/858 safety and the protection of vehicle
the Council and repealing the Council and repealing of the European Parliament and of occupants and vulnerable road users,
Regulations (EC) No 78/2009, (EC) Regulations (EC) No 78/2009, (EC) the Council and repealing amending Regulation (EU) 2018/858
No 79/2009 and (EC) No 661/2009 No 79/2009 and (EC) No 661/2009 Regulations (EC) No 78/2009, (EC) of the European Parliament and of
of the European Parliament and of of the European Parliament and of No 79/2009 and (EC) No 661/2009 the Council and repealing
the Council and Commission the Council and Commission of the European Parliament and of Regulations (EC) No 78/2009, (EC)
Regulations (EC) No 631/2009, Regulations (EC) No 631/2009, the Council and Commission No 79/2009 and (EC) No 661/2009
(EU) No 406/2010, (EU) No (EU) No 406/2010, (EU) No Regulations (EC) No 631/2009, of the European Parliament and of
672/2010, (EU) No 1003/2010, (EU) 672/2010, (EU) No 1003/2010, (EU) (EU) No 406/2010, (EU) No the Council and Commission
No 1005/2010, (EU) No 1008/2010, No 1005/2010, (EU) No 1008/2010, 672/2010, (EU) No 1003/2010, (EU) Regulations (EC) No 631/2009,
(EU) No 1009/2010, (EU) No (EU) No 1009/2010, (EU) No No 1005/2010, (EU) No 1008/2010, (EU) No 406/2010, (EU) No
19/2011, (EU) No 109/2011, (EU) 19/2011, (EU) No 109/2011, (EU) (EU) No 1009/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU)
No 458/2011, (EU) No 65/2012, No 458/2011, (EU) No 65/2012, 19/2011, (EU) No 109/2011, (EU) No 1005/2010, (EU) No 1008/2010,
(EU) No 130/2012, (EU) No (EU) No 130/2012, (EU) No No 458/2011, (EU) No 65/2012, (EU) No 1009/2010, (EU) No
347/2012, (EU) No 351/2012, (EU) 347/2012, (EU) No 351/2012, (EU) (EU) No 130/2012, (EU) No 19/2011, (EU) No 109/2011, (EU)
No 1230/2012 and (EU) 2015/166 No 1230/2012 and (EU) 2015/166 347/2012, (EU) No 351/2012, (EU) No 458/2011, (EU) No 65/2012,
(OJ L 325, 16.12.2019, p. 1); (OJ L 325, 16.12.2019, p. 1); No 1230/2012 and (EU) 2015/166 (EU) No 130/2012, (EU) No
(OJ L 325, 16.12.2019, p. 1); 347/2012, (EU) No 351/2012, (EU)
No 1230/2012 and (EU) 2015/166
(OJ L 325, 16.12.2019, p. 1);
Proposal
Annex II, point 19.
G 806 G
Council of 4 July 2018 on common Council of 4 July 2018 on common Council of 4 July 2018 on common Council of 4 July 2018 on common
rules in the field of civil aviation and rules in the field of civil aviation and rules in the field of civil aviation and rules in the field of civil aviation and
establishing a European Union establishing a European Union establishing a European Union establishing a European Union
Aviation Safety Agency, and Aviation Safety Agency, and Aviation Safety Agency, and Aviation Safety Agency, and
amending Regulations (EC) No amending Regulations (EC) No amending Regulations (EC) No amending Regulations (EC) No
2111/2005, (EC) No 1008/2008, 2111/2005, (EC) No 1008/2008, 2111/2005, (EC) No 1008/2008, 2111/2005, (EC) No 1008/2008,
(EU) No 996/2010, (EU) No (EU) No 996/2010, (EU) No (EU) No 996/2010, (EU) No (EU) No 996/2010, (EU) No
376/2014 and Directives 376/2014 and Directives 376/2014 and Directives 376/2014 and Directives
2014/30/EU and 2014/53/EU of the 2014/30/EU and 2014/53/EU of the 2014/30/EU and 2014/53/EU of the 2014/30/EU and 2014/53/EU of the
Council, and repealing Regulations Council, and repealing Regulations Council, and repealing Regulations Council, and repealing Regulations
(EC) No 552/2004 and (EC) No (EC) No 552/2004 and (EC) No (EC) No 552/2004 and (EC) No (EC) No 552/2004 and (EC) No
Parliament and of the Council and Parliament and of the Council and Parliament and of the Council and Parliament and of the Council and
Council Regulation (EEC) No Council Regulation (EEC) No Council Regulation (EEC) No Council Regulation (EEC) No
3922/91 (OJ L 212, 22.8.2018, p. 1), 3922/91 (OJ L 212, 22.8.2018, p. 1), 3922/91 (OJ L 212, 22.8.2018, p. 1), 3922/91 (OJ L 212, 22.8.2018, p. 1),
in so far as the design, production in so far as the design, production in so far as the design, production in so far as the design, production
and placing on the market of and placing on the market of and placing on the market of and placing on the market of
aircrafts referred to in points (a) and aircrafts referred to in points (a) and aircrafts referred to in points (a) and aircrafts referred to in points (a) and
(b) of Article 2(1) thereof, where it (b) of Article 2(1) thereof, where it (b) of Article 2(1) thereof, where it (b) of Article 2(1) thereof, where it
concerns unmanned aircraft and their concerns unmanned aircraft and their concerns unmanned aircraft and their concerns unmanned aircraft and their
engines, propellers, parts and engines, propellers, parts and engines, propellers, parts and engines, propellers, parts and
equipment to control them remotely, equipment to control them remotely, equipment to control them remotely, equipment to control them remotely,
are concerned. are concerned. are concerned. are concerned.
Proposal
Annex IIa
ANNEX IIa List of criminal

offences referred to in Article 5
G 806a G
(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.
Annex III
Annex III HIGH-RISK AI Annex III HIGH-RISK AI Annex III HIGH-RISK AI Annex III HIGH-RISK AI
SYSTEMS REFERRED TO IN SYSTEMS REFERRED TO IN SYSTEMS REFERRED TO IN SYSTEMS REFERRED TO IN
G 807 ARTICLE 6(2) ARTICLE 6(2) ARTICLE 6(2)6(3) ARTICLE 6(2) G
Annex III, first paragraph

G 808 G
High-risk AI systems pursuant to The AI systems specifically refered High-riskIn each of the areas listed High-risk AI systems pursuant to
Article 6(2) are the AI systems listed to in under points 1 to 8a stand for under points 1-8, the AI systems Article 6(2) are the AI systems listed
in any of the following areas: critical use cases and are each pursuant to Article 6(2) are the AI in any of the following areas:
considered to be high-risk AI systems listed in any of the following
systems pursuant to Article 6(2), areasspecifically mentioned under Proposal
provided that they fulfil the criteria each letter are considered to be
set out in that Article are the AI high-risk AI systems pursuant to
systems listed in any of the following Article 6(3):
areas:
Annex III, second paragraph
1. Biometric identification and 1. Biometric identification and 1. Biometric identification and 1. Biometric identification and
categorisation of natural persons: categorisation of natural categorisation of natural categorisation of natural
persons:and biometrics-based personsBiometrics: persons:Biometrics, insofar as their
G 809 systems use is permitted under relevant G
Union or national law

Annex III, second paragraph, point (a)
(a) AI systems intended to be used (a) AI systems intended to be used (a) AI systems intended to be used (a) Remote biometric identification
for the ‘real-time’ and ‘post’ remote for the ‘real-time’ and ‘post’ remote for the ‘real-time’ and ‘post’ systems.
biometric identification of natural biometric identification of natural Remote biometric identification of
persons; personsbiometric identification of natural persons;systems. This shall not include AI systems
natural persons, with the exception intended to be used for the ‘real-
of those mentioned in Article 5; time’ and ‘post’ remote biometric
G 810 identification ofbiometric G
verification whose sole purpose is to

confirm that a specific natural
personsperson is the person he or
she claims to be;
Annex III, second paragraph, point (aa)
(aa) AI systems intended to be used (aa) AI systems intended to be used

to make inferences about personal for biometric categorisation,
characteristics of natural persons according to sensitive or protected
on the basis of biometric or attributes or characteristics based
biometrics-based data, including on the inference of those attributes
emotion recognition systems, with or characteristics.
the exception of those mentioned in
G 810a G
Article 5; (ab) AI systems intended to be used
Point 1 shall not include AI for emotion recognition;
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.
Annex III, third paragraph
2. Management and operation of 2. Management and operation of 2. Management and operation of 2. Management and operation of
G 811 critical infrastructure: critical infrastructure: Critical infrastructure: Critical infrastructure: G
Annex III, third paragraph, point (a)
(a) AI systems intended to be used (a) AI systems intended to be used (a) AI systems intended to be used (a) AI systems intended to be used
as safety components in the as safety components in the as safety components in the as safety components in the
management and operation of road management and operation of road, management and operation of management and operation of
G 812 traffic and the supply of water, gas, rail and air traffic unless they are critical digital infrastructure, road critical digital infrastructure, road G
heating and electricity. regulated in harmonisation or traffic and the supply of water, gas, traffic and the supply of water, gas,
sectoral law traffic and the supply of heating and electricity. heating and electricity.
water, gas, heating and electricity.
Annex III, first paragraph, point 2 - point (aa)

(aa) AI systems intended to be used

as safety components in the
management and operation of the
G 812a G
supply of water, gas, heating,
electricity and critical digital
infrastructure;
Annex III, fourth paragraph
3. Education and vocational 3. Education and vocational 3. Education and vocational 3. Education and vocational
training: training: training: training:
G 813 G

Proposal
Annex III, fourth paragraph, point (a)
for the purpose of determining for the purpose of determining for the purpose of determining for the purpose of determining
access or assigning natural persons access or materially influence access or assigningto determine access or assigningto determine
to educational and vocational decisions on admission or assigning access, admission or to assign access or admission or to assign
G 814 training institutions; natural persons to educational and natural persons to educational and natural persons to educational and G
vocational training institutions; vocational training institutions or vocational training institutions at all
programmes at all levels; levels;
Annex III, fourth paragraph, point (b)
(b) AI systems intended to be used (b) AI systems intended to be used (b) AI systems intended to be used (b) AI systems intended to be used
for the purpose of assessing students for the purpose of assessing students for the purpose of assessing students for the purpose of assessing students
G 815 G
in educational and vocational in educational and vocational in educational and vocational in educational and vocational
training institutions and for assessing training institutions and for assessing training institutions and for training institutions and for
participants in tests commonly participants in tests commonly assessing participants in tests assessing participants in tests
required for admission to required for admission to commonly required for admission to commonly required for admission to
educational institutions. educationalthose institutions.; educational institutionsto evaluate educational institutionsto evaluate
learning outcomes, including when learning outcomes, including when
those outcomes are used to steer the those outcomes are used to steer the
learning process of natural persons learning process of natural persons
in educational and vocational in educational and vocational
training institutions or programmes training institutions at all levels.
at all levels.
Annex III, fourth paragraph, point (ba)
(ba) AI systems intended to be used (ba) AI systems intended to be used

for the purpose of assessing the for the purpose of assessing the
appropriate level of education for appropriate level of education that
an individual and materially individual will receive or will be
G 815a influencing the level of education able to access, in the context G
and vocational training that of/within education and vocational

individual will receive or will be training institution;
able to access;
Annex III, fourth paragraph, point (bb)
(bb) AI systems intended to be used (bb) AI systems intended to be used

for monitoring and detecting for monitoring and detecting
prohibited behaviour of students prohibited behaviour of students
G 815b during tests in the context of/within during tests in the context of/within G
education and vocational training education and vocational training

institutions; institutions;
Annex III, fifth paragraph

G 816 G
4. Employment, workers 4. Employment, workers 4. Employment, workers 4. Employment, workers
management and access to self- management and access to self- management and access to self- management and access to self-
employment: employment: employment: employment:
Proposal
Annex III, fifth paragraph, point (a)
for recruitment or selection of for recruitment or selection of for recruitment or selection of for recruitment or selection of
natural persons, notably for natural persons, notably for natural persons, notably for natural persons, notably for
advertising vacancies, screening or advertising vacancies,placing advertising vacancies, screening or advertising vacancies, screening or
filtering applications, evaluating targeted job advertisements filtering applications, evaluating filtering applications, evaluating
G 817 candidates in the course of screening or filtering applications, candidates in the course of candidates in the course of G
interviews or tests; evaluating candidates in the course interviews or teststo place targeted interviews or teststo place targeted
of interviews or tests; job advertisements, to analyse and job advertisements, to analyse and
filter job applications, and to filter job applications, and to
evaluate candidates; evaluate candidates;
Annex III, fifth paragraph, point (b)
(b) AI intended to be used for (b) AI systems intended to be used (b) AI intended to be used for (b) AI intended to be used for
making decisions on promotion and for makingto make or materially makingto make decisions on makingto make decisions
termination of work-related influence decisions onaffecting the promotion and termination of work- onaffecting terms of the work
contractual relationships, for task initiation, promotion and related contractual relationships, for related relationships, promotion and
allocation and for monitoring and termination of work-related task allocation and for monitoring termination of work-related
G 818 evaluating performance and contractual relationships, for task and evaluatingto allocate tasks contractual relationships, for task G
behavior of persons in such allocation andbased on individual based on individual behavior or allocation and for monitoring and
relationships. behaviour or personal traits or personal traits or characteristics evaluatingto allocate tasks based on
characteristics, or for monitoring and to monitor and evaluate individual behavior or personal
and evaluating performance and performance and behavior of persons traits or characteristics and to
behavior of persons in such in such relationships. monitor and evaluate performance
relationships.; and behavior of persons in such
relationships.
Annex III, sixth paragraph
5. Access to and enjoyment of 5. Access to and enjoyment of 5. Access to and enjoyment of 5. Access to and enjoyment of
essential private services and public essential private services and public essential private services and essential private services and
G 819 services and benefits: services and benefits: essential public services and essential public services and G
benefits: benefits:
Annex III, sixth paragraph, point (a)
by public authorities or on behalf of by public authorities or on behalf of by public authorities or on behalf of by public authorities or on behalf of
public authorities to evaluate the public authorities to evaluate the public authorities to evaluate the public authorities to evaluate the
eligibility of natural persons for eligibility of natural persons for eligibility of natural persons for eligibility of natural persons for
public assistance benefits and public assistance benefits and essential public assistance benefits essential public assistance benefits
services, as well as to grant, reduce, services, including healthcare and services, as well as to grant, and services, including healthcare
G 820 G
revoke, or reclaim such benefits and services and essential services, reduce, revoke, or reclaim such services, as well as to grant, reduce,
services; including but not limited to benefits and services; revoke, or reclaim such benefits and
housing, electricity, heating/cooling services;
and internet, as well as to grant,
reduce, revoke, increase or reclaim
such benefits and services;
Annex III, sixth paragraph, point (b)
to evaluate the creditworthiness of to evaluate the creditworthiness of to evaluate the creditworthiness of to evaluate the creditworthiness of
G 821 natural persons or establish their natural persons or establish their natural persons or establish their natural persons or establish their G
credit score, with the exception of credit score , with the exception of credit score, with the exception of credit score , with the exception of
AI systems put into service by small AI systems put into service by small AI systems put into service by small AI systems put into service by small
scale providers for their own use; scale providers for their own scale providers by providers that are scale providers for their own
useused for the purpose of detecting micro and small-sized enterprises as useused for the purpose of detecting
financial fraud; defined in the Annex of financial fraud;
2003/361/EC for their own use;
Annex III, sixth paragraph, point (ba)
(ba) AI systems intended to be used

for making decisions or materially
G 821a influencing decisions on the G
eligibility of natural persons for

health and life insurance;
Annex III, sixth paragraph, point (c)
(c) AI systems intended to be used (c) AI systems intended to evaluate (c) AI systems intended to be used (c) AI systems intended to evaluate
to dispatch, or to establish priority in and classify emergency calls by to dispatch, or to establish priority in and classify emergency calls by
the dispatching of emergency first natural persons or to be used to the dispatching of emergency first natural persons or to be used to
response services, including by dispatch, or to establish priority in response services, including by dispatch, or to establish priority in
firefighters and medical aid. the dispatching of emergency first firefighters and medical aid.; the dispatching of emergency first
G 822 response services, including by response services, including by G
police and law enforcement, police, firefighters and medical aid.,

firefighters and medical aid., as well as well as of emergency healthcare
as of emergency healthcare patient patient triage systems;
triage systems;
Annex III, sixth paragraph, point (ca)
(ca) AI systems intended to be used (ca) AI systems intended to be used

for risk assessment and pricing in for risk assessment and pricing in
G 822a relation to natural persons in the relation to natural persons in the G
case of life and health insurance case of life and health insurance.
with the exception of AI systems put
into service by providers that are
micro and small-sized enterprises as
defined in the Annex of
2003/361/EC for their own use.
Annex III, seventh paragraph
6. Law enforcement: 6. Law enforcement: 6. Law enforcement: 6. Law enforcement:, insofar as

their use is permitted under
G 823 relevant Union or national law G

Proposal
Annex III, seventh paragraph, point (a)
(a) AI systems intended to be used (a) AI systems intended to be used (a) AI systems intended to be used
by law enforcement authorities for deleted by law enforcement authorities for by or on behalf of law enforcement
making individual risk assessments making individual risk assessments authorities, or by Union institutions,
of natural persons in order to assess of natural persons in orderor on agencies, offices or bodies in
the risk of a natural person for their behalf to assess the risk of a support of law enforcement
offending or reoffending or the risk natural person for offending or authorities or on their behalf for
G 824 G
for potential victims of criminal reoffending or the risk for a natural making individual risk assessments
offences; person to become a potential of natural persons in order to assess
victimsvictim of criminal offences; the risk of a natural person for
offending or reoffending or the risk
for potential victimsto become a
victim of criminal offences;
Annex III, seventh paragraph, point (b)
G 825 (b) AI systems intended to be used (b) AI systems intended to be used (b) AI systems intended to be used (b) AI systems intended to be used G
by law enforcement authorities as by or on behalf of law enforcement by law enforcement authorities or on by or on behalf of law enforcement
polygraphs and similar tools or to authorities, or by Union agencies, their behalf as polygraphs and authorities as polygraphs and
detect the emotional state of a offices or bodies in support of law similar tools or to detect the similar tools or to detect the
natural person; enforcement authorities as emotional state of a natural person; emotional state of a natural
polygraphs and similar tools, insofar personor by Union institutions,
as their use is permitted under bodies and agencies in support of
relevant Union and national law or Law enforcement authorities as
to detect the emotional state of a polygraphs and similar tools ;
natural person;
Annex III, seventh paragraph, point (c)
(c) AI systems intended to be used (c) AI systems intended to be used

by law enforcement authorities to deleted deleted by law enforcement authorities to
G 826 G
detect deep fakes as referred to in detect deep fakes as referred to in
article 52(3); article 52(3);deleted
Annex III, seventh paragraph, point (d)
(d) AI systems intended to be used (d) AI systems intended to be used (d) AI systems intended to be used (d) AI systems intended to be used
by law enforcement authorities for by or on behalf of law enforcement by law enforcement authorities for by or on behalf of law enforcement
evaluation of the reliability of authorities, or by Union agencies, evaluation ofor on their behalf to authorities, or by Union institutions,
evidence in the course of offices or bodies in support of law evaluate the reliability of evidence agencies, offices or bodies in
investigation or prosecution of enforcement authorities to evaluate in the course of investigation or support of law enforcement
G 827 criminal offences; for evaluation of the reliability of prosecution of criminal offences; authorities to evaluate for G
evidence in the course of evaluation of the reliability of

investigation or prosecution of evidence in the course of
criminal offences; investigation or prosecution of
criminal offences;
Annex III, seventh paragraph, point (e)
G 828 G
(e) AI systems intended to be used (e) AI systems intended to be used (e) AI systems intended to be used
by law enforcement authorities for deleted by law enforcement authorities for by law enforcement authorities or on
predicting the occurrence or predicting the or on their behalf to their behalf or by Union
reoccurrence of an actual or predict the occurrence or institutions, agencies, offices or
potential criminal offence based on reoccurrence of an actual or bodies in support of law
profiling of natural persons as potential criminal offence based on enforcement authorities for
referred to in Article 3(4) of profiling of natural persons as assessing the risk of a natural
Directive (EU) 2016/680 or referred to in Article 3(4) of person of offending or re-offending
assessing personality traits and Directive (EU) 2016/680 or not solelyfor predicting the
characteristics or past criminal assessingto assess personality traits occurrence or reoccurrence of an
behaviour of natural persons or and characteristics or past criminal actual or potential criminal offence
groups; behaviour of natural persons or based on profiling of natural persons
groups; as referred to in Article 3(4) of
Directive (EU) 2016/680 or
assessingto assess personality traits
and characteristics or past criminal
behaviour of natural persons or
groups;
Annex III, seventh paragraph, point (f)
(f) AI systems intended to be used (f) AI systems intended to be used (f) AI systems intended to be used (f) AI systems intended to be used
by law enforcement authorities for by or on behalf of law enforcement by law enforcement authorities for by or on behalf of law enforcement
profiling of natural persons as authorities or by Union agencies, profiling ofor on their behalf to authorities or by Union agencies
referred to in Article 3(4) of offices or bodies in support of law profile natural persons as referred to institutions, agencies, offices or
Directive (EU) 2016/680 in the enforcement authorities for profiling in Article 3(4) of Directive (EU) bodies in support of law
course of detection, investigation or of natural persons as referred to in 2016/680 in the course of detection, enforcement authorities for profiling
G 829 prosecution of criminal offences; Article 3(4) of Directive (EU) investigation or prosecution of of natural persons as referred to in G
2016/680 in the course of detection, criminal offences;. Article 3(4) of Directive (EU)
investigation or prosecution of 2016/680 in the course of detection,
criminal offences or, in the case of investigation or prosecution of
Union agencies, offices or bodies, criminal offences;.
as referred to in Article 3(5) of
Annex III, seventh paragraph, point (g)
(g) AI systems intended to be used (g) AI systems intended to be used (g) AI systems intended to be used
for crime analytics regarding natural by or on behalf of law enforcement deleted for crime analytics regarding
persons, allowing law enforcement authorities or by Union agencies, natural persons, allowing law
authorities to search complex related offices or bodies in support of law enforcement authorities to search
and unrelated large data sets enforcement authorities for crime complex related and unrelated large
available in different data sources or analytics regarding natural persons, data sets available in different data
in different data formats in order to allowing law enforcement sources or in different data formats
G 830 G
identify unknown patterns or authorities to search complex related in order to identify unknown
discover hidden relationships in the and unrelated large data sets patterns or discover hidden
data. available in different data sources or relationships in the data.Deleted
in different data formats in order to
identify unknown patterns or
discover hidden relationships in the
data.
Annex III, eighth paragraph
7. Migration, asylum and border 7. Migration, asylum and border 7. Migration, asylum and border 7. Migration, asylum and border
control management: control management: control management: control management, insofar as
their use is permitted under
G 831 relevant Union or national law:
G

Proposal
Annex III, eighth paragraph, point (a)
by competent public authorities as by or on behalf of competent public by competent public authorities or by competent public authorities as
polygraphs and similar tools or to authorities or by Union agencies, on their behalf as polygraphs and polygraphs and similar tools or to
G 832 G
detect the emotional state of a offices or bodies as polygraphs and similar tools or to detect the detect the emotional state of a
natural person; similar tools or to detect the emotional state of a natural person; natural person;;
emotional state of a natural
person;insofar as their use is
permitted under relevant Union or
national law
Annex III, eighth paragraph, point (b)
by competent public authorities to by or on behalf of competent public by competent public authorities or by or on behalf of competent public
assess a risk, including a security authorities or by Union agencies, on their behalf to assess a risk, authorities or by Union agencies,
risk, a risk of irregular immigration, offices or bodies to assess a risk, including a security risk, a risk of offices or bodies to assess a risk,
or a health risk, posed by a natural including a security risk, a risk of irregular immigrationmigration, or a including a security risk, a risk of
G 833 person who intends to enter or has irregular immigration, or a health health risk, posed by a natural irregular immigrationmigration, or a G
entered into the territory of a risk, posed by a natural person who person who intends to enter or has health risk, posed by a natural
Member State; intends to enter or has entered into entered into the territory of a person who intends to enter or has
the territory of a Member State; Member State; entered into the territory of a
Member State;
Annex III, eighth paragraph, point (c)
(c) AI systems intended to be used (c) AI systems intended to be used (c) AI systems intended to be used
by competent public authorities for by or on behalf of competent public deleted by competent public authorities for
the verification of the authenticity of authorities or by Union agencies, the verification of the authenticity of
travel documents and supporting offices or bodies for the verification travel documents and supporting
G 834 documentation of natural persons of the authenticity of travel documentation of natural persons G
and detect non-authentic documents documents and supporting and detect non-authentic documents
by checking their security features; documentation of natural persons by checking their security
and detect non-authentic documents features;deleted
by checking their security features;
Annex III, eighth paragraph, point (d)
G 835 (d) AI systems intended to assist (d) AI systems intended to be used (d) AI systems intended to assistbe (d) AI systems intended to be used G
competent public authorities for the by or on behalf of competent public used by competent public authorities by or on behalf of competent public
examination of applications for authorities or by Union agencies, for the examination ofor on their authorities or by Union agencies,
asylum, visa and residence permits offices or bodies to assist competent behalf to examine applications for offices or bodies to assist competent
and associated complaints with public authorities for the asylum, visa and residence permits public authorities for the
regard to the eligibility of the natural examination and assessment of the and associated complaints with examination of applications for
persons applying for a status. veracity of evidence in relation to of regard to the eligibility of the natural asylum, visa and residence permits
applications for asylum, visa and persons applying for a status. and associated complaints with
residence permits and associated regard to the eligibility of the natural
complaints with regard to the persons applying for a status.,
eligibility of the natural persons including related assessment of the
applying for a status.; reliability of evidence;
Annex III, eighth paragraph, point (da)
(da) AI systems intended to be used (da) AI systems intended to be used

by or on behalf of competent public by or on behalf of competent public
authorities or by Union agencies, authorities, including Union
offices or bodies in migration, agencies, offices or bodies, in the
asylum and border control context of migration, asylum and
G 835a management to monitor, surveil or border control management, for the G
process data in the context of purpose of detecting, recognising or

border management activities, for identifying natural persons with the
the purpose of detecting, exception of verification of travel
recognising or identifying natural documents;
persons;
Annex III, eighth paragraph, point (db)
(db) AI systems intended to be used (db)

by or on behalf of competent public
G 835b authorities or by Union agencies, G
offices or bodies in migration,

asylum and border control
management for the forecasting or
prediction of trends related to
migration movement and border
crossing;
Annex III, ninth paragraph
8. Administration of justice and 8. Administration of justice and 8. Administration of justice and 8. Administration of justice and
democratic processes: democratic processes: democratic processes: democratic processes:
G 836 G

Proposal
Annex III, ninth paragraph, point (a)
(a) AI systems intended to assist a (a) AI systems intended to be used (a) AI systems intended to assistbe (a) AI systems intended to be used
judicial authority in researching and by a judicial authority ot used by a judicial authority in by a judicial authority or on their
interpreting facts and the law and in administrative body or on their researching and interpretingor on behalf to assist a judicial authority in
applying the law to a concrete set of behalf to assist a judicial authority their behalf to interpret facts andor researching and interpreting facts
facts. or administrative body in the law and in applyingto apply the and the law and in applying the law
G 837 G
researching and interpreting facts law to a concrete set of facts. to a concrete set of facts. or used in
and the law and in applying the law a similar way in alternative dispute
to a concrete set of facts or used in a resolution
similar way in alternative dispute
resolution.
Annex III, ninth paragraph, point (aa), first subparagraph
(aa) AI systems intended to be used (aa) AI systems intended to be used

for influencing the outcome of an for influencing the outcome of an
election or referendum or the election or referendum or the
G 837a G
voting behaviour of natural persons voting behaviour of natural persons
in the exercise of their vote in in the exercise of their vote in
elections or referenda. This does elections or referenda. This does
not include AI systems whose not include AI systems whose
output natural persons are not output natural persons are not
directly exposed to, such as tools directly exposed to, such as tools
used to organise, optimise and used to organise, optimise and
structure political campaigns from structure political campaigns from
an administrative and logistic point an administrative and logistic point
of view. of view.
Annex III, ninth paragraph, point (aa), second subparagraph
G 837b G
Annex III, ninth paragraph, point (aa), third subparagraph
(ab) AI systems intended to be used deleted

by social media platforms that have
been designated as very large
online platforms within the
meaning of Article 33 of Regulation
G 837c G
EU 2022/2065, in their
recommender systems to
recommend to the recipient of the
service user-generated content
available on the platform.
Annex IV
Annex IV TECHNICAL Annex IV TECHNICAL Annex IV TECHNICAL Annex IV TECHNICAL

DOCUMENTATION referred to in DOCUMENTATION referred to in DOCUMENTATION referred to in DOCUMENTATION referred to in
G 838 Article 11(1) Article 11(1) Article 11(1) Article 11(1) G

Proposal
Annex IV, first paragraph
The technical documentation The technical documentation The technical documentation The technical documentation
referred to in Article 11(1) shall referred to in Article 11(1) shall referred to in Article 11(1) shall referred to in Article 11(1) shall
contain at least the following contain at least the following contain at least the following contain at least the following
G 839 information, as applicable to the information, as applicable to the information, as applicable to the information, as applicable to the G
relevant AI system: relevant AI system: relevant AI system: relevant AI system:

Proposal
Annex IV, second paragraph
1. A general description of the AI 1. A general description of the AI 1. A general description of the AI 1. A general description of the AI
system including: system including: system including: system including:
G 840 G

Proposal
Annex IV, second paragraph, point (a)
(a) its intended purpose, the (a) its intended purpose, the (a) its intended purpose, the (a) its intended purpose, the
person/s developing the system the person/s developing the system the person/s developing the system the person/s developing the system the
date and the version of the system; datename of the provider and the date and the version of the system; datename of the provider and the
G 841 version of the system reflecting its version of the system reflecting its G
relation to previous and, where relation to previous versions ;

applicable, more recent, versions in
the succession of revisions;
Annex IV, second paragraph, point (aa)
(aa) the nature of data likely or

intended to be processed by the
G 841a G
system and, in the case of personal
data, the categories of natural
persons and groups likely or
intended to be affected;
Annex IV, second paragraph, point (b)
(b) how the AI system interacts or (b) how the AI system interactscan (b) how the AI system interacts or (b) how the AI system interacts or
can be used to interact with interact or can be used to interact can be used to interact with can be used to interact with
hardware or software that is not part with hardware or software, hardware or software that is not part hardware or software, including
G 842 G
of the AI system itself, where including other AI systems, that are of the AI system itself, where other AI systems, that are that is not
applicable; that is not part of the AI system applicable; part of the AI system itself, where
itself, where applicable; applicable;
Annex IV, second paragraph, point (c)
(c) the versions of relevant software (c) the versions of relevant software (c) the versions of relevant software (c) the versions of relevant software
or firmware and any requirement or firmware and, where applicable, or firmware and any requirement or firmware and any requirement
G 843 related to version update; information for the deployer on any related to version update; related to version update; G
requirement related to version

update;
Annex IV, second paragraph, point (d)
(d) the description of all forms in (d) the description of all forms in (d) the description of all forms in (d) the description of all forms in
which the AI system is placed on the whichthe various configurations which the AI system is placed on the which the AI system is placed on the
G 844 market or put into service; and variants of the AI system market or put into service (e.g. market or put into service (e.g. G
iswhich are intended to be placed on software package embedded into software package embedded into
the market or put into service; hardware, downloadable, API etc.); hardware, downloadable, API etc.);
Annex IV, second paragraph, point (e)
(e) the description of hardware on (e) the description of hardware on (e) the description of hardware on (e) the description of hardware on
G 845 which the AI system is intended to which the AI system is intended to which the AI system is intended to which the AI system is intended to G
run; run; run; run;
Proposal
Annex IV, second paragraph, point (f)
(f) where the AI system is a (f) where the AI system is a (f) where the AI system is a (f) where the AI system is a
component of products, photographs component of products, photographs component of products, photographs component of products, photographs
or illustrations showing external or illustrations showing external or illustrations showing external or illustrations showing external
G 846 features, marking and internal layout features, marking and internal layout features, marking and internal layout features, marking and internal layout G
of those products; of those products; of those products; of those products;

Proposal
Annex IV, second paragraph, point (fa)
(fa) the description of the deployer (fa) a basic description of the user-
G 846a G
interface; interface provided to the deployer;
Annex IV, second paragraph, point (g)
(g) instructions of use for the user (g) instructions of use for the (g) instructions of use for the user (g) instructions of use for the user
and, where applicable installation userdeployer in accordance with and, where applicable installation and,deployer and a basic
G 847 instructions; Article 13(2) and (3) as well as instructions; description of the user-interface G
14(4)(e) and, where applicable provided to the deployer where

installation instructions; applicable installation instructions;
Annex IV, second paragraph, point (ga)
(ga) a detailed and easily

intellegible description of the
G 847a G
system’s main optimisation goal or
goals;
Annex IV, second paragraph, point (gb)
(gb) a detailed and easily

intellegible description of the
G 847b G
system’s expected output and
expected output quality;
Annex IV, second paragraph, point (gc)
(gc) detailed and easily intellegible

G 847c instructions for interpreting the G
system’s output;
Annex IV, second paragraph, point (gd)
(gd) examples of scenarios for

G 847d which the system should not be G
used;
Annex IV, third paragraph
2. A detailed description of the 2. A detailed description of the 2. A detailed description of the 2. A detailed description of the
elements of the AI system and of the elements of the AI system and of the elements of the AI system and of the elements of the AI system and of the
process for its development, process for its development, process for its development, process for its development,
G 848 including: including: including: including:
G

Proposal
Annex IV, third paragraph, point (a)
G 849 (a) the methods and steps performed (a) the methods and steps performed (a) the methods and steps performed (a) the methods and steps performed G
for the development of the AI for the development of the AI for the development of the AI for the development of the AI
system, including, where relevant, system, including, where relevant, system, including, where relevant, system, including, where relevant,
recourse to pre-trained systems or recourse to pre-trained systems or recourse to pre-trained systems or recourse to pre-trained systems or
tools provided by third parties and tools provided by third parties and tools provided by third parties and tools provided by third parties and
how these have been used, integrated how these have been used, integrated how these have been used, integrated how these have been used, integrated
or modified by the provider; or modified by the provider; or modified by the provider; or modified by the provider;
Proposal
Annex IV, third paragraph, point (b)
(b) the design specifications of the (b) a description of the (b) the design specifications of the (b) the design specifications of the
system, namely the general logic of architecture,the design system, namely the general logic of system, namely the general logic of
the AI system and of the algorithms; specifications, algorithms and the the AI system and of the algorithms; the AI system and of the algorithms;
the key design choices including the data structures including a the key design choices including the the key design choices including the
rationale and assumptions made, decomposition of its components rationale and assumptions made, rationale and assumptions made,
also with regard to persons or groups and interfaces, how they relate to also with regard to persons or groups also with regard to persons or groups
of persons on which the system is one another and how they provide of persons on which the system is of persons on which the system is
intended to be used; the main for the overall processing or logic intended to be used; the main intended to be used; the main
classification choices; what the of the system, namely the general classification choices; what the classification choices; what the
system is designed to optimise for logic of the AI system and of the system is designed to optimise for system is designed to optimise for
and the relevance of the different algorithmsAI system; the key design and the relevance of the different and the relevance of the different
parameters; the decisions about any choices including the rationale and parameters; the description of the parameters; the description of the
G 850 G
possible trade-off made regarding assumptions made, also with regard expected output of the system; the expected output and output quality
the technical solutions adopted to to persons or groups of persons on decisions about any possible trade- of the system; the decisions about
comply with the requirements set out which the system is intended to be off made regarding the technical any possible trade-off made
in Title III, Chapter 2; used; the main classification choices; solutions adopted to comply with the regarding the technical solutions
what the system is designed to requirements set out in Title III, adopted to comply with the
optimise for and the relevance of the Chapter 2; requirements set out in Title III,
different parameters; the decisions Chapter 2;
about any possible trade-off made
regarding the technical solutions
adopted to comply with the
Chapter 2;
Annex IV, third paragraph, point (c)
(c) the description of the system (c) the description of the system (c) the description of the system
architecture explaining how software deleted architecture explaining how software architecture explaining how software
components build on or feed into components build on or feed into components build on or feed into
each other and integrate into the each other and integrate into the each other and integrate into the
G 851 overall processing; the overall processing; the overall processing; the G
computational resources used to computational resources used to computational resources used to

develop, train, test and validate the develop, train, test and validate the develop, train, test and validate the
AI system; AI system; AI system;
Annex IV, third paragraph, point (d)
(d) where relevant, the data (d) where relevant, the data (d) where relevant, the data (d) where relevant, the data
requirements in terms of datasheets requirements in terms of datasheets requirements in terms of datasheets requirements in terms of datasheets
describing the training describing the training describing the training describing the training
methodologies and techniques and methodologies and techniques and methodologies and techniques and methodologies and techniques and
the training data sets used, including the training data sets used, including the training data sets used, including the training data sets used, including
information about the provenance of information about the provenance of information about the provenance of information about the provenance of
those data sets, their scope and main those data sets, their scope and main thosea general description of these thosea general description of these
characteristics; how the data was characteristics; how the data was data sets, information about their data sets, information about their
G 852 obtained and selected; labelling obtained and selected; labelling provenance, scope and main provenance, scope and main G
procedures (e.g. for supervised procedures (e.g. for supervised characteristics; how the data was characteristics; how the data was
learning), data cleaning learning), data cleaning obtained and selected; labelling obtained and selected; labelling
methodologies (e.g. outliers methodologies (e.g. outliers procedures (e.g. for supervised procedures (e.g. for supervised
detection); detection); learning), data cleaning learning), data cleaning
methodologies (e.g. outliers methodologies (e.g. outliers
detection); detection);
Annex IV, third paragraph, point (e)

G 853 G
(e) assessment of the human (e) assessment of the human (e) assessment of the human (e) assessment of the human
oversight measures needed in oversight measures needed in oversight measures needed in oversight measures needed in
accordance with Article 14, accordance with Article 14, accordance with Article 14, accordance with Article 14,
including an assessment of the including an assessment of the including an assessment of the including an assessment of the
technical measures needed to technical measures needed to technical measures needed to technical measures needed to
facilitate the interpretation of the facilitate the interpretation of the facilitate the interpretation of the facilitate the interpretation of the
outputs of AI systems by the users, outputs of AI systems by the outputs of AI systems by the users, outputs of AI systems by the
in accordance with Articles 13(3)(d); usersdeployers, in accordance with in accordance with Articles 13(3)(d); usersdeployers, in accordance with
Articles 13(3)(d); Articles 13(3)(d);
Annex IV, third paragraph, point (f)
(f) where applicable, a detailed (f) where applicable, a detailed (f) where applicable, a detailed (f) where applicable, a detailed
description of pre-determined description of pre-determined description of pre-determined description of pre-determined
changes to the AI system and its changes to the AI system and its changes to the AI system and its changes to the AI system and its
performance, together with all the performance, together with all the performance, together with all the performance, together with all the
relevant information related to the relevant information related to the relevant information related to the relevant information related to the
technical solutions adopted to ensure technical solutions adopted to ensure technical solutions adopted to ensure technical solutions adopted to ensure
G 854 continuous compliance of the AI continuous compliance of the AI continuous compliance of the AI continuous compliance of the AI
G
system with the relevant system with the relevant system with the relevant system with the relevant
Chapter 2; Chapter 2; Chapter 2; Chapter 2;
Proposal
Annex IV, third paragraph, point (g)
(g) the validation and testing (g) the validation and testing (g) the validation and testing (g) the validation and testing
procedures used, including procedures used, including procedures used, including procedures used, including
G 855 information about the validation and information about the validation and information about the validation and information about the validation and G
testing data used and their main testing data used and their main testing data used and their main testing data used and their main
characteristics; metrics used to characteristics; metrics used to characteristics; metrics used to characteristics; metrics used to
measure accuracy, robustness, measure accuracy, robustness, measure accuracy, robustness, measure accuracy, robustness,
cybersecurity and compliance with cybersecurity and compliance with cybersecurity and compliance with cybersecurity and compliance with
other relevant requirements set out other relevant requirements set out other relevant requirements set out other relevant requirements set out
in Title III, Chapter 2 as well as in Title III, Chapter 2 as well as in Title III, Chapter 2 as well as in Title III, Chapter 2 as well as
potentially discriminatory impacts; potentially discriminatory impacts; potentially discriminatory impacts; potentially discriminatory impacts;
test logs and all test reports dated test logs and all test reports dated test logs and all test reports dated test logs and all test reports dated
and signed by the responsible and signed by the responsible and signed by the responsible and signed by the responsible
persons, including with regard to persons, including with regard to persons, including with regard to persons, including with regard to
pre-determined changes as referred pre-determined changes as referred pre-determined changes as referred pre-determined changes as referred
to under point (f). to under point (f). to under point (f). to under point (f).
Annex IV, third paragraph, point (ga)
(ga) cybersecurity measures put in (ga) cybersecurity measures put in

G 855a place. place. G
Annex IV, fourth paragraph
3. Detailed information about the 3. Detailed information about the 3. Detailed information about the 3. Detailed information about the
monitoring, functioning and control monitoring, functioning and control monitoring, functioning and control monitoring, functioning and control
of the AI system, in particular with of the AI system, in particular with of the AI system, in particular with of the AI system, in particular with
regard to: its capabilities and regard to: its capabilities and regard to: its capabilities and regard to: its capabilities and
limitations in performance, including limitations in performance, including limitations in performance, including limitations in performance, including
the degrees of accuracy for specific the degrees of accuracy for specific the degrees of accuracy for specific the degrees of accuracy for specific
persons or groups of persons on persons or groups of persons on persons or groups of persons on persons or groups of persons on
G 856 G
which the system is intended to be which the system is intended to be which the system is intended to be which the system is intended to be
used and the overall expected level used and the overall expected level used and the overall expected level used and the overall expected level
of accuracy in relation to its intended of accuracy in relation to its intended of accuracy in relation to its intended of accuracy in relation to its intended
purpose; the foreseeable unintended purpose; the foreseeable unintended purpose; the foreseeable unintended purpose; the foreseeable unintended
outcomes and sources of risks to outcomes and sources of risks to outcomes and sources of risks to outcomes and sources of risks to
health and safety, fundamental rights health and safety, fundamental rights health and safety, fundamental rights health and safety, fundamental rights
and discrimination in view of the and discrimination in view of the and discrimination in view of the and discrimination in view of the
intended purpose of the AI system; intended purpose of the AI system; intended purpose of the AI system; intended purpose of the AI system;
the human oversight measures the human oversight measures the human oversight measures the human oversight measures
needed in accordance with Article needed in accordance with Article needed in accordance with Article needed in accordance with Article
14, including the technical measures 14, including the technical measures 14, including the technical measures 14, including the technical measures
put in place to facilitate the put in place to facilitate the put in place to facilitate the put in place to facilitate the
interpretation of the outputs of AI interpretation of the outputs of AI interpretation of the outputs of AI interpretation of the outputs of AI
systems by the users; specifications systems by the usersdeployers; systems by the users; specifications systems by the usersdeployers;
on input data, as appropriate; specifications on input data, as on input data, as appropriate; specifications on input data, as
appropriate; appropriate;
Annex IV, fourth paragraph a
A description of the appropriateness 3. A description of the

of the performance metrics for the appropriateness of the performance
G 856a specific AI system; metrics for the specific AI system; G
Annex IV, fifth paragraph
Information about the energy

consumption of the AI system
during the development phase and
G 856b the expected energy consumption G
during use, taking into account,

where applicable, relevant Union
and national law;
Annex IV, fifth paragraph
4. A detailed description of the risk 4. A detailed description of the risk 4. A detailed description of the risk 4. A detailed description of the risk
G 857 management system in accordance management system in accordance management system in accordance management system in accordance G
with Article 9; with Article 9; with Article 9; with Article 9;
Proposal
Annex IV, sixth paragraph
5. A description of any change 5. A description of any relevant 5. A description of any change 5. A description of any change
made to the system through its change made by providers to the maderelevant changes made by the maderelevant changes made by the
G 858 lifecycle; system through its lifecycle ; provider to the system through its provider to the system through its G
lifecycle; lifecycle;
Annex IV, seventh paragraph
6. A list of the harmonised 6. A list of the harmonised 6. A list of the harmonised 6. A list of the harmonised
standards applied in full or in part standards applied in full or in part standards applied in full or in part standards applied in full or in part
the references of which have been the references of which have been the references of which have been the references of which have been
published in the Official Journal of published in the Official Journal of published in the Official Journal of published in the Official Journal of
the European Union; where no such the European Union; where no such the European Union; where no such the European Union; where no such
harmonised standards have been harmonised standards have been harmonised standards have been harmonised standards have been
G 859 applied, a detailed description of the applied, a detailed description of the applied, a detailed description of the applied, a detailed description of the G
solutions adopted to meet the solutions adopted to meet the solutions adopted to meet the solutions adopted to meet the
Chapter 2, including a list of other Chapter 2, including a list of other Chapter 2, including a list of other Chapter 2, including a list of other
relevant standards and technical relevant standards and technicalor relevant standards and technical relevant standards and technical
specifications applied; common specifications applied; specifications applied; specifications applied;
Annex IV, eighth paragraph
7. A copy of the EU declaration of 7. A copy of the EU declaration of 7. A copy of the EU declaration of 7. A copy of the EU declaration of
G 860 conformity; conformity; conformity; conformity; G

Proposal
Annex IV, ninth paragraph
8. A detailed description of the 8. A detailed description of the 8. A detailed description of the 8. A detailed description of the
system in place to evaluate the AI system in place to evaluate the AI system in place to evaluate the AI system in place to evaluate the AI
system performance in the post- system performance in the post- system performance in the post- system performance in the post-
market phase in accordance with market phase in accordance with market phase in accordance with market phase in accordance with
G 861 Article 61, including the post-market Article 61, including the post-market Article 61, including the post-market Article 61, including the post-market G
monitoring plan referred to in monitoring plan referred to in monitoring plan referred to in monitoring plan referred to in
Article 61(3). Article 61(3). Article 61(3). Article 61(3).
Proposal
Annex V
Annex V EU DECLARATION OF Annex V EU DECLARATION OF Annex V EU DECLARATION OF Annex V EU DECLARATION OF

CONFORMITY CONFORMITY CONFORMITY CONFORMITY
G 862 G

Proposal
Annex V, first paragraph
The EU declaration of conformity The EU declaration of conformity The EU declaration of conformity The EU declaration of conformity
referred to in Article 48, shall referred to in Article 48, shall referred to in Article 48, shall referred to in Article 48, shall
contain all of the following contain all of the following contain all of the following contain all of the following
G 863 information: information: information: information:
G

Proposal
Annex V, second paragraph
G 864 G
1. AI system name and type and any 1. AI system name and type and any 1. AI system name and type and any 1. AI system name and type and any
additional unambiguous reference additional unambiguous reference additional unambiguous reference additional unambiguous reference
allowing identification and allowing identification and allowing identification and allowing identification and
traceability of the AI system; traceability of the AI system; traceability of the AI system; traceability of the AI system;
Proposal
Annex V, third paragraph
2. Name and address of the provider 2. Name and address of the provider 2. Name and address of the provider 2. Name and address of the provider
or, where applicable, their authorised or, where applicable, their authorised or, where applicable, their authorised or, where applicable, their authorised
G 865 representative; representative; representative; representative; G

Proposal
Annex V, fourth paragraph
3. A statement that the EU 3. A statement that the EU 3. A statement that the EU 3. A statement that the EU
declaration of conformity is issued declaration of conformity is issued declaration of conformity is issued declaration of conformity is issued
under the sole responsibility of the under the sole responsibility of the under the sole responsibility of the under the sole responsibility of the
G 866 provider; provider; provider; provider;
G

Proposal
Annex V, fifth paragraph
4. A statement that the AI system in 4. A statement that the AI system in 4. A statement that the AI system in 4. A statement that the AI system in
question is in conformity with this question is in conformity with this question is in conformity with this question is in conformity with this
Regulation and, if applicable, with Regulation and, if applicable, with Regulation and, if applicable, with Regulation and, if applicable, with
G 867 any other relevant Union legislation any other relevant Union legislation any other relevant Union legislation any other relevant Union legislation G
that provides for the issuing of an that provides for the issuing of an that provides for the issuing of an that provides for the issuing of an
EU declaration of conformity; EU declaration of conformity; EU declaration of conformity; EU declaration of conformity;
Proposal
Annex V, fifth paragraph a
4 a. Where an AI system 4. 4a. Where an AI system involves

involves the processing of personal the processing of personal data, a
data, a statement that that AI statement that that AI system
G 867a system complies with Regulations complies with Regulations (EU) G
(EU) 2016/679 and (EU) 2018/1725 2016/679 and (EU) 2018/1725 and
and Directive (EU) 2016/680. Directive (EU) 2016/680.
Annex V, sixth paragraph
5. References to any relevant 5. References to any relevant 5. References to any relevant 5. References to any relevant
harmonised standards used or any harmonised standards used or any harmonised standards used or any harmonised standards used or any
other common specification in other common specification in other common specification in other common specification in
G 868 relation to which conformity is relation to which conformity is relation to which conformity is relation to which conformity is G
declared; declared; declared; declared;

Proposal
Annex V, seventh paragraph
6. Where applicable, the name and 6. Where applicable, the name and 6. Where applicable, the name and 6. Where applicable, the name and
identification number of the notified identification number of the notified identification number of the notified identification number of the notified
body, a description of the conformity body, a description of the conformity body, a description of the conformity body, a description of the conformity
assessment procedure performed and assessment procedure performed and assessment procedure performed and assessment procedure performed and
G 869 identification of the certificate identification of the certificate identification of the certificate identification of the certificate
G
issued; issued; issued; issued;

Proposal
Annex V, eighth paragraph
7. Place and date of issue of the 7. Place and date of issue of the 7. Place and date of issue of the 7. Place and date of issue of the
declaration, name and function of declaration, signature, name and declaration, name and function of declaration, name and function of
the person who signed it as well as function of the person who signed it the person who signed it as well as the person who signed it as well as
G 870 G
an indication for, and on behalf of as well as an indication for, and on an indication for, and on behalf of an indication for, and on behalf of
whom, that person signed, signature. behalf of whom, that person signed, whom, that person signed, signature. whom, that person signed, signature.
signature.
Annex VI
Annex VI CONFORMITY Annex VI CONFORMITY Annex VI CONFORMITY Annex VI CONFORMITY

ASSESSMENT PROCEDURE ASSESSMENT PROCEDURE ASSESSMENT PROCEDURE ASSESSMENT PROCEDURE
BASED ON INTERNAL BASED ON INTERNAL BASED ON INTERNAL BASED ON INTERNAL
G 871 CONTROL CONTROL CONTROL CONTROL
G

Proposal
Annex VI, point 1.
1. The conformity assessment 1. The conformity assessment 1. The conformity assessment 1. The conformity assessment
procedure based on internal control procedure based on internal control procedure based on internal control procedure based on internal control
is the conformity assessment is the conformity assessment is the conformity assessment is the conformity assessment
G 872 procedure based on points 2 to 4. procedure based on points 2 to 4. procedure based on points 2 to 4. procedure based on points 2 to 4.
G

Proposal
Annex VI, point 2.
2. The provider verifies that the 2. The provider verifies that the 2. The provider verifies that the 2. The provider verifies that the
G 873 established quality management established quality management established quality management established quality management G
system is in compliance with the system is in compliance with the system is in compliance with the system is in compliance with the
requirements of Article 17. requirements of Article 17. requirements of Article 17. requirements of Article 17.

Proposal
Annex VI, point 3.
3. The provider examines the 3. The provider examines the 3. The provider examines the 3. The provider examines the
information contained in the information contained in the information contained in the information contained in the
technical documentation in order to technical documentation in order to technical documentation in order to technical documentation in order to
assess the compliance of the AI assess the compliance of the AI assess the compliance of the AI assess the compliance of the AI
G 874 system with the relevant essential system with the relevant essential system with the relevant essential system with the relevant essential G
Chapter 2. Chapter 2. Chapter 2. Chapter 2.
Proposal
Annex VI, point 4.
4. The provider also verifies that the 4. The provider also verifies that the 4. The provider also verifies that the 4. The provider also verifies that the
design and development process of design and development process of design and development process of design and development process of
the AI system and its post-market the AI system and its post-market the AI system and its post-market the AI system and its post-market
monitoring as referred to in Article monitoring as referred to in Article monitoring as referred to in Article monitoring as referred to in Article
G 875 61 is consistent with the technical 61 is consistent with the technical 61 is consistent with the technical 61 is consistent with the technical
G
documentation. documentation. documentation. documentation.

Proposal
Annex VII
Annex VII CONFORMITY Annex VII CONFORMITY Annex VII CONFORMITY Annex VII CONFORMITY
BASED ON ASSESSMENT OF BASED ON ASSESSMENT OF BASED ON ASSESSMENT OF BASED ON ASSESSMENT OF
G 876 G
QUALITY MANAGEMENT QUALITY MANAGEMENT QUALITY MANAGEMENT QUALITY MANAGEMENT
SYSTEM AND ASSESSMENT OF SYSTEM AND ASSESSMENT OF SYSTEM AND ASSESSMENT OF SYSTEM AND ASSESSMENT OF
TECHNICAL DOCUMENTATION TECHNICAL DOCUMENTATION TECHNICAL DOCUMENTATION TECHNICAL DOCUMENTATION

Proposal
Annex VII, point 1., first subparagraph
1. Introduction 1. Introduction 1. Introduction 1. Introduction

G
Proposal
Annex VII, point 1., second subparagraph
Conformity based on assessment of Conformity based on assessment of Conformity based on assessment of Conformity based on assessment of
quality management system and quality management system and quality management system and quality management system and
assessment of the technical assessment of the technical assessment of the technical assessment of the technical
documentation is the conformity documentation is the conformity documentation is the conformity documentation is the conformity
G 878 assessment procedure based on assessment procedure based on assessment procedure based on assessment procedure based on
G
points 2 to 5. points 2 to 5. points 2 to 5. points 2 to 5.

Proposal
Annex VII, point 2., first subparagraph
2. Overview 2. Overview 2. Overview 2. Overview

G
Proposal
Annex VII, point 2., second subparagraph
The approved quality management The approved quality management The approved quality management The approved quality management
G 880 G
system for the design, development system for the design, development system for the design, development system for the design, development
and testing of AI systems pursuant to and testing of AI systems pursuant to and testing of AI systems pursuant to and testing of AI systems pursuant to
Article 17 shall be examined in Article 17 shall be examined in Article 17 shall be examined in Article 17 shall be examined in
accordance with point 3 and shall be accordance with point 3 and shall be accordance with point 3 and shall be accordance with point 3 and shall be
subject to surveillance as specified subject to surveillance as specified subject to surveillance as specified subject to surveillance as specified
in point 5. The technical in point 5. The technical in point 5. The technical in point 5. The technical
documentation of the AI system documentation of the AI system documentation of the AI system documentation of the AI system
shall be examined in accordance shall be examined in accordance shall be examined in accordance shall be examined in accordance
with point 4. with point 4. with point 4. with point 4.
Proposal
Annex VII, point 3.
3. Quality management system 3. Quality management system 3. Quality management system 3. Quality management system
G
Proposal
Annex VII, first paragraph
3.1. The application of the provider 3.1. The application of the provider 3.1. The application of the provider 3.1. The application of the provider
shall include: shall include: shall include: shall include:
G 882 G

Proposal
Annex VII, first paragraph, point (a)
(a) the name and address of the (a) the name and address of the (a) the name and address of the (a) the name and address of the
provider and, if the application is provider and, if the application is provider and, if the application is provider and, if the application is
lodged by the authorised lodged by the authorised lodged by the authorised lodged by the authorised
G 883 representative, their name and representative, their name and representative, their name and representative, their name and
G
address as well; address as well; address as well; address as well;

Proposal
Annex VII, first paragraph, point (b)
(b) the list of AI systems covered (b) the list of AI systems covered (b) the list of AI systems covered (b) the list of AI systems covered
under the same quality management under the same quality management under the same quality management under the same quality management
G 884 system; system; system; system; G

Proposal
Annex VII, first paragraph, point (c)
(c) the technical documentation for (c) the technical documentation for (c) the technical documentation for (c) the technical documentation for
each AI system covered under the each AI system covered under the each AI system covered under the each AI system covered under the
G 885 same quality management system; same quality management system; same quality management system; same quality management system; G

Proposal
Annex VII, first paragraph, point (d)
(d) the documentation concerning (d) the documentation concerning (d) the documentation concerning (d) the documentation concerning
the quality management system the quality management system the quality management system the quality management system
which shall cover all the aspects which shall cover all the aspects which shall cover all the aspects which shall cover all the aspects
G 886 listed under Article 17; listed under Article 17; listed under Article 17; listed under Article 17;
G

Proposal
Annex VII, first paragraph, point (e)
(e) a description of the procedures (e) a description of the procedures (e) a description of the procedures (e) a description of the procedures
G 887 in place to ensure that the quality in place to ensure that the quality in place to ensure that the quality in place to ensure that the quality G
management system remains management system remains management system remains management system remains
adequate and effective; adequate and effective; adequate and effective; adequate and effective;

Proposal
Annex VII, first paragraph, point (f)
(f) a written declaration that the (f) a written declaration that the (f) a written declaration that the (f) a written declaration that the
same application has not been same application has not been same application has not been same application has not been
G 888 lodged with any other notified body. lodged with any other notified body. lodged with any other notified body. lodged with any other notified body. G

Proposal
Annex VII, third paragraph
3.2. The quality management 3.2. The quality management 3.2. The quality management 3.2. The quality management
system shall be assessed by the system shall be assessed by the system shall be assessed by the system shall be assessed by the
notified body, which shall determine notified body, which shall determine notified body, which shall determine notified body, which shall determine
G 889 whether it satisfies the requirements whether it satisfies the requirements whether it satisfies the requirements whether it satisfies the requirements G
referred to in Article 17. referred to in Article 17. referred to in Article 17. referred to in Article 17.
Proposal
Annex VII, fourth paragraph
The decision shall be notified to the The decision shall be notified to the The decision shall be notified to the The decision shall be notified to the
provider or its authorised provider or its authorised provider or its authorised provider or its authorised
G 890 representative. representative. representative. representative. G

Proposal
Annex VII, fifth paragraph

G 891 G
The notification shall contain the The notification shall contain the The notification shall contain the The notification shall contain the
conclusions of the assessment of the conclusions of the assessment of the conclusions of the assessment of the conclusions of the assessment of the
quality management system and the quality management system and the quality management system and the quality management system and the
reasoned assessment decision. reasoned assessment decision. reasoned assessment decision. reasoned assessment decision.
Proposal
Annex VII, sixth paragraph
3.3. The quality management 3.3. The quality management 3.3. The quality management 3.3. The quality management
system as approved shall continue to system as approved shall continue to system as approved shall continue to system as approved shall continue to
be implemented and maintained by be implemented and maintained by be implemented and maintained by be implemented and maintained by
G 892 the provider so that it remains the provider so that it remains the provider so that it remains the provider so that it remains G
adequate and efficient. adequate and efficient. adequate and efficient. adequate and efficient.
Proposal
Annex VII, eighth paragraph
3.4. Any intended change to the 3.4. Any intended change to the 3.4. Any intended change to the 3.4. Any intended change to the
approved quality management approved quality management approved quality management approved quality management
system or the list of AI systems system or the list of AI systems system or the list of AI systems system or the list of AI systems
covered by the latter shall be brought covered by the latter shall be brought covered by the latter shall be brought covered by the latter shall be brought
G 893 to the attention of the notified body to the attention of the notified body to the attention of the notified body to the attention of the notified body
G
by the provider. by the provider. by the provider. by the provider.

Proposal
Annex VII, ninth paragraph
The proposed changes shall be The proposed changes shall be The proposed changes shall be The proposed changes shall be
G 894 G
examined by the notified body, examined by the notified body, examined by the notified body, examined by the notified body,
which shall decide whether the which shall decide whether the which shall decide whether the which shall decide whether the
modified quality management modified quality management modified quality management modified quality management
system continues to satisfy the system continues to satisfy the system continues to satisfy the system continues to satisfy the
requirements referred to in point 3.2 requirements referred to in point 3.2 requirements referred to in point 3.2 requirements referred to in point 3.2
or whether a reassessment is or whether a reassessment is or whether a reassessment is or whether a reassessment is
necessary. necessary. necessary. necessary.
Proposal
Annex VII, tenth paragraph
The notified body shall notify the The notified body shall notify the The notified body shall notify the The notified body shall notify the
provider of its decision. The provider of its decision. The provider of its decision. The provider of its decision. The
notification shall contain the notification shall contain the notification shall contain the notification shall contain the
conclusions of the examination of conclusions of the examination of conclusions of the examination of conclusions of the examination of
G 895 the changes and the reasoned the changes and the reasoned the changes and the reasoned the changes and the reasoned
G
assessment decision. assessment decision. assessment decision. assessment decision.

Proposal
Annex VII, point 4.
4. Control of the technical 4. Control of the technical 4. Control of the technical 4. Control of the technical
documentation. documentation. documentation. documentation.
G 896 G

Proposal
Annex VII, eleventh paragraph
4.1. In addition to the application 4.1. In addition to the application 4.1. In addition to the application 4.1. In addition to the application
referred to in point 3, an application referred to in point 3, an application referred to in point 3, an application referred to in point 3, an application
G 897 G
with a notified body of their choice with a notified body of their choice with a notified body of their choice with a notified body of their choice
shall be lodged by the provider for shall be lodged by the provider for shall be lodged by the provider for shall be lodged by the provider for
the assessment of the technical the assessment of the technical the assessment of the technical the assessment of the technical
documentation relating to the AI documentation relating to the AI documentation relating to the AI documentation relating to the AI
system which the provider intends to system which the provider intends to system which the provider intends to system which the provider intends to
place on the market or put into place on the market or put into place on the market or put into place on the market or put into
service and which is covered by the service and which is covered by the service and which is covered by the service and which is covered by the
quality management system referred quality management system referred quality management system referred quality management system referred
to under point 3. to under point 3. to under point 3. to under point 3.
Proposal
Annex VII, twelfth paragraph
4.2. The application shall include: 4.2. The application shall include: 4.2. The application shall include: 4.2. The application shall include:
G
Proposal
Annex VII, twelfth paragraph, point (a)
(a) the name and address of the (a) the name and address of the (a) the name and address of the (a) the name and address of the
provider; provider; provider; provider;
G 899 G

Proposal
Annex VII, twelfth paragraph, point (b)
(b) a written declaration that the (b) a written declaration that the (b) a written declaration that the (b) a written declaration that the
same application has not been same application has not been same application has not been same application has not been
G 900 lodged with any other notified body; lodged with any other notified body; lodged with any other notified body; lodged with any other notified body; G

Proposal
Annex VII, twelfth paragraph, point (c)
(c) the technical documentation (c) the technical documentation (c) the technical documentation (c) the technical documentation
referred to in Annex IV. referred to in Annex IV. referred to in Annex IV. referred to in Annex IV.
G 901 G

Proposal
Annex VII, thirteenth paragraph
4.3. The technical documentation 4.3. The technical documentation 4.3. The technical documentation 4.3. The technical documentation
shall be examined by the notified shall be examined by the notified shall be examined by the notified shall be examined by the notified
body. To this purpose, the notified body. To this purpose, the notified body. Where relevant and limited to body. Where relevant and limited to
body shall be granted full access to body shall be granted full access to what is necessary to fulfil their what is necessary to fulfil their
the training and testing datasets used the training and testing datasets used tasksTo this purpose, the notified tasksTo this purpose, the notified
by the provider, including through by the provider, including through body shall be granted full access to body shall be granted full access to
application programming interfaces application programming interfaces the training, validation, and testing the training, validation, and testing
G 902 (API) or other appropriate means (API) or other appropriate means datasets used, including, where datasets used, including, where G
and tools enabling remote access. and tools enabling remote access. appropriate and subject to security appropriate and subject to security
safeguards, by the provider, safeguards, by the provider,
including through application including through application
programming interfaces (API) or programming interfaces (API) or
other appropriaterelevant technical other appropriaterelevant technical
means and tools enabling remote means and tools enabling remote
access. access.
Annex VII, fourteenth paragraph
4.4. In examining the technical 4.4. In examining the technical 4.4. In examining the technical 4.4. In examining the technical
documentation, the notified body documentation, the notified body documentation, the notified body documentation, the notified body
may require that the provider may require that the provider may require that the provider may require that the provider
G 903 supplies further evidence or carries supplies further evidence or carries supplies further evidence or carries supplies further evidence or carries G
out further tests so as to enable a out further tests so as to enable a out further tests so as to enable a out further tests so as to enable a
proper assessment of conformity of proper assessment of conformity of proper assessment of conformity of proper assessment of conformity of
the AI system with the requirements the AI system with the requirements the AI system with the requirements the AI system with the requirements
set out in Title III, Chapter 2. set out in Title III, Chapter 2. set out in Title III, Chapter 2. set out in Title III, Chapter 2.
Whenever the notified body is not Whenever the notified body is not Whenever the notified body is not Whenever the notified body is not
satisfied with the tests carried out by satisfied with the tests carried out by satisfied with the tests carried out by satisfied with the tests carried out by
the provider, the notified body shall the provider, the notified body shall the provider, the notified body shall the provider, the notified body shall
directly carry out adequate tests, as directly carry out adequate tests, as directly carry out adequate tests, as directly carry out adequate tests, as
appropriate. appropriate. appropriate. appropriate.
Proposal
Annex VII, fifteenth paragraph
4.5. Where necessary to assess the 4.5. Where necessary to assess the 4.5. Where necessary to assess the 4.5. Where necessary to assess the
conformity of the high-risk AI conformity of the high-risk AI conformity of the high-risk AI system conformity of the high-risk AI
system with the requirements set out system with the requirements set out with the requirements set out in Title system with the requirements set out
in Title III, Chapter 2 and upon a in Title III, Chapter 2, after all other III, Chapter 2 andNotified bodies in Title III, Chapter 2, after all other
reasoned request, the notified body reasonable ways to verify shall be granted access to the reasonable ways to verify
shall also be granted access to the conformity have been exhausted source code of the AI system upon a conformity have been exhausted
source code of the AI system. and have proven to be insufficient, reasoned request, the notified body and have proven to be insufficient,
and upon a reasoned request, the shall also be granted access to the and upon a reasoned request, the
notified body shall also be granted source code of the AI system. and notified body shall also be granted
access to the source codetraining only when the following cumulative access to the source codetraining
G 904 G
and trained models of the AI conditions are fulfilled: and trained models of the AI
system, including its relevant system, including its relevant
parameters. Such access shall be parameters. Such access shall be
subject to existing Union law on the subject to existing Union law on the
protection of intellectual property protection of intellectual property
and trade secrets. They shall take and trade secrets.
technical and organisational
measures to ensure the protection
of intellectual property and trade
secrets.
Annex VII, fifteenth paragraph, point (a)
G 904a G
(a) access to source code is
necessary to assess the conformity
of the high-risk AI system with the
Chapter 2, and
Annex VII, fifteenth paragraph, point (b)
(b) testing/auditing procedures and

verifications based on the data and
G 904b documentation provided by the G
provider have been exhausted or

proved insufficient.
Annex VII, seventeenth paragraph
4.6. The decision shall be notified to 4.6. The decision shall be notified to 4.6. The decision shall be notified to 4.6. The decision shall be notified to
the provider or its authorised the provider or its authorised the provider or its authorised the provider or its authorised
representative. The notification shall representative. The notification shall representative. The notification shall representative. The notification shall
contain the conclusions of the contain the conclusions of the contain the conclusions of the contain the conclusions of the
G 905 assessment of the technical assessment of the technical assessment of the technical assessment of the technical G
documentation and the reasoned documentation and the reasoned documentation and the reasoned documentation and the reasoned
assessment decision. assessment decision. assessment decision. assessment decision.
Proposal
Annex VII, eighteenth paragraph
Where the AI system is in Where the AI system is in Where the AI system is in Where the AI system is in
conformity with the requirements set conformity with the requirements set conformity with the requirements set conformity with the requirements set
G 906 out in Title III, Chapter 2, an EU out in Title III, Chapter 2, an EU out in Title III, Chapter 2, an EU out in Title III, Chapter 2, an EU G
certificate shall be issued by the certificate shall be issued by the certificate shall be issued by the certificate shall be issued by the
notified body. The certificate shall notified body. The certificate shall notified body. The certificate shall notified body. The certificate shall
indicate the name and address of the indicate the name and address of the indicate the name and address of the indicate the name and address of the
provider, the conclusions of the provider, the conclusions of the provider, the conclusions of the provider, the conclusions of the
examination, the conditions (if any) examination, the conditions (if any) examination, the conditions (if any) examination, the conditions (if any)
for its validity and the data necessary for its validity and the data necessary for its validity and the data necessary for its validity and the data necessary
for the identification of the AI for the identification of the AI for the identification of the AI for the identification of the AI
Proposal
Annex VII, nineteenth paragraph
The certificate and its annexes shall The certificate and its annexes shall The certificate and its annexes shall The certificate and its annexes shall
contain all relevant information to contain all relevant information to contain all relevant information to contain all relevant information to
allow the conformity of the AI allow the conformity of the AI allow the conformity of the AI allow the conformity of the AI
system to be evaluated, and to allow system to be evaluated, and to allow system to be evaluated, and to allow system to be evaluated, and to allow
G 907 for control of the AI system while in for control of the AI system while in for control of the AI system while in for control of the AI system while in
G
use, where applicable. use, where applicable. use, where applicable. use, where applicable.
Proposal
Annex VII, twentieth paragraph
Where the AI system is not in Where the AI system is not in Where the AI system is not in Where the AI system is not in
conformity with the requirements set conformity with the requirements set conformity with the requirements set conformity with the requirements set
out in Title III, Chapter 2, the out in Title III, Chapter 2, the out in Title III, Chapter 2, the out in Title III, Chapter 2, the
notified body shall refuse to issue an notified body shall refuse to issue an notified body shall refuse to issue an notified body shall refuse to issue an
EU technical documentation EU technical documentation EU technical documentation EU technical documentation
G 908 assessment certificate and shall assessment certificate and shall assessment certificate and shall assessment certificate and shall G
inform the applicant accordingly, inform the applicant accordingly, inform the applicant accordingly, inform the applicant accordingly,
giving detailed reasons for its giving detailed reasons for its giving detailed reasons for its giving detailed reasons for its
refusal. refusal. refusal. refusal.
Proposal
Annex VII, twenty-first paragraph
Where the AI system does not meet Where the AI system does not meet Where the AI system does not meet Where the AI system does not meet
the requirement relating to the data the requirement relating to the data the requirement relating to the data the requirement relating to the data
used to train it, re-training of the AI used to train it, re-training of the AI used to train it, re-training of the AI used to train it, re-training of the AI
system will be needed prior to the system will be needed prior to the system will be needed prior to the system will be needed prior to the
application for a new conformity application for a new conformity application for a new conformity application for a new conformity
assessment. In this case, the assessment. In this case, the assessment. In this case, the assessment. In this case, the
reasoned assessment decision of the reasoned assessment decision of the reasoned assessment decision of the reasoned assessment decision of the
notified body refusing to issue the notified body refusing to issue the notified body refusing to issue the notified body refusing to issue the
G 909 EU technical documentation EU technical documentation EU technical documentation EU technical documentation
G
assessment certificate shall contain assessment certificate shall contain assessment certificate shall contain assessment certificate shall contain
specific considerations on the quality specific considerations on the quality specific considerations on the quality specific considerations on the quality
data used to train the AI system, data used to train the AI system, data used to train the AI system, data used to train the AI system,
notably on the reasons for non- notably on the reasons for non- notably on the reasons for non- notably on the reasons for non-
compliance. compliance. compliance. compliance.
Proposal
Annex VII, 11 paragraph
4.7. Any change to the AI system 4.7. Any change to the AI system 4.7. Any change to the AI system 4.7. Any change to the AI system
that could affect the compliance of that could affect the compliance of that could affect the compliance of that could affect the compliance of
the AI system with the requirements the AI system with the requirements the AI system with the requirements the AI system with the requirements
or its intended purpose shall be or its intended purpose shall be or its intended purpose shall be or its intended purpose shall be
approved by the notified body which approved by the notified body which approved by the notified body which approved by the notified body which
issued the EU technical issued the EU technical issued the EU technical issued the EU technical
G 910 documentation assessment documentation assessment documentation assessment documentation assessment G
certificate. The provider shall inform certificate. The provider shall inform certificate. The provider shall inform certificate. The provider shall inform
such notified body of its intention to such notified body of its intention to such notified body of its intention to such notified body of its intention to
introduce any of the above- introduce any of the above- introduce any of the above- introduce any of the above-
mentioned changes or if it becomes mentioned changes or if it becomes mentioned changes or if it becomes mentioned changes or if it becomes
otherwise aware of the occurrence of otherwise aware of the occurrence of otherwise aware of the occurrence of otherwise aware of the occurrence of
such changes. The intended changes such changes. The intended changes such changes. The intended changes such changes. The intended changes
shall be assessed by the notified shall be assessed by the notified shall be assessed by the notified shall be assessed by the notified
body which shall decide whether body which shall decide whether body which shall decide whether body which shall decide whether
those changes require a new those changes require a new those changes require a new those changes require a new
conformity assessment in conformity assessment in conformity assessment in conformity assessment in
accordance with Article 43(4) or accordance with Article 43(4) or accordance with Article 43(4) or accordance with Article 43(4) or
whether they could be addressed by whether they could be addressed by whether they could be addressed by whether they could be addressed by
means of a supplement to the EU means of a supplement to the EU means of a supplement to the EU means of a supplement to the EU
certificate. In the latter case, the certificate. In the latter case, the certificate. In the latter case, the certificate. In the latter case, the
notified body shall assess the notified body shall assess the notified body shall assess the notified body shall assess the
changes, notify the provider of its changes, notify the provider of its changes, notify the provider of its changes, notify the provider of its
decision and, where the changes are decision and, where the changes are decision and, where the changes are decision and, where the changes are
approved, issue to the provider a approved, issue to the provider a approved, issue to the provider a approved, issue to the provider a
supplement to the EU technical supplement to the EU technical supplement to the EU technical supplement to the EU technical
documentation assessment documentation assessment documentation assessment documentation assessment
certificate. certificate. certificate. certificate.
Proposal
Annex VII, point 5.
5. Surveillance of the approved 5. Surveillance of the approved 5. Surveillance of the approved 5. Surveillance of the approved
quality management system. quality management system. quality management system. quality management system.
G 911 G

Proposal
5.1. The purpose of the surveillance 5.1. The purpose of the surveillance 5.1. The purpose of the surveillance 5.1. The purpose of the surveillance
carried out by the notified body carried out by the notified body carried out by the notified body carried out by the notified body
referred to in Point 3 is to make sure referred to in Point 3 is to make sure referred to in Point 3 is to make sure referred to in Point 3 is to make sure
G 912 G
that the provider duly fulfils the that the provider duly fulfils the that the provider duly fulfils the that the provider duly fulfils the
terms and conditions of the approved terms and conditions of the approved terms and conditions of the approved terms and conditions of the approved
quality management system. quality management system. quality management system. quality management system.
Proposal
5.2. For assessment purposes, the 5.2. For assessment purposes, the 5.2. For assessment purposes, the 5.2. For assessment purposes, the
provider shall allow the notified provider shall allow the notified provider shall allow the notified provider shall allow the notified
body to access the premises where body to access the premises where body to access the premises where body to access the premises where
the design, development, testing of the design, development, testing of the design, development, testing of the design, development, testing of
the AI systems is taking place. The the AI systems is taking place. The the AI systems is taking place. The the AI systems is taking place. The
G 913 provider shall further share with the provider shall further share with the provider shall further share with the provider shall further share with the
G
notified body all necessary notified body all necessary notified body all necessary notified body all necessary
information. information. information. information.
Proposal
5.3. The notified body shall carry 5.3. The notified body shall carry 5.3. The notified body shall carry 5.3. The notified body shall carry
out periodic audits to make sure that out periodic audits to make sure that out periodic audits to make sure that out periodic audits to make sure that
the provider maintains and applies the provider maintains and applies the provider maintains and applies the provider maintains and applies
the quality management system and the quality management system and the quality management system and the quality management system and
shall provide the provider with an shall provide the provider with an shall provide the provider with an shall provide the provider with an
audit report. In the context of those audit report. In the context of those audit report. In the context of those audit report. In the context of those
G 914 audits, the notified body may carry audits, the notified body may carry audits, the notified body may carry audits, the notified body may carry G
out additional tests of the AI systems out additional tests of the AI systems out additional tests of the AI systems out additional tests of the AI systems
for which an EU technical for which an EU technical for which an EU technical for which an EU technical
documentation assessment certificate documentation assessment certificate documentation assessment certificate documentation assessment certificate
was issued. was issued. was issued. was issued.
Proposal
Annex VIII
Annex VIII INFORMATION TO Annex VIII INFORMATION TO Annex VIII INFORMATION TO Annex VIII INFORMATION TO
BE SUBMITTED UPON THE BE SUBMITTED UPON THE BE SUBMITTED UPON THE BE SUBMITTED UPON THE
REGISTRATION OF HIGH-RISK REGISTRATION OF HIGH-RISK REGISTRATION OF REGISTRATION OF HIGH-RISK
G 915 AI SYSTEMS IN ACCORDANCE AI SYSTEMS IN ACCORDANCE OPERATORS AND HIGH-RISK AI SYSTEMS IN ACCORDANCE G
WITH ARTICLE 51 WITH ARTICLE 51 AI SYSTEMS IN ACCORDANCE WITH ARTICLE 51

WITH ARTICLE 51
Proposal
Annex VIII, first paragraph
The following information shall be Section A - The following The following informationProviders, Section A - The following
provided and thereafter kept up to information shall be provided and authorised representatives and information shall be provided and
date with regard to high-risk AI thereafter kept up to date with regard users that are public authorities, thereafter kept up to date with regard
systems to be registered in to high-risk AI systems to be agencies or bodies shall be provided to high-risk AI systems to be
accordance with Article 51. registered in accordance with Article and thereafter kept up to date with registered in accordance with Article
51 (1). regard tosubmit the information 51 (1).
referred to in Part I. Providers or,
when applicable, authorised
G 916 representatives shall ensure that the G
information on their high-risk AI

systems referred to in Part II, 1 to
11 is complete, correct and kept up-
to-date. Information laid down in
II.12 shall be automatically
generated by the databaseto be
registered in accordance with
Article 51.
Annex VIII, first paragraph a
1. Type of operator (provider,

G 916a Text Origin: Council Mandate G
authorised representative or user);
Annex VIII, Part I
Part I Information related to

G 916b operators (upon G
operators’registration)
Annex VIII, point 1.
1. Name, address and contact details 1. Name, address and contact details 1. Name, address and contact details 1. Name, address and contact details
of the provider; of the provider; of the provider; of the provider;
G 917 G

Proposal
2. Where submission of information 2. Where submission of information 2. Where submission of information 2. Where submission of information
is carried out by another person on is carried out by another person on is carried out by another person on is carried out by another person on
behalf of the provider, the name, behalf of the provider, the name, behalf of the provideroperator, the behalf of the provider, the name,
G 918 address and contact details of that address and contact details of that name, address and contact details of address and contact details of that G
person; person; that person; person;

Proposal
Annex VIII, Part II
Part II Information related to the

G 918a G
high-risk AI system
G 919 3. Name, address and contact details 3. Name, address and contact details 3. Name, address and contact details 3. Name, address and contact details G
of the authorised representative, of the authorised representative, of the authorised representative, of the authorised representative,
where applicable; where applicable; where applicable;provider where applicable;
Proposal
Annex VIII, point 3a.
3a. Name, address and contact

G 919a details of the authorised G
representative, where applicable;
4. AI system trade name and any 4. AI system trade name and any 4. AI system trade name and any 4. AI system trade name and any
additional unambiguous reference additional unambiguous reference additional unambiguous reference additional unambiguous reference
allowing identification and allowing identification and allowing identification and allowing identification and
G 920 traceability of the AI system; traceability of the AI system; traceability of the AI system; traceability of the AI system;
G

Proposal
4a. Foundation model trade name 4a.

and any additional unambiguous
G 920a Text Origin: EP Mandate G
refernce allowing identification and
traceability
5. Description of the intended 5. A simple and comprehensible 5. Description of the intended 5. Description of the intended
G 921 purpose of the AI system; description of purpose of the AI system; purpose of the AI system and of the G
a. the intended purpose of the AI components and functions

system; supported through this AI system;
b. the components and functions
supported through AI; 5a A basic and concise description
c. a basic explanation of the logic of the information used by the
of the AI system system (data, inputs) and its
operating logic.
Annex VIII, point 5a (new).
5a. where applicable, the

categories and nature of data likely
G 921a G
or foreseen to be processed by the
AI system.
6. Status of the AI system (on the 6. Status of the AI system (on the 6. Status of the AI system (on the 6. Status of the AI system (on the
market, or in service; no longer market, or in service; no longer market, or in service; no longer market, or in service; no longer
placed on the market/in service, placed on the market/in service, placed on the market/in service, placed on the market/in service,
G 922 recalled); recalled); recalled); recalled);
G

Proposal
7. Type, number and expiry date of 7. Type, number and expiry date of 7. Type, number and expiry date of 7. Type, number and expiry date of
the certificate issued by the notified the certificate issued by the notified the certificate issued by the notified the certificate issued by the notified
body and the name or identification body and the name or identification body and the name or identification body and the name or identification
G 923 number of that notified body, when number of that notified body, when number of that notified body, when number of that notified body, when G
applicable; applicable; applicable; applicable;

Proposal

8. A scanned copy of the certificate 8. A scanned copy of the certificate 8. A scanned copy of the certificate 8. A scanned copy of the certificate
referred to in point 7, when referred to in point 7, when referred to in point 7, when referred to in point 7, when
G 924 applicable; applicable; applicable; applicable; G

Proposal
9. Member States in which the AI 9. Member States in which the AI 9. Member States in which the AI 9. Member States in which the AI
system is or has been placed on the system is or has been placed on the system is or has been placed on the system is or has been placed on the
market, put into service or made market, put into service or made market, put into service or made market, put into service or made
G 925 available in the Union; available in the Union; available in the Union; available in the Union;
G

Proposal
10. A copy of the EU declaration of 10. A copy of the EU declaration of 10. A copy of the EU declaration of 10. A copy of the EU declaration of
conformity referred to in Article 48; conformity referred to in Article 48; conformity referred to in Article 48; conformity referred to in Article 48;
G 926 G

Proposal
11. Electronic instructions for use; 11. Electronic instructions for use; 11. Electronic instructions for use;
this information shall not be deleted this information shall not be this information shall not be
provided for high-risk AI systems in provided for high-risk AI systems in provided for high-risk AI systems in
G 927 the areas of law enforcement and the areas of law enforcement and the areas of law enforcement and G
migration, asylum and border migration, asylum and border migration, asylum and border
control management referred to in control management referred to in control management referred to in
Annex III, points 1, 6 and 7. Annex III, points 1, 6 and 7. Annex III, points 1, 6 and 7.
Proposal
12. URL for additional information 12. URL for additional information 12. URL for additional information 12. URL for additional information
(optional). (optional). (optional).; (optional).
G 928 G

Proposal
12a. Name, address and contact

G 928a G
details of users.
Annex VIII - SECTION B (new)
Annex VIII SECTION B The Annex VIII SECTION B The

following information shall be following information shall be
provided and thereafter kept up to provided and thereafter kept up to
date with regard to high-risk AI date with regard to high-risk AI
systems to be registered in systems to be registered in
accordance with Article 51 (1a) (a) accordance with Article 51.
and (1b). 1. the name, address and
1. the name, address and contact details of the deployer;
G 928b G
contact details of the deployer ; 2. the name, address and
2. the name, address and contact details of the person
contact details of the person submitting information on behalf of
submitting information on behalf of the deployer ;
the deployer ; 5. a summary of the findings of the
3. the high risk AI system fundamental rights impact
trade name and any additional assessment conducted in
unambiguous reference allowing accordance with Article 29a
identification and traceability of the 6. The URL of the entry of the AI
AI system used; system in the EU database by its
4. a) A simple and provider.
comprehensible description of the 7. A summary of the data protection
intended use of the AI system, impact assessment carried out in
including the specific outcomes accordance with Article 35 of
sought through the use of the Regulation (EU) 2016/679 or
systemn, the geographic and Article 27 of Directive (EU)
temporal scope of application 2016/680 as specified in paragraph
b. Where applicable, the 6 of Article 29 of this Regulation,
categories and nature of data to be where applicable.
processed by the AI system;
c. Arrangements for human ANNEX VIII SECTION C
oversight and governance INFORMATION TO BE
d. Where relevant, the bodies or SUBMITTED UPON THE
natural persons responsible for REGISTRATION OF HIGH-RISK
decisions taken or supported by the AI SYSTEMS IN ACCORDANCE
AI system; WITH ARTICLE 51
5. a summary of the findings of
the fundamental rights impact The following information shall be
assessment conducted in provided and thereafter kept up to
accordance with Article 29a date with regard to AI systems to be
6. The URL of the entry of the AI registered in accordance with
system in the EU database by its Article 51(1a).
provider 1. Name, address and
7. A summary of the data contact details of the provider;
protection impact assessment 1. Where submission of
carried out in accordance with information is carried out by
Article 35 of Regulation (EU) another person on behalf of the
2016/679 or Article 27 of Directive provider, the name, address and
(EU) 2016/680 as specified in contact details of that person;
paragraph 6 of Article 29 of this 2. Name, address and
Regulation, where applicable. contact details of the authorised
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.
Annex VIII - SECTION B (new)
Annex VIIIa INFORMATION TO Annex VIIIa INFORMATION TO

BE SUBMITTED UPON THE BE SUBMITTED UPON THE
REGISTRATION OF HIGH-RISK REGISTRATION OF HIGH-RISK
AI SYSTEMS LISTED IN ANNEX AI SYSTEMS LISTED IN ANNEX
III IN RELATION TO TESTING III IN RELATION TO TESTING
G 928c IN REAL WORLD CONDITIONS IN REAL WORLD CONDITIONS G
IN ACCORDANCE WITH IN ACCORDANCE WITH

ARTICLE 54a ARTICLE 54a
The following information shall be The following information shall be

provided and thereafter kept up to provided and thereafter kept up to
date with regard to testing in real date with regard to testing in real
world conditions to be registered in world conditions to be registered in
accordance with Article 54a: accordance with Article 54a:
1. Union-wide unique single 1. Union-wide unique single

identification number of the testing identification number of the testing
2. Name and contact details of the 2. Name and contact details of the
provider or prospective provider provider or prospective provider
and users involved in the testing in and users involved in the testing in
real world conditions; real world conditions;
3. A brief description of the AI 3. A brief description of the AI
system, its intended purpose and system, its intended purpose and
other information necessary for the other information necessary for the
identification of the system; identification of the system;
4. A summary of the main 4. A summary of the main
characteristics of the plan for characteristics of the plan for
testing in real world conditions; testing in real world conditions;
5. Information on the suspension or 5. Information on the suspension or
world conditions. world conditions.
Annex VIII SECTION C - (new)
Annex VIII Section C The

following information shall be
provided and thereafter kept up to
date with regard to foundation
models to be registered in
G 928d G
accordance with Article 28b (e).
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
4. Trade name and any additional
unambiguous reference allowing
the identification of the foundation
model
5. Description of the data sources
used in the development of the
foundational model
6. Description of the capabilities
and limitations of the foundation
model, including the reasonably
foreseeable risks and the measures
that have been taken to mitigate
them as well as remaining non-
mitigated risks with an explanation
on the reason why they cannot be
mitigated
7. Description of the training
resources used by the foundation
model including computing power
required, training time, and other
relevant information related to the
size and power of the model 8.
Description of the model’s
performance, including on public
benchmarks or state of the art
industry benchmarks
8. Description of the results of
relevant internal and external
testing and optimisation of the
model
9. Member States in which the
foundation model is or has been
placed on the market, put into
service or made available in the
Union;
10. URL for additional
information (optional).
Annex VIIIb
G 928e G
Annex VIIId
G 928f G
Annex IX
Annex IX Union legislation ON Annex IX Union legislation ON Annex IX Union legislation ON Annex IX Union legislation ON
large-scale IT systems in the area of large-scale IT systems in the area of large-scale IT systems in the area of large-scale IT systems in the area of
G 929 Freedom, Security and Justice Freedom, Security and Justice Freedom, Security and Justice Freedom, Security and Justice G

Proposal
Annex IX, point 1.
1. Schengen Information System 1. Schengen Information System 1. Schengen Information System 1. Schengen Information System
G
Proposal
Annex IX, point 1.(a)
(a) Regulation (EU) 2018/1860 of (a) Regulation (EU) 2018/1860 of (a) Regulation (EU) 2018/1860 of (a) Regulation (EU) 2018/1860 of
G 931 G
the use of the Schengen Information the use of the Schengen Information the use of the Schengen Information the use of the Schengen Information
System for the return of illegally System for the return of illegally System for the return of illegally System for the return of illegally
staying third-country nationals (OJ L staying third-country nationals (OJ L staying third-country nationals (OJ L staying third-country nationals (OJ L
312, 7.12.2018, p. 1). 312, 7.12.2018, p. 1). 312, 7.12.2018, p. 1). 312, 7.12.2018, p. 1).
Proposal
Annex IX, point 1.(b)
(b) Regulation (EU) 2018/1861 of (b) Regulation (EU) 2018/1861 of (b) Regulation (EU) 2018/1861 of (b) Regulation (EU) 2018/1861 of
the establishment, operation and use the establishment, operation and use the establishment, operation and use the establishment, operation and use
of the Schengen Information System of the Schengen Information System of the Schengen Information System of the Schengen Information System
(SIS) in the field of border checks, (SIS) in the field of border checks, (SIS) in the field of border checks, (SIS) in the field of border checks,
and amending the Convention and amending the Convention and amending the Convention and amending the Convention
G 932 implementing the Schengen implementing the Schengen implementing the Schengen implementing the Schengen
G
Agreement, and amending and Agreement, and amending and Agreement, and amending and Agreement, and amending and
repealing Regulation (EC) No repealing Regulation (EC) No repealing Regulation (EC) No repealing Regulation (EC) No
1987/2006 (OJ L 312, 7.12.2018, p. 1987/2006 (OJ L 312, 7.12.2018, p. 1987/2006 (OJ L 312, 7.12.2018, p. 1987/2006 (OJ L 312, 7.12.2018, p.
14) 14) 14) 14)
Proposal
Annex IX, point 1.(c)
(c) Regulation (EU) 2018/1862 of (c) Regulation (EU) 2018/1862 of (c) Regulation (EU) 2018/1862 of (c) Regulation (EU) 2018/1862 of
G 933 the establishment, operation and use the establishment, operation and use the establishment, operation and use the establishment, operation and use G
of the Schengen Information System of the Schengen Information System of the Schengen Information System of the Schengen Information System
(SIS) in the field of police (SIS) in the field of police (SIS) in the field of police (SIS) in the field of police
cooperation and judicial cooperation cooperation and judicial cooperation cooperation and judicial cooperation cooperation and judicial cooperation
in criminal matters, amending and in criminal matters, amending and in criminal matters, amending and in criminal matters, amending and
repealing Council Decision repealing Council Decision repealing Council Decision repealing Council Decision
2007/533/JHA, and repealing 2007/533/JHA, and repealing 2007/533/JHA, and repealing 2007/533/JHA, and repealing
Regulation (EC) No 1986/2006 of Regulation (EC) No 1986/2006 of Regulation (EC) No 1986/2006 of Regulation (EC) No 1986/2006 of
Council and Commission Decision Council and Commission Decision Council and Commission Decision Council and Commission Decision
2010/261/EU (OJ L 312, 7.12.2018, 2010/261/EU (OJ L 312, 7.12.2018, 2010/261/EU (OJ L 312, 7.12.2018, 2010/261/EU (OJ L 312, 7.12.2018,
p. 56). p. 56). p. 56). p. 56).
Proposal
Annex IX, point 2.
2. Visa Information System 2. Visa Information System 2. Visa Information System 2. Visa Information System
G
Proposal
(a) Proposal for a REGULATION (a) Proposal for a REGULATION (a) Proposal for a REGULATION (a) Proposal for a REGULATION
OF THE EUROPEAN OF THE EUROPEAN OF THE EUROPEAN OF THE EUROPEAN
PARLIAMENT AND OF THE PARLIAMENT AND OF THE PARLIAMENT AND OF THE PARLIAMENT AND OF THE
COUNCIL amending Regulation COUNCIL amending Regulation COUNCIL amending Regulation COUNCIL amending Regulation
(EC) No 767/2008, Regulation (EC) (EC) No 767/2008, Regulation (EC) (EC) No 767/2008, Regulation (EC) (EC) No 767/2008, Regulation (EC)
No 810/2009, Regulation (EU) No 810/2009, Regulation (EU) No 810/2009, Regulation (EU) No 810/2009, Regulation (EU)
2017/2226, Regulation (EU) 2017/2226, Regulation (EU) 2017/2226, Regulation (EU) 2017/2226, Regulation (EU)
G 935 2016/399, Regulation XX/2018 2016/399, Regulation XX/2018 2016/399, Regulation XX/2018 2016/399, Regulation XX/2018 G
[Interoperability Regulation], and [Interoperability Regulation], and [Interoperability Regulation], and [Interoperability Regulation], and
Decision 2004/512/EC and repealing Decision 2004/512/EC and repealing Decision 2004/512/EC and repealing Decision 2004/512/EC and repealing
Council Decision 2008/633/JHA - Council Decision 2008/633/JHA - Council Decision 2008/633/JHA - Council Decision 2008/633/JHA -
COM(2018) 302 final. To be COM(2018) 302 final. To be COM(2018) 302 final. To be COM(2018) 302 final. To be
updated once the Regulation is updated once the Regulation is updated once the Regulation is updated once the Regulation is
adopted (April/May 2021) by the co- adopted (April/May 2021) by the co- adopted (April/May 2021) by the co- adopted (April/May 2021) by the co-
legislators. legislators. legislators. legislators.
Proposal
Annex IX, point 3.
3. Eurodac 3. Eurodac 3. Eurodac 3. Eurodac

G
Proposal
(a) Amended proposal for a (a) Amended proposal for a (a) Amended proposal for a (a) Amended proposal for a
REGULATION OF THE REGULATION OF THE REGULATION OF THE REGULATION OF THE
EUROPEAN PARLIAMENT AND EUROPEAN PARLIAMENT AND EUROPEAN PARLIAMENT AND EUROPEAN PARLIAMENT AND
OF THE COUNCIL on the OF THE COUNCIL on the OF THE COUNCIL on the OF THE COUNCIL on the
establishment of 'Eurodac' for the establishment of 'Eurodac' for the establishment of 'Eurodac' for the establishment of 'Eurodac' for the
comparison of biometric data for the comparison of biometric data for the comparison of biometric data for the comparison of biometric data for the
effective application of Regulation effective application of Regulation effective application of Regulation effective application of Regulation
(EU) XXX/XXX [Regulation on (EU) XXX/XXX [Regulation on (EU) XXX/XXX [Regulation on (EU) XXX/XXX [Regulation on
Asylum and Migration Asylum and Migration Asylum and Migration Asylum and Migration
Management] and of Regulation Management] and of Regulation Management] and of Regulation Management] and of Regulation
(EU) XXX/XXX [Resettlement (EU) XXX/XXX [Resettlement (EU) XXX/XXX [Resettlement (EU) XXX/XXX [Resettlement
G 937 Regulation], for identifying an Regulation], for identifying an Regulation], for identifying an Regulation], for identifying an
G
illegally staying third-country illegally staying third-country illegally staying third-country illegally staying third-country
national or stateless person and on national or stateless person and on national or stateless person and on national or stateless person and on
requests for the comparison with requests for the comparison with requests for the comparison with requests for the comparison with
Eurodac data by Member States' law Eurodac data by Member States' law Eurodac data by Member States' law Eurodac data by Member States' law
enforcement authorities and Europol enforcement authorities and Europol enforcement authorities and Europol enforcement authorities and Europol
for law enforcement purposes and for law enforcement purposes and for law enforcement purposes and for law enforcement purposes and
amending Regulations (EU) amending Regulations (EU) amending Regulations (EU) amending Regulations (EU)
2018/1240 and (EU) 2019/818 – 2018/1240 and (EU) 2019/818 – 2018/1240 and (EU) 2019/818 – 2018/1240 and (EU) 2019/818 –
COM(2020) 614 final. COM(2020) 614 final. COM(2020) 614 final. COM(2020) 614 final.
Proposal
Annex IX, point 4.
4. Entry/Exit System 4. Entry/Exit System 4. Entry/Exit System 4. Entry/Exit System

G
Proposal
Council of 30 November 2017 Council of 30 November 2017 Council of 30 November 2017 Council of 30 November 2017
establishing an Entry/Exit System establishing an Entry/Exit System establishing an Entry/Exit System establishing an Entry/Exit System
(EES) to register entry and exit data (EES) to register entry and exit data (EES) to register entry and exit data (EES) to register entry and exit data
and refusal of entry data of third- and refusal of entry data of third- and refusal of entry data of third- and refusal of entry data of third-
country nationals crossing the country nationals crossing the country nationals crossing the country nationals crossing the
external borders of the Member external borders of the Member external borders of the Member external borders of the Member
States and determining the States and determining the States and determining the States and determining the
G 939 conditions for access to the EES for conditions for access to the EES for conditions for access to the EES for conditions for access to the EES for
G
law enforcement purposes, and law enforcement purposes, and law enforcement purposes, and law enforcement purposes, and
amending the Convention amending the Convention amending the Convention amending the Convention
implementing the Schengen implementing the Schengen implementing the Schengen implementing the Schengen
Agreement and Regulations (EC) No Agreement and Regulations (EC) No Agreement and Regulations (EC) No Agreement and Regulations (EC) No
767/2008 and (EU) No 1077/2011 767/2008 and (EU) No 1077/2011 767/2008 and (EU) No 1077/2011 767/2008 and (EU) No 1077/2011
(OJ L 327, 9.12.2017, p. 20). (OJ L 327, 9.12.2017, p. 20). (OJ L 327, 9.12.2017, p. 20). (OJ L 327, 9.12.2017, p. 20).
Proposal
Annex IX, point 5.
5. European Travel Information and 5. European Travel Information and 5. European Travel Information and 5. European Travel Information and
G 940 G
Authorisation System Authorisation System Authorisation System Authorisation System
Proposal
Council of 12 September 2018 Council of 12 September 2018 Council of 12 September 2018 Council of 12 September 2018
establishing a European Travel establishing a European Travel establishing a European Travel establishing a European Travel
Information and Authorisation Information and Authorisation Information and Authorisation Information and Authorisation
System (ETIAS) and amending System (ETIAS) and amending System (ETIAS) and amending System (ETIAS) and amending
G 941 Regulations (EU) No 1077/2011, Regulations (EU) No 1077/2011, Regulations (EU) No 1077/2011, Regulations (EU) No 1077/2011, G
(EU) No 515/2014, (EU) 2016/399, (EU) No 515/2014, (EU) 2016/399, (EU) No 515/2014, (EU) 2016/399, (EU) No 515/2014, (EU) 2016/399,
(EU) 2016/1624 and (EU) (EU) 2016/1624 and (EU) (EU) 2016/1624 and (EU) (EU) 2016/1624 and (EU)
1). 1). 1). 1).
Proposal
(b) Regulation (EU) 2018/1241 of (b) Regulation (EU) 2018/1241 of (b) Regulation (EU) 2018/1241 of (b) Regulation (EU) 2018/1241 of
Council of 12 September 2018 Council of 12 September 2018 Council of 12 September 2018 Council of 12 September 2018
amending Regulation (EU) 2016/794 amending Regulation (EU) 2016/794 amending Regulation (EU) 2016/794 amending Regulation (EU) 2016/794
for the purpose of establishing a for the purpose of establishing a for the purpose of establishing a for the purpose of establishing a
G 942 European Travel Information and European Travel Information and European Travel Information and European Travel Information and
G
Authorisation System (ETIAS) (OJ Authorisation System (ETIAS) (OJ Authorisation System (ETIAS) (OJ Authorisation System (ETIAS) (OJ
L 236, 19.9.2018, p. 72). L 236, 19.9.2018, p. 72). L 236, 19.9.2018, p. 72). L 236, 19.9.2018, p. 72).
Proposal
Annex IX, point 6.
6. European Criminal Records 6. European Criminal Records 6. European Criminal Records 6. European Criminal Records
Information System on third-country Information System on third-country Information System on third-country Information System on third-country
G 943 nationals and stateless persons nationals and stateless persons nationals and stateless persons nationals and stateless persons G

Proposal
(a) Regulation (EU) 2019/816 of the (a) Regulation (EU) 2019/816 of the (a) Regulation (EU) 2019/816 of the (a) Regulation (EU) 2019/816 of the
Council of 17 April 2019 Council of 17 April 2019 Council of 17 April 2019 Council of 17 April 2019
establishing a centralised system for establishing a centralised system for establishing a centralised system for establishing a centralised system for
the identification of Member States the identification of Member States the identification of Member States the identification of Member States
holding conviction information on holding conviction information on holding conviction information on holding conviction information on
third-country nationals and stateless third-country nationals and stateless third-country nationals and stateless third-country nationals and stateless
G 944 persons (ECRIS-TCN) to persons (ECRIS-TCN) to persons (ECRIS-TCN) to persons (ECRIS-TCN) to G
supplement the European Criminal supplement the European Criminal supplement the European Criminal supplement the European Criminal
Records Information System and Records Information System and Records Information System and Records Information System and
amending Regulation (EU) amending Regulation (EU) amending Regulation (EU) amending Regulation (EU)
1). 1). 1). 1).
Proposal
Annex IX, point 7.
7. Interoperability 7. Interoperability 7. Interoperability 7. Interoperability

G
Proposal

G 946 G
(a) Regulation (EU) 2019/817 of the (a) Regulation (EU) 2019/817 of the (a) Regulation (EU) 2019/817 of the (a) Regulation (EU) 2019/817 of the
establishing a framework for establishing a framework for establishing a framework for establishing a framework for
interoperability between EU interoperability between EU interoperability between EU interoperability between EU
information systems in the field of information systems in the field of information systems in the field of information systems in the field of
borders and visa (OJ L 135, borders and visa (OJ L 135, borders and visa (OJ L 135, borders and visa (OJ L 135,
22.5.2019, p. 27). 22.5.2019, p. 27). 22.5.2019, p. 27). 22.5.2019, p. 27).
Proposal
(b) Regulation (EU) 2019/818 of the (b) Regulation (EU) 2019/818 of the (b) Regulation (EU) 2019/818 of the (b) Regulation (EU) 2019/818 of the
establishing a framework for establishing a framework for establishing a framework for establishing a framework for
interoperability between EU interoperability between EU interoperability between EU interoperability between EU
G 947 information systems in the field of information systems in the field of information systems in the field of information systems in the field of G
police and judicial cooperation, police and judicial cooperation, police and judicial cooperation, police and judicial cooperation,
asylum and migration (OJ L 135, asylum and migration (OJ L 135, asylum and migration (OJ L 135, asylum and migration (OJ L 135,
22.5.2019, p. 85). 22.5.2019, p. 85). 22.5.2019, p. 85). 22.5.2019, p. 85).
Proposal
Annex IXa
Annex IXa TECHNICAL

DOCUMENTATION referred to in
Article C(1a): technical
G 947a G
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 refered 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;
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
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.
Where applicable, detailed

description of the system
architecture explaining how
software components build or feed
into each other and integrate into
the overall processing.
Annex IXb
Annex IXb TRANSPARENCY

INFORMATION referred to in
Article C(1b): technical
G 947b documentation for providers of G
general-purpose AI models to
downstream providers that integrate
the model into their AI system
The information referred to in
Article X(c) 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.);
c) information on the data
used for training, testing and
validation, where applicable,
including, type and provenance of
data and curation methodologies
Annex IXc
Annex IXc 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 A, 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;
G 947c G
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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Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING

DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT)

Commission Proposal EP Mandate Council Mandate Draft Agreement

2021/0106 (COD) 2021/0106 (COD) 2021/0106 (COD) 2021/0106 (COD)

Proposal for a Proposal for a Proposal for a Proposal for a

Text Origin: Commission

Text Origin: Commission

Text Origin: Commission

Text Origin: Commission

1. Reference to ECB opinion

Text Origin: EP Mandate

Protection Supervisor, Protection Supervisor,

Text Origin: Commission

5a Having regard to the opinion of

Text Origin: Commission

Whereas: Whereas: Whereas: Whereas:

(1a) This Regulation should (1a) This Regulation should be

(2a) As artificial intelligence often

(2b) The fundamental right to the

providing conditions for any

(2c) Artificial intelligence systems

down by other Union legal acts

(2d) In accordance with Article

(2e) This Regulation should not

platform work set out in Directive ...

(2f) This Regulation should help in

(3a) To contribute to reaching the

artificial intelligence can have on artificial intelligence can have on

(5aa) The fundamental right to the

It also does not affect the

(5ab) This Regulation should be

(5a) Furthermore, in order to

AI systems are designed to operate

(6a) Machine learning approaches

parameters of the model, which is a

(6a) AI systems often have

supervised, unsupervised and

(6b) Logic- and knowledge based

(6b) AI systems can be used as

(6c) In order to ensure uniform

(6d) The notion of ‘user’ referred (6a) The notion of ‘deployer’

(7a) The notion of biometric (7a) The notion of biometric

(7b) The notion of biometric (7b) The notion of biometric

technical reasons, be used without

(8a) The identification of natural

purpose is to confirm whether or

(8a) The notion of emotion

detecting the state of fatigue of

(9a) It is important to note that AI

trustworthy AI in line with the

(12b) This Regulation should be

(12c) This Regulation should not (12c) This Regulation should

(12a) The developers of free and

(12d) In the light of the nature and

provider to perform generally

(14a) While the risk-based

(16a) AI systems that categorise (16a) Biometric categorisation

political orientation, sexual filtering or categorisation of

(21a) In order to carry out their

identification system’. National

(26a) AI systems used by law (26a) In line with the presumption

profiling of natural persons or data persons should never be judged on

untargeted scraping of biometric putting into service for this specific