EUROPEAN
COMMISSION

Brussels, 21.4.2021
COM(2021) 206 final

2021/0106 (COD)

Proposal for a

**REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**


**LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE**

**(ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION**

**LEGISLATIVE ACTS**

{SEC(2021) 167 final} - {SWD(2021) 84 final} - {SWD(2021) 85 final}

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**EXPLANATORY MEMORANDUM**

**1.** **CONTEXT** **OF** **THE** **PROPOSAL**

**1.1.** **Reasons for and objectives of the proposal**

This explanatory memorandum accompanies the proposal for a Regulation laying down
harmonised rules on artificial intelligence (Artificial Intelligence Act). Artificial Intelligence
(AI) is a fast evolving family of technologies that can bring a wide array of economic and
societal benefits across the entire spectrum of industries and social activities. By improving
prediction, optimising operations and resource allocation, and personalising service delivery,
the use of artificial intelligence can support socially and environmentally beneficial outcomes
and provide key competitive advantages to companies and the European economy. Such
action is especially needed in high-impact sectors, including climate change, environment and
health, the public sector, finance, mobility, home affairs and agriculture. However, the same
elements and techniques that power the socio-economic benefits of AI can also bring about
new risks or negative consequences for individuals or the society. In light of the speed of
technological change and possible challenges, the EU is committed to strive for a balanced
approach. It is in the Union interest to preserve the EU’s technological leadership and to
ensure that Europeans can benefit from new technologies developed and functioning
according to Union values, fundamental rights and principles.

This proposal delivers on the political commitment by President von der Leyen, who
announced in her political guidelines for the 2019-2024 Commission “A Union that strives for
more”[1], that the Commission would put forward legislation for a coordinated European
approach on the human and ethical implications of AI. Following on that announcement, on
19 February 2020 the Commission published the White Paper on AI - A European approach
to excellence and trust[2]. The White Paper sets out policy options on how to achieve the twin
objective of promoting the uptake of AI and of addressing the risks associated with certain
uses of such technology. This proposal aims to implement the second objective for the
development of an ecosystem of trust by proposing a legal framework for trustworthy AI. The
proposal is based on EU values and fundamental rights and aims to give people and other
users the confidence to embrace AI-based solutions, while encouraging businesses to develop
them. AI should be a tool for people and be a force for good in society with the ultimate aim
of increasing human well-being. Rules for AI available in the Union market or otherwise
affecting people in the Union should therefore be human centric, so that people can trust that
the technology is used in a way that is safe and compliant with the law, including the respect
of fundamental rights. Following the publication of the White Paper, the Commission
launched a broad stakeholder consultation, which was met with a great interest by a large
number of stakeholders who were largely supportive of regulatory intervention to address the
challenges and concerns raised by the increasing use of AI.

The proposal also responds to explicit requests from the European Parliament (EP) and the
European Council, which have repeatedly expressed calls for legislative action to ensure a
well-functioning internal market for artificial intelligence systems (‘AI systems’) where both
benefits and risks of AI are adequately addressed at Union level. It supports the objective of
the Union being a global leader in the development of secure, trustworthy and ethical artificial

1 [https://ec.europa.eu/commission/sites/beta-political/files/political-guidelines-next-commission_en.pdf](https://ec.europa.eu/commission/sites/beta-political/files/political-guidelines-next-commission_en.pdf)

2 European Commission, White Paper on Artificial Intelligence - A European approach to excellence and
trust, COM(2020) 65 final, 2020.

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intelligence as stated by the European Council[3] and ensures the protection of ethical principles
as specifically requested by the European Parliament[4].

In 2017, the European Council called for a ‘sense of urgency to address emerging trends’
including ‘issues such as artificial intelligence …, while at the same time ensuring a high
level of data protection, digital rights and ethical standards’[5]. In its 2019 Conclusions on the
Coordinated Plan on the development and use of artificial intelligence Made in Europe[6], the
Council further highlighted the importance of ensuring that European citizens’ rights are fully
respected and called for a review of the existing relevant legislation to make it fit for purpose
for the new opportunities and challenges raised by AI. The European Council has also called
for a clear determination of the AI applications that should be considered high-risk[7].

The most recent Conclusions from 21 October 2020 further called for addressing the opacity,
complexity, bias, a certain degree of unpredictability and partially autonomous behaviour of
certain AI systems, to ensure their compatibility with fundamental rights and to facilitate the
enforcement of legal rules[8].

The European Parliament has also undertaken a considerable amount of work in the area of
AI. In October 2020, it adopted a number of resolutions related to AI, including on ethics[9],
liability[10] and copyright[11]. In 2021, those were followed by resolutions on AI in criminal
matters[12] and in education, culture and the audio-visual sector[13]. The EP Resolution on a
Framework of Ethical Aspects of Artificial Intelligence, Robotics and Related Technologies
specifically recommends to the Commission to propose legislative action to harness the
opportunities and benefits of AI, but also to ensure protection of ethical principles. The
resolution includes a text of the legislative proposal for a regulation on ethical principles for
the development, deployment and use of AI, robotics and related technologies. In accordance
with the political commitment made by President von der Leyen in her Political Guidelines as
regards resolutions adopted by the European Parliament under Article 225 TFEU, this


3 European Council, [Special meeting of the European Council (1 and 2 October 2020) – Conclusions,](https://www.consilium.europa.eu/media/45910/021020-euco-final-conclusions.pdf)
EUCO 13/20, 2020, p. 6.

4 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).

5 [European Council, European Council meeting (19 October 2017) – Conclusion](https://www.consilium.europa.eu/media/21620/19-euco-final-conclusions-en.pdf) EUCO 14/17, 2017, p.
8.

6 Council of the European Union, _[Artificial intelligence b) Conclusions on the coordinated plan on](https://data.consilium.europa.eu/doc/document/ST-6177-2019-INIT/en/pdf)_
_[artificial intelligence-Adoption](https://data.consilium.europa.eu/doc/document/ST-6177-2019-INIT/en/pdf)_ 6177/19, 2019.

7 European Council, _[Special meeting of the European Council (1and 2 October 2020) – Conclusions](https://www.consilium.europa.eu/media/45910/021020-euco-final-conclusions.pdf)_
EUCO 13/20, 2020.

8 Council of the European Union, _[Presidency conclusions - The Charter of Fundamental Rights in the](https://www.consilium.europa.eu/media/46496/st11481-en20.pdf)_
_[context of Artificial Intelligence and Digital Change, 11481/20, 2020.](https://www.consilium.europa.eu/media/46496/st11481-en20.pdf)_

9 European Parliament resolution of 20 October 2020 on a framework of ethical aspects of artificial
[intelligence, robotics and related technologies, 2020/2012(INL).](https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2020/2012(INL))

10 European Parliament resolution of 20 October 2020 on a civil liability regime for artificial intelligence,
[2020/2014(INL).](https://www.europarl.europa.eu/doceo/document/TA-9-2020-0276_EN.html)

11 European Parliament resolution of 20 October 2020 on intellectual property rights for the development
[of artificial intelligence technologies, 2020/2015(INI).](https://www.europarl.europa.eu/doceo/document/A-9-2020-0176_EN.html)

12 European Parliament Draft Report, Artificial intelligence in criminal law and its use by the police and
judicial authorities in criminal matters, [2020/2016(INI).](https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2020/2016(INI))

13 European Parliament Draft Report, Artificial intelligence in education, culture and the audiovisual
[sector, 2020/2017(INI). In that regard, the Commission has adopted the Digital Education Action Plan](https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?reference=2020/2017(INI)&l=en)
2021-2027: Resetting education and training for the digital age, which foresees the development of
ethical guidelines in AI and Data usage in education – Commission Communication COM(2020) 624
final.

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proposal takes into account the aforementioned resolution of the European Parliament in full
respect of proportionality, subsidiarity and better law making principles.

Against this political context, the Commission puts forward the proposed regulatory
framework on Artificial Intelligence with the following specific objectives:



-  ensure that AI systems placed on the Union market and used are safe and respect

existing law on fundamental rights and Union values;

-  ensure legal certainty to facilitate investment and innovation in AI;

-  enhance governance and effective enforcement of existing law on fundamental

rights and safety requirements applicable to AI systems;

-  facilitate the development of a single market for lawful, safe and trustworthy AI

applications and prevent market fragmentation.

To achieve those objectives, this proposal presents a balanced and proportionate horizontal
regulatory approach to AI that is limited to the minimum necessary requirements to address
the risks and problems linked to AI, without unduly constraining or hindering technological
development or otherwise disproportionately increasing the cost of placing AI solutions on
the market. The proposal sets a robust and flexible legal framework. On the one hand, it is
comprehensive and future-proof in its fundamental regulatory choices, including the
principle-based requirements that AI systems should comply with. On the other hand, it puts
in place a proportionate regulatory system centred on a well-defined risk-based regulatory
approach that does not create unnecessary restrictions to trade, whereby legal intervention is
tailored to those concrete situations where there is a justified cause for concern or where such
concern can reasonably be anticipated in the near future. At the same time, the legal
framework includes flexible mechanisms that enable it to be dynamically adapted as the
technology evolves and new concerning situations emerge.

The proposal sets harmonised rules for the development, placement on the market and use of
AI systems in the Union following a proportionate risk-based approach. It proposes a single
future-proof definition of AI. Certain particularly harmful AI practices are prohibited as
contravening Union values, while specific restrictions and safeguards are proposed in relation
to certain uses of remote biometric identification systems for the purpose of law enforcement.
The proposal lays down a solid risk methodology to define “high-risk” AI systems that pose
significant risks to the health and safety or fundamental rights of persons. Those AI systems
will have to comply with a set of horizontal mandatory requirements for trustworthy AI and
follow conformity assessment procedures before those systems can be placed on the Union
market. Predictable, proportionate and clear obligations are also placed on providers and users
of those systems to ensure safety and respect of existing legislation protecting fundamental
rights throughout the whole AI systems’ lifecycle. For some specific AI systems, only
minimum transparency obligations are proposed, in particular when chatbots or ‘deep fakes’
are used.

The proposed rules will be enforced through a governance system at Member States level,
building on already existing structures, and a cooperation mechanism at Union level with the
establishment of a European Artificial Intelligence Board. Additional measures are also
proposed to support innovation, in particular through AI regulatory sandboxes and other
measures to reduce the regulatory burden and to support Small and Medium-Sized Enterprises
(‘SMEs’) and start-ups.

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**1.2.** **Consistency with existing policy provisions in the policy area**

The horizontal nature of the proposal requires full consistency with existing Union legislation
applicable to sectors where high-risk AI systems are already used or likely to be used in the
near future.

Consistency is also ensured with the EU Charter of Fundamental Rights and the existing
secondary Union legislation on data protection, consumer protection, non-discrimination and
gender equality. The proposal is without prejudice and complements the General Data
Protection Regulation (Regulation (EU) 2016/679) and the Law Enforcement Directive
(Directive (EU) 2016/680) with a set of harmonised rules applicable to the design,
development and use of certain high-risk AI systems and restrictions on certain uses of remote
biometric identification systems. Furthermore, the proposal complements existing Union law
on non-discrimination with specific requirements that aim to minimise the risk of algorithmic
discrimination, in particular in relation to the design and the quality of data sets used for the
development of AI systems complemented with obligations for testing, risk management,
documentation and human oversight throughout the AI systems’ lifecycle. The proposal is
without prejudice to the application of Union competition law.

As regards high-risk AI systems which are safety components of products, this proposal will
be integrated into the existing sectoral safety legislation to ensure consistency, avoid
duplications and minimise additional burdens. In particular, as regards high-risk AI systems
related to products covered by the New Legislative Framework (NLF) legislation (e.g.
machinery, medical devices, toys), the requirements for AI systems set out in this proposal
will be checked as part of the existing conformity assessment procedures under the relevant
NLF legislation. With regard to the interplay of requirements, while the safety risks specific
to AI systems are meant to be covered by the requirements of this proposal, NLF legislation
aims at ensuring the overall safety of the final product and therefore may contain specific
requirements regarding the safe integration of an AI system into the final product. The
proposal for a Machinery Regulation, which is adopted on the same day as this proposal fully
reflects this approach. As regards high-risk AI systems related to products covered by relevant
Old Approach legislation (e.g. aviation, cars), this proposal would not directly apply.
However, the ex-ante essential requirements for high-risk AI systems set out in this proposal
will have to be taken into account when adopting relevant implementing or delegated
legislation under those acts.

As regards AI systems provided or used by regulated credit institutions, the authorities
responsible for the supervision of the Union’s financial services legislation should be
designated as competent authorities for supervising the requirements in this proposal to ensure
a coherent enforcement of the obligations under this proposal and the Union’s financial
services legislation where AI systems are to some extent implicitly regulated in relation to the
internal governance system of credit institutions. To further enhance consistency, the
conformity assessment procedure and some of the providers’ procedural obligations under this
proposal are integrated into the procedures under Directive 2013/36/EU on access to the
activity of credit institutions and the prudential supervision[14].

14 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 Text with EEA
relevance, OJ L 176, 27.6.2013, p. 338–436.

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This proposal is also consistent with the applicable Union legislation on services, including on
intermediary services regulated by the e-Commerce Directive 2000/31/EC[15] and the
Commission’s recent proposal for the Digital Services Act (DSA)[16].

In relation to AI systems that are components of large-scale IT systems in the Area of
Freedom, Security and Justice managed by the European Union Agency for the Operational
Management of Large-Scale IT Systems (eu-LISA), the proposal will not apply to those AI
systems that have been placed on the market or put into service before one year has elapsed
from the date of application of this Regulation, unless the replacement or amendment of those
legal acts leads to a significant change in the design or intended purpose of the AI system or
AI systems concerned.

**1.3.** **Consistency with other Union policies**

The proposal is part of a wider comprehensive package of measures that address problems
posed by the development and use of AI, as examined in the White Paper on AI. Consistency
and complementarity is therefore ensured with other ongoing or planned initiatives of the
Commission that also aim to address those problems, including the revision of sectoral
product legislation (e.g. the Machinery Directive, the General Product Safety Directive) and
initiatives that address liability issues related to new technologies, including AI systems.
Those initiatives will build on and complement this proposal in order to bring legal clarity and
foster the development of an ecosystem of trust in AI in Europe.

The proposal is also coherent with the Commission’s overall digital strategy in its
contribution to promoting technology that works for people, one of the three main pillars of
the policy orientation and objectives announced in the Communication ‘Shaping Europe's
digital future’[17]. It lays down a coherent, effective and proportionate framework to ensure AI
is developed in ways that respect people’s rights and earn their trust, making Europe fit for the
digital age and turning the next ten years into the Digital Decade[18].

Furthermore, the promotion of AI-driven innovation is closely linked to the **Data**
**Governance Act[19], the Open Data Directive[20] and other initiatives under** **the EU strategy**
**for data[21], which will establish trusted mechanisms and services for the re-use, sharing and**
pooling of data that are essential for the development of data-driven AI models of high
quality.

The proposal also strengthens significantly the Union’s role to help shape global norms and
standards and promote trustworthy AI that is consistent with Union values and interests. It
provides the Union with a powerful basis to engage further with its external partners,
including third countries, and at international fora on issues relating to AI.


15 Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal
aspects of information society services, in particular electronic commerce, in the Internal Market
('Directive on electronic commerce'), OJ L 178, 17.7.2000, p. 1–16.

16 See Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on a Single Market For Digital Services (Digital Services Act) and amending Directive 2000/31/EC
COM/2020/825 final.

17 Communication from the Commission, Shaping Europe's Digital Future, COM/2020/67 final.

18 [2030 Digital Compass: the European way for the Digital Decade.](https://ec.europa.eu/info/strategy/priorities-2019-2024/europe-fit-digital-age/europes-digital-decade-digital-targets-2030_en)

19 [Proposal for a Regulation on European data governance (Data Governance Act) COM/2020/767.](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020PC0767)

20 Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data
and the re-use of public sector information, PE/28/2019/REV/1, OJ L 172, 26.6.2019, p. 56–83.

21 Commission Communication, A European strategy for data COM/2020/66 final.

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**2.** **LEGAL** **BASIS,** **SUBSIDIARITY** **AND** **PROPORTIONALITY**

**2.1.** **Legal basis**

The legal basis for the proposal is in the first place Article 114 of the Treaty on the
Functioning of the European Union (TFEU), which provides for the adoption of measures to
ensure the establishment and functioning of the internal market.

This proposal constitutes a core part of the EU digital single market strategy. The primary
objective of this proposal is to ensure the proper functioning of the internal market by setting
harmonised rules in particular on the development, placing on the Union market and the use
of products and services making use of AI technologies or provided as stand-alone AI
systems. Some Member States are already considering national rules to ensure that AI is safe
and is developed and used in compliance with fundamental rights obligations. This will likely
lead to two main problems: i) a fragmentation of the internal market on essential elements
regarding in particular the requirements for the AI products and services, their marketing,
their use, the liability and the supervision by public authorities, and ii) the substantial
diminishment of legal certainty for both providers and users of AI systems on how existing
and new rules will apply to those systems in the Union. Given the wide circulation of products
and services across borders, these two problems can be best solved through EU harmonizing
legislation.

Indeed, the proposal defines common mandatory requirements applicable to the design and
development of certain AI systems before they are placed on the market that will be further
operationalised through harmonised technical standards. The proposal also addresses the
situation after AI systems have been placed on the market by harmonising the way in which
ex-post controls are conducted.

In addition, considering that this proposal contains certain specific rules on the protection of
individuals with regard to the processing of personal data, notably restrictions of the use of AI
systems for ‘real-time’ remote biometric identification in publicly accessible spaces for the
purpose of law enforcement, it is appropriate to base this regulation, in as far as those specific
rules are concerned, on Article 16 of the TFEU.

**2.2.** **Subsidiarity (for non-exclusive competence)**

The nature of AI, which often relies on large and varied datasets and which may be embedded
in any product or service circulating freely within the internal market, entails that the
objectives of this proposal cannot be effectively achieved by Member States alone.
Furthermore, an emerging patchwork of potentially divergent national rules will hamper the
seamless circulation of products and services related to AI systems across the EU and will be
ineffective in ensuring the safety and protection of fundamental rights and Union values
across the different Member States. National approaches in addressing the problems will only
create additional legal uncertainty and barriers, and will slow market uptake of AI.

The objectives of this proposal can be better achieved at Union level to avoid a further
fragmentation of the Single Market into potentially contradictory national frameworks
preventing the free circulation of goods and services embedding AI. A solid European
regulatory framework for trustworthy AI will also ensure a level playing field and protect all
people, while strengthening Europe’s competitiveness and industrial basis in AI. Only
common action at Union level can also protect the Union’s digital sovereignty and leverage
its tools and regulatory powers to shape global rules and standards.

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**2.3.** **Proportionality**

The proposal builds on existing legal frameworks and is proportionate and necessary to
achieve its objectives, since it follows a risk-based approach and imposes regulatory burdens
only when an AI system is likely to pose high risks to fundamental rights and safety. For
other, non-high-risk AI systems, only very limited transparency obligations are imposed, for
example in terms of the provision of information to flag the use of an AI system when
interacting with humans. For high-risk AI systems, the requirements of high quality data,
documentation and traceability, transparency, human oversight, accuracy and robustness, are
strictly necessary to mitigate the risks to fundamental rights and safety posed by AI and that
are not covered by other existing legal frameworks. Harmonised standards and supporting
guidance and compliance tools will assist providers and users in complying with the
requirements laid down by the proposal and minimise their costs. The costs incurred by
operators are proportionate to the objectives achieved and the economic and reputational
benefits that operators can expect from this proposal.

**2.4.** **Choice of the instrument**

The choice of a regulation as a legal instrument is justified by the need for a uniform
application of the new rules, such as definition of AI, the prohibition of certain harmful AIenabled practices and the classification of certain AI systems. The direct applicability of a
Regulation, in accordance with Article 288 TFEU, will reduce legal fragmentation and
facilitate the development of a single market for lawful, safe and trustworthy AI systems. It
will do so, in particular, by introducing a harmonised set of core requirements with regard to
AI systems classified as high-risk and obligations for providers and users of those systems,
improving the protection of fundamental rights and providing legal certainty for operators and
consumers alike.

At the same time, the provisions of the regulation are not overly prescriptive and leave room
for different levels of Member State action for elements that do not undermine the objectives
of the initiative, in particular the internal organisation of the market surveillance system and
the uptake of measures to foster innovation.

**3.** **RESULTS** **OF** **EX-POST** **EVALUATIONS,** **STAKEHOLDER**

**CONSULTATIONS** **AND** **IMPACT** **ASSESSMENTS**

**3.1.** **Stakeholder consultation**

This proposal is the result of extensive consultation with all major stakeholders, in which the
general principles and minimum standards for consultation of interested parties by the
Commission were applied.

An online public consultation was launched on 19 February 2020 along with the publication
of the White Paper on Artificial Intelligence and ran until 14 June 2020. The objective of that
consultation was to collect views and opinions on the White Paper. It targeted all interested
stakeholders from the public and private sectors, including governments, local authorities,
commercial and non-commercial organisations, social partners, experts, academics and
citizens. After analysing all the responses received, the Commission published a summary
outcome and the individual responses on its website[22].

In total, 1215 contributions were received, of which 352 were from companies or business
organisations/associations, 406 from individuals (92%individuals from EU ), 152 on behalf of

22 [See all consultation results here.](https://ec.europa.eu/digital-single-market/en/news/white-paper-artificial-intelligence-public-consultation-towards-european-approach-excellence)

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academic/research institutions, and 73 from public authorities. Civil society’s voices were
represented by 160 respondents (among which 9 consumers’ organisations, 129 nongovernmental organisations and 22 trade unions), 72 respondents contributed as ‘others’. Of
the 352 business and industry representatives, 222 were companies and business
representatives, 41.5% of which were micro, small and medium-sized enterprises. The rest
were business associations. Overall, 84% of business and industry replies came from the EU27. Depending on the question, between 81 and 598 of the respondents used the free text
option to insert comments. Over 450 position papers were submitted through the EU Survey
website, either in addition to questionnaire answers (over 400) or as stand-alone contributions
(over 50).

Overall, there is a general agreement amongst stakeholders on a need for action. A large
majority of stakeholders agree that legislative gaps exist or that new legislation is needed.
However, several stakeholders warn the Commission to avoid duplication, conflicting
obligations and overregulation. There were many comments underlining the importance of a
technology neutral and proportionate regulatory framework.

Stakeholders mostly requested a narrow, clear and precise definition for AI. Stakeholders also
highlighted that besides the clarification of the term of AI, it is important to define ‘risk’,
‘high-risk’, ‘low-risk’, ‘remote biometric identification’ and ‘harm’.

Most of the respondents are explicitly in favour of the risk-based approach. Using a risk-based
framework was considered a better option than blanket regulation of all AI systems. The types
of risks and threats should be based on a sector-by-sector and case-by-case approach. Risks
also should be calculated taking into account the impact on rights and safety.

Regulatory sandboxes could be very useful for the promotion of AI and are welcomed by
certain stakeholders, especially the Business Associations.

Among those who formulated their opinion on the enforcement models, more than 50%,
especially from the business associations, were in favour of a combination of an ex-ante risk
self-assessment and an ex-post enforcement for high-risk AI systems.

**3.2.** **Collection and use of expertise**

The proposal builds on two years of analysis and close involvement of stakeholders, including
academics, businesses, social partners, non-governmental organisations, Member States and
citizens. The preparatory work started in 2018 with the setting up of a **High-Level Expert**
**Group on AI (HLEG)** which had an inclusive and broad composition of 52 well-known
experts tasked to advise the Commission on the implementation of the Commission’s Strategy
on Artificial Intelligence. In April 2019, the Commission supported[23] the key requirements set
out in the HLEG ethics guidelines for Trustworthy AI[24], which had been revised to take into
account more than 500 submissions from stakeholders. The key requirements reflect a
widespread and common approach, as evidenced by a plethora of ethical codes and principles
developed by many private and public organisations in Europe and beyond, that AI
development and use should be guided by certain essential value-oriented principles. The
Assessment List for Trustworthy Artificial Intelligence (ALTAI)[25] made those requirements
operational in a piloting process with over 350 organisations.


23 [European Commission, Building Trust in Human-Centric Artificial Intelligence, COM(2019) 168.](https://ec.europa.eu/digital-single-market/en/news/communication-building-trust-human-centric-artificial-intelligence)

24 [HLEG, Ethics Guidelines for Trustworthy AI, 2019.](https://ec.europa.eu/newsroom/dae/document.cfm?doc_id=60419)

25 [HLEG, Assessment List for Trustworthy Artificial Intelligence (ALTAI) for self-assessment, 2020.](https://ec.europa.eu/digital-single-market/en/news/assessment-list-trustworthy-artificial-intelligence-altai-self-assessment)

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In addition, the AI Alliance[26] was formed as a platform for approximately 4000 stakeholders
to debate the technological and societal implications of AI, culminating in a yearly AI
Assembly.

The White Paper on AI further developed this inclusive approach, inciting comments from
more than 1250 stakeholders, including over 450 additional position papers. As a result, the
Commission published an Inception Impact Assessment, which in turn attracted more than
130 comments[27]. **Additional stakeholder workshops and events** were also organised the
results of which support the analysis in the impact assessment and the policy choices made in
this proposal[28]. An external study was also procured to feed into the impact assessment.

**3.3.** **Impact assessment**

In line with its “Better Regulation” policy, the Commission conducted an impact assessment
for this proposal examined by the Commission's Regulatory Scrutiny Board. A meeting with
the Regulatory Scrutiny Board was held on 16 December 2020, which was followed by a
negative opinion. After substantial revision of the impact assessment to address the comments
and a resubmission of the impact assessment, the Regulatory Scrutiny Board issued a positive
opinion on 21 March 2021. The opinions of the Regulatory Scrutiny Board, the
recommendations and an explanation of how they have been taken into account are presented
in Annex 1 of the impact assessment.

The Commission examined different policy options to achieve the general objective of the
proposal, which is to **ensure the proper functioning of the single market by creating the**
conditions for the development and use of trustworthy AI in the Union.

Four policy options of different degrees of regulatory intervention were assessed:

-  **Option 1: EU legislative instrument setting up a voluntary labelling scheme;**

-  **Option 2: a sectoral, “ad-hoc” approach;**

-  **Option 3: Horizontal EU legislative instrument following a proportionate risk-**

based approach;

-  **Option 3+: Horizontal EU legislative instrument following a proportionate risk-**

based approach + codes of conduct for non-high-risk AI systems;



-  **Option 4: Horizontal EU legislative instrument establishing mandatory**

requirements for all AI systems, irrespective of the risk they pose.

According to the Commission's established methodology, each policy option was evaluated
against economic and societal impacts, with a particular focus on impacts on fundamental
rights. The preferred option is option 3+, a regulatory framework for high-risk AI systems
only, with the possibility for all providers of non-high-risk AI systems to follow a code of
conduct. The requirements will concern data, documentation and traceability, provision of
information and transparency, human oversight and robustness and accuracy and would be
mandatory for high-risk AI systems. Companies that introduced codes of conduct for other AI
systems would do so voluntarily.


26 The AI Alliance is a multi-stakeholder forum launched in June 2018, AI Alliance
[https://ec.europa.eu/digital-single-market/en/european-ai-alliance](https://ec.europa.eu/digital-single-market/en/european-ai-alliance)

27 European Commission, _[Inception Impact Assessment For a Proposal for a legal act of the European](https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12527-Artificial-intelligence-ethical-and-legal-requirements)_
_[Parliament and the Council laying down requirements for Artificial Intelligence.](https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12527-Artificial-intelligence-ethical-and-legal-requirements)_

28 For details of all the consultations that have been carried out see Annex 2 of the impact assessment.

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The preferred option was considered suitable to address in the most effective way the
objectives of this proposal. By requiring a restricted yet effective set of actions from AI
developers and users, the preferred option limits the risks of violation of fundamental rights
and safety of people and foster effective supervision and enforcement, by targeting the
requirements only to systems where there is a high risk that such violations could occur. As a
result, that option keeps compliance costs to a minimum, thus avoiding an unnecessary
slowing of uptake due to higher prices and compliance costs. In order to address possible
disadvantages for SMEs, this option includes several provisions to support their compliance
and reduce their costs, including creation of regulatory sandboxes and obligation to consider
SMEs interests when setting fees related to conformity assessment.

The preferred option will increase people’s trust in AI, companies will gain in legal certainty,
and Member States will see no reason to take unilateral action that could fragment the single
market. As a result of higher demand due to higher trust, more available offers due to legal
certainty, and the absence of obstacles to cross-border movement of AI systems, the single
market for AI will likely flourish. The European Union will continue to develop a fastgrowing AI ecosystem of innovative services and products embedding AI technology or
stand-alone AI systems, resulting in increased digital autonomy.

Businesses or public authorities that develop or use AI applications that constitute a high risk
for the safety or fundamental rights of citizens would have to comply with specific
requirements and obligations. Compliance with these requirements would imply costs

amounting to approximately EUR € 6000 to EUR € 7000 for the supply of an average highrisk AI system of around EUR € 170000 by 2025. For AI users, there would also be the
annual cost for the time spent on ensuring human oversight where this is appropriate,
depending on the use case. Those have been estimated at approximately EUR € 5000 to EUR
€ 8000 per year. Verification costs could amount to another EUR € 3000 to EUR € 7500 for
suppliers of high-risk AI. Businesses or public authorities that develop or use any AI
applications not classified as high risk would only have minimal obligations of information.
However, they could choose to join others and together adopt a code of conduct to follow
suitable requirements, and to ensure that their AI systems are trustworthy. In such a case,
costs would be at most as high as for high-risk AI systems, but most probably lower.

The impacts of the policy options on different categories of stakeholders (economic operators/
business; conformity assessment bodies, standardisation bodies and other public bodies;
individuals/citizens; researchers) are explained in detail in Annex 3 of the Impact assessment
supporting this proposal.

**3.4.** **Regulatory fitness and simplification**

This proposal lays down obligation that will apply to providers and users of high-risk AI
systems. For providers who develop and place such systems on the Union market, it will
create legal certainty and ensure that no obstacle to the cross-border provision of AI-related
services and products emerge. For companies using AI, it will promote trust among their
customers. For national public administrations, it will promote public trust in the use of AI
and strengthen enforcement mechanisms (by introducing a European coordination
mechanism, providing for appropriate capacities, and facilitating audits of the AI systems
with new requirements for documentation, traceability and transparency). Moreover, the
framework will envisage specific measures supporting innovation, including regulatory
sandboxes and specific measures supporting small-scale users and providers of high-risk AI
systems to comply with the new rules.

The proposal also specifically aims at strengthening Europe’s competitiveness and industrial
basis in AI. Full consistency is ensured with existing sectoral Union legislation applicable to

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AI systems (e.g. on products and services) that will bring further clarity and simplify the
enforcement of the new rules.

**3.5.** **Fundamental rights**

The use of AI with its specific characteristics (e.g. opacity, complexity, dependency on data,
autonomous behaviour) can adversely affect a number of fundamental rights enshrined in the
EU Charter of Fundamental Rights (‘the Charter’). This proposal seeks to ensure a high level
of protection for those fundamental rights and aims to address various sources of risks
through a clearly defined risk-based approach. With a set of requirements for trustworthy AI
and proportionate obligations on all value chain participants, the proposal will enhance and
promote the protection of the rights protected by the Charter: the right to human dignity
(Article 1), respect for private life and protection of personal data (Articles 7 and 8), nondiscrimination (Article 21) and equality between women and men (Article 23). It aims to
prevent a chilling effect on the rights to freedom of expression (Article 11) and freedom of
assembly (Article 12), to ensure protection of the right to an effective remedy and to a fair
trial, the rights of defence and the presumption of innocence (Articles 47 and 48), as well as
the general principle of good administration. Furthermore, as applicable in certain domains,
the proposal will positively affect the rights of a number of special groups, such as the
workers’ rights to fair and just working conditions (Article 31), a high level of consumer
protection (Article 28), the rights of the child (Article 24) and the integration of persons with
disabilities (Article 26). The right to a high level of environmental protection and the
improvement of the quality of the environment (Article 37) is also relevant, including in
relation to the health and safety of people. The obligations for ex ante testing, risk
management and human oversight will also facilitate the respect of other fundamental rights
by minimising the risk of erroneous or biased AI-assisted decisions in critical areas such as
education and training, employment, important services, law enforcement and the judiciary. In
case infringements of fundamental rights still happen, effective redress for affected persons
will be made possible by ensuring transparency and traceability of the AI systems coupled
with strong ex post controls.

This proposal imposes some restrictions on the freedom to conduct business (Article 16) and
the freedom of art and science (Article 13) to ensure compliance with overriding reasons of
public interest such as health, safety, consumer protection and the protection of other
fundamental rights (‘responsible innovation’) when high-risk AI technology is developed and
used. Those restrictions are proportionate and limited to the minimum necessary to prevent
and mitigate serious safety risks and likely infringements of fundamental rights.

The increased transparency obligations will also not disproportionately affect the right to
protection of intellectual property (Article 17(2)), since they will be limited only to the
minimum necessary information for individuals to exercise their right to an effective remedy
and to the necessary transparency towards supervision and enforcement authorities, in line
with their mandates. Any disclosure of information will be carried out in compliance with
relevant legislation in the field, including Directive 2016/943 on the protection of undisclosed
know-how and business information (trade secrets) against their unlawful acquisition, use and
disclosure. When public authorities and notified bodies need to be given access to confidential
information or source code to examine compliance with substantial obligations, they are
placed under binding confidentiality obligations.

**4.** **BUDGETARY** **IMPLICATIONS**

Member States will have to designate supervisory authorities in charge of implementing the
legislative requirements. Their supervisory function could build on existing arrangements, for

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example regarding conformity assessment bodies or market surveillance, but would require
sufficient technological expertise and human and financial resources. Depending on the preexisting structure in each Member State, this could amount to 1 to 25 Full Time Equivalents
per Member State.

A detailed overview of the costs involved is provided in the ‘financial statement’ linked to
this proposal.

**5.** **OTHER** **ELEMENTS**

**5.1.** **Implementation plans and monitoring, evaluation and reporting arrangements**

Providing for a robust monitoring and evaluation mechanism is crucial to ensure that the
proposal will be effective in achieving its specific objectives. The Commission will be in
charge of monitoring the effects of the proposal. It will establish a system for registering
stand-alone high-risk AI applications in a public EU-wide database. This registration will also
enable competent authorities, users and other interested people to verify if the high-risk AI
system complies with the requirements laid down in the proposal and to exercise enhanced
oversight over those AI systems posing high risks to fundamental rights. To feed this
database, AI providers will be obliged to provide meaningful information about their systems
and the conformity assessment carried out on those systems.

Moreover, AI providers will be obliged to inform national competent authorities about serious
incidents or malfunctioning that constitute a breach of fundamental rights obligations as soon
as they become aware of them, as well as any recalls or withdrawals of AI systems from the
market. National competent authorities will then investigate the incidents/or malfunctioning,
collect all the necessary information and regularly transmit it to the Commission with
adequate metadata. The Commission will complement this information on the incidents by a
comprehensive analysis of the overall market for AI.

The Commission will publish a report evaluating and reviewing the proposed AI framework
five years following the date on which it becomes applicable.

**5.2.** **Detailed explanation of the specific provisions of the proposal**

_5.2.1._ _SCOPE AND DEFINITIONS (TITLE I)_

**Title I** defines the subject matter of the regulation and the scope of application of the new
rules that cover the placing on the market, putting into service and use of AI systems. It also
sets out the definitions used throughout the instrument. The definition of AI system in the
legal framework aims to be as technology neutral and future proof as possible, taking into
account the fast technological and market developments related to AI. In order to provide the
needed legal certainty, Title I is complemented by Annex I, which contains a detailed list of
approaches and techniques for the development of AI to be adapted by the Commission in line
with new technological developments. Key participants across the AI value chain are also
clearly defined such as providers and users of AI systems that cover both public and private
operators to ensure a level playing field.

_5.2.2._ _PROHIBITED ARTIFICIAL INTELLIGENCE PRACTICES (TITLE II)_

**Title II** establishes a list of prohibited AI. The regulation follows a risk-based approach,
differentiating between uses of AI that create (i) an unacceptable risk, (ii) a high risk, and (iii)
low or minimal risk. The list of prohibited practices in Title II comprises all those AI systems
whose use is considered unacceptable as contravening Union values, for instance by violating
fundamental rights. The prohibitions covers practices that have a significant potential to
manipulate persons through subliminal techniques beyond their consciousness or exploit

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vulnerabilities of specific vulnerable groups such as children or persons with disabilities in
order to materially distort their behaviour in a manner that is likely to cause them or another
person psychological or physical harm. Other manipulative or exploitative practices affecting
adults that might be facilitated by AI systems could be covered by the existing data
protection, consumer protection and digital service legislation that guarantee that natural
persons are properly informed and have free choice not to be subject to profiling or other
practices that might affect their behaviour. The proposal also prohibits AI-based social
scoring for general purposes done by public authorities. Finally, the use of ‘real time’ remote
biometric identification systems in publicly accessible spaces for the purpose of law
enforcement is also prohibited unless certain limited exceptions apply.

_5.2.3._ _HIGH-RISK AI SYSTEMS (TITLE III)_

**Title III contains specific rules for AI systems that create a high risk to the health and safety**
or fundamental rights of natural persons. In line with a risk-based approach, those high-risk
AI systems are permitted on the European market subject to compliance with certain
mandatory requirements and an ex-ante conformity assessment. The classification of an AI
system as high-risk is based on the intended purpose of the AI system, in line with existing
product safety legislation. Therefore, the classification as high-risk does not only depend on
the function performed by the AI system, but also on the specific purpose and modalities for
which that system is used.

Chapter 1 of Title III sets the classification rules and identifies two main categories of highrisk AI systems:

-  AI systems intended to be used as safety component of products that are subject to

third party ex-ante conformity assessment;



-  other stand-alone AI systems with mainly fundamental rights implications that are

explicitly listed in Annex III.

This list of high-risk AI systems in Annex III contains a limited number of AI systems whose
risks have already materialised or are likely to materialise in the near future. To ensure that
the regulation can be adjusted to emerging uses and applications of AI, the Commission may
expand the list of high-risk AI systems used within certain pre-defined areas, by applying a
set of criteria and risk assessment methodology.

Chapter 2 sets out the legal requirements for high-risk AI systems in relation to data and data
governance, documentation and recording keeping, transparency and provision of information
to users, human oversight, robustness, accuracy and security. The proposed minimum
requirements are already state-of-the-art for many diligent operators and the result of two
years of preparatory work, derived from the Ethics Guidelines of the HLEG[29], piloted by
more than 350 organisations[30]. They are also largely consistent with other international
recommendations and principles, which ensures that the proposed AI framework is
compatible with those adopted by the EU’s international trade partners. The precise technical
solutions to achieve compliance with those requirements may be provided by standards or by
other technical specifications or otherwise be developed in accordance with general
engineering or scientific knowledge at the discretion of the provider of the AI system. This
flexibility is particularly important, because it allows providers of AI systems to choose the

29 [High-Level Expert Group on Artificial Intelligence, Ethics Guidelines for Trustworthy AI, 2019.](https://ec.europa.eu/newsroom/dae/document.cfm?doc_id=60419)

30 They were also endorsed by the Commission in its 2019 Communication on human-centric approach to
AI.

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way to meet their requirements, taking into account the state-of-the-art and technological and
scientific progress in this field.

Chapter 3 places a clear set of horizontal obligations on providers of high-risk AI systems.
Proportionate obligations are also placed on users and other participants across the AI value
chain (e.g., importers, distributors, authorized representatives).

Chapter 4 sets the framework for notified bodies to be involved as independent third parties in
conformity assessment procedures, while Chapter 5 explains in detail the conformity
assessment procedures to be followed for each type of high-risk AI system. The conformity
assessment approach aims to minimise the burden for economic operators as well as for
notified bodies, whose capacity needs to be progressively ramped up over time. AI systems
intended to be used as safety components of products that are regulated under the New
Legislative Framework legislation (e.g. machinery, toys, medical devices, etc.) will be subject
to the same ex-ante and ex-post compliance and enforcement mechanisms of the products of
which they are a component. The key difference is that the ex-ante and ex-post mechanisms
will ensure compliance not only with the requirements established by sectorial legislation, but
also with the requirements established by this regulation.

As regards stand-alone high-risk AI systems that are referred to in Annex III, a new
compliance and enforcement system will be established. This follows the model of the New
Legislative Framework legislation implemented through internal control checks by the
providers with the exception of remote biometric identification systems that would be subject
to third party conformity assessment. A comprehensive ex-ante conformity assessment
through internal checks, combined with a strong ex-post enforcement, could be an effective
and reasonable solution for those systems, given the early phase of the regulatory intervention
and the fact the AI sector is very innovative and expertise for auditing is only now being
accumulated. An assessment through internal checks for ‘stand-alone’ high-risk AI systems
would require a full, effective and properly documented ex ante compliance with all
requirements of the regulation and compliance with robust quality and risk management
systems and post-market monitoring. After the provider has performed the relevant
conformity assessment, it should register those stand-alone high-risk AI systems in an EU
database that will be managed by the Commission to increase public transparency and
oversight and strengthen ex post supervision by competent authorities. By contrast, for
reasons of consistency with the existing product safety legislation, the conformity assessments
of AI systems that are safety components of products will follow a system with third party
conformity assessment procedures already established under the relevant sectoral product
safety legislation. New ex ante re-assessments of the conformity will be needed in case of
substantial modifications to the AI systems (and notably changes which go beyond what is
pre-determined by the provider in its technical documentation and checked at the moment of
the ex-ante conformity assessment).

_5.2.4._ _TRANSPARENCY OBLIGATIONS FOR CERTAIN AI SYSTEMS (TITLE IV)_

**Title IV concerns certain AI systems to take account of the specific risks of manipulation they**
pose. Transparency obligations will apply for systems that (i) interact with humans, (ii) are
used to detect emotions or determine association with (social) categories based on biometric
data, or (iii) generate or manipulate content (‘deep fakes’). When persons interact with an AI
system or their emotions or characteristics are recognised through automated means, people
must be informed of that circumstance. If an AI system is used to generate or manipulate
image, audio or video content that appreciably resembles authentic content, there should be an
obligation to disclose that the content is generated through automated means, subject to

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exceptions for legitimate purposes (law enforcement, freedom of expression). This allows
persons to make informed choices or step back from a given situation.

_5.2.5._ _MEASURES IN SUPPORT OF INNOVATION (TITLE V)_

**Title V** contributes to the objective to create a legal framework that is innovation-friendly,
future-proof and resilient to disruption. To that end, it encourages national competent
authorities to set up regulatory sandboxes and sets a basic framework in terms of governance,
supervision and liability. AI regulatory sandboxes establish a controlled environment to test
innovative technologies for a limited time on the basis of a testing plan agreed with the
competent authorities. Title V also contains measures to reduce the regulatory burden on
SMEs and start-ups.

_5.2.6._ _GOVERNANCE AND IMPLEMENTATION (TITLES VI, VII AND VII)_

**Title VI** sets up the governance systems at Union and national level. At Union level, the
proposal establishes a European Artificial Intelligence Board (the ‘Board’), composed of
representatives from the Member States and the Commission. The Board will facilitate a
smooth, effective and harmonised implementation of this regulation by contributing to the
effective cooperation of the national supervisory authorities and the Commission and
providing advice and expertise to the Commission. It will also collect and share best practices
among the Member States.

At national level, Member States will have to designate one or more national competent
authorities and, among them, the national supervisory authority, for the purpose of
supervising the application and implementation of the regulation. The European Data
Protection Supervisor will act as the competent authority for the supervision of the Union
institutions, agencies and bodies when they fall within the scope of this regulation.

**Title VII aims to facilitate the monitoring work of the Commission and national authorities**
through the establishment of an EU-wide database for stand-alone high-risk AI systems with
mainly fundamental rights implications. The database will be operated by the Commission
and provided with data by the providers of the AI systems, who will be required to register
their systems before placing them on the market or otherwise putting them into service.

**Title VIII sets out the monitoring and reporting obligations for providers of AI systems with**
regard to post-market monitoring and reporting and investigating on AI-related incidents and
malfunctioning. Market surveillance authorities would also control the market and investigate
compliance with the obligations and requirements for all high-risk AI systems already placed
on the market. Market surveillance authorities would have all powers under Regulation (EU)
2019/1020 on market surveillance. Ex-post enforcement should ensure that once the AI
system has been put on the market, public authorities have the powers and resources to
intervene in case AI systems generate unexpected risks, which warrant rapid action. They will
also monitor compliance of operators with their relevant obligations under the regulation. The
proposal does not foresee the automatic creation of any additional bodies or authorities at
Member State level. Member States may therefore appoint (and draw upon the expertise of)
existing sectorial authorities, who would be entrusted also with the powers to monitor and
enforce the provisions of the regulation.

All this is without prejudice to the existing system and allocation of powers of ex-post
enforcement of obligations regarding fundamental rights in the Member States. When
necessary for their mandate, existing supervision and enforcement authorities will also have
the power to request and access any documentation maintained following this regulation and,
where needed, request market surveillance authorities to organise testing of the high-risk AI
system through technical means.

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_5.2.7._ _CODES OF CONDUCT (TITLE IX)_

**Title IX** creates a framework for the creation of codes of conduct, which aim to encourage
providers of non-high-risk AI systems to apply voluntarily the mandatory requirements for
high-risk AI systems (as laid out in Title III). Providers of non-high-risk AI systems may
create and implement the codes of conduct themselves. Those codes may also include
voluntary commitments related, for example, to environmental sustainability, accessibility for
persons with disability, stakeholders’ participation in the design and development of AI
systems, and diversity of development teams.

_5.2.8._ _FINAL PROVISIONS (TITLES X, XI AND XII)_

**Title X emphasizes the obligation of all parties to respect the confidentiality of information**
and data and sets out rules for the exchange of information obtained during the
implementation of the regulation. Title X also includes measures to ensure the effective
implementation of the regulation through effective, proportionate, and dissuasive penalties for
infringements of the provisions.

**Title XI sets out rules for the exercise of delegation and implementing powers. The proposal**
empowers the Commission to adopt, where appropriate, implementing acts to ensure uniform
application of the regulation or delegated acts to update or complement the lists in Annexes I
to VII.

**Title XII contains an obligation for the Commission to assess regularly the need for an update**
of Annex III and to prepare regular reports on the evaluation and review of the regulation. It
also lays down final provisions, including a differentiated transitional period for the initial
date of the applicability of the regulation to facilitate the smooth implementation for all
parties concerned.

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2021/0106 (COD)

Proposal for a

**REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**

**LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE**

**(ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION**

**LEGISLATIVE ACTS**


THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular
Articles 16 and 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee[31],

Having regard to the opinion of the Committee of the Regions[32],

Acting in accordance with the ordinary legislative procedure,

Whereas:

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

(2) Artificial intelligence systems (AI systems) can be easily deployed in multiple sectors
of the economy and society, including cross border, and circulate throughout the
Union. Certain Member States have already explored the adoption of national rules to
ensure that artificial intelligence is safe and is developed and used in compliance with
fundamental rights obligations. Differing national rules may lead to fragmentation of
the internal market and decrease legal certainty for operators that develop or use AI
systems. A consistent and high level of protection throughout the Union should
therefore be ensured, while divergences hampering the free circulation of AI systems
and related products and services within the internal market should be prevented, by
laying down uniform obligations for operators and guaranteeing the uniform
protection of overriding reasons of public interest and of rights of persons throughout
the internal market based on Article 114 of the Treaty on the Functioning of the
European Union (TFEU). To the extent that this Regulation contains specific rules on
the protection of individuals with regard to the processing of personal data concerning

31 OJ C […], […], p. […].

32 OJ C […], […], p. […].

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restrictions of the use of AI systems for ‘real-time’ remote biometric identification in
publicly accessible spaces for the purpose of law enforcement, it is appropriate to base
this Regulation, in as far as those specific rules are concerned, on Article 16 of the
TFEU. In light of those specific rules and the recourse to Article 16 TFEU, it is
appropriate to consult the European Data Protection Board.

(3) Artificial intelligence is a fast evolving family of technologies that can contribute to a
wide array of economic and societal benefits across the entire spectrum of industries
and social activities. By improving prediction, optimising operations and resource
allocation, and personalising digital solutions available for individuals and
organisations, the use of artificial intelligence can provide key competitive advantages
to companies and support socially and environmentally beneficial outcomes, for
example in healthcare, farming, education and training, infrastructure management,
energy, transport and logistics, public services, security, justice, resource and energy
efficiency, and climate change mitigation and adaptation.

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

(5) A Union legal framework laying down harmonised rules on artificial intelligence is
therefore needed to foster the development, use and uptake of artificial intelligence in
the internal market that at the same time meets a high level of protection of public
interests, such as health and safety and the protection of fundamental rights, as
recognised and protected by Union law. To achieve that objective, rules regulating the
placing on the market and putting into service of certain AI systems should be laid
down, thus ensuring the smooth functioning of the internal market and allowing those
systems to benefit from the principle of free movement of goods and services. By
laying down those rules, this Regulation supports the objective of the Union of being a
global leader in the development of secure, trustworthy and ethical artificial
intelligence, as stated by the European Council[33], and it ensures the protection of
ethical principles, as specifically requested by the European Parliament[34].

(6) The notion of AI system should be clearly defined to ensure legal certainty, while
providing the flexibility to accommodate future technological developments. The
definition should be based on the key functional characteristics of the software, in
particular the ability, for a given set of human-defined objectives, to generate outputs
such as content, predictions, recommendations, or decisions which influence the
environment with which the system interacts, be it in a physical or digital dimension.
AI systems can be designed to operate with varying levels of autonomy and be used on
a stand-alone basis or as a component of a product, irrespective of whether the system
is physically integrated into the product (embedded) or serve the functionality of the
product without being integrated therein (non-embedded). The definition of AI system
should be complemented by a list of specific techniques and approaches used for its
development, which should be kept up-to–date in the light of market and technological

33 European Council, Special meeting of the European Council (1 and 2 October 2020) – Conclusions,
EUCO 13/20, 2020, p. 6.

34 European Parliament resolution of 20 October 2020 with recommendations to the Commission on a
framework of ethical aspects of artificial intelligence, robotics and related technologies,
2020/2012(INL).

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developments through the adoption of delegated acts by the Commission to amend that
list.

(7) The notion of biometric data used in this Regulation is in line with and should be
interpreted consistently with the notion of biometric data as defined in Article 4(14) of
Regulation (EU) 2016/679 of the European Parliament and of the Council[35], Article
3(18) of Regulation (EU) 2018/1725 of the European Parliament and of the Council[36]
and Article 3(13) of Directive (EU) 2016/680 of the European Parliament and of the
Council[37].

(8) The notion of remote biometric identification system as used in this Regulation should
be defined functionally, as an AI system intended for the identification of natural
persons at a distance through the comparison of a person’s biometric data with the
biometric data contained in a reference database, and without prior knowledge whether
the targeted person will be present and can be identified, irrespectively of the
particular technology, processes or types of biometric data used. Considering their
different characteristics and manners in which they are used, as well as the different
risks involved, a distinction should be made between ‘real-time’ and ‘post’ remote
biometric identification systems. In the case of ‘real-time’ systems, the capturing of
the biometric data, the comparison and the identification occur all instantaneously,
near-instantaneously or in any event without a significant delay. In this regard, there
should be no scope for circumventing the rules of this Regulation on the ‘real-time’
use of the AI systems in question by providing for minor delays. ‘Real-time’ systems
involve the use of ‘live’ or ‘near-‘live’ material, such as video footage, generated by a
camera or other device with similar functionality. In the case of ‘post’ systems, in
contrast, the biometric data have already been captured and the comparison and
identification occur only after a significant delay. This involves material, such as
pictures or video footage generated by closed circuit television cameras or private
devices, which has been generated before the use of the system in respect of the
natural persons concerned.

(9) For the purposes of this Regulation the notion of publicly accessible space should be
understood as referring to any physical place that is accessible to the public,
irrespective of whether the place in question is privately or publicly owned. Therefore,
the notion does not cover places that are private in nature and normally not freely
accessible for third parties, including law enforcement authorities, unless those parties
have been specifically invited or authorised, such as homes, private clubs, offices,
warehouses and factories. Online spaces are not covered either, as they are not
physical spaces. However, the mere fact that certain conditions for accessing a


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

36 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the
protection of natural persons with regard to the processing of personal data by the Union institutions,
bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No
45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39)

37 Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the
protection of natural persons with regard to the processing of personal data by competent authorities for
the purposes of the prevention, investigation, detection or prosecution of criminal offences or the
execution of criminal penalties, and on the free movement of such data, and repealing Council
Framework Decision 2008/977/JHA (Law Enforcement Directive) (OJ L 119, 4.5.2016, p. 89).

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particular space may apply, such as admission tickets or age restrictions, does not
mean that the space is not publicly accessible within the meaning of this Regulation.
Consequently, in addition to public spaces such as streets, relevant parts of
government buildings and most transport infrastructure, spaces such as cinemas,
theatres, shops and shopping centres are normally also publicly accessible. Whether a
given space is accessible to the public should however be determined on a case-bycase basis, having regard to the specificities of the individual situation at hand.

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

(11) In light of their digital nature, certain AI systems should fall within the scope of this
Regulation even when they are neither placed on the market, nor put into service, nor
used in the Union. This is the case for example of an operator established in the Union
that contracts certain services to an operator established outside the Union in relation
to an activity to be performed by an AI system that would qualify as high-risk and
whose effects impact natural persons located in the Union. In those circumstances, the
AI system used by the operator outside the Union could process data lawfully
collected in and transferred from the Union, and provide to the contracting operator in
the Union the output of that AI system resulting from that processing, without that AI
system being placed on the market, put into service or used in the Union. To prevent
the circumvention of this Regulation and to ensure an effective protection of natural
persons located in the Union, this Regulation should also apply to providers and users
of AI systems that are established in a third country, to the extent the output produced
by those systems is used in the Union. Nonetheless, to take into account existing
arrangements and special needs for cooperation with foreign partners with whom
information and evidence is exchanged, this Regulation should not apply to public
authorities of a third country and international organisations when acting in the
framework of international agreements concluded at national or European level for law
enforcement and judicial cooperation with the Union or with its Member States. Such
agreements have been concluded bilaterally between Member States and third
countries or between the European Union, Europol and other EU agencies and third
countries and international organisations.

(12) This Regulation should also apply to Union institutions, offices, bodies and agencies
when acting as a provider or user of an AI system. AI systems exclusively developed
or used for military purposes should be excluded from the scope of this Regulation
where that use falls under the exclusive remit of the Common Foreign and Security
Policy regulated under Title V of the Treaty on the European Union (TEU). 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].

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

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(14) In order to introduce a proportionate and effective set of binding rules for AI systems,
a clearly defined risk-based approach should be followed. That approach should tailor
the type and content of such rules to the intensity and scope of the risks that AI
systems can generate. It is therefore necessary to prohibit certain artificial intelligence
practices, to lay down requirements for high-risk AI systems and obligations for the
relevant operators, and to lay down transparency obligations for certain AI systems.

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

(16) The placing on the market, putting into service or use of certain AI systems intended
to distort human behaviour, whereby physical or psychological harms are likely to
occur, should be forbidden. Such AI systems deploy subliminal components
individuals cannot perceive or exploit vulnerabilities of children and people due to
their age, physical or mental incapacities. They do so with the intention to materially
distort the behaviour of a person and in a manner that causes or is likely to cause harm
to that or another person. The intention may not be presumed if the distortion of
human behaviour results from factors external to the AI system which are outside of
the control of the provider or the user. Research for legitimate purposes in relation to
such AI systems should not be stifled by the prohibition, if such research does not
amount to use of the AI system in human-machine relations that exposes natural
persons to harm and such research is carried out in accordance with recognised ethical
standards for scientific research.

(17) AI systems providing social scoring of natural persons for general purpose by public
authorities or on their behalf may lead to discriminatory outcomes and the exclusion of
certain groups. They may violate the right to dignity and non-discrimination and the
values of equality and justice. Such AI systems evaluate or classify the trustworthiness
of natural persons based on their social behaviour in multiple contexts or known or
predicted personal or personality characteristics. The social score obtained from such
AI systems may lead to the detrimental or unfavourable treatment of natural persons or
whole groups thereof in social contexts, which are unrelated to the context in which
the data was originally generated or collected or to a detrimental treatment that is
disproportionate or unjustified to the gravity of their social behaviour. Such AI
systems should be therefore prohibited.

(18) The use of AI systems for ‘real-time’ remote biometric identification of natural
persons in publicly accessible spaces for the purpose of law enforcement is considered
particularly intrusive in the rights and freedoms of the concerned persons, to the extent
that it may affect the private life of a large part of the population, evoke a feeling of
constant surveillance and indirectly dissuade the exercise of the freedom of assembly
and other fundamental rights. In addition, the immediacy of the impact and the limited
opportunities for further checks or corrections in relation to the use of such systems
operating in ‘real-time’ carry heightened risks for the rights and freedoms of the
persons that are concerned by law enforcement activities.

(19) The use of those systems for the purpose of law enforcement should therefore be
prohibited, except in three exhaustively listed and narrowly defined situations, where

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the use is strictly necessary to achieve a substantial public interest, the importance of
which outweighs the risks. Those situations involve the search for potential victims of
crime, including missing children; certain threats to the life or physical safety of
natural persons or of a terrorist attack; and the detection, localisation, identification or
prosecution of perpetrators or suspects of the criminal offences referred to in Council
Framework Decision 2002/584/JHA[38] if those criminal offences are punishable in the
Member State concerned by a custodial sentence or a detention order for a maximum
period of at least three years and as they are defined in the law of that Member State.
Such threshold for the custodial sentence or detention order in accordance with
national law contributes to ensure that the offence should be serious enough to
potentially justify the use of ‘real-time’ remote biometric identification systems.
Moreover, of the 32 criminal offences listed in the Council Framework Decision
2002/584/JHA, some are in practice likely to be more relevant than others, in that the
recourse to ‘real-time’ remote biometric identification will foreseeably be necessary
and proportionate to highly varying degrees for the practical pursuit of the detection,
localisation, identification or prosecution of a perpetrator or suspect of the different
criminal offences listed and having regard to the likely differences in the seriousness,
probability and scale of the harm or possible negative consequences.

(20) In order to ensure that those systems are used in a responsible and proportionate
manner, it is also important to establish that, in each of those three exhaustively listed
and narrowly defined situations, certain elements should be taken into account, in
particular as regards the nature of the situation giving rise to the request and the
consequences of the use for the rights and freedoms of all persons concerned and the
safeguards and conditions provided for with the use. In addition, the use of ‘real-time’
remote biometric identification systems in publicly accessible spaces for the purpose
of law enforcement should be subject to appropriate limits in time and space, having
regard in particular to the evidence or indications regarding the threats, the victims or
perpetrator. The reference database of persons should be appropriate for each use case
in each of the three situations mentioned above.

(21) Each use of a ‘real-time’ remote biometric identification system in publicly accessible
spaces for the purpose of law enforcement should be subject to an express and specific
authorisation by a judicial authority or by an independent administrative authority of a
Member State. Such authorisation should in principle be obtained prior to the use,
except in duly justified situations of urgency, that is, situations where the need to use
the systems in question is such as to make it effectively and objectively impossible to
obtain an authorisation before commencing the use. In such situations of urgency, the
use should be restricted to the absolute minimum necessary and be subject to
appropriate safeguards and conditions, as determined in national law and specified in
the context of each individual urgent use case by the law enforcement authority itself.
In addition, the law enforcement authority should in such situations seek to obtain an
authorisation as soon as possible, whilst providing the reasons for not having been able
to request it earlier.

(22) Furthermore, it is appropriate to provide, within the exhaustive framework set by this
Regulation that such use in the territory of a Member State in accordance with this
Regulation should only be possible where and in as far as the Member State in
question has decided to expressly provide for the possibility to authorise such use in its

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

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detailed rules of national law. Consequently, Member States remain free under this
Regulation not to provide for such a possibility at all or to only provide for such a
possibility in respect of some of the objectives capable of justifying authorised use
identified in this Regulation.

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

(24) Any processing of biometric data and other personal data involved in the use of AI
systems for biometric identification, other than in connection to the use of ‘real-time’
remote biometric identification systems in publicly accessible spaces for the purpose
of law enforcement as regulated by this Regulation, including where those systems are
used by competent authorities in publicly accessible spaces for other purposes than
law enforcement, should continue to comply with all requirements resulting from
Article 9(1) of Regulation (EU) 2016/679, Article 10(1) of Regulation (EU)
2018/1725 and Article 10 of Directive (EU) 2016/680, as applicable.

(25) In accordance with Article 6a of Protocol No 21 on the position of the United
Kingdom and Ireland in respect of the area of freedom, security and justice, as
annexed to the TEU and to the TFEU, Ireland is not bound by the rules laid down in
Article 5(1), point (d), (2) and (3) of this Regulation adopted on the basis of Article 16
of the TFEU which relate to the processing of personal data by the Member States
when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of Title
V of Part Three of the TFEU, where Ireland is not bound by the rules governing the
forms of judicial cooperation in criminal matters or police cooperation which require
compliance with the provisions laid down on the basis of Article 16 of the TFEU.

(26) In accordance with Articles 2 and 2a of Protocol No 22 on the position of Denmark,
annexed to the TEU and TFEU, Denmark is not bound by rules laid down in Article
5(1), point (d), (2) 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.

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(27) High-risk AI systems should only be placed on the Union market or put into service if
they comply with certain mandatory requirements. Those requirements should ensure
that high-risk AI systems available in the Union or whose output is otherwise used in
the Union do not pose unacceptable risks to important Union public interests as
recognised and protected by Union law. AI systems identified as high-risk should be
limited to those that have a significant harmful impact on the health, safety and
fundamental rights of persons in the Union and such limitation minimises any
potential restriction to international trade, if any.

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

(29) As regards high-risk AI systems that are safety components of products or systems, or
which are themselves products or systems falling within the scope of Regulation (EC)
No 300/2008 of the European Parliament and of the Council[39], Regulation (EU) No
167/2013 of the European Parliament and of the Council[40], Regulation (EU) No
168/2013 of the European Parliament and of the Council[41], Directive 2014/90/EU of


39 Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on
common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L
97, 9.4.2008, p. 72).

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

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

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the European Parliament and of the Council[42], Directive (EU) 2016/797 of the
European Parliament and of the Council[43], Regulation (EU) 2018/858 of the European
Parliament and of the Council[44], Regulation (EU) 2018/1139 of the European
Parliament and of the Council[45], and Regulation (EU) 2019/2144 of the European
Parliament and of the Council[46], it is appropriate to amend those acts to ensure that the
Commission takes into account, on the basis of the technical and regulatory
specificities of each sector, and without interfering with existing governance,
conformity assessment and enforcement mechanisms and authorities established
therein, the mandatory requirements for high-risk AI systems laid down in this
Regulation when adopting any relevant future delegated or implementing acts on the
basis of those acts.

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

(31) The classification of an AI system as high-risk pursuant to this Regulation should not
necessarily mean that the product whose safety component is the AI system, or the AI
system itself as a product, is considered ‘high-risk’ under the criteria established in the
relevant Union harmonisation legislation that applies to the product. This is notably
the case for Regulation (EU) 2017/745 of the European Parliament and of the


42 Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine
equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146).

43 Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the
interoperability of the rail system within the European Union (OJ L 138, 26.5.2016, p. 44).

44 Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the
approval and market surveillance of motor vehicles and their trailers, and of systems, components and
separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC)
No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).

45 Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common
rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and
amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014
and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and
repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the
Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).

46 Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on
type-approval requirements for motor vehicles and their trailers, and systems, components and separate
technical units intended for such vehicles, as regards their general safety and the protection of vehicle
occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament
and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No
661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No
631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No
1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No
65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU)
2015/166 (OJ L 325, 16.12.2019, p. 1).

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Council[47] and Regulation (EU) 2017/746 of the European Parliament and of the
Council[48], where a third-party conformity assessment is provided for medium-risk and
high-risk products.

(32) As regards stand-alone AI systems, meaning high-risk AI systems other than those that
are safety components of products, or which are themselves products, it is appropriate
to classify them as high-risk if, in the light of their intended purpose, they pose a high
risk of harm to the health and safety or the fundamental rights of persons, taking into
account both the severity of the possible harm and its probability of occurrence and
they are used in a number of specifically pre-defined areas specified in the Regulation.
The identification of those systems is based on the same methodology and criteria
envisaged also for any future amendments of the list of high-risk AI systems.

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

(34) As regards the management and operation of critical infrastructure, it is appropriate to
classify as high-risk the AI systems intended to be used as safety components in the
management and operation of road traffic and the supply of water, gas, heating and
electricity, since their failure or malfunctioning may put at risk the life and health of
persons at large scale and lead to appreciable disruptions in the ordinary conduct of
social and economic activities.

(35) AI systems used in education or vocational training, notably for determining access or
assigning persons to educational and vocational training institutions or to evaluate
persons on tests as part of or as a precondition for their education should be considered
high-risk, since they may determine the educational and professional course of a
person’s life and therefore affect their ability to secure their livelihood. When
improperly designed and used, such systems may violate the right to education and
training as well as the right not to be discriminated against and perpetuate historical
patterns of discrimination.

(36) AI systems used in employment, workers management and access to self-employment,
notably for the recruitment and selection of persons, for making decisions on
promotion and termination and for task allocation, monitoring or evaluation of persons
in work-related contractual relationships, should also be classified as high-risk, since
those systems may appreciably impact future career prospects and livelihoods of these
persons. Relevant work-related contractual relationships should involve employees
and persons providing services through platforms as referred to in the Commission
Work Programme 2021. Such persons should in principle not be considered users
within the meaning of this Regulation. Throughout the recruitment process and in the

47 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

48 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro
diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
(OJ L 117, 5.5.2017, p. 176).

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evaluation, promotion, or retention of persons in work-related contractual
relationships, such systems may perpetuate historical patterns of discrimination, for
example against women, certain age groups, persons with disabilities, or persons of
certain racial or ethnic origins or sexual orientation. AI systems used to monitor the
performance and behaviour of these persons may also impact their rights to data
protection and privacy.

(37) Another area in which the use of AI systems deserves special consideration is the
access to and enjoyment of certain essential private and public services and benefits
necessary for people to fully participate in society or to improve one’s standard of
living. In particular, AI systems used to evaluate the credit score or creditworthiness of
natural persons should be classified as high-risk AI systems, since they determine
those persons’ access to financial resources or essential services such as housing,
electricity, and telecommunication services. AI systems used for this purpose may lead
to discrimination of persons or groups and perpetuate historical patterns of
discrimination, for example based on racial or ethnic origins, disabilities, age, sexual
orientation, or create new forms of discriminatory impacts. Considering the very
limited scale of the impact and the available alternatives on the market, it is
appropriate to exempt AI systems for the purpose of creditworthiness assessment and
credit scoring when put into service by small-scale providers for their own use.
Natural persons applying for or receiving public assistance benefits and services from
public authorities are typically dependent on those benefits and services and in a
vulnerable position in relation to the responsible authorities. If AI systems are used for
determining whether such benefits and services should be denied, reduced, revoked or
reclaimed by authorities, they may have a significant impact on persons’ livelihood
and may infringe their fundamental rights, such as the right to social protection, nondiscrimination, human dignity or an effective remedy. Those systems should therefore
be classified as high-risk. Nonetheless, this Regulation should not hamper the
development and use of innovative approaches in the public administration, which
would stand to benefit from a wider use of compliant and safe AI systems, provided
that those systems do not entail a high risk to legal and natural persons. Finally, AI
systems used to dispatch or establish priority in the dispatching of emergency first
response services should also be classified as high-risk since they make decisions in
very critical situations for the life and health of persons and their property.

(38) Actions by law enforcement authorities involving certain uses of AI systems are
characterised by a significant degree of power imbalance and may lead to surveillance,
arrest or deprivation of a natural person’s liberty as well as other adverse impacts on
fundamental rights guaranteed in the Charter. In particular, if the AI system is not
trained with high quality data, does not meet adequate requirements in terms of its
accuracy or robustness, or is not properly designed and tested before being put on the
market or otherwise put into service, it may single out people in a discriminatory or
otherwise incorrect or unjust manner. Furthermore, the exercise of important
procedural fundamental rights, such as the right to an effective remedy and to a fair
trial as well as the right of defence and the presumption of innocence, could be
hampered, in particular, where such AI systems are not sufficiently transparent,
explainable and documented. It is therefore appropriate to classify as high-risk a
number of AI systems intended to be used in the law enforcement context where
accuracy, reliability and transparency is particularly important to avoid adverse
impacts, retain public trust and ensure accountability and effective redress. In view of
the nature of the activities in question and the risks relating thereto, those high-risk AI
systems should include in particular AI systems intended to be used by law

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enforcement authorities for individual risk assessments, polygraphs and similar tools
or to detect the emotional state of natural person, to detect ‘deep fakes’, for the
evaluation of the reliability of evidence in criminal proceedings, for predicting the
occurrence or reoccurrence of an actual or potential criminal offence based on
profiling of natural persons, or assessing personality traits and characteristics or past
criminal behaviour of natural persons or groups, for profiling in the course of
detection, investigation or prosecution of criminal offences, as well as for crime
analytics regarding natural persons. AI systems specifically intended to be used for
administrative proceedings by tax and customs authorities should not be considered
high-risk AI systems used by law enforcement authorities for the purposes of
prevention, detection, investigation and prosecution of criminal offences.

(39) AI systems used in migration, asylum and border control management affect people
who are often in particularly vulnerable position and who are dependent on the
outcome of the actions of the competent public authorities. The accuracy, nondiscriminatory nature and transparency of the AI systems used in those contexts are
therefore particularly important to guarantee the respect of the fundamental rights of
the affected persons, notably their rights to free movement, non-discrimination,
protection of private life and personal data, international protection and good
administration. It is therefore appropriate to classify as high-risk AI systems intended
to be used by the competent public authorities charged with tasks in the fields of
migration, asylum and border control management as polygraphs and similar tools or
to detect the emotional state of a natural person; for assessing certain risks posed by
natural persons entering the territory of a Member State or applying for visa or
asylum; for verifying the authenticity of the relevant documents of natural persons; for
assisting competent public authorities for the examination of applications for asylum,
visa and residence permits and associated complaints with regard to the objective to
establish the eligibility of the natural persons applying for a status. AI systems in the
area of migration, asylum and border control management covered by this Regulation
should comply with the relevant procedural requirements set by the Directive
2013/32/EU of the European Parliament and of the Council[49], the Regulation (EC) No
810/2009 of the European Parliament and of the Council[50] and other relevant
legislation.

(40) Certain AI systems intended for the administration of justice and democratic processes
should be classified as high-risk, considering their potentially significant impact on
democracy, rule of law, individual freedoms as well as the right to an effective remedy
and to a fair trial. In particular, to address the risks of potential biases, errors and
opacity, it is appropriate to qualify as high-risk AI systems intended to assist judicial
authorities in researching and interpreting facts and the law and in applying the law to
a concrete set of facts. Such qualification should not extend, however, to AI systems
intended for purely ancillary administrative activities that do not affect the actual
administration of justice in individual cases, such as anonymisation or
pseudonymisation of judicial decisions, documents or data, communication between
personnel, administrative tasks or allocation of resources.

49 Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common
procedures for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60).

50 Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009
establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, p. 1).

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

(42) To mitigate the risks from high-risk AI systems placed or otherwise put into service on
the Union market for users and affected persons, certain mandatory requirements
should apply, taking into account the intended purpose of the use of the system and
according to the risk management system to be established by the provider.

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

(44) High data quality is essential for the performance of many AI systems, especially
when techniques involving the training of models are used, with a view to ensure that
the high-risk AI system performs as intended and safely and it does not become the
source of discrimination prohibited by Union law. High quality training, validation
and testing data sets require the implementation of appropriate data governance and
management practices. Training, validation and testing data sets should be sufficiently
relevant, representative and free of errors and complete in view of the intended
purpose of the system. They should also have the appropriate statistical properties,
including as regards the persons or groups of persons on which the high-risk AI
system is intended to be used. In particular, training, validation and testing data sets
should take into account, to the extent required in the light of their intended purpose,
the features, characteristics or elements that are particular to the specific geographical,
behavioural or functional setting or context within which the AI system is intended to
be used. In order to protect the right of others from the discrimination that might result
from the bias in AI systems, the providers shouldbe able to process also special
categories of personal 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.

(45) For the development of high-risk AI systems, certain actors, such as providers,
notified bodies and other relevant entities, such as digital innovation hubs, testing
experimentation facilities and researchers, should be able to access and use high
quality datasets within their respective fields of activities which are related to this
Regulation. European common data spaces established by the Commission and the
facilitation of data sharing between businesses and with government in the public
interest will be instrumental to provide trustful, accountable and non-discriminatory
access to high quality data for the training, validation and testing of AI systems. For
example, in health, the European health data space will facilitate non-discriminatory
access to health data and the training of artificial intelligence algorithms on those
datasets, in a privacy-preserving, secure, timely, transparent and trustworthy manner,
and with an appropriate institutional governance. Relevant competent authorities,

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including sectoral ones, providing or supporting the access to data may also support
the provision of high-quality data for the training, validation and testing of AI systems.

(46) Having information on how high-risk AI systems have been developed and how they
perform throughout their lifecycle is essential to verify compliance with the
requirements under this Regulation. This requires keeping records and the availability
of a technical documentation, containing information which is necessary to assess the
compliance of the AI system with the relevant requirements. Such information should
include the general characteristics, capabilities and limitations of the system,
algorithms, data, training, testing and validation processes used as well as
documentation on the relevant risk management system. The technical documentation
should be kept up to date.

(47) To address the opacity that may make certain AI systems incomprehensible to or too
complex for natural persons, a certain degree of transparency should be required for
high-risk AI systems. Users should be able to interpret the system output and use it
appropriately. High-risk AI systems should therefore be accompanied by relevant
documentation and instructions of use and include concise and clear information,
including in relation to possible risks to fundamental rights and discrimination, where
appropriate.

(48) High-risk AI systems should be designed and developed in such a way that natural
persons can oversee their functioning. For this purpose, appropriate human oversight
measures should be identified by the provider of the system before its placing on the
market or putting into service. In particular, where appropriate, such measures should
guarantee that the system is subject to in-built operational constraints that cannot be
overridden by the system itself and is responsive to the human operator, and that the
natural persons to whom human oversight has been assigned have the necessary
competence, training and authority to carry out that role.

(49) High-risk AI systems should perform consistently throughout their lifecycle and meet
an appropriate level of accuracy, robustness and cybersecurity in accordance with the
generally acknowledged state of the art. The level of accuracy and accuracy metrics
should be communicated to the users.

(50) The technical robustness is a key requirement for high-risk AI systems. They should
be resilient against risks connected to the limitations of the system (e.g. errors, faults,
inconsistencies, unexpected situations) as well as against malicious actions that may
compromise the security of the AI system and result in harmful or otherwise
undesirable behaviour. Failure to protect against these risks could lead to safety
impacts or negatively affect the fundamental rights, for example due to erroneous
decisions or wrong or biased outputs generated by the AI system.

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

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(52) As part of Union harmonisation legislation, rules applicable to the placing on the
market, putting into service and use of high-risk AI systems should be laid down
consistently with Regulation (EC) No 765/2008 of the European Parliament and of the
Council[51] setting out the requirements for accreditation and the market surveillance of
products, Decision No 768/2008/EC of the European Parliament and of the Council[52]
on a common framework for the marketing of products and Regulation (EU)
2019/1020 of the European Parliament and of the Council[53] on market surveillance
and compliance of products (‘New Legislative Framework for the marketing of
products’).

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

(54) The provider should establish a sound quality management system, ensure the
accomplishment of the required conformity assessment procedure, draw up the
relevant documentation and establish a robust post-market monitoring system. Public
authorities which put into service high-risk AI systems for their own use may adopt
and implement the rules for the quality management system as part of the quality
management system adopted at a national or regional level, as appropriate, taking into
account the specificities of the sector and the competences and organisation of the
public authority in question.

(55) Where a high-risk AI system that is a safety component of a product which is covered
by a relevant New Legislative Framework sectorial legislation is not placed on the
market or put into service independently from the product, the manufacturer of the
final product 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.

(56) To enable enforcement of this Regulation and create a level-playing field for
operators, and taking into account the different forms of making available of digital
products, it is important to ensure that, under all circumstances, a person established in
the Union can provide authorities with all the necessary information on the compliance
of an AI system. Therefore, prior to making their AI systems available in the Union,
where an importer cannot be identified, providers established outside the Union shall,
by written mandate, appoint an authorised representative established in the Union.

(57) In line with New Legislative Framework principles, specific obligations for relevant
economic operators, such as importers and distributors, should be set to ensure legal
certainty and facilitate regulatory compliance by those relevant operators.


51 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out
the requirements for accreditation and market surveillance relating to the marketing of products and
repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).

52 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218,
13.8.2008, p. 82).

53 Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market
surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No
765/2008 and (EU) No 305/2011 (Text with EEA relevance) (OJ L 169, 25.6.2019, p. 1–44).

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(58) Given the nature of AI systems and the risks to safety and fundamental rights possibly
associated with their use, including as regard the need to ensure proper monitoring of
the performance of an AI system in a real-life setting, it is appropriate to set specific
responsibilities for users. Users should in particular use high-risk AI systems in
accordance with the instructions of use and certain other obligations should be
provided for with regard to monitoring of the functioning of the AI systems and with
regard to record-keeping, as appropriate.

(59) It is appropriate to envisage that the user of the AI system should be the natural or
legal person, public authority, agency or other body under whose authority the AI
system is operated except where the use is made in the course of a personal nonprofessional activity.

(60) In the light of the complexity of the artificial intelligence value chain, relevant third
parties, notably the ones involved in the sale and the supply of software, software tools
and components, pre-trained models and data, or providers of network services, should
cooperate, as appropriate, with providers and users to enable their compliance with the
obligations under this Regulation and with competent authorities established under this
Regulation.

(61) Standardisation should play a key role to provide technical solutions to providers to
ensure compliance with this Regulation. Compliance with harmonised standards as
defined in Regulation (EU) No 1025/2012 of the European Parliament and of the
Council[54] should be a means for providers to demonstrate conformity with the
requirements of this Regulation. However, the Commission could adopt common
technical specifications in areas where no harmonised standards exist or where they
are insufficient.

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

(63) It is appropriate that, in order to minimise the burden on operators and avoid any
possible duplication, for high-risk AI systems related to products which are covered by
existing Union harmonisation legislation following the New Legislative Framework
approach, the compliance of those AI systems with the requirements of this Regulation
should be assessed as part of the conformity assessment already foreseen under that
legislation. The applicability of the requirements of this Regulation should thus not
affect the specific logic, methodology or general structure of conformity assessment
under the relevant specific New Legislative Framework legislation. This approach is
fully reflected in the interplay between this Regulation and the [Machinery
Regulation]. While safety risks of AI systems ensuring safety functions in machinery
are addressed by the requirements of this Regulation, certain specific requirements in
the [Machinery Regulation] will ensure the safe integration of the AI system into the
overall machinery, so as not to compromise the safety of the machinery as a whole.

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

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The [Machinery Regulation] applies the same definition of AI system as this
Regulation.

(64) Given the more extensive experience of professional pre-market certifiers in the field
of product safety and the different nature of risks involved, it is appropriate to limit, at
least in an initial phase of application of this Regulation, the scope of application of
third-party conformity assessment for high-risk AI systems other than those related to
products. Therefore, the conformity assessment of such systems should be carried out
as a general rule by the provider under its own responsibility, with the only exception
of AI systems intended to be used for the remote biometric identification of persons,
for which the involvement of a notified body in the conformity assessment should be
foreseen, to the extent they are not prohibited.

(65) In order to carry out third-party conformity assessment for AI systems intended to be
used for the remote biometric identification of persons, notified bodies should be
designated under this Regulation by the national competent authorities, provided they
are compliant with a set of requirements, notably on independence, competence and
absence of conflicts of interests.

(66) In line with the commonly established notion of substantial modification for products
regulated by Union harmonisation legislation, it is appropriate that an AI system
undergoes a new conformity assessment whenever a change occurs which may affect
the compliance of the system with this Regulation or when the intended purpose of the
system changes. In addition, as regards AI systems which continue to ‘learn’ after
being placed on the market or put into service (i.e. they automatically adapt how
functions are carried out), it is necessary to provide rules establishing that changes to
the algorithm and its performance that have been pre-determined by the provider and
assessed at the moment of the conformity assessment should not constitute a
substantial modification.

(67) High-risk AI systems should bear the CE marking to indicate their conformity with
this Regulation so that they can move freely within the internal market. Member States
should not create unjustified obstacles to the placing on the market or putting into
service of high-risk AI systems that comply with the requirements laid down in this
Regulation and bear the CE marking.

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

(69) In order to facilitate the work of the Commission and the Member States in the
artificial intelligence field as well as to increase the transparency towards the public,
providers of high-risk AI systems other than those related to products falling within
the scope of relevant existing Union harmonisation legislation, should be required to
register their high-risk AI system in a EU database, to be established and managed by
the Commission. The Commission should be the controller of that database, in
accordance with Regulation (EU) 2018/1725 of the European Parliament and of the

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Council[55]. In order to ensure the full functionality of the database, when deployed, the
procedure for setting the database should include the elaboration of functional
specifications by the Commission and an independent audit report.

(70) Certain AI systems intended to interact with natural persons or to generate content
may pose specific risks of impersonation or deception irrespective of whether they
qualify as high-risk or not. In certain circumstances, the use of these systems should
therefore be subject to specific transparency obligations without prejudice to the
requirements and obligations for high-risk AI systems. In particular, natural persons
should be notified that they are interacting with an AI system, unless this is obvious
from the circumstances and the context of use. Moreover, natural persons should be
notified when they are exposed to an emotion recognition system or a biometric
categorisation system. Such information and notifications should be provided in
accessible formats for persons with disabilities. Further, users, who use an AI system
to generate or manipulate image, audio or video content that appreciably resembles
existing persons, places or events and would falsely appear to a person to be authentic,
should disclose that the content has been artificially created or manipulated by
labelling the artificial intelligence output accordingly and disclosing its artificial
origin.

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

(72) The objectives of the regulatory sandboxes should be to foster AI innovation by
establishing a controlled experimentation and testing environment in the development
and pre-marketing phase with a view to ensuring compliance of the innovative AI
systems with this Regulation and other relevant Union and Member States legislation;
to enhance legal certainty for innovators and the competent authorities’ oversight and
understanding of the opportunities, emerging risks and the impacts of AI use, and to
accelerate access to markets, including by removing barriers for small and medium
enterprises (SMEs) and start-ups. To ensure uniform implementation across the Union
and economies of scale, it is appropriate to establish common rules for the regulatory
sandboxes’ implementation and a framework for cooperation between the relevant
authorities involved in the supervision of the sandboxes. 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,
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.
Participants in the sandbox should ensure appropriate safeguards and cooperate with
the competent authorities, including by following their guidance and acting

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

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expeditiously and in good faith to mitigate any high-risks to safety and fundamental
rights that may arise during the development and experimentation in the sandbox. The
conduct of the participants in the sandbox should be taken into account when
competent authorities decide whether to impose an administrative fine under Article
83(2) of Regulation 2016/679 and Article 57 of Directive 2016/680.

(73) In order to promote and protect innovation, it is important that the interests of smallscale providers and users of AI systems are taken into particular account. To this
objective, Member States should develop initiatives, which are targeted at those
operators, including on awareness raising and information communication. Moreover,
the specific interests and needs of small-scale providers shall be taken into account
when Notified Bodies set conformity assessment fees. Translation costs related to
mandatory documentation and communication with authorities may constitute a
significant cost for providers and other operators, notably those of a smaller scale.
Member States should possibly ensure that one of the languages determined and
accepted by them for relevant providers’ documentation and for communication with
operators is one which is broadly understood by the largest possible number of crossborder users.

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

(75) It is appropriate that the Commission facilitates, to the extent possible, access to
Testing and Experimentation Facilities to bodies, groups or laboratories established or
accredited pursuant to any relevant Union harmonisation legislation and which fulfil
tasks in the context of conformity assessment of products or devices covered by that
Union harmonisation legislation. This is notably the case for expert panels, expert
laboratories and reference laboratories in the field of medical devices pursuant to
Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

(76) In order to facilitate a smooth, effective and harmonised implementation of this
Regulation a European Artificial Intelligence Board should be established. The Board
should be responsible for a number of advisory tasks, including issuing opinions,
recommendations, advice or guidance on matters related to the implementation of this
Regulation, including on technical specifications or existing standards regarding the
requirements established in this Regulation and providing advice to and assisting the
Commission on specific questions related to artificial intelligence.

(77) Member States hold a key role in the application and enforcement of this Regulation.
In this respect, each Member State should designate one or more national competent
authorities for the purpose of supervising the application and implementation of this
Regulation. In order to increase organisation efficiency on the side of Member States
and to set an official point of contact vis-à-vis the public and other counterparts at
Member State and Union levels, in each Member State one national authority should
be designated as national supervisory authority.

(78) In order to ensure that providers of high-risk AI systems can take into account the
experience on the use of high-risk AI systems for improving their systems and the

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design and development process or can take any possible corrective action in a timely
manner, all providers should have a post-market monitoring system in place. This
system is also key to ensure that the possible risks emerging from AI systems which
continue to ‘learn’ after being placed on the market or put into service can be more
efficiently and timely addressed. In this context, providers should also be required to
have a system in place to report to the relevant authorities any serious incidents or any
breaches to national and Union law protecting fundamental rights resulting from the
use of their AI systems.

(79) In order to ensure an appropriate and effective enforcement of the requirements and
obligations set out by this Regulation, which is Union harmonisation legislation, the
system of market surveillance and compliance of products established by Regulation
(EU) 2019/1020 should apply in its entirety. Where necessary for their mandate,
national public authorities or bodies, which supervise the application of Union law
protecting fundamental rights, including equality bodies, should also have access to
any documentation created under this Regulation.

(80) Union legislation on financial services includes internal governance and risk
management rules and requirements which are applicable to regulated financial
institutions in the course of provision of those services, including when they make use
of AI systems. In order to ensure coherent application and enforcement of the
obligations under this Regulation and relevant rules and requirements of the Union
financial services legislation, the authorities responsible for the supervision and
enforcement of the financial services legislation, including where applicable the
European Central Bank, should be designated as competent authorities for the purpose
of supervising the implementation of this Regulation, including for market
surveillance activities, as regards AI systems provided or used by regulated and
supervised financial institutions. To further enhance the consistency between this
Regulation and the rules applicable to credit institutions regulated under Directive
2013/36/EU of the European Parliament and of the Council[56], it is also appropriate to
integrate the conformity assessment procedure and some of the providers’ procedural
obligations in relation to risk management, post marketing monitoring and
documentation into the existing obligations and procedures under Directive
2013/36/EU. In order to avoid overlaps, limited derogations should also be envisaged
in relation to the quality management system of providers and the monitoring
obligation placed on users of high-risk AI systems to the extent that these apply to
credit institutions regulated by Directive 2013/36/EU.

(81) The development of AI systems other than high-risk AI systems in accordance with
the requirements of this Regulation may lead to a larger uptake of trustworthy artificial
intelligence in the Union. Providers of non-high-risk AI systems should be encouraged
to create codes of conduct intended to foster the voluntary application of the
mandatory requirements applicable to high-risk AI systems. Providers should also be
encouraged to apply on a voluntary basis additional requirements related, for example,
to environmental sustainability, accessibility to persons with disability, stakeholders’
participation in the design and development of AI systems, and diversity of the
development teams. The Commission may develop initiatives, including of a sectorial

56 Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the
activity of credit institutions and the prudential supervision of credit institutions and investment firms,
amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176,
27.6.2013, p. 338).

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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.

(82) It is important that AI systems related to products that are not high-risk in accordance
with this Regulation and thus are not required to comply with the requirements set out
herein are nevertheless safe when placed on the market or put into service. To
contribute to this objective, the Directive 2001/95/EC of the European Parliament and
of the Council[57] would apply as a safety net.

(83) In order to ensure trustful and constructive cooperation of competent authorities on
Union and national level, all parties involved in the application of this Regulation
should respect the confidentiality of information and data obtained in carrying out
their tasks.

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

(85) In order to ensure that the regulatory framework can be adapted where necessary, the
power to adopt acts in accordance with Article 290 TFEU should be delegated to the
Commission to amend the techniques and approaches referred to in Annex I to define
AI systems, the Union harmonisation legislation listed in Annex II, the high-risk AI
systems listed in Annex III, the provisions regarding technical documentation listed in
Annex IV, the content of the EU declaration of conformity in Annex V, the provisions
regarding the conformity assessment procedures in Annex VI and VII and the
provisions establishing the high-risk AI systems to which the conformity assessment
procedure based on assessment of the quality management system and assessment of
the technical documentation should apply. It is of particular importance that the
Commission carry out appropriate consultations during its preparatory work, including
at expert level, and that those consultations be conducted in accordance with the
principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better
Law-Making[58]. In particular, to ensure equal participation in the preparation of
delegated acts, the European Parliament and the Council receive all documents at the
same time as Member States’ experts, and their experts systematically have access to
meetings of Commission expert groups dealing with the preparation of delegated acts.

(86) In order to ensure uniform conditions for the implementation of this Regulation,
implementing powers should be conferred on the Commission. Those powers should
be exercised in accordance with Regulation (EU) No 182/2011 of the European
Parliament and of the Council[59].

(87) Since the objective of this Regulation cannot be sufficiently achieved by the Member
States and can rather, by reason of the scale or effects of the action, be better achieved


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

58 OJ L 123, 12.5.2016, p. 1.

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

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at Union level, the Union may adopt measures in accordance with the principle of
subsidiarity as set out in Article 5 TEU. In accordance with the principle of
proportionality as set out in that Article, this Regulation does not go beyond what is
necessary in order to achieve that objective.

(88) This Regulation should apply from … [OP – please insert the date established in Art.
_85]. However, the infrastructure related to the governance and the conformity_
assessment system should be operational before that date, therefore the provisions on
notified bodies and governance structure should apply from … [OP – please insert the
_date – three months following the entry into force of this Regulation]. In addition,_
Member States should lay down and notify to the Commission the rules on penalties,
including administrative fines, and ensure that they are properly and effectively
implemented by the date of application of this Regulation. Therefore the provisions on
penalties should apply from [OP – please insert the date – twelve months following the
_entry into force of this Regulation]._

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

HAVE ADOPTED THIS REGULATION:

## TITLE I

 GENERAL PROVISIONS

_Article 1_

_Subject matter_


This Regulation lays down:

(a) harmonised rules for the placing on the market, the putting into service and the
use of artificial intelligence systems (‘AI systems’) in the Union;

(a) prohibitions of certain artificial intelligence practices;

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

(c) harmonised transparency rules for AI systems intended to interact with natural
persons, emotion recognition systems and biometric categorisation systems,
and AI systems used to generate or manipulate image, audio or video content;

(d) rules on market monitoring and surveillance.


_Article 2_

_Scope_

1. This Regulation applies to:

(a) providers placing on the market or putting into service AI systems in the
Union, irrespective of whether those providers are established within the Union
or in a third country;

(b) users of AI systems located within the Union;

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(c) providers and users of AI systems that are located in a third country, where the
output produced by the system is used in the Union;

2. For high-risk AI systems that are safety components of products or systems, or which
are themselves products or systems, falling within the scope of the following acts,
only Article 84 of this Regulation shall apply:

(a) Regulation (EC) 300/2008;

(b) Regulation (EU) No 167/2013;

(c) Regulation (EU) No 168/2013;

(d) Directive 2014/90/EU;

(e) Directive (EU) 2016/797;

(f) Regulation (EU) 2018/858;

(g) Regulation (EU) 2018/1139;

(h) Regulation (EU) 2019/2144.

3. This Regulation shall not apply to AI systems developed or used exclusively for
military purposes.

4. This Regulation shall not apply to public authorities in a third country nor to
international organisations falling within the scope of this Regulation pursuant to
paragraph 1, where those authorities or organisations use AI systems in the
framework of international agreements for law enforcement and judicial cooperation
with the Union or with one or more Member States.

5. This Regulation shall not affect the application of the provisions on the liability of
intermediary service providers set out in Chapter II, Section IV of Directive
2000/31/EC of the European Parliament and of the Council[60] [as to be replaced by
_the corresponding provisions of the Digital Services Act]._

_Article 3_

_Definitions_

For the purpose of this Regulation, the following definitions apply:

(1) ‘artificial intelligence system’ (AI system) means software that is developed with one
or more of the techniques and approaches listed in Annex I and can, for a given set of
human-defined objectives, generate outputs such as content, predictions,
recommendations, or decisions influencing the environments they interact with;

(1) ‘provider’ means a natural or legal person, public authority, agency or other body
that develops an AI system or that has an AI system developed with a view to
placing it on the market or putting it into service under its own name or trademark,
whether for payment or free of charge;

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

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(3) ‘small-scale provider’ means a provider that is a micro or small enterprise within the
meaning of Commission Recommendation 2003/361/EC[61];

(4) ‘user’ means any natural or legal person, public authority, agency or other body
using an AI system under its authority, except where the AI system is used in the
course of a personal non-professional activity;

(5) ‘authorised representative’ means any natural or legal person established in the
Union who has received a written mandate from a provider of an AI system to,
respectively, perform and carry out on its behalf the obligations and procedures
established by this Regulation;

(6) ‘importer’ means any natural or legal person established in the Union that places on
the market or puts into service an AI system that bears the name or trademark of a
natural or legal person established outside the Union;

(7) ‘distributor’ means any natural or legal person in the supply chain, other than the
provider or the importer, that makes an AI system available on the Union market
without affecting its properties;

(8) ‘operator’ means the provider, the user, the authorised representative, the importer
and the distributor;

(9) ‘placing on the market’ means the first making available of an AI system on the
Union market;

(10) ‘making available on the market’ means any supply of an AI system for distribution
or use on the Union market in the course of a commercial activity, whether in return
for payment or free of charge;

(11) ‘putting into service’ means the supply of an AI system for first use directly to the
user or for own use on the Union market for its intended purpose;

(12) ‘intended purpose’ means the use for which an AI system is intended by the provider,
including the specific context and conditions of use, as specified in the information
supplied by the provider in the instructions for use, promotional or sales materials
and statements, as well as in the technical documentation;

(13) ‘reasonably foreseeable misuse’ means the use of an AI system in a way that is not in
accordance with its intended purpose, but which may result from reasonably
foreseeable human behaviour or interaction with other systems;

(14) ‘safety component of a product or system’ means a component of a product or of a
system which fulfils a safety function for that product or system or the failure or
malfunctioning of which endangers the health and safety of persons or property;

(15) ‘instructions for use’ means the information provided by the provider to inform the
user of in particular an AI system’s intended purpose and proper use, inclusive of the
specific geographical, behavioural or functional setting within which the high-risk AI
system is intended to be used;

(16) ‘recall of an AI system’ means any measure aimed at achieving the return to the
provider of an AI system made available to users;

61 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and mediumsized enterprises (OJ L 124, 20.5.2003, p. 36).

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(17) ‘withdrawal of an AI system’ means any measure aimed at preventing the
distribution, display and offer of an AI system;

(18) ‘performance of an AI system’ means the ability of an AI system to achieve its
intended purpose;

(19) ‘notifying authority’ means the national authority responsible for setting up and
carrying out the necessary procedures for the assessment, designation and
notification of conformity assessment bodies and for their monitoring;

(20) ‘conformity assessment’ means the process of verifying whether the requirements set
out in Title III, Chapter 2 of this Regulation relating to an AI system have been
fulfilled;

(21) ‘conformity assessment body’ means a body that performs third-party conformity
assessment activities, including testing, certification and inspection;

(22) ‘notified body’ means a conformity assessment body designated in accordance with
this Regulation and other relevant Union harmonisation legislation;

(23) ‘substantial modification’ means a change to the AI system following its placing on
the market or putting into service which affects the compliance of the AI system with
the requirements set out in Title III, Chapter 2 of this Regulation or results in a
modification to the intended purpose for which the AI system has been assessed;

(24) ‘CE marking of conformity’ (CE marking) means a marking by which a provider
indicates that an AI system is in conformity with the requirements set out in Title III,
Chapter 2 of this Regulation and other applicable Union legislation harmonising the
conditions for the marketing of products (‘Union harmonisation legislation’)
providing for its affixing;

(25) ‘post-market monitoring’ means all activities carried out by providers of AI systems
to proactively collect and review experience gained from the use of AI systems they
place on the market or put into service for the purpose of identifying any need to
immediately apply any necessary corrective or preventive actions;

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

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

(28) ‘common specifications’ means a document, other than a standard, containing
technical solutions providing a means to, comply with certain requirements and
obligations established under this Regulation;

(29) ‘training data’ means data used for training an AI system through fitting its learnable
parameters, including the weights of a neural network;

(30) ‘validation data’ means data used for providing an evaluation of the trained AI
system and for tuning its non-learnable parameters and its learning process, among
other things, in order to prevent overfitting; whereas the validation dataset can be a
separate dataset or part of the training dataset, either as a fixed or variable split;

(31) ‘testing data’ means data used for providing an independent evaluation of the trained
and validated AI system in order to confirm the expected performance of that system
before its placing on the market or putting into service;

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(32) ‘input data’ means data provided to or directly acquired by an AI system on the basis
of which the system produces an output;

(33) ‘biometric data’ means personal data resulting from specific technical processing
relating to the physical, physiological or behavioural characteristics of a natural
person, which allow or confirm the unique identification of that natural person, such
as facial images or dactyloscopic data;

(34) ‘emotion recognition system’ means an AI system for the purpose of identifying or
inferring emotions or intentions of natural persons on the basis of their biometric
data;

(35) ‘biometric categorisation system’ means an AI system for the purpose of assigning
natural persons to specific categories, such as sex, age, hair colour, eye colour,
tattoos, ethnic origin or sexual or political orientation, on the basis of their biometric
data;

(36) ‘remote biometric identification system’ means an AI system for the purpose of
identifying natural persons at a distance through the comparison of a person’s
biometric data with the biometric data contained in a reference database, and without
prior knowledge of the user of the AI system whether the person will be present and
can be identified ;

(37) ‘‘real-time’ remote biometric identification system’ means a remote biometric
identification system whereby the capturing of biometric data, the comparison and
the identification all occur without a significant delay. This comprises not only
instant identification, but also limited short delays in order to avoid circumvention.

(38) ‘‘post’ remote biometric identification system’ means a remote biometric
identification system other than a ‘real-time’ remote biometric identification system;

(39) ‘publicly accessible space’ means any physical place accessible to the public,
regardless of whether certain conditions for access may apply;

(40) ‘law enforcement authority’ means:

(a) any public authority competent for the prevention, investigation, detection or
prosecution of criminal offences or the execution of criminal penalties,
including the safeguarding against and the prevention of threats to public
security; or

(b) any other body or entity entrusted by Member State law to exercise public
authority and public powers for the purposes of the prevention, investigation,
detection or prosecution of criminal offences or the execution of criminal
penalties, including the safeguarding against and the prevention of threats to
public security;

(41) ‘law enforcement’ means activities carried out by law enforcement authorities for the
prevention, investigation, detection or prosecution of criminal offences or the
execution of criminal penalties, including the safeguarding against and the
prevention of threats to public security;

(42) ‘national supervisory authority’ means the authority to which a Member State assigns
the 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;

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(43) ‘national competent authority’ means the national supervisory authority, the
notifying authority and the market surveillance authority;

(44) ‘serious incident’ means any incident that directly or indirectly leads, might have led
or might lead to any of the following:

(a) the death of a person or serious damage to a person’s health, to property or the
environment,

(b) a serious and irreversible disruption of the management and operation of
critical infrastructure.

_Article 4_

_Amendments to Annex I_

The Commission is empowered to adopt delegated acts in accordance with Article 73 to
amend the list of techniques and approaches listed in Annex I, in order to update that list to
market and technological developments on the basis of characteristics that are similar to the
techniques and approaches listed therein.

## TITLE II

 PROHIBITED ARTIFICIAL INTELLIGENCE PRACTICES

_Article 5_

1. The following artificial intelligence practices shall be prohibited:

(a) the placing on the market, putting into service or use of an AI system that
deploys subliminal techniques beyond a person’s consciousness in order to
materially distort a person’s behaviour in a manner that causes or is likely to
cause that person or another person physical or psychological harm;

(b) the placing on the market, putting into service or use of an AI system that
exploits any of the vulnerabilities of a specific group of persons due to their
age, physical or mental disability, in order to materially distort the behaviour of
a person pertaining to that group in a manner that causes or is likely to cause
that person or another person physical or psychological harm;

(c) the placing on the market, putting into service or use of AI systems by public
authorities or on their behalf for the evaluation or classification of the
trustworthiness of natural persons over a certain period of time based on their
social behaviour or known or predicted personal or personality characteristics,
with the social score leading to either or both of the following:

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

(ii) detrimental or unfavourable treatment of certain natural persons or whole
groups thereof that is unjustified or disproportionate to their social
behaviour or its gravity;

(d) the use of ‘real-time’ remote biometric identification systems in publicly
accessible spaces for the purpose of law enforcement, unless and in as far as
such use is strictly necessary for one of the following objectives:

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(i) the targeted search for specific potential victims of crime, including
missing children;

(ii) the prevention of a specific, substantial and imminent threat to the life or
physical safety of natural persons or of a terrorist attack;

(iii) the detection, localisation, identification or prosecution of a perpetrator

or suspect of a criminal offence referred to in Article 2(2) of Council
Framework Decision 2002/584/JHA[62] and punishable in the Member
State concerned by a custodial sentence or a detention order for a
maximum period of at least three years, as determined by the law of that
Member State.

2. The use of ‘real-time’ remote biometric identification systems in publicly accessible
spaces for the purpose of law enforcement for any of the objectives referred to in
paragraph 1 point d) shall take into account the following elements:

(a) the nature of the situation giving rise to the possible use, in particular the
seriousness, probability and scale of the harm caused in the absence of the use
of the system;

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

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

3. As regards paragraphs 1, point (d) and 2, each individual use for the purpose of law
enforcement of a ‘real-time’ remote biometric identification system in publicly
accessible spaces shall be subject to a prior authorisation granted by a judicial
authority or by an independent administrative authority of the Member State in
which the use is to take place, issued upon a reasoned request and in accordance with
the detailed rules of national law referred to in paragraph 4. However, in a duly
justified situation of urgency, the use of the system may be commenced without an
authorisation and the authorisation may be requested only during or after the use.

The competent judicial or administrative authority shall only grant the authorisation
where it is satisfied, based on objective evidence or clear indications presented to it,
that the use of the ‘real-time’ remote biometric identification system at issue is
necessary for and proportionate to achieving one of the objectives specified in
paragraph 1, point (d), as identified in the request. In deciding on the request, the
competent judicial or administrative authority shall take into account the elements
referred to in paragraph 2.

4. A Member State may decide to provide for the possibility to fully or partially
authorise the use of ‘real-time’ remote biometric identification systems in publicly
accessible spaces for the purpose of law enforcement within the limits and under the

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

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

## TITLE III

 HIGH-RISK AI SYSTEMS

 CHAPTER 1

 CLASSIFICATION OF AI SYSTEMS AS HIGH-RISK

_Article 6_

_Classification rules for high-risk AI systems_

1. Irrespective of whether an AI system is placed on the market or put into service
independently from the products referred to in points (a) and (b), that AI system shall
be considered high-risk where both of the following conditions are fulfilled:

(a) the AI system is intended to be used as a safety component of a product, or is
itself a product, covered by the Union harmonisation legislation listed in Annex
II;

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

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

_Article 7_

_Amendments to Annex III_

1. The Commission is empowered to adopt delegated acts in accordance with Article 73
to update the list in Annex III by adding high-risk AI systems where both of the
following conditions are fulfilled:

(a) the AI systems are intended to be used in any of the areas listed in points 1 to 8
of Annex III;

(b) the AI systems pose a risk of harm to the health and safety, or a risk of adverse
impact on fundamental rights, that is, in respect of its severity and probability
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.

2. When assessing for the purposes of paragraph 1 whether an AI system poses a risk of
harm to the health and safety or a risk of adverse impact on fundamental rights that is
equivalent to or greater than the risk of harm posed by the high-risk AI systems

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already referred to in Annex III, the Commission shall take into account the
following criteria:

(a) the intended purpose of the AI system;

(b) the extent to which an AI system has been used or is likely to be used;

(c) the extent to which the use of an AI system has already caused harm to the
health and safety or adverse impact on the fundamental rights or has given rise
to significant concerns in relation to the materialisation of such harm or
adverse impact, as demonstrated by reports or documented allegations
submitted to national competent authorities;

(d) the potential extent of such harm or such adverse impact, in particular in terms
of its intensity and its ability to affect a plurality of persons;

(e) the extent to which potentially harmed or adversely impacted persons are
dependent on the outcome produced with an AI system, in particular because
for practical or legal reasons it is not reasonably possible to opt-out from that
outcome;

(f) the extent to which potentially harmed or adversely impacted persons are in a
vulnerable position in relation to the user of an AI system, in particular due to
an imbalance of power, knowledge, economic or social circumstances, or age;

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

(h) the extent to which existing Union legislation provides for:

(i) effective measures of redress in relation to the risks posed by an AI
system, with the exclusion of claims for damages;

(ii) effective measures to prevent or substantially minimise those risks.

## CHAPTER 2

**REQUIREMENTS FOR HIGH-RISK AI SYSTEMS**


_Article 8_

_Compliance with the requirements_

1. High-risk AI systems shall comply with the requirements established in this Chapter.

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

_Article 9_

_Risk management system_

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

2. The risk management system shall consist of a continuous iterative process run
throughout the entire lifecycle of a high-risk AI system, requiring regular systematic
updating. It shall comprise the following steps:

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(a) identification and analysis of the known and foreseeable risks associated with
each high-risk AI system;

(b) estimation and evaluation of the risks that may emerge when the high-risk AI
system is used in accordance with its intended purpose and under conditions of
reasonably foreseeable misuse;

(c) evaluation of other possibly arising risks based on the analysis of data gathered
from the post-market monitoring system referred to in Article 61;

(d) adoption of suitable risk management measures in accordance with the
provisions of the following paragraphs.

3. The risk management measures referred to in paragraph 2, point (d) shall give due
consideration to the effects and possible interactions resulting from the combined
application of the requirements set out in this Chapter 2. They shall take into account
the generally acknowledged state of the art, including as reflected in relevant
harmonised standards or common specifications.

4. The risk management measures referred to in paragraph 2, point (d) shall be such that
any residual risk associated with each hazard as well as the overall residual risk of
the high-risk AI systems is judged acceptable, provided that the high-risk AI system
is used in accordance with its intended purpose or under conditions of reasonably
foreseeable misuse. Those residual risks shall be communicated to the user.

In identifying the most appropriate risk management measures, the following shall be
ensured:

(a) elimination or reduction of risks as far as possible through adequate design and
development;

(b) where appropriate, implementation of adequate mitigation and control
measures in relation to risks that cannot be eliminated;

(c) provision of adequate information pursuant to Article 13, in particular as
regards the risks referred to in paragraph 2, point (b) of this Article, and, where
appropriate, training to users.

In eliminating or reducing risks related to the use of the high-risk AI system, due
consideration shall be given to the technical knowledge, experience, education,
training to be expected by the user and the environment in which the system is
intended to be used.

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

6. Testing procedures shall be suitable to achieve the intended purpose of the AI system
and do not need to go beyond what is necessary to achieve that purpose.

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

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8. When implementing the risk management system described in paragraphs 1 to 7,
specific consideration shall be given to whether the high-risk AI system is likely to
be accessed by or have an impact on children.

9. For credit institutions regulated by Directive 2013/36/EU, the aspects described in
paragraphs 1 to 8 shall be part of the risk management procedures established by
those institutions pursuant to Article 74 of that Directive.

_Article 10_

_Data and data governance_

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

2. Training, validation and testing data sets shall be subject to appropriate data
governance and management practices. Those practices shall concern in particular,

(a) the relevant design choices;

(b) data collection;

(c) relevant data preparation processing operations, such as annotation, labelling,
cleaning, enrichment and aggregation;

(d) the formulation of relevant assumptions, notably with respect to the
information that the data are supposed to measure and represent;

(e) a prior assessment of the availability, quantity and suitability of the data sets
that are needed;

(f) examination in view of possible biases;

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

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

4. Training, validation and testing data sets shall take into account, to the extent
required by the intended purpose, the characteristics or elements that are particular to
the specific geographical, behavioural or functional setting within which the highrisk AI system is intended to be used.

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

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6. Appropriate data governance and management practices shall apply for the
development of high-risk AI systems other than those which make use of techniques
involving the training of models in order to ensure that those high-risk AI systems
comply with paragraph 2.

_Article 11_

_Technical documentation_

1. The technical documentation of a high-risk AI system shall be drawn up before that
system is placed on the market or put into service and shall be kept up-to date.

The technical documentation shall be drawn up in such a way to demonstrate that the
high-risk AI system complies with the requirements set out in this Chapter and
provide national competent authorities and notified bodies with all the necessary
information to assess the compliance of the AI system with those requirements. It
shall contain, at a minimum, the elements set out in Annex IV.

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

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

_Article 12_

_Record-keeping_

1. High-risk AI systems shall be designed and developed with capabilities enabling the
automatic recording of events (‘logs’) while the high-risk AI systems is operating.
Those logging capabilities shall conform to recognised standards or common
specifications.

2. The logging capabilities shall ensure a level of traceability of the AI system’s
functioning throughout its lifecycle that is appropriate to the intended purpose of the
system.

3. In particular, logging capabilities shall enable the monitoring of the operation of the
high-risk AI system with respect to the occurrence of situations that may result in the
AI system presenting a risk within the meaning of Article 65(1) or lead to a
substantial modification, and facilitate the post-market monitoring referred to in
Article 61.

4. For high-risk AI systems referred to in paragraph 1, point (a) of Annex III, the
logging capabilities shall provide, at a minimum:

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

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

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

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

_Article 13_

_Transparency and provision of information to users_

1. High-risk AI systems shall be designed and developed in such a way to ensure that
their operation is sufficiently transparent to enable users to interpret the system’s
output and use it appropriately. An appropriate type and degree of transparency shall
be ensured, with a view to achieving compliance with the relevant obligations of the
user and of the provider set out in Chapter 3 of this Title.

2. High-risk AI systems shall be accompanied by instructions for use in an appropriate
digital format or otherwise that include concise, complete, correct and clear
information that is relevant, accessible and comprehensible to users.

3. The information referred to in paragraph 2 shall specify:

(a) the identity and the contact details of the provider and, where applicable, of its
authorised representative;

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

(i) its intended purpose;

(ii) the level of accuracy, robustness and cybersecurity referred to in Article
15 against which the high-risk AI system has been tested and validated
and which can be expected, and any known and foreseeable
circumstances that may have an impact on that expected level of
accuracy, robustness and cybersecurity;


(iii) any known or foreseeable circumstance, related to the use of the high
risk AI system in accordance with its intended purpose or under
conditions of reasonably foreseeable misuse, which may lead to risks to
the health and safety or fundamental rights;

(iv) its performance as regards the persons or groups of persons on which the

system is intended to be used;

(v) when appropriate, specifications for the input data, or any other relevant
information in terms of the training, validation and testing data sets used,
taking into account the intended purpose of the AI system.

(c) the changes to the high-risk AI system and its performance which have been
pre-determined by the provider at the moment of the initial conformity
assessment, if any;

(d) the human oversight measures referred to in Article 14, including the technical
measures put in place to facilitate the interpretation of the outputs of AI
systems by the users;

(e) the expected lifetime of the high-risk AI system and any necessary
maintenance and care measures to ensure the proper functioning of that AI
system, including as regards software updates.

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_Article 14_

_Human oversight_

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

2. Human oversight shall aim at preventing or minimising the risks to health, safety or
fundamental rights that may emerge when a high-risk AI system is used in
accordance with its intended purpose or under conditions of reasonably foreseeable
misuse, in particular when such risks persist notwithstanding the application of other
requirements set out in this Chapter.

3. Human oversight shall be ensured through either one or all of the following
measures:

(a) identified and built, when technically feasible, into the high-risk AI system by
the provider before it is placed on the market or put into service;

(b) identified by the provider before placing the high-risk AI system on the market
or putting it into service and that are appropriate to be implemented by the
user.

4. The measures referred to in paragraph 3 shall enable the individuals to whom human
oversight is assigned to do the following, as appropriate to the circumstances:

(a) fully understand the capacities and limitations of the high-risk AI system and
be able to duly monitor its operation, so that signs of anomalies, dysfunctions
and unexpected performance can be detected and addressed as soon as
possible;

(b) remain aware of the possible tendency of automatically relying or over-relying
on the output produced by a high-risk AI system (‘automation bias’), in
particular for high-risk AI systems used to provide information or
recommendations for decisions to be taken by natural persons;

(c) be able to correctly interpret the high-risk AI system’s output, taking into
account in particular the characteristics of the system and the interpretation
tools and methods available;

(d) be able to decide, in any particular situation, not to use the high-risk AI system
or otherwise disregard, override or reverse the output of the high-risk AI
system;

(e) be able to intervene on the operation of the high-risk AI system or interrupt the
system through a “stop” button or a similar procedure.

5. For high-risk AI systems referred to in point 1(a) of Annex III, the measures referred
to in paragraph 3 shall be such as to ensure that, in addition, no action or decision is
taken by the user on the basis of the identification resulting from the system unless
this has been verified and confirmed by at least two natural persons.

_Article 15_

_Accuracy, robustness and cybersecurity_

1. High-risk AI systems shall be designed and developed in such a way that they
achieve, in the light of their intended purpose, an appropriate level of accuracy,

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robustness and cybersecurity, and perform consistently in those respects throughout
their lifecycle.

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

3. High-risk AI systems shall be resilient as regards errors, faults or inconsistencies that
may occur within the system or the environment in which the system operates, in
particular due to their interaction with natural persons or other systems.

The robustness of high-risk AI systems may be achieved through technical
redundancy solutions, which may include backup or fail-safe plans.

High-risk AI systems that continue to learn after being placed on the market or put
into service shall be developed in such a way to ensure that possibly biased outputs
due to outputs used as an input for future operations (‘feedback loops’) are duly
addressed with appropriate mitigation measures.

4. High-risk AI systems shall be resilient as regards attempts by unauthorised third
parties to alter their use or performance by exploiting the system vulnerabilities.

The technical solutions aimed at ensuring the cybersecurity of high-risk AI systems
shall be appropriate to the relevant circumstances and the risks.

The technical solutions to address AI specific vulnerabilities shall include, where
appropriate, measures to prevent and control for attacks trying to manipulate the
training dataset (‘data poisoning’), inputs designed to cause the model to make a
mistake (‘adversarial examples’), or model flaws.

## CHAPTER 3


**OBLIGATIONS OF PROVIDERS AND USERS OF HIGH-RISK AI SYSTEMS AND**

**OTHER PARTIES**

_Article 16_

_Obligations of providers of high-risk AI systems_

Providers of high-risk AI systems shall:

(a) ensure that their high-risk AI systems are compliant with the requirements set out in
Chapter 2 of this Title;

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

(c) draw-up the technical documentation of the high-risk AI system;

(d) when under their control, keep the logs automatically generated by their high-risk AI
systems;

(e) ensure that the high-risk AI system undergoes the relevant conformity assessment
procedure, prior to its placing on the market or putting into service;

(f) comply with the registration obligations referred to in Article 51;

(g) take the necessary corrective actions, if the high-risk AI system is not in conformity
with the requirements set out in Chapter 2 of this Title;

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(h) inform the national competent authorities of the Member States in which they made
the AI system available or put it into service and, where applicable, the notified body
of the non-compliance and of any corrective actions taken;

(i) to affix the CE marking to their high-risk AI systems to indicate the conformity with
this Regulation in accordance with Article 49;

(j) upon request of a national competent authority, demonstrate the conformity of the
high-risk AI system with the requirements set out in Chapter 2 of this Title.

_Article 17_

_Quality management system_

1. Providers of high-risk AI systems shall put a quality management system in place
that ensures compliance with this Regulation. That system shall be documented in a
systematic and orderly manner in the form of written policies, procedures and
instructions, and shall include at least the following aspects:

(a) a strategy for regulatory compliance, including compliance with conformity
assessment procedures and procedures for the management of modifications to
the high-risk AI system;

(b) techniques, procedures and systematic actions to be used for the design, design
control and design verification of the high-risk AI system;

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

(d) examination, test and validation procedures to be carried out before, during and
after the development of the high-risk AI system, and the frequency with which
they have to be carried out;

(e) technical specifications, including standards, to be applied and, where the
relevant harmonised standards are not applied in full, the means to be used to
ensure that the high-risk AI system complies with the requirements set out in
Chapter 2 of this Title;

(f) systems and procedures for data management, including data collection, data
analysis, data labelling, data storage, data filtration, data mining, data
aggregation, data retention and any other operation regarding the data that is
performed before and for the purposes of the placing on the market or putting
into service of high-risk AI systems;

(g) the risk management system referred to in Article 9;

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

(i) procedures related to the reporting of serious incidents and of malfunctioning
in accordance with Article 62;

(j) the handling of communication with national competent authorities, competent
authorities, including sectoral ones, providing or supporting the access to data,
notified bodies, other operators, customers or other interested parties;

(k) systems and procedures for record keeping of all relevant documentation and
information;

(l) resource management, including security of supply related measures;

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(m) an accountability framework setting out the responsibilities of the management

and other staff with regard to all aspects listed in this paragraph.

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

3. For providers that are credit institutions regulated by Directive 2013/36/ EU, the
obligation to put a quality management system in place shall be deemed to be
fulfilled by complying with the rules on internal governance arrangements, processes
and mechanisms pursuant to Article 74 of that Directive. In that context, any
harmonised standards referred to in Article 40 of this Regulation shall be taken into
account.

_Article 18_

_Obligation to draw up technical documentation_

1. Providers of high-risk AI systems shall draw up the technical documentation referred
to in Article 11 in accordance with Annex IV.

2. Providers that are credit institutions regulated by Directive 2013/36/EU shall
maintain the technical documentation as part of the documentation concerning
internal governance, arrangements, processes and mechanisms pursuant to Article 74
of that Directive.


_Article 19_

_Conformity assessment_

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

2. For high-risk AI systems referred to in point 5(b) of Annex III that are placed on the
market or put into service by providers that are credit institutions regulated by
Directive 2013/36/EU, the conformity assessment shall be carried out as part of the
procedure referred to in Articles 97 to101 of that Directive.

_Article 20_

_Automatically generated logs_

1. Providers of high-risk AI systems shall keep the logs automatically generated by
their high-risk AI systems, to the extent such logs are under their control by virtue of
a contractual arrangement with the user or otherwise by law. The logs shall be kept
for a period that is appropriate in the light of the intended purpose of high-risk AI
system and applicable legal obligations under Union or national law.

2. Providers that are credit institutions regulated by Directive 2013/36/EU shall
maintain the logs automatically generated by their high-risk AI systems as part of the
documentation under Articles 74 of that Directive.

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_Article 21_

_Corrective actions_

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

_Article 22_

_Duty of information_

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


_Article 23_

_Cooperation with competent authorities_

Providers of high-risk AI systems shall, upon request by a national competent authority,
provide that authority with all the information and documentation necessary to demonstrate
the conformity of the high-risk AI system with the requirements set out in Chapter 2 of this
Title, in an official Union language determined by the Member State concerned. Upon a
reasoned request from a national competent authority, providers shall also give that authority
access to the logs automatically generated by the high-risk AI system, to the extent such logs
are under their control by virtue of a contractual arrangement with the user or otherwise by
law.


_Article 24_

_Obligations of product manufacturers_

Where a high-risk AI system related to products to which the legal acts listed in Annex II,
section A, apply, is placed on the market or put into service together with the product
manufactured in accordance with those legal acts and under the name of the product
manufacturer, the manufacturer of the product shall take the responsibility of the compliance
of the AI system with this Regulation and, as far as the AI system is concerned, have the same
obligations imposed by the present Regulation on the provider.

_Article 25_

_Authorised representatives_

1. Prior to making their systems available on the Union market, where an importer
cannot be identified, providers established outside the Union shall, by written
mandate, appoint an authorised representative which is established in the Union.

2. The authorised representative shall perform the tasks specified in the mandate
received from the provider. The mandate shall empower the authorised representative
to carry out the following tasks:

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(a) keep a copy of the EU declaration of conformity and the technical
documentation at the disposal of the national competent authorities and
national authorities referred to in Article 63(7);

(b) provide a national competent authority, upon a reasoned request, with all the
information and documentation necessary to demonstrate the conformity of a
high-risk AI system with the requirements set out in Chapter 2 of this Title,
including access to the logs automatically generated by the high-risk AI system
to the extent such logs are under the control of the provider by virtue of a
contractual arrangement with the user or otherwise by law;

(c) cooperate with competent national authorities, upon a reasoned request, on any
action the latter takes in relation to the high-risk AI system.

_Article 26_

_Obligations of importers_

1. Before placing a high-risk AI system on the market, importers of such system shall
ensure that:

(a) the appropriate conformity assessment procedure has been carried out by the
provider of that AI system

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

(c) the system bears the required conformity marking and is accompanied by the
required documentation and instructions of use.

2. Where an importer considers or has reason to consider that a high-risk AI system is
not in conformity with this Regulation, it shall not place that system on the market
until that AI system has been brought into conformity. Where the high-risk AI
system presents a risk within the meaning of Article 65(1), the importer shall inform
the provider of the AI system and the market surveillance authorities to that effect.

3. Importers shall indicate their name, registered trade name or registered trade mark,
and the address at which they can be contacted on the high-risk AI system or, where
that is not possible, on its packaging or its accompanying documentation, as
applicable.

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

5. Importers shall provide national competent authorities, upon a reasoned request, with
all necessary information and documentation to demonstrate the conformity of a
high-risk AI system with the requirements set out in Chapter 2 of this Title in a
language which can be easily understood by that national competent authority,
including access to the logs automatically generated by the high-risk AI system to the
extent such logs are under the control of the provider by virtue of a contractual
arrangement with the user or otherwise by law. They shall also cooperate with those
authorities on any action national competent authority takes in relation to that
system.

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_Article 27_

_Obligations of distributors_

1. Before making a high-risk AI system available on the market, distributors shall
verify that the high-risk AI system bears the required CE conformity marking, that it
is accompanied by the required documentation and instruction of use, and that the
provider and the importer of the system, as applicable, have complied with the
obligations set out in this Regulation.

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

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

4. A distributor that considers or has reason to consider that a high-risk AI system
which it has made available on the market is not in conformity with the requirements
set out in Chapter 2 of this Title shall take the corrective actions necessary to bring
that system into conformity with those requirements, to withdraw it or recall it or
shall ensure that the provider, the importer or any relevant operator, as appropriate,
takes those corrective actions. Where the high-risk AI system presents a risk within
the meaning of Article 65(1), the distributor shall immediately inform the national
competent authorities of the Member States in which it has made the product
available to that effect, giving details, in particular, of the non-compliance and of any
corrective actions taken.

5. Upon a reasoned request from a national competent authority, distributors of highrisk AI systems shall provide that authority with all the information and
documentation necessary to demonstrate the conformity of a high-risk system with
the requirements set out in Chapter 2 of this Title. Distributors shall also cooperate
with that national competent authority on any action taken by that authority.

_Article 28_

_Obligations of distributors, importers, users or any other third-party_

1. Any distributor, importer, user or other third-party shall be considered a provider for
the purposes of this Regulation and shall be subject to the obligations of the provider
under Article 16, in any of the following circumstances:

(a) they place on the market or put into service a high-risk AI system under their
name or trademark;

(b) they modify the intended purpose of a high-risk AI system already placed on
the market or put into service;

(c) they make a substantial modification to the high-risk AI system.

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

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_Article 29_

_Obligations of users of high-risk AI systems_

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

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

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

4. Users shall monitor the operation of the high-risk AI system on the basis of the
instructions of use. When they have reasons to consider that the use in accordance
with the instructions of use may result in the AI system presenting a risk within the
meaning of Article 65(1) they shall inform the provider or distributor and suspend
the use of the system. They shall also inform the provider or distributor when they
have identified any serious incident or any malfunctioning within the meaning of
Article 62 and interrupt the use of the AI system. In case the user is not able to reach
the provider, Article 62 shall apply mutatis mutandis.

For users that are credit institutions regulated by Directive 2013/36/EU, the
monitoring obligation set out in the first subparagraph shall be deemed to be fulfilled
by complying with the rules on internal governance arrangements, processes and
mechanisms pursuant to Article 74 of that Directive.

5. Users of high-risk AI systems shall keep the logs automatically generated by that
high-risk AI system, to the extent such logs are under their control. The logs shall be
kept for a period that is appropriate in the light of the intended purpose of the highrisk AI system and applicable legal obligations under Union or national law.

Users that are credit institutions regulated by Directive 2013/36/EU shall maintain
the logs as part of the documentation concerning internal governance arrangements,
processes and mechanisms pursuant to Article 74 of that Directive.

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

## CHAPTER 4

**NOTIFIYING AUTHORITIES AND NOTIFIED BODIES**

_Article 30_

_Notifying authorities_

1. Each Member State shall designate or establish a notifying authority responsible for
setting up and carrying out the necessary procedures for the assessment, designation
and notification of conformity assessment bodies and for their monitoring.

2. Member States may designate a national accreditation body referred to in Regulation
(EC) No 765/2008 as a notifying authority.

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3. Notifying authorities shall be established, organised and operated in such a way that
no conflict of interest arises with conformity assessment bodies and the objectivity
and impartiality of their activities are safeguarded.

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

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

6. Notifying authorities shall safeguard the confidentiality of the information they
obtain.

7. Notifying authorities shall have a sufficient number of competent personnel at their
disposal for the proper performance of their tasks.

8. Notifying authorities shall make sure that conformity assessments are carried out in a
proportionate manner, avoiding unnecessary burdens for providers and that notified
bodies perform their activities taking due account of the size of an undertaking, the
sector in which it operates, its structure and the degree of complexity of the AI
system in question.


_Article 31_

_Application of a conformity assessment body for notification_

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

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

3. Where the conformity assessment body concerned cannot provide an accreditation
certificate, it shall provide the notifying authority with the documentary evidence
necessary for the verification, recognition and regular monitoring of its compliance
with the requirements laid down in Article 33. For notified bodies which are
designated under any other Union harmonisation legislation, all documents and
certificates linked to those designations may be used to support their designation
procedure under this Regulation, as appropriate.

_Article 32_

_Notification procedure_

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

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

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3. The notification shall include full details of the conformity assessment activities, the
conformity assessment module or modules and the artificial intelligence technologies
concerned.

4. The conformity assessment body concerned may perform the activities of a notified
body only where no objections are raised by the Commission or the other Member
States within one month of a notification.

5. Notifying authorities shall notify the Commission and the other Member States of
any subsequent relevant changes to the notification.

_Article 33_

_Notified bodies_

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

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

3. The organisational structure, allocation of responsibilities, reporting lines and
operation of notified bodies shall be such as to ensure that there is confidence in the
performance by and in the results of the conformity assessment activities that the
notified bodies conduct.

4. Notified bodies shall be independent of the provider of a high-risk AI system in
relation to which it performs conformity assessment activities. Notified bodies shall
also be independent of any other operator having an economic interest in the highrisk AI system that is assessed, as well as of any competitors of the provider.

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

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

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

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

9. Notified bodies shall be capable of carrying out all the tasks falling to them under
this Regulation with the highest degree of professional integrity and the requisite

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competence in the specific field, whether those tasks are carried out by notified
bodies themselves or on their behalf and under their responsibility.

10. Notified bodies shall have sufficient internal competences to be able to effectively
evaluate the tasks conducted by external parties on their behalf. To that end, at all
times and for each conformity assessment procedure and each type of high-risk AI
system in relation to which they have been designated, the notified body shall have
permanent availability of sufficient administrative, technical and scientific personnel
who possess experience and knowledge relating to the relevant artificial intelligence
technologies, data and data computing and to the requirements set out in Chapter 2 of
this Title.

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

12. Notified bodies shall make available and submit upon request all relevant
documentation, including the providers’ documentation, to the notifying authority
referred to in Article 30 to allow it to conduct its assessment, designation,
notification, monitoring and surveillance activities and to facilitate the assessment
outlined in this Chapter.

_Article 34_

_Subsidiaries of and subcontracting by notified bodies_

1. Where a notified body subcontracts specific tasks connected with the conformity
assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or
the subsidiary meets the requirements laid down in Article 33 and shall inform the
notifying authority accordingly.

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

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

4. Notified bodies shall keep at the disposal of the notifying authority the relevant
documents concerning the assessment of the qualifications of the subcontractor or the
subsidiary and the work carried out by them under this Regulation.

_Article 35_

_Identification numbers and lists of notified bodies designated under this Regulation_

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

2. The Commission shall make publicly available the list of the bodies notified under
this Regulation, including the identification numbers that have been assigned to them
and the activities for which they have been notified. The Commission shall ensure
that the list is kept up to date.

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_Article 36_

_Changes to notifications_

1. Where a notifying authority has suspicions or has been informed that a notified body
no longer meets the requirements laid down in Article 33, or that it is failing to fulfil
its obligations, that authority shall without delay investigate the matter with the
utmost diligence. In that context, it shall inform the notified body concerned about
the objections raised and give it the possibility to make its views known. If the
notifying authority comes to the conclusion that the notified body investigation no
longer meets the requirements laid down in Article 33 or that it is failing to fulfil its
obligations, it shall restrict, suspend or withdraw the notification as appropriate,
depending on the seriousness of the failure. It shall also immediately inform the
Commission and the other Member States accordingly.

2. In the event of restriction, suspension or withdrawal of notification, or where the
notified body has ceased its activity, the notifying authority shall take appropriate
steps to ensure that the files of that notified body are either taken over by another
notified body or kept available for the responsible notifying authorities at their
request.


_Article 37_

_Challenge to the competence of notified bodies_

1. The Commission shall, where necessary, investigate all cases where there are reasons
to doubt whether a notified body complies with the requirements laid down in Article
33.

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

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

4. Where the Commission ascertains that a notified body does not meet or no longer
meets the requirements laid down in Article 33, it shall adopt a reasoned decision
requesting the notifying Member State to take the necessary corrective measures,
including withdrawal of notification if necessary. That implementing act shall be
adopted in accordance with the examination procedure referred to in Article 74(2).

_Article 38_

_Coordination of notified bodies_

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

2. Member States shall ensure that the bodies notified by them participate in the work
of that group, directly or by means of designated representatives.

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_Article 39_

_Conformity assessment bodies of third countries_

Conformity assessment bodies established under the law of a third country with which the
Union has concluded an agreement may be authorised to carry out the activities of notified
Bodies under this Regulation.

## CHAPTER 5

**STANDARDS,** **CONFORMITY** **ASSESSMENT,** **CERTIFICATES,** **REGISTRATION**

_Article 40_

_Harmonised standards_

High-risk AI systems which are in conformity with harmonised standards or parts thereof the
references of which have been published in the Official Journal of the European Union shall
be presumed to be in conformity with the requirements set out in Chapter 2 of this Title, to the
extent those standards cover those requirements.


_Article 41_

_Common specifications_

1. Where harmonised standards referred to in Article 40 do not exist or where the
Commission considers that the relevant harmonised standards are insufficient or that
there is a need to address specific safety or fundamental right concerns, the
Commission may, by means of implementing acts, adopt common specifications in
respect of the requirements set out in Chapter 2 of this Title. Those implementing
acts shall be adopted in accordance with the examination procedure referred to in
Article 74(2).

2. The Commission, when preparing the common specifications referred to in
paragraph 1, shall gather the views of relevant bodies or expert groups established
under relevant sectorial Union law.

3. High-risk AI systems which are in conformity with the common specifications
referred to in paragraph 1 shall be presumed to be in conformity with the
requirements set out in Chapter 2 of this Title, to the extent those common
specifications cover those requirements.

4. Where providers do not comply with the common specifications referred to in
paragraph 1, they shall duly justify that they have adopted technical solutions that are
at least equivalent thereto.

_Article 42_

_Presumption of conformity with certain requirements_

1. Taking into account their intended purpose, high-risk AI systems that have been
trained and tested on data concerning the specific geographical, behavioural and
functional setting within which they are intended to be used shall be presumed to be
in compliance with the requirement set out in Article 10(4).

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2. High-risk AI systems that have been certified or for which a statement of conformity
has been issued under a cybersecurity scheme pursuant to Regulation (EU) 2019/881
of the European Parliament and of the Council[63] and the references of which have
been published in the Official Journal of the European Union shall be presumed to be
in compliance with the cybersecurity requirements set out in Article 15 of this
Regulation in so far as the cybersecurity certificate or statement of conformity or
parts thereof cover those requirements.

_Article 43_

_Conformity assessment_

1. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the
compliance of a high-risk AI system with the requirements set out in Chapter 2 of
this Title, the provider has applied harmonised standards referred to in Article 40, or,
where applicable, common specifications referred to in Article 41, the provider shall
follow one of the following procedures:

(a) the conformity assessment procedure based on internal control referred to in
Annex VI;

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

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

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

2. For high-risk AI systems referred to in points 2 to 8 of Annex III, providers shall
follow the conformity assessment procedure based on internal control as referred to
in Annex VI, which does not provide for the involvement of a notified body. For
high-risk AI systems referred to in point 5(b) of Annex III, placed on the market or
put into service by credit institutions regulated by Directive 2013/36/EU, the
conformity assessment shall be carried out as part of the procedure referred to in
Articles 97 to101 of that Directive.

3. For high-risk AI systems, to which legal acts listed in Annex II, section A, apply, the
provider shall follow the relevant conformity assessment as required under those
legal acts. The requirements set out in Chapter 2 of this Title shall apply to those

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

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high-risk AI systems and shall be part of that assessment. Points 4.3., 4.4., 4.5. and
the fifth paragraph of point 4.6 of Annex VII shall also apply.

For the purpose of that assessment, notified bodies which have been notified under
those legal acts shall be entitled to control the conformity of the high-risk AI systems
with the requirements set out in Chapter 2 of this Title, provided that the compliance
of those notified bodies with requirements laid down in Article 33(4), (9) and (10)
has been assessed in the context of the notification procedure under those legal acts.

Where the legal acts listed in Annex II, section A, enable the manufacturer of the
product to opt out from a third-party conformity assessment, provided that that
manufacturer has applied all harmonised standards covering all the relevant
requirements, that manufacturer may make use of that option only if he has also
applied harmonised standards or, where applicable, common specifications referred
to in Article 41, covering the requirements set out in Chapter 2 of this Title.

4. High-risk AI systems shall undergo a new conformity assessment procedure
whenever they are substantially modified, regardless of whether the modified system
is intended to be further distributed or continues to be used by the current user.

For high-risk AI systems that continue to learn after being placed on the market or
put into service, changes to the high-risk AI system and its performance that have
been pre-determined by the provider at the moment of the initial conformity
assessment and are part of the information contained in the technical documentation
referred to in point 2(f) of Annex IV, shall not constitute a substantial modification.

5. The Commission is empowered to adopt delegated acts in accordance with Article 73
for the purpose of updating Annexes VI and Annex VII in order to introduce
elements of the conformity assessment procedures that become necessary in light of
technical progress.

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

_Article 44_

_Certificates_

1. Certificates issued by notified bodies in accordance with Annex VII shall be drawnup in an official Union language determined by the Member State in which the
notified body is established or in an official Union language otherwise acceptable to
the notified body.

2. Certificates shall be valid for the period they indicate, which shall not exceed five
years. On application by the provider, the validity of a certificate may be extended
for further periods, each not exceeding five years, based on a re-assessment in
accordance with the applicable conformity assessment procedures.

3. Where a notified body finds that an AI system no longer meets the requirements set
out in Chapter 2 of this Title, it shall, taking account of the principle of

# EN EN


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proportionality, suspend or withdraw the certificate issued or impose any restrictions
on it, unless compliance with those requirements is ensured by appropriate corrective
action taken by the provider of the system within an appropriate deadline set by the
notified body. The notified body shall give reasons for its decision.

_Article 45_

_Appeal against decisions of notified bodies_

Member States shall ensure that an appeal procedure against decisions of the notified bodies
is available to parties having a legitimate interest in that decision.


_Article 46_

_Information obligations of notified bodies_

1. Notified bodies shall inform the notifying authority of the following:

(a) any Union technical documentation assessment certificates, any supplements to
those certificates, quality management system approvals issued in accordance
with the requirements of Annex VII;

(b) any refusal, restriction, suspension or withdrawal of a Union technical
documentation assessment certificate or a quality management system approval
issued in accordance with the requirements of Annex VII;

(c) any circumstances affecting the scope of or conditions for notification;

(d) any request for information which they have received from market surveillance
authorities regarding conformity assessment activities;

(e) on request, conformity assessment activities performed within the scope of
their notification and any other activity performed, including cross-border
activities and subcontracting.

2. Each notified body shall inform the other notified bodies of:

(a) quality management system approvals which it has refused, suspended or
withdrawn, and, upon request, of quality system approvals which it has issued;

(b) EU technical documentation assessment certificates or any supplements thereto
which it has refused, withdrawn, suspended or otherwise restricted, and, upon
request, of the certificates and/or supplements thereto which it has issued.

3. Each notified body shall provide the other notified bodies carrying out similar
conformity assessment activities covering the same artificial intelligence
technologies with relevant information on issues relating to negative and, on request,
positive conformity assessment results.

_Article 47_

_Derogation from conformity assessment procedure_

1. By way of derogation from Article 43, any market surveillance authority may
authorise the placing on the market or putting into service of specific high-risk AI
systems within the territory of the Member State concerned, for exceptional reasons
of public security or the protection of life and health of persons, environmental
protection and the protection of key industrial and infrastructural assets. That
authorisation shall be for a limited period of time, while the necessary conformity

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assessment procedures are being carried out, and shall terminate once those
procedures have been completed. The completion of those procedures shall be
undertaken without undue delay.

2. The authorisation referred to in paragraph 1 shall be issued only if the market
surveillance authority concludes that the high-risk AI system complies with the
requirements of Chapter 2 of this Title. The market surveillance authority shall
inform the Commission and the other Member States of any authorisation issued
pursuant to paragraph 1.

3. Where, within 15 calendar days of receipt of the information referred to in paragraph
2, no objection has been raised by either a Member State or the Commission in
respect of an authorisation issued by a market surveillance authority of a Member
State in accordance with paragraph 1, that authorisation shall be deemed justified.

4. Where, within 15 calendar days of receipt of the notification referred to in paragraph
2, objections are raised by a Member State against an authorisation issued by a
market surveillance authority of another Member State, or where the Commission
considers the authorisation to be contrary to Union law or the conclusion of the
Member States regarding the compliance of the system as referred to in paragraph 2
to be unfounded, the Commission shall without delay enter into consultation with the
relevant Member State; the operator(s) concerned shall be consulted and have the
possibility to present their views. In view thereof, the Commission shall decide
whether the authorisation is justified or not. The Commission shall address its
decision to the Member State concerned and the relevant operator or operators.

5. If the authorisation is considered unjustified, this shall be withdrawn by the market
surveillance authority of the Member State concerned.

6. By way of derogation from paragraphs 1 to 5, for high-risk AI systems intended to be
used as safety components of devices, or which are themselves devices, covered by
Regulation (EU) 2017/745 and Regulation (EU) 2017/746, Article 59 of Regulation
(EU) 2017/745 and Article 54 of Regulation (EU) 2017/746 shall apply also with
regard to the derogation from the conformity assessment of the compliance with the
requirements set out in Chapter 2 of this Title.

_Article 48_

_EU declaration of conformity_

1. The provider shall draw up a written EU declaration of conformity for each AI
system and keep it at the disposal of the national competent authorities for 10 years
after the AI system has been placed on the market or put into service. The EU
declaration of conformity shall identify the AI system for which it has been drawn
up. A copy of the EU declaration of conformity shall be given to the relevant
national competent authorities upon request.

2. The EU declaration of conformity shall state that the high-risk AI system in question
meets the requirements set out in Chapter 2 of this Title. The EU declaration of
conformity shall contain the information set out in Annex V and shall be translated
into an official Union language or languages required by the Member State(s) in
which the high-risk AI system is made available.

3. Where high-risk AI systems are subject to other Union harmonisation legislation
which also requires an EU declaration of conformity, a single EU declaration of
conformity shall be drawn up in respect of all Union legislations applicable to the

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high-risk AI system. The declaration shall contain all the information required for
identification of the Union harmonisation legislation to which the declaration relates.

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

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

_Article 49_

_CE marking of conformity_

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

2. The CE marking referred to in paragraph 1 of this Article shall be subject to the
general principles set out in Article 30 of Regulation (EC) No 765/2008.

3. Where applicable, the CE marking shall be followed by the identification number of
the notified body responsible for the conformity assessment procedures set out in
Article 43. The identification number shall also be indicated in any promotional
material which mentions that the high-risk AI system fulfils the requirements for CE
marking.


_Article 50_

_Document retention_

The provider shall, for a period ending 10 years after the AI system has been placed on the
market or put into service, keep at the disposal of the national competent authorities:

(a) the technical documentation referred to in Article 11;

(b) the documentation concerning the quality management system referred to Article 17;

(c) the documentation concerning the changes approved by notified bodies where
applicable;

(d) the decisions and other documents issued by the notified bodies where applicable;

(e) the EU declaration of conformity referred to in Article 48.

_Article 51_

_Registration_

Before placing on the market or putting into service a high-risk AI system referred to in
Article 6(2), the provider or, where applicable, the authorised representative shall register that
system in the EU database referred to in Article 60.

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## TITLE IV

 TRANSPARENCY OBLIGATIONS FOR CERTAIN AI SYSTEMS

_Article 52_

_Transparency obligations for certain AI systems_

1. Providers shall ensure that AI systems intended to interact with natural persons are
designed and developed in such a way that natural persons are informed that they are
interacting with an AI system, unless this is obvious from the circumstances and the
context of use. This obligation shall not apply to AI systems authorised by law to
detect, prevent, investigate and prosecute criminal offences, unless those systems are
available for the public to report a criminal offence.

2. Users of an emotion recognition system or a biometric categorisation system shall
inform of the operation of the system the natural persons exposed thereto. This
obligation shall not apply to AI systems used for biometric categorisation, which are
permitted by law to detect, prevent and investigate criminal offences.

3. Users of an AI system that generates or manipulates image, audio or video content
that appreciably resembles existing persons, objects, places or other entities or events
and would falsely appear to a person to be authentic or truthful (‘deep fake’), shall
disclose that the content has been artificially generated or manipulated.

However, the first subparagraph shall not apply where the use is authorised by law to
detect, prevent, investigate and prosecute criminal offences or it is necessary for the
exercise of 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, and subject to
appropriate safeguards for the rights and freedoms of third parties.

4. Paragraphs 1, 2 and 3 shall not affect the requirements and obligations set out in Title
III of this Regulation.

**TITLE V**

## MEASURES IN SUPPORT OF INNOVATION

_Article 53_

_AI regulatory sandboxes_

1. AI regulatory sandboxes established by one or more Member States competent
authorities or the European Data Protection Supervisor shall provide a controlled
environment that facilitates the 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. This shall take place under the direct supervision
and guidance by the competent authorities with a view to ensuring compliance with
the requirements of this Regulation and, where relevant, other Union and Member
States legislation supervised within the sandbox.

2. Member States shall ensure that to the extent the innovative AI systems involve the
processing of personal data or otherwise fall under the supervisory remit of other
national authorities or competent authorities providing or supporting access to data,

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the national data protection authorities and those other national authorities are
associated to the operation of the AI regulatory sandbox.

3. The AI regulatory sandboxes shall not affect the supervisory and corrective powers
of the competent authorities. Any significant risks to health and safety and
fundamental rights identified during the development and testing of such systems
shall result in immediate mitigation and, failing that, in the suspension of the
development and testing process until such mitigation takes place.

4. Participants in the AI regulatory sandbox shall remain liable under applicable Union
and Member States liability legislation for any harm inflicted on third parties as a
result from the experimentation taking place in the sandbox.

5. Member States’ competent authorities that have established AI regulatory sandboxes
shall coordinate their activities and cooperate within the framework of the European
Artificial Intelligence Board. They shall submit annual reports to the Board and the
Commission on the results from the implementation of those scheme, including good
practices, lessons learnt and recommendations on their setup and, where relevant, on
the application of this Regulation and other Union legislation supervised within the
sandbox.

6. The modalities and the conditions of the operation of the AI regulatory sandboxes,
including the eligibility criteria and the procedure for the application, selection,
participation and exiting from the sandbox, and the rights and obligations of the
participants shall be set out in implementing acts. Those implementing acts shall be
adopted in accordance with the examination procedure referred to in Article 74(2).


_Article 54_

_Further processing of personal data for developing certain AI systems in the public interest in_

_the AI regulatory sandbox_

1. In the AI regulatory sandbox personal data lawfully collected for other purposes shall
be processed for the purposes of developing and testing certain innovative AI
systems in the sandbox under the following conditions:

(a) the innovative AI systems shall be developed for safeguarding substantial
public interest in one or more of the following areas:

(i) the prevention, investigation, detection or prosecution of criminal
offences or the execution of criminal penalties, including the
safeguarding against and the prevention of threats to public security,
under the control and responsibility of the competent authorities. The
processing shall be based on Member State or Union law;

(ii) public safety and public health, including disease prevention, control and
treatment;

(iii) a high level of protection and improvement of the quality of the

environment;

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

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(c) there are effective monitoring mechanisms to identify if any high risks to the
fundamental rights of the data subjects may arise during the sandbox
experimentation as well as response mechanism to promptly mitigate those
risks and, where necessary, stop the processing;

(d) any personal data to be processed in the context of the sandbox are in a
functionally separate, isolated and protected data processing environment
under the control of the participants and only authorised persons have access to
that data;

(e) any personal data processed are not be transmitted, transferred or otherwise
accessed by other parties;

(f) any processing of personal data in the context of the sandbox do not lead to
measures or decisions affecting the data subjects;

(g) any personal data processed in the context of the sandbox are deleted once the
participation in the sandbox has terminated or the personal data has reached the
end of its retention period;

(h) the logs of the processing of personal data in the context of the sandbox are
kept for the duration of the participation in the sandbox and 1 year after its
termination, solely for the purpose of and only as long as necessary for
fulfilling accountability and documentation obligations under this Article or
other application Union or Member States legislation;

(i) complete and detailed description of the process and rationale behind the
training, testing and validation of the AI system is kept together with the
testing results as part of the technical documentation in Annex IV;

(j) a short summary of the AI project developed in the sandbox, its objectives and
expected results published on the website of the competent authorities.

2. Paragraph 1 is without prejudice to Union or Member States legislation excluding
processing for other purposes than those explicitly mentioned in that legislation.

_Article 55_

_Measures for small-scale providers and users_

1. Member States shall undertake the following actions:

(a) provide small-scale providers and start-ups with priority access to the AI
regulatory sandboxes to the extent that they fulfil the eligibility conditions;

(b) organise specific awareness raising activities about the application of this
Regulation tailored to the needs of the small-scale providers and users;

(c) where appropriate, establish a dedicated channel for communication with
small-scale providers and user and other innovators to provide guidance and
respond to queries about the implementation of this Regulation.

2. The specific interests and needs of the small-scale providers shall be taken into
account when setting the fees for conformity assessment under Article 43, reducing
those fees proportionately to their size and market size.

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## TITLE VI

 GOVERNANCE

 CHAPTER 1

 EUROPEAN ARTIFICIAL INTELLIGENCE BOARD


_Article 56_

_Establishment of the European Artificial Intelligence Board_

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

2. The Board shall provide advice and assistance to the Commission in order to:

(a) contribute to the effective cooperation of the national supervisory authorities
and the Commission with regard to matters covered by this Regulation;

(b) coordinate and contribute to guidance and analysis by the Commission and the
national supervisory authorities and other 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 ensuring the
consistent application of this Regulation.

_Article 57_

_Structure of the Board_

1. The Board shall be composed of the national supervisory authorities, who shall be
represented by the head or equivalent high-level official of that authority, and the
European Data Protection Supervisor. Other national authorities may be invited to
the meetings, where the issues discussed are of relevance for them.

2. The Board shall adopt its rules of procedure by a simple majority of its members,
following the consent of the Commission. The rules of procedure shall also contain
the operational aspects related to the execution of the Board’s tasks as listed in
Article 58. The Board may establish sub-groups as appropriate for the purpose of
examining specific questions.

3. The Board shall be chaired by the Commission. The Commission shall convene the
meetings and prepare the agenda in accordance with the tasks of the Board pursuant
to this Regulation and with its rules of procedure. The Commission shall provide
administrative and analytical support for the activities of the Board pursuant to this
Regulation.

4. The Board may invite external experts and observers to attend its meetings and may
hold exchanges with interested third parties to inform its 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.

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_Article 58_

_Tasks of the Board_

When providing advice and assistance to the Commission in the context of Article 56(2), the
Board shall in particular:

(a) collect and share expertise and best practices among Member States;

(b) contribute to uniform administrative practices in the Member States, including for
the functioning of regulatory sandboxes referred to in Article 53;

(c) issue opinions, recommendations or written contributions on matters related to the
implementation of this Regulation, in particular

(i) on technical specifications or existing standards regarding the requirements set
out in Title III, Chapter 2,

(ii) on the use of harmonised standards or common specifications referred to in
Articles 40 and 41,


(iii) on the preparation of guidance documents, including the guidelines concerning

the setting of administrative fines referred to in Article 71.

## CHAPTER 2

**NATIONAL COMPETENT AUTHORITIES**

_Article 59_

_Designation of national competent authorities_

1. National competent authorities shall be established or designated by each Member
State for the purpose of ensuring the application and implementation of this
Regulation. National competent authorities shall be organised so as to safeguard the
objectivity and impartiality of their activities and tasks.

2. Each Member State shall designate a national supervisory authority among the
national competent authorities. The national supervisory authority shall act as
notifying authority and market surveillance authority unless a Member State has
organisational and administrative reasons to designate more than one authority.

3. Member States shall inform the Commission of their designation or designations and,
where applicable, the reasons for designating more than one authority.

4. Member States shall ensure that national competent authorities are provided with
adequate financial and human resources to fulfil their tasks under this Regulation. In
particular, national competent authorities shall have a sufficient number of personnel
permanently available whose competences and expertise shall include an in-depth
understanding of artificial intelligence technologies, data and data computing,
fundamental rights, health and safety risks and knowledge of existing standards and
legal requirements.

5. Member States shall report to the Commission on an annual basis on the status of the
financial and human resources of the national competent authorities with an
assessment of their adequacy. The Commission shall transmit that information to the
Board for discussion and possible recommendations.

6. The Commission shall facilitate the exchange of experience between national
competent authorities.

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7. National competent authorities may provide guidance and advice on the
implementation of this Regulation, including to small-scale providers. Whenever
national competent authorities intend to provide guidance and advice with regard to
an AI system in areas covered by other Union legislation, the competent national
authorities under that Union legislation shall be consulted, as appropriate. Member
States may also establish one central contact point for communication with operators.

8. When Union institutions, agencies and bodies fall within the scope of this
Regulation, the European Data Protection Supervisor shall act as the competent
authority for their supervision.

**TITLE VII**

## EU DATABASE FOR STAND-ALONE HIGH-RISK AI SYSTEMS

_Article 60_

_EU database for stand-alone high-risk AI systems_

1. The Commission shall, in collaboration with the Member States, set up and maintain
a EU database containing information referred to in paragraph 2 concerning high-risk
AI systems referred to in Article 6(2) which are registered in accordance with Article
51.

2. The data listed in Annex VIII shall be entered into the EU database by the providers.
The Commission shall provide them with technical and administrative support.

3. Information contained in the EU database shall be accessible to the public.

4. The EU database shall contain personal data only insofar as necessary for collecting
and processing information in accordance with this Regulation. That information
shall include the names and contact details of natural persons who are responsible for
registering the system and have the legal authority to represent the provider.

5. The Commission shall be the controller of the EU database. It shall also ensure to
providers adequate technical and administrative support.

## TITLE VIII


## POST-MARKET MONITORING, INFORMATION SHARING, MARKET
 SURVEILLANCE

 CHAPTER 1

 POST-MARKET MONITORING


_Article 61_

_Post-market monitoring by providers and post-market monitoring plan for high-risk AI_

_systems_

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

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2. The post-market monitoring system shall actively and systematically collect,
document and analyse relevant data provided by users or collected through other
sources on the performance of high-risk AI systems throughout their lifetime, and
allow the provider to evaluate the continuous compliance of AI systems with the
requirements set out in Title III, Chapter 2.

3. The post-market monitoring system shall be based on a post-market monitoring plan.
The post-market monitoring plan shall be part of the technical documentation
referred to in Annex IV. The Commission shall adopt an implementing act laying
down detailed provisions establishing a template for the post-market monitoring plan
and the list of elements to be included in the plan.

4. For high-risk AI systems covered by the legal acts referred to in Annex II, where a
post-market monitoring system and plan is already established under that legislation,
the elements described in paragraphs 1, 2 and 3 shall be integrated into that system
and plan as appropriate.

The first subparagraph shall also apply to high-risk AI systems referred to in point
5(b) of Annex III placed on the market or put into service by credit institutions
regulated by Directive 2013/36/EU.

## CHAPTER 2

 SHARING OF INFORMATION ON INCIDENTS AND MALFUNCTIONING

_Article 62_

_Reporting of serious incidents and of malfunctioning_

1. Providers of high-risk AI systems placed on the Union market shall report any
serious incident or any malfunctioning of those systems which constitutes a breach of
obligations under Union law intended to protect fundamental rights to the market
surveillance authorities of the Member States where that incident or breach occurred.

Such notification shall be made immediately after the provider has established a
causal link between the AI system and the incident or malfunctioning or the
reasonable likelihood of such a link, and, in any event, not later than 15 days after the
providers becomes aware of the serious incident or of the malfunctioning.

2. Upon receiving a notification related to a breach of obligations under Union law
intended to protect fundamental rights, the market surveillance authority shall inform
the national public authorities or bodies referred to in Article 64(3). The Commission
shall develop dedicated guidance to facilitate compliance with the obligations set out
in paragraph 1. That guidance shall be issued 12 months after the entry into force of
this Regulation, at the latest.

3. For high-risk AI systems referred to in point 5(b) of Annex III which are placed on
the market or put into service by providers that are credit institutions regulated by
Directive 2013/36/EU and for high-risk AI systems which are safety components of
devices, or are themselves devices, covered by Regulation (EU) 2017/745 and
Regulation (EU) 2017/746, the notification of serious incidents or malfunctioning
shall be limited to those that that constitute a breach of obligations under Union law
intended to protect fundamental rights.

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## CHAPTER 3

 ENFORCEMENT

_Article 63_

_Market surveillance and control of AI systems in the Union market_

1. Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation.
However, for the purpose of the effective enforcement of this Regulation:

(a) any reference to an economic operator under Regulation (EU) 2019/1020 shall
be understood as including all operators identified in Title III, Chapter 3 of this
Regulation;

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

2. The national supervisory authority shall report to the Commission on a regular basis
the outcomes of relevant market surveillance activities. The national supervisory
authority shall report, without delay, to the Commission and relevant national
competition authorities any information identified in the course of market
surveillance activities that may be of potential interest for the application of Union
law on competition rules.

3. For high-risk AI systems, related to products to which legal acts listed in Annex II,
section A apply, the market surveillance authority for the purposes of this Regulation
shall be the authority responsible for market surveillance activities designated under
those legal acts.

4. For AI systems placed on the market, put into service or used by financial institutions
regulated by Union legislation on financial services, the market surveillance
authority for the purposes of this Regulation shall be the relevant authority
responsible for the financial supervision of those institutions under that legislation.

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

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

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

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_Article 64_

_Access to data and documentation_

1. Access to data and documentation in the context of their activities, the market
surveillance authorities shall be granted full access to the training, validation and
testing datasets used by the provider, including through application programming
interfaces (‘API’) or other appropriate technical means and tools enabling remote
access.

2. Where necessary to assess the conformity of the high-risk AI system with the
requirements set out in Title III, Chapter 2 and upon a reasoned request, the market
surveillance authorities shall be granted access to the source code of the AI system.

3. National public authorities or bodies which supervise or enforce the respect of
obligations under Union law protecting fundamental rights in relation to the use of
high-risk AI systems referred to in Annex III shall have the power to request and
access any documentation created or maintained under this Regulation when access
to that documentation is necessary for the fulfilment of the competences under their
mandate within the limits of their jurisdiction. The relevant public authority or body
shall inform the market surveillance authority of the Member State concerned of any
such request.

4. By 3 months after the entering into force of this Regulation, each Member State shall
identify the public authorities or bodies referred to in paragraph 3 and make a list
publicly available on the website of the national supervisory authority. Member
States shall notify the list to the Commission and all other Member States and keep
the list up to date.

5. Where the documentation referred to in paragraph 3 is insufficient to ascertain
whether a breach of obligations under Union law intended to protect fundamental
rights has occurred, the public authority or body referred to paragraph 3 may make a
reasoned request to the market surveillance authority to organise testing of the highrisk AI system through technical means. The market surveillance authority shall
organise the testing with the close involvement of the requesting public authority or
body within reasonable time following the request.

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

_Article 65_

_Procedure for dealing with AI systems presenting a risk at national level_

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

2. Where the market surveillance authority of a Member State has sufficient reasons to
consider that an AI system presents a risk as referred to in paragraph 1, they shall
carry out an evaluation of the AI system concerned in respect of its compliance with
all the requirements and obligations laid down in this Regulation. When risks to the
protection of fundamental rights are present, the market surveillance authority shall
also inform the relevant national public authorities or bodies referred to in Article
64(3). The relevant operators shall cooperate as necessary with the market

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surveillance authorities and the other national public authorities or bodies referred to
in Article 64(3).

Where, in the course of that evaluation, the market surveillance authority finds that
the AI system does not comply with the requirements and obligations laid down in
this Regulation, it shall without delay require the relevant operator to take all
appropriate corrective actions to bring the AI system into compliance, to withdraw
the AI system from the market, or to recall it within a reasonable period,
commensurate with the nature of the risk, as it may prescribe.

The market surveillance authority shall inform the relevant notified body
accordingly. Article 18 of Regulation (EU) 2019/1020 shall apply to the measures
referred to in the second subparagraph.

3. Where the market surveillance authority considers that non-compliance is not
restricted to its national territory, it shall inform the Commission and the other
Member States of the results of the evaluation and of the actions which it has
required the operator to take.

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

5. Where the operator of an AI system does not take adequate corrective action within
the period referred to in paragraph 2, the market surveillance authority shall take all
appropriate provisional measures to prohibit or restrict the AI system's being made
available on its national market, to withdraw the product from that market or to recall
it. That authority shall inform the Commission and the other Member States, without
delay, of those measures.

6. The information referred to in paragraph 5 shall include all available details, in
particular the data necessary for the identification of the non-compliant AI system,
the origin of the AI system, the nature of the non-compliance alleged and the risk
involved, the nature and duration of the national measures taken and the arguments
put forward by the relevant operator. In particular, the market surveillance authorities
shall indicate whether the non-compliance is due to one or more of the following:

(a) a failure of the AI system to meet requirements set out in Title III, Chapter 2;

(b) shortcomings in the harmonised standards or common specifications referred to
in Articles 40 and 41 conferring a presumption of conformity.

7. The market surveillance authorities of the Member States other than the market
surveillance authority of the Member State initiating the procedure shall without
delay inform the Commission and the other Member States of any measures adopted
and of any additional information at their disposal relating to the non-compliance of
the AI system concerned, and, in the event of disagreement with the notified national
measure, of their objections.

8. Where, within three months of receipt of the information referred to in paragraph 5,
no objection has been raised by either a Member State or the Commission in respect
of a provisional measure taken by a Member State, that measure shall be deemed
justified. This is without prejudice to the procedural rights of the concerned operator
in accordance with Article 18 of Regulation (EU) 2019/1020.

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


_Article 66_

_Union safeguard procedure_

1. Where, within three months of receipt of the notification referred to in Article 65(5),
objections are raised by a Member State against a measure taken by another Member
State, or where the Commission considers the measure to be contrary to Union law,
the Commission shall without delay enter into consultation with the relevant Member
State and operator or operators and shall evaluate the national measure. On the basis
of the results of that evaluation, the Commission shall decide whether the national
measure is justified or not within 9 months from the notification referred to in Article
65(5) and notify such decision to the Member State concerned.

2. If the national measure is considered justified, all Member States shall take the
measures necessary to ensure that the non-compliant AI system is withdrawn from
their market, and shall inform the Commission accordingly. If the national measure
is considered unjustified, the Member State concerned shall withdraw the measure.

3. Where the national measure is considered justified and the non-compliance of the AI
system is attributed to shortcomings in the harmonised standards or common
specifications referred to in Articles 40 and 41 of this Regulation, the Commission
shall apply the procedure provided for in Article 11 of Regulation (EU) No
1025/2012.

_Article 67_

_Compliant AI systems which present a risk_

1. Where, having performed an evaluation under Article 65, the market surveillance
authority of a Member State finds that although an AI system is in compliance with
this Regulation, it presents a risk to the health or safety of persons, to the compliance
with obligations under Union or national law intended to protect fundamental rights
or to other aspects of public interest protection, it shall require the relevant operator
to take all appropriate measures to ensure that the AI system concerned, when placed
on the market or put into service, no longer presents that risk, to withdraw the AI
system from the market or to recall it within a reasonable period, commensurate with
the nature of the risk, as it may prescribe.

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

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

4. The Commission shall without delay enter into consultation with the Member States
and the relevant operator and shall evaluate the national measures taken. On the basis

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of the results of that evaluation, the Commission shall decide whether the measure is
justified or not and, where necessary, propose appropriate measures.

5. The Commission shall address its decision to the Member States.


_Article 68_

_Formal non-compliance_

1. Where the market surveillance authority of a Member State makes one of the
following findings, it shall require the relevant provider to put an end to the noncompliance concerned:

(a) the conformity marking has been affixed in violation of Article 49;

(b) the conformity marking has not been affixed;

(c) the EU declaration of conformity has not been drawn up;

(d) the EU declaration of conformity has not been drawn up correctly;

(e) the identification number of the notified body, which is involved in the
conformity assessment procedure, where applicable, has not been affixed;

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

## TITLE IX

 CODES OF CONDUCT

_Article 69_

_Codes of conduct_

1. The Commission and the Member States shall encourage and facilitate the drawing
up of codes of conduct intended to foster the voluntary application to AI systems
other than high-risk AI systems of the requirements set out in Title III, Chapter 2 on
the basis of technical specifications and solutions that are appropriate means of
ensuring compliance with such requirements in light of the intended purpose of the
systems.

2. The Commission and the Board shall encourage and facilitate the drawing up of
codes of conduct intended to foster the voluntary application to AI systems of
requirements related for example to environmental sustainability, accessibility for
persons with a disability, stakeholders participation in the design and development of
the AI systems and diversity of development teams on the basis of clear objectives
and key performance indicators to measure the achievement of those objectives.

3. Codes of conduct may be drawn up by individual providers of AI systems or by
organisations representing them or by both, including with the involvement of users
and any interested stakeholders and their representative organisations. Codes of
conduct may cover one or more AI systems taking into account the similarity of the
intended purpose of the relevant systems.

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4. The Commission and the Board shall take into account the specific interests and
needs of the small-scale providers and start-ups when encouraging and facilitating
the drawing up of codes of conduct.

## TITLE X

 CONFIDENTIALITY AND PENALTIES

_Article 70_

_Confidentiality_

1. National competent authorities and notified bodies involved in the application of this
Regulation shall respect the confidentiality of information and data obtained in
carrying out their tasks and activities in such a manner as to protect, in particular:

(a) intellectual property rights, and confidential business information or trade
secrets of a natural or legal person, including source code, except the cases
referred to in Article 5 of Directive 2016/943 on the protection of undisclosed
know-how and business information (trade secrets) against their unlawful
acquisition, use and disclosure apply.

(b) the effective implementation of this Regulation, in particular for the purpose of
inspections, investigations or audits;(c) public and national security interests;

(c) integrity of criminal or administrative proceedings.

2. Without prejudice to paragraph 1, information exchanged on a confidential basis
between the national competent authorities and between national competent
authorities and the Commission shall not be disclosed without the prior consultation
of the originating national competent authority and the user when high-risk AI
systems referred to in points 1, 6 and 7 of Annex III are used by law enforcement,
immigration or asylum authorities, when such disclosure would jeopardise public and
national security interests.

When the law enforcement, immigration or asylum authorities are providers of highrisk AI systems referred to in points 1, 6 and 7 of Annex III, the technical
documentation referred to in Annex IV shall remain within the premises of those
authorities. Those authorities shall ensure that the market surveillance authorities
referred to in Article 63(5) and (6), as applicable, can, upon request, immediately
access the documentation or obtain a copy thereof. Only staff of the market
surveillance authority holding the appropriate level of security clearance shall be
allowed to access that documentation or any copy thereof.

3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission,
Member States and notified bodies with regard to the exchange of information and
the dissemination of warnings, nor the obligations of the parties concerned to provide
information under criminal law of the Member States.

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

# EN EN


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_Article 71_

_Penalties_

1. In compliance with the terms and conditions laid down in this Regulation, Member
States shall lay down the rules on penalties, including administrative fines, applicable
to infringements of this Regulation and shall take all measures necessary to ensure
that they are properly and effectively implemented. The penalties provided for shall
be effective, proportionate, and dissuasive. They shall take into particular account the
interests of small-scale providers and start-up and their economic viability.

2. The Member States shall notify the Commission of those rules and of those measures
and shall notify it, without delay, of any subsequent amendment affecting them.

3. The following infringements shall be subject to administrative fines of up to 30 000
000 EUR or, if the offender is company, up to 6 % of its total worldwide annual
turnover for the preceding financial year, whichever is higher:

(a) non-compliance with the prohibition of the artificial intelligence practices
referred to in Article 5;

(b) non-compliance of the AI system with the requirements laid down in Article
10.

4. The non-compliance of the AI system with any requirements or obligations under
this Regulation, other than those laid down in Articles 5 and 10, shall be subject to
administrative fines of up to 20 000 000 EUR or, if the offender is a company, up to
4 % of its total worldwide annual turnover for the preceding financial year,
whichever is higher.

5. The supply of incorrect, incomplete or misleading information to notified bodies and
national competent authorities in reply to a request shall be subject to administrative
fines of up to 10 000 000 EUR or, if the offender is a company, up to 2 % of its total
worldwide annual turnover for the preceding financial year, whichever is higher.

6. When deciding on the amount of the administrative fine in each individual case, all
relevant circumstances of the specific situation shall be taken into account and due
regard shall be given to the following:

(a) the nature, gravity and duration of the infringement and of its consequences;

(b) whether administrative fines have been already applied by other market
surveillance authorities to the same operator for the same infringement.

(c) the size and market share of the operator committing the infringement;

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

8. Depending on the legal system of the Member States, the rules on administrative
fines may be applied in such a manner that the fines are imposed by competent
national courts of other bodies as applicable in those Member States. The application
of such rules in those Member States shall have an equivalent effect.

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_Article 72_

_Administrative fines on Union institutions, agencies and bodies_

1. The European Data Protection Supervisor may impose administrative fines on Union
institutions, agencies and bodies falling within the scope of this Regulation. When
deciding whether to impose an administrative fine and deciding on the amount of the
administrative fine in each individual case, all relevant circumstances of the specific
situation shall be taken into account and due regard shall be given to the following:

(a) the nature, gravity and duration of the infringement and of its consequences;

(b) the cooperation with the European Data Protection Supervisor in order to
remedy the infringement and mitigate the possible adverse effects of the
infringement, including compliance with any of the measures previously
ordered by the European Data Protection Supervisor against the Union
institution or agency or body concerned with regard to the same subject matter;

(c) any similar previous infringements by the Union institution, agency or body;

2. The following infringements shall be subject to administrative fines of up to 500 000
EUR:

(a) non-compliance with the prohibition of the artificial intelligence practices
referred to in Article 5;

(b) non-compliance of the AI system with the requirements laid down in Article
10.

3. The non-compliance of the AI system with any requirements or obligations under
this Regulation, other than those laid down in Articles 5 and 10, shall be subject to
administrative fines of up to 250 000 EUR.

4. Before taking decisions pursuant to this Article, the European Data Protection
Supervisor shall give the Union institution, agency or body which is the subject of
the proceedings conducted by the European Data Protection Supervisor the
opportunity of being heard on the matter regarding the possible infringement. The
European Data Protection Supervisor shall base his or her decisions only on elements
and circumstances on which the parties concerned have been able to comment.
Complainants, if any, shall be associated closely with the proceedings.

5. The rights of defense of the parties concerned shall be fully respected in the
proceedings. They shall be entitled to have access to the European Data Protection
Supervisor’s file, subject to the legitimate interest of individuals or undertakings in
the protection of their personal data or business secrets.

6. Funds collected by imposition of fines in this Article shall be the income of the
general budget of the Union.

## TITLE XI

 DELEGATION OF POWER AND COMMITTEE PROCEDURE

_Article 73_

_Exercise of the delegation_

1. The power to adopt delegated acts is conferred on the Commission subject to the
conditions laid down in this Article.

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2. The delegation of power referred to in Article 4, Article 7(1), Article 11(3), Article
43(5) and (6) and Article 48(5) shall be conferred on the Commission for an
indeterminate period of time from [entering into force of the Regulation].

3. The delegation of power referred to in Article 4, Article 7(1), Article 11(3), Article
43(5) and (6) and Article 48(5) may be revoked at any time by the European
Parliament or by the Council. A decision of revocation shall put an end to the
delegation of power specified in that decision. It shall take effect the day following
that of its publication in the Official Journal of the European Union or at a later date
specified therein. It shall not affect the validity of any delegated acts already in force.

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

5. Any delegated act adopted pursuant to Article 4, Article 7(1), Article 11(3), Article
43(5) and (6) and Article 48(5) shall enter into force only if no objection has been
expressed by either the European Parliament or the Council within a period of three
months of notification of that act to the European Parliament and the Council or if,
before the expiry of that period, the European Parliament and the Council have both
informed the Commission that they will not object. That period shall be extended by
three months at the initiative of the European Parliament or of the Council.

_Article 74_

_Committee procedure_

1. The Commission shall be assisted by a committee. That committee shall be a
committee within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No
182/2011 shall apply.

## TITLE XII

 FINAL PROVISIONS


_Article 75_

_Amendment to Regulation (EC) No 300/2008_

In Article 4(3) of Regulation (EC) No 300/2008, the following subparagraph is added:

“When adopting detailed measures related to technical specifications and procedures for
approval and use of security equipment concerning Artificial Intelligence systems in the
meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament
and of the Council*, the requirements set out in Chapter 2, Title III of that Regulation shall be
taken into account.”

__________

-  Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”

_Article 76_

_Amendment to Regulation (EU) No 167/2013_

In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added:

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“When adopting delegated acts pursuant to the first subparagraph concerning artificial
intelligence systems which are safety components in the meaning of Regulation (EU)
YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council*, the
requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.

__________

-  Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”

_Article 77_

_Amendment to Regulation (EU) No 168/2013_

In Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added:

“When adopting delegated acts pursuant to the first subparagraph concerning Artificial
Intelligence systems which are safety components in the meaning of Regulation (EU)
YYY/XX on [Artificial Intelligence] of the European Parliament and of the Council*, the
requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.

__________

-  Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”


_Article 78_

_Amendment to Directive 2014/90/EU_

In Article 8 of Directive 2014/90/EU, the following paragraph is added:

“4. For Artificial Intelligence systems which are safety components in the meaning of
Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the
Council*, when carrying out its activities pursuant to paragraph 1 and when adopting
technical specifications and testing standards in accordance with paragraphs 2 and 3, the
Commission shall take into account the requirements set out in Title III, Chapter 2 of that
Regulation.

__________

-  Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.

_Article 79_

_Amendment to Directive (EU) 2016/797_

In Article 5 of Directive (EU) 2016/797, the following paragraph is added:

“12. When adopting delegated acts pursuant to paragraph 1 and implementing acts pursuant to
paragraph 11 concerning Artificial Intelligence systems which are safety components in the
meaning of Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament
and of the Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be
taken into account.

__________

-  Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.

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_Article 80_

_Amendment to Regulation (EU) 2018/858_

In Article 5 of Regulation (EU) 2018/858 the following paragraph is added:

“4. When adopting delegated acts pursuant to paragraph 3 concerning Artificial Intelligence
systems which are safety components in the meaning of Regulation (EU) YYY/XX [on
Artificial Intelligence] of the European Parliament and of the Council *, the requirements set
out in Title III, Chapter 2 of that Regulation shall be taken into account.

__________

-  Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.

_Article 81_

_Amendment to Regulation (EU) 2018/1139_

Regulation (EU) 2018/1139 is amended as follows:

(1) In Article 17, the following paragraph is added:

“3. Without prejudice to paragraph 2, when adopting implementing acts pursuant to paragraph
1 concerning Artificial Intelligence systems which are safety components in the meaning of
Regulation (EU) YYY/XX [on Artificial Intelligence] of the European Parliament and of the
Council*, the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into
account.

__________

-  Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”

(2) In Article 19, the following paragraph is added:

“4. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial
Intelligence systems which are safety components in the meaning of Regulation (EU)
YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that
Regulation shall be taken into account.”

(3) In Article 43, the following paragraph is added:

“4. When adopting implementing acts pursuant to paragraph 1 concerning Artificial
Intelligence systems which are safety components in the meaning of Regulation (EU)
YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that
Regulation shall be taken into account.”

(4) In Article 47, the following paragraph is added:

“3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial
Intelligence systems which are safety components in the meaning of Regulation (EU)
YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that
Regulation shall be taken into account.”

(5) In Article 57, the following paragraph is added:

“When adopting those implementing acts concerning Artificial Intelligence systems which are
safety components in the meaning of Regulation (EU) YYY/XX [on Artificial Intelligence],
the requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.”

(6) In Article 58, the following paragraph is added:

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“3. When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial
Intelligence systems which are safety components in the meaning of Regulation (EU)
YYY/XX [on Artificial Intelligence], the requirements set out in Title III, Chapter 2 of that
Regulation shall be taken into account.”.

_Article 82_

_Amendment to Regulation (EU) 2019/2144_

In Article 11 of Regulation (EU) 2019/2144, the following paragraph is added:

“3. When adopting the implementing acts pursuant to paragraph 2, concerning artificial
intelligence systems which are safety components in the meaning of Regulation (EU)
YYY/XX [on Artificial Intelligence] of the European Parliament and of the Council*, the
requirements set out in Title III, Chapter 2 of that Regulation shall be taken into account.

__________

-  Regulation (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.

_Article 83_

_AI systems already placed on the market or put into service_

1. This Regulation shall not apply to the AI systems which are components of the largescale IT systems established by the legal acts listed in Annex IX that have been
placed on the market or put into service before _[12 months after the date of_
_application of this Regulation referred to in Article 85(2)], unless the replacement or_
amendment of those legal acts leads to a significant change in the design or intended
purpose of the AI system or AI systems concerned.

The requirements laid down in this Regulation shall be taken into account, where
applicable, in the evaluation of each large-scale IT systems established by the legal
acts listed in Annex IX to be undertaken as provided for in those respective acts.

2. This Regulation shall apply to the high-risk AI systems, other than the ones referred
to in paragraph 1, that have been placed on the market or put into service before

[date of application of this Regulation referred to in Article 85(2)], only if, from that
date, those systems are subject to significant changes in their design or intended
purpose.

_Article 84_

_Evaluation and review_

1. The Commission shall assess the need for amendment of the list in Annex III once a
year following the entry into force of this Regulation.

2. By [three years after the date of application of this Regulation referred to in Article
_85(2)] and every four years thereafter, the Commission shall submit a report on the_
evaluation and review of this Regulation to the European Parliament and to the
Council. The reports shall be made public.

3. The reports referred to in paragraph 2 shall devote specific attention to the following:

(a) the status of the financial and human resources of the national competent
authorities in order to effectively perform the tasks assigned to them under this
Regulation;

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

4. Within [three years after the date of application of this Regulation referred to in
_Article 85(2)] and every four years thereafter, the Commission shall evaluate the_
impact and effectiveness of codes of conduct to foster the application of the
requirements set out in Title III, Chapter 2 and possibly other additional requirements
for AI systems other than high-risk AI systems.

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

6. In carrying out the evaluations and reviews referred to in paragraphs 1 to 4 the
Commission shall take into account the positions and findings of the Board, of the
European Parliament, of the Council, and of other relevant bodies or sources.

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

_Article 85_

_Entry into force and application_

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

2. This Regulation shall apply from [24 months following the entering into force of the
Regulation].

3. By way of derogation from paragraph 2:

(a) Title III, Chapter 4 and Title VI shall apply from [three months following the
entry into force of this Regulation];

(b) Article 71 shall apply from [twelve months following the entry into force of
this Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

_For the European Parliament_ _For the Council_

_The President_ _The President_

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**LEGISLATIVE FINANCIAL STATEMENT**

**1.** **FRAMEWORK** **OF** **THE** **PROPOSAL/INITIATIVE**

1.1. Title of the proposal/initiative

1.2. Policy area(s) concerned

1.3. The proposal/initiative relates to:

1.4. Objective(s)

1.4.1. General objective(s)

1.4.2. Specific objective(s)

1.4.3. Expected result(s) and impact

1.4.4. Indicators of performance

1.5. Grounds for the proposal/initiative

1.5.1. Requirement(s) to be met in the short or long term including a detailed

timeline for roll-out of the implementation of the initiative

1.5.2. Added value of Union involvement (it may result from different factors, e.g.
coordination gains, legal certainty, greater effectiveness or complementarities). For
the purposes of this point 'added value of Union involvement' is the value resulting
from Union intervention which is additional to the value that would have been
otherwise created by Member States alone

1.5.3.  Lessons learned from similar experiences in the past

1.5.4. Compatibility with the Multiannual Financial Framework and possible
synergies with other appropriate instruments

1.5.5  Assessment of the different available financing options, including scope for
redeployment

1.6.   Duration and financial impact of the proposal/initiative

1.7.  Management mode(s) planned

**2.** **MANAGEMENT** **MEASURES**

2.1. Monitoring and reporting rules

2.2. Management and control system

2.2.1. Justification of the management mode(s), the funding implementation
mechanism(s), the payment modalities and the control strategy proposed

2.2.2. Information concerning the risks identified and the internal control system(s)
set up to mitigate them

2.2.3. Estimation and justification of the cost-effectiveness of the controls (ratio of
"control costs ÷ value of the related funds managed"), and assessment of the
expected levels of risk of error (at payment & at closure)

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2.3. Measures to prevent fraud and irregularities

**3.** **ESTIMATED** **FINANCIAL** **IMPACT** **OF** **THE** **PROPOSAL/INITIATIVE**

3.1. Heading(s) of the multiannual financial framework and expenditure budget
line(s) affected

3.2. Estimated financial impact of the proposal on appropriations

_3.2.1. Summary of estimated impact on operational appropriations_

_3.2.2. Estimated output funded with operational appropriations_

_3.2.3. Summary of estimated impact on administrative appropriations_

_3.2.4. Compatibility with the current multiannual financial framework_

_3.2.5. Third-party contributions_

3.3. Estimated impact on revenue

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**LEGISLATIVE FINANCIAL STATEMENT**

**1.** **FRAMEWORK** **OF** **THE** **PROPOSAL/INITIATIVE**

**1.1.** **Title of the proposal/initiative**

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

**1.2.** **Policy area(s) concerned**

Communications Networks, Content and Technology;

Internal Market, Industry, Entrepreneurship and SMEs;

The budgetary impact concerns the new tasks entrusted with the Commission,
including the support to the EU AI Board;

Activity: Shaping Europe's digital future.

**1.3.** **The proposal/initiative relates to:**

X **a new action**

 **a new action following a pilot project/preparatory action[64]**

 **the extension of an existing action**

 **an action redirected towards a new action**

**1.4.** **Objective(s)**

_1.4.1._ _General objective(s)_

The general objective of the intervention is to ensure the proper functioning of the
single market by creating the conditions for the development and use of trustworthy
artificial intelligence in the Union.

_1.4.2._ _Specific objective(s)_

Specific objective No 1

To set requirements specific to AI systems and obligations on all value chain
participants in order to ensure that AI systems placed on the market and used are safe
and respect existing law on fundamental rights and Union values;

Specific objective No 2

To ensure legal certainty to facilitate investment and innovation in AI by making it
clear what essential requirements, obligations, as well as conformity and compliance
procedures must be followed to place or use an AI system in the Union market;

Specific objective No 3

To enhance governance and effective enforcement of existing law on fundamental
rights and safety requirements applicable to AI systems by providing new powers,
resources and clear rules for relevant authorities on conformity assessment and ex

64 As referred to in Article 54(2)(a) or (b) of the Financial Regulation

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post monitoring procedures and the division of governance and supervision tasks
between national and EU levels;

Specific objective No 4

To facilitate the development of a single market for lawful, safe and trustworthy AI
applications and prevent market fragmentation by taking EU action to set minimum
requirement for AI systems to be placed and used in the Union market in compliance
with existing law on fundamental rights and safety.

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_1.4.3._ _Expected result(s) and impact_

_Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted._

AI suppliers should benefit from a minimal but clear set of requirements, creating
legal certainty and ensuring access to the entire single market.

AI users should benefit from legal certainty that the high-risk AI systems they buy
comply with European laws and values.

Consumers should benefit by reducing the risk of violations of their safety or
fundamental rights.

_1.4.4._ _Indicators of performance_

_Specify the indicators for monitoring implementation of the proposal/initiative._

Indicator 1

Number of serious incidents or AI performances which constitute a serious incident
or a breach of fundamental rights obligations (semi-annual) by fields of applications
and calculated a) in absolute terms, b) as share of applications deployed and c) as
share of citizens concerned.

Indicator 2

a) Total AI investment in the EU (annual)

b) Total AI investment by Member State (annual)

c) Share of companies using AI (annual)

d) Share of SMEs using AI (annual)

a) and b) will be calculated based on official sources and benchmarked against
private estimates

c) and d) will be collected by regular company surveys

**1.5.** **Grounds for the proposal/initiative**

_1.5.1._ _Requirement(s) to be met in the short or long term including a detailed timeline for_
_roll-out of the implementation of the initiative_

The Regulation should be fully applicable one year and a half after its adoption.
However, elements of the governance structure should be in place before then. In
particular, Member States shall have appointed existing authorities and/or established
new authorities performing the tasks set out in the legislation earlier, and the EU AI
Board should be set-up and effective. By the time of applicability, the European
database of AI systems should be fully operative. In parallel to the adoption process,
it is therefore necessary to develop the database, so that its development has come to
an end when the regulation enters into force.

_1.5.2._ _Added value of Union involvement (it may result from different factors, e.g._
_coordination gains, legal certainty, greater effectiveness or complementarities). For_
_the purposes of this point 'added value of Union involvement' is the value resulting_
_from Union intervention which is additional to the value that would have been_
_otherwise created by Member States alone._

An emerging patchy framework of potentially divergent national rules will hamper
the seamless provision of AI systems across the EU and is ineffective in ensuring the

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safety and protection of fundamental rights and Union values across the different
Member States. A common EU legislative action on AI could boost the internal
market and has great potential to provide European industry with a competitive edge
at the global scene and economies of scale that cannot be achieved by individual
Member States alone.

_1.5.3._ _Lessons learned from similar experiences in the past_

The E-commerce Directive 2000/31/EC provides the core framework for the
functioning of the single market and the supervision of digital services and sets a
basic structure for a general cooperation mechanism among Member States, covering
in principle all requirements applicable to digital services. The evaluation of the
Directive pointed to shortcomings in several aspects of this cooperation mechanism,
including important procedural aspects such as the lack of clear timeframes for
response from Member States coupled with a general lack of responsiveness to
requests from their counterparts. This has led over the years to a lack of trust
between Member States in addressing concerns about providers offering digital
services cross-border. The evaluation of the Directive showed the need to define a
differentiated set of rules and requirements at European level. For this reason, the
implementation of the specific obligations laid down in this Regulation would
require a specific cooperation mechanism at EU level, with a governance structure
ensuring coordination of specific responsible bodies at EU level.

_1.5.4._ _Compatibility with the Multiannual Financial Framework and possible synergies_
_with other appropriate instruments_

The Regulation Laying Down Harmonised Rules on Artificial Intelligence and
Amending Certain Union Legislative Acts defines a new common framework of
requirements applicable to AI systems, which goes well beyond the framework
provided by existing legislation. For this reason, a new national and European
regulatory and coordination function needs to be established with this proposal.

As regards possible synergies with other appropriate instruments, the role of
notifying authorities at national level can be performed by national authorities
fulfilling similar functions sunder other EU regulations.

Moreover, by increasing trust in AI and thus encouraging investment in development
and adoption of AI, it complements Digital Europe, for which promoting the
diffusion of AI is one of five priorities.

_1.5.5._ _Assessment of the different available financing options, including scope for_
_redeployment_

The staff will be redeployed. The other costs will be supported from the DEP.
envelope, given that the objective of this regulation – ensuring trustworthy AI –
contributes directly to one key objective of Digital Europe – accelerating AI
development and deployment in Europe.

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**1.6.** **Duration and financial impact of the proposal/initiative**

 **limited duration**

–  in effect from [DD/MM]YYYY to [DD/MM]YYYY

–  Financial impact from YYYY to YYYY for commitment appropriations and

from YYYY to YYYY for payment appropriations.

X **unlimited duration**

– Implementation with a start-up period from one/two (tbc) year,

– followed by full-scale operation.

**1.7.** **Management mode(s) planned[65]**

X **Direct management by the Commission**

–  by its departments, including by its staff in the Union delegations;

–  by the executive agencies

 **Shared management with the Member States**

 **Indirect management by entrusting budget implementation tasks to:**

–  third countries or the bodies they have designated;

–  international organisations and their agencies (to be specified);

–  the EIB and the European Investment Fund;

–  bodies referred to in Articles 70 and 71 of the Financial Regulation;

–  public law bodies;


–  bodies governed by private law with a public service mission to the extent that

they provide adequate financial guarantees;

–  bodies governed by the private law of a Member State that are entrusted with

the implementation of a public-private partnership and that provide adequate
financial guarantees;

–  persons entrusted with the implementation of specific actions in the CFSP

pursuant to Title V of the TEU, and identified in the relevant basic act.

– _If more than one management mode is indicated, please provide details in the ‘Comments’ section._

Comments

65 Details of management modes and references to the Financial Regulation may be found on the
[BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html](http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html)

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**2.** **MANAGEMENT** **MEASURES**

**2.1.** **Monitoring and reporting rules**

_Specify frequency and conditions._

The Regulation will be reviewed and evaluated five years from the entry into force of
the regulation. The Commission will report on the findings of the evaluation to the
European Parliament, the Council and the European Economic and Social
Committee.

**2.2.** **Management and control system(s)**

_2.2.1._ _Justification of the management mode(s), the funding implementation mechanism(s),_
_the payment modalities and the control strategy proposed_

The Regulation establishes a new policy with regard to harmonised rules for the
provision of artificial intelligence systems in the internal market while ensuring the
respect of safety and fundamental rights. These new rules require a consistency
mechanism for the cross-border application of the obligations under this Regulation
in the form of a new advisory group coordinating the activities of national
authorities.

In order to face these new tasks, it is necessary to appropriately resource the
Commission’s services. The enforcement of the new Regulation is estimated to
require 10 FTE à regime (5 FTE for the support to the activities of the Board and 5
FTE for the European Data Protection Supervisor acting as a notifying body for AI
systems deployed by a body of the European Union).

_2.2.2._ _Information concerning the risks identified and the internal control system(s) set up_
_to mitigate them_

In order to ensure that the members of the Board have the possibility to make
informed analysis on the basis of factual evidence, it is foreseen that the Board
should be supported by the administrative structure of the Commission and that an
expert group be created to provide additional expertise where required.

_2.2.3._ _Estimate and justification of the cost-effectiveness of the controls (ratio of "control_
_costs ÷ value of the related funds managed"), and assessment of the expected levels_
_of risk of error (at payment & at closure)_

For the meeting expenditure, given the low value per transaction (e.g. refunding
travel costs for a delegate for a meeting), standard control procedures seem
sufficient. Regarding the development of the database, contract attribution has a
strong internal control system in place in DG CNECT through centralised
procurement activities.

**2.3.** **Measures to prevent fraud and irregularities**

_Specify existing or envisaged prevention and protection measures, e.g. from the Anti-Fraud Strategy._

The existing fraud prevention measures applicable to the Commission will cover the
additional appropriations necessary for this Regulation.

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**3.** **ESTIMATED** **FINANCIAL** **IMPACT** **OF** **THE** **PROPOSAL/INITIATIVE**

**3.1.** **Heading(s) of the multiannual financial framework and expenditure budget line(s) affected**

-  Existing budget lines

In order of multiannual financial framework headings and budget lines.

|Heading of multiannual financial framework|Budget line|Type of expenditure|Contribution|Col5|Col6|Col7|
|---|---|---|---|---|---|---|
||Number|Diff./Non- 66 diff.|from EFTA countries 67|from candidate 68 countries|from third countries|within the meaning of Article 21(2)(b) of the Financial Regulation|
|7|20 02 06 Administrative expenditure|Non-diff.|NO|NO|NO|NO|
|1|02 04 03 DEP Artificial Intelligence|Diff.|YES|NO|NO|NO|
|1|02 01 30 01 Support expenditure for the Digital Europe programme|Non-diff.|YES|NO|NO|NO|



**3.2.** **Estimated financial impact of the proposal on appropriations**

_3.2.1._ _Summary of estimated impact on expenditure on operational appropriations_

–  The proposal/initiative does not require the use of operational appropriations

– X The proposal/initiative requires the use of operational appropriations, as explained below:


EUR million (to three decimal places)


66 Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.

67 EFTA: European Free Trade Association.

68 Candidate countries and, where applicable, potential candidate countries from the Western Balkans.

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|Heading of multiannual financial framework|1|Col3|
|---|---|---|

|DG: CNECT|Col2|Col3|Col4|Year 2022|Year 2023|Year 2024|Year 2025|Year 2026|Year 69 2027|TOTAL|Col12|
|---|---|---|---|---|---|---|---|---|---|---|---|
| Operational appropriations||||||||||||
|70 Budget line 02 04 03||Commitments|(1a)||1.000||||||1.000|
|||Payments|(2a)||0.600|0.100|0.100|0.100|0.100||1.000|
|Budget line||Commitments|(1b)|||||||||
|||Payments|(2b)|||||||||
|Appropriations of an administrative nature financed from the envelope of specific 71 programmes||||||||||||
|Budget line 02 01 30 01|||(3)||0.240|0.240|0.240|0.240|0.240||1.200|
|TOTAL appropriations for DG CNECT||Commitments|=1a+1b +3||1.240||0.240|0.240|0.240||2.200|
|||Payments|=2a+2b +3||0.840|0.340|0.340|0.340|0.340||2.200|


69 Indicative and dependent on budget availability.

70 According to the official budget nomenclature.

71 Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former ‘BA’ lines), indirect research,
direct research.

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| TOTAL operational appropriations|Commitments|(4)|Col4|1.000|Col6|Col7|Col8|Col9|Col10|1.000|
|---|---|---|---|---|---|---|---|---|---|---|
||Payments|(5)||0.600|0.100|0.100|0.100|0.100||1.000|
| TOTAL appropriations of an administrative nature financed from the envelope for specific programmes||(6)||0.240|0.240|0.240|0.240|0.240||1.200|
|TOTAL appropriations under HEADING 1 of the multiannual financial framework|Commitments|=4+ 6||1.240|0.240|0.240|.0.240|0.240||2.200|
||Payments|=5+ 6||0.840|0.340|0.340|0.340|0.340||2.200|


**If more than one heading is affected by the proposal / initiative, repeat the section above:**

| TOTAL operational appropriations (all operational headings)|Commitments|(4)|Col4|Col5|Col6|Col7|Col8|Col9|Col10|Col11|
|---|---|---|---|---|---|---|---|---|---|---|
||Payments|(5)|||||||||
| TOTAL appropriations of an administrative nature financed from the envelope for specific programmes (all operational headings)||(6)|||||||||
|TOTAL appropriations under HEADINGS 1 to 6 of the multiannual financial framework (Reference amount)|Commitments|=4+ 6|||||||||
||Payments|=5+ 6|||||||||



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|Heading of multiannual financial framework|7|‘Administrative expenditure’|
|---|---|---|


[This section should be filled in using the 'budget data of an administrative nature' to be firstly introduced in the Annex to the Legislative](https://myintracomm.ec.europa.eu/budgweb/EN/leg/internal/Documents/2016-5-legislative-financial-statement-ann-en.docx)
[Financial Statement (Annex V to the internal rules), which is uploaded to DECIDE for interservice consultation purposes.](https://myintracomm.ec.europa.eu/budgweb/EN/leg/internal/Documents/2016-5-legislative-financial-statement-ann-en.docx)

EUR million (to three decimal places)

|Col1|Year 2023|Year 2024|Year 2025|Year 2026|Year 2027|After 72 2027|
|---|---|---|---|---|---|---|



DG: CNECT

| Human resources|Col2|Col3|0.760|0.760|0.760|0.760|0.760|0.760|
|---|---|---|---|---|---|---|---|---|
| Other administrative expenditure|||0.010|0.010|0.010|0.010|0.010|0.010|
|TOTAL DG CNECT||Appropriations|0.760|0.760|0.760|0.760|0.760|0.760|
|European Data Protection Supervisor|||||||||
| Human resources|||0.760|0.760|0.760|0.760|0.760|0.760|
| Other administrative expenditure|||||||||
|TOTAL EDPS||Appropriations|0.760|0.760|0.760|0.760|0.760|0.760|
|TOTAL appropriations under HEADING 7 of the multiannual financial framework|(Total commitments = Total payments)||1.530|1.530|1.530|1.530|1.530|1.530|



EUR million (to three decimal places)

|Col1|Col2|Year 2022|Year 2023|Year 2024|Year 2025|Year 2026|Year 2027|Col9|
|---|---|---|---|---|---|---|---|---|
|TOTAL appropriations|Commitments||2.770|1.770|1.770|1.770|1.770||



72 All figures in this column are indicative and subject to the continuation of the programmes and availability of appropriations

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|under HEADINGS 1 to 7 of the multiannual financial framework|Payments|Col3|2.370|1.870|1.870|1.870|1.870|
|---|---|---|---|---|---|---|---|


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_3.2.2._ _Estimated output funded with operational appropriations_


Commitment appropriations in EUR million (to three decimal places)

|Indicate objectives and outputs |Col2|Col3|Year 2022|Col5|Year 2023|Col7|Year 2024|Col9|Year 2025|Col11|Year 2026|Col13|Year 2027|Col15|After 73 2027|Col17|TOTAL|Col19|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
||OUTPUTS||||||||||||||||||
||Type|Average cost|Cost No||Cost No||Cost No||Cost No||Cost No||Cost No||Cost No||Tota Total l No cost||
|74 SPECIFIC OBJECTIVE No 1 …|||||||||||||||||||
|Database|||||1 1.000||1||1||1||1||1 0.100||1|1.000|
|Meetings- Output|||||10 0.200||10 0.200||10 0.200||10 0.200||10 0.200||10 0.200||50|1.000|
|Communication activities|||||2|0.040|2|0.040|2|0.040|2|0.040|2|0.040|2|0.040|10|0.040|
|Subtotal for specific objective No 1|||||||||||||||||||
|SPECIFIC OBJECTIVE No 2 ...|||||||||||||||||||
|- Output|||||||||||||||||||
|Subtotal for specific objective No 2|||||||||||||||||||
|TOTALS|||||13|0.240|13|0.240|13|0.240|13|0.240|13|0.240|13|0.100|65|2.200|



73 All figures in this column are indicative and subject to the continuation of the programmes and availability of appropriations

74 As described in point 1.4.2. ‘Specific objective(s)…’

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_3.2.3._ _Summary of estimated impact on administrative appropriations_

–  The proposal/initiative does not require the use of appropriations of an

administrative nature

– X The proposal/initiative requires the use of appropriations of an administrative

nature, as explained below:

EUR million (to three decimal places)

|Col1|Year 2022|Year 2023|Year 2024|Year 2025|Year 2026|Year 2027|Yearly after 75 2027|TOTAL|
|---|---|---|---|---|---|---|---|---|


|HEADING 7 of the multiannual financial framework|Col2|Col3|Col4|Col5|Col6|Col7|Col8|Col9|
|---|---|---|---|---|---|---|---|---|
|Human resources||1.520|1.520|1.520|1.520|1.520|1.520|7.600|
|Other administrative expenditure||0.010|0.010|0.010|0.010|0.010|0.010|0.050|
|Subtotal HEADING 7 of the multiannual financial framework||1.530|1.530|1.530|1.530|1.530|1.530|7.650|


|76 Outside HEADING 7 of the multiannual financial framework|Col2|Col3|Col4|Col5|Col6|Col7|Col8|Col9|
|---|---|---|---|---|---|---|---|---|
|Human resources|||||||||
|Other expenditure of an administrative nature||0.240|0.240|0.240|0.240|0.240|0.240|1.20|
|Subtotal outside HEADING 7 of the multiannual financial framework||0.240|0.240|0.240|0.240|0.240|0.240|1.20|


|TOTAL|Col2|1.770|1.770|1.770|1.770|1.770|1.770|8.850|
|---|---|---|---|---|---|---|---|---|


The appropriations required for human resources and other expenditure of an administrative nature will be met by
appropriations from the DG that are already assigned to management of the action and/or have been redeployed within the
DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual
allocation procedure and in the light of budgetary constraints.

75 All figures in this column are indicative and subject to the continuation of the programmes and availability of
appropriations.

76 Technical and/or administrative assistance and expenditure in support of the implementation of
EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research.

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3.2.3.1. Estimated requirements of human resources

–  The proposal/initiative does not require the use of human resources.

– X The proposal/initiative requires the use of human resources, as explained

below:

_Estimate to be expressed in full time equivalent units_

|.|Col2|Col3|Year 2023|Year 2024|Year 2025|2026|2027|After 202777|Col10|
|---|---|---|---|---|---|---|---|---|---|
| Establishment plan posts (officials and temporary staff)||||||||||
|20 01 02 01 (Headquarters and Commission’s Representation Offices)|||10|10|10|10|10|10||
|20 01 02 03 (Delegations)||||||||||
|01 01 01 01 (Indirect research)||||||||||
|01 01 01 11 (Direct research)||||||||||
|Other budget lines (specify)||||||||||
|78  External staff (in Full Time Equivalent unit: FTE)||||||||||
|20 02 01 (AC, END, INT from the ‘global envelope’)||||||||||
|20 02 03 (AC, AL, END, INT and JPD in the delegations)||||||||||
|79 XX 01 xx yy zz|- at Headquarters|||||||||
||- in Delegations|||||||||
|01 01 01 02 (AC, END, INT - Indirect research)||||||||||
|01 01 01 12 (AC, END, INT - Direct research)||||||||||
|Other budget lines (specify)||||||||||
|TOTAL|||10|10|10|10|10|10||



**XX is the policy area or budget title concerned.**

The human resources required will be met by staff from the DG who are already assigned to management of the
action and/or have been redeployed within the DG, together if necessary with any additional allocation which
may be granted to the managing DG under the annual allocation procedure and in the light of budgetary
constraints.

EDPS is expected to provide half of the resources required.

Description of tasks to be carried out:

|Officials and temporary staff|To prepare a total of 13-16 meetings, draft reports, continue policy work, e.g. regarding future amendments of the list of high-risk AI applications, and maintain relations with Member States’ authorities will require four AD FTE and 1 AST FTE. For AI systems developed by the EU institutions, the European Data Protection Supervisor is responsible. Based on past experience, it can be estimated that 5 AD FTE are reuqired to fulfill the EDPS responsibilites under the draft legislation.|
|---|---|


77 All figures in this column are indicative and subject to the continuation of the programmes and
availability of appropriations.

78 AC = Contract Staff; AL = Local Staff; END = Seconded National Expert; INT = agency staff; JPD
= Junior Professionals in Delegations.

79 Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines).

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|External staff|Col2|
|---|---|


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_3.2.4._ _Compatibility with the current multiannual financial framework_

The proposal/initiative:


– X can be fully financed through redeployment within the relevant heading of the

Multiannual Financial Framework (MFF).

No reporgramming is needed.

–  requires use of the unallocated margin under the relevant heading of the MFF

and/or use of the special instruments as defined in the MFF Regulation.

Explain what is required, specifying the headings and budget lines concerned, the corresponding
amounts, and the instruments proposed to be used.

–  requires a revision of the MFF.

Explain what is required, specifying the headings and budget lines concerned and the corresponding
amounts.

_3.2.5._ _Third-party contributions_

The proposal/initiative:

– X does not provide for co-financing by third parties

–  provides for the co-financing by third parties estimated below:

Appropriations in EUR million (to three decimal places)

|Col1|Year 80 N|Year N+1|Year N+2|Year N+3|Enter as many years as necessary to show the duration of the impact (see point 1.6)|Col7|Col8|Total|
|---|---|---|---|---|---|---|---|---|
|Specify the co-financing body|||||||||
|TOTAL appropriations co-financed|||||||||



80 Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the
expected first year of implementation (for instance: 2021). The same for the following years.

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**3.3.** **Estimated impact on revenue**

–  The proposal/initiative has the following financial impact:

–  The proposal/initiative has the following financial impact:

–  on other revenue

–  on other revenue

– Please indicate, if the revenue is assigned to expenditure lines 

EUR million (to three decimal places)

|Budget revenue line:|Appropriation s available for the current financial year|81 Impact of the proposal/initiative|Col4|Col5|Col6|Col7|Col8|Col9|
|---|---|---|---|---|---|---|---|---|
|||Year N|Year N+1|Year N+2|Year N+3|Enter as many years as necessary to show the duration of the impact (see point 1.6)|||
|Article ………….|||||||||



For assigned revenue, specify the budget expenditure line(s) affected.

Other remarks (e.g. method/formula used for calculating the impact on revenue or any other
information).

81 As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net
amounts, i.e. gross amounts after deduction of 20 % for collection costs.

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