EN   EN 
 
 
 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}   EN 1  EN 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 s pectrum 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 pro vide 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, t he 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 principl es. 
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 trust2. 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 us ed 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, w hich 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 objecti ve 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  
2 European Commission, White Paper on Artificial Intelligence - A European approach to excellence and 
trust, COM(2020) 65 final, 2020.  EN 2  EN intelligence as stated by the European Council3 and ensures the protection of ethical principles 
as specifically requested by the European Parliament4.  
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 20 19 Conclusions on the 
Coordinated Plan on the development and use of artificial intelligence Made in Europe6, the 
Council further highlighted the importance of ensuring that European citizens’ rights are fully 
respected and called for a review of the exist ing 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 -risk7.  
The most recent Conclusi ons 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 rules8. 
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 ethics9, 
liability10 and copyright11. In 2021, those were followed by resolutions on AI in criminal 
matters12 and in education, culture and the audio -visual sector13. 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 develo pment, 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, th is 
                                                 
3 European Council, Special meeting of the European Council (1 and 2 October 2020) – Conclusions , 
EUCO 13/20, 2020, p. 6.  
4 European Parliament resolution of 20 Oct ober 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  EUCO 14/17, 2017, p. 
8. 
6 Council of the European Union, Artificial intelligence b) Conclusion s on the coordinated plan on 
artificial intelligence -Adoption  6177/19, 2019.  
7 European Council, Special meeting of the European Council (1and 2 October 2020) – Conclusions  
EUCO 13/20, 2020.  
8 Council of the European Union, Presidency conclusions - The Charter of Fundamental Rights in the 
context of Artificial Intelligence and Digital Chan ge, 11481/20, 2020.  
9 European Parliament resolution of 20 October 2020 on a framework of ethical aspects of artificial 
intelligence, robotics and related technologies, 2020/2012(INL) . 
10 European Parliament resolution of 20 October 2020 on a civil liability regime for artificial intelligence, 
2020/2014(INL).  
11 European Parliament resolution of 20 October 2020 on intellectual property rights for the development 
of artificial intelligence technologies, 2020/2015(INI).  
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) .  
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 
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 Communicatio n COM(2020) 624 
final.  EN 3  EN 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 investmen t 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, withou t 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, t he 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 i n 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 ri ghts 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 clea r 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 obl igations 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 measu res 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. EN 4  EN 1.2. Consistency with existing policy pr ovisions 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 ensu red 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 Regula tion (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 id entification 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 set s 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 pro cedures 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 ar e 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 integr ated into the procedures under Directive 2013/36/EU on access to the 
activity of credit institutions and the prudential supervision14.  
                                                 
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. EN 5  EN This proposal is also consistent with the applicable Union legislation on services, including on 
intermediary services re gulated by the e -Commerce Directive 2000/31/EC15 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 tho se 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 intend ed 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 o n 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 Genera l 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 ecosy stem 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 Decade18. 
Furthermore, the promotion of AI -driven innovation is closely linked to the Data 
Governance Act19, the Open Data Directive20 and other initiatives under the EU strategy 
for data21, which will establish trusted mech anisms 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 promo te 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 S ervices 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 . 
19 Proposal for a Regulation on European data governance (Data Governance Act) COM/2020/767 . 
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.  
 EN 6  EN 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 f unctioning 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 a nd 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 marketin g, 
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 befor e 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 cond ucted.  
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, a n 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 slo w 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 emb edding 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 t he Union’s digital sovereignty and leverage 
its tools and regulatory powers to shape global rules and standards.   EN 7  EN 2.3. Proportionality  
The proposal builds on existing legal frameworks and is proportionate and necessary to 
achieve its objectives, since it f ollows 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 te rms 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 AI -
enabled practices and the classification of certain AI syst ems. 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 1 9 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 p ublic 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 t he individual responses on its website22. 
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.  EN 8  EN academic/research institutions, a nd 73 from public authorities. Civil society’s voices were 
represented by 160 respondents (among which 9 consumers’ organisations, 129 non -
governmental organisations and 22 trade unions), 72 respondents contributed as ‘others’. Of 
the 352 business and indu stry 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 EU -
27. Depending on the q uestion, 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 duplicat ion, 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 a lso 
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%, 
especi ally 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 involve ment 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 an d 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 supported23 the key requirements set 
out in the HLEG ethics guidelines for Trustworthy AI24, 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 privat e 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 pilo ting process with over 350 organisations.  
                                                 
23 European Commission, Building Trust in Human -Centric Artificial Intelligence , COM(2019) 168.  
24 HLEG, Ethics Guidelines for Trustworthy AI , 2019.  
25 HLEG, Assessment List for Trustworthy Artificial Intelligence (ALTAI) for self -assessment , 2020.  EN 9  EN In addition, the AI Alliance26 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 f urther 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 comment s27. 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 proposal28. 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 follow ed 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 Scru tiny 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.europ a.eu/digital -single -market/en/european -ai-alliance  
27 European Commission, Inception Impact Assessment For  a Proposal for a legal act of the European 
Parliament and the Council laying down requirements for Artificial Intelligence .  
28 For details of all the consultations that have been carried out see Annex 2 of the impact assessment.  EN 10  EN 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 ad dress 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 t rust, 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 fast -
growing AI ecosystem of innovative se rvices 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 citizen s 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 high -
risk 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 amoun t 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 poli cy 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 lega l 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). More over, 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 EN 11  EN AI systems (e.g. on products and services) that will bring further clarity and simplify the 
enforc ement 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 Fundamen tal 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 (Articl es 7 and 8), non -
discrimination (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 t o 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 aff ect 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 
disabilit ies (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 enforceme nt 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 imp oses 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 requ irements. Their supervisory function could build on existing arrangements, for EN 12  EN example regarding conformity assessment bodies or market surveillance, but would require 
sufficient technological expertise and human and financial resources. Depending on the p re-
existing 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. Implementati on 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 mon itoring 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 inform ation 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 Ann ex 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 a nd 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 Unio n 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 EN 13  EN vulnerabilities of specific vulnerable gro ups 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 m ight 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 hi gh-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 mo dalities for 
which that system is used.  
Chapter 1 of Title III sets the classification rules and identifies two main categories of high -
risk 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 materi alised 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 over sight, 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 HLEG29, piloted by 
more than 350 organisations30. 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 
solution s 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. T his 
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.  
30 They were also endorsed by the Commission in its 2019 Communication on human -centric approach to 
AI. EN 14  EN 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 se t 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 app roach 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 
Legislat ive 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 
comp liance 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 r egulatory 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 documen ted 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 s afety 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 ant e 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 con formity 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 ar e 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 EN 15  EN 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 INNOV ATION (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 bas ic 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 implementati on 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 monito ring 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 b y 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 syste ms 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 cr eation 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 a uthorities 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.  EN 16  EN 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). Pro viders 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 
infringe ments 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 t o 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 d own 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.  EN 17  EN 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 COUNCI L 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 Committee31, 
Having regard to the opinion of the Committee of the Regions32, 
Acting in accordance with the ordinary legislative procedure,  
Whereas:  
(1) The purpose of thi s 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 th e 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 t o 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 o f 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 throug hout 
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  concerni ng 
                                                 
31 OJ C […], […], p. […].  
32 OJ C […], […], p. […].  EN 18  EN 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 Articl e 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 arr ay 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, th e 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 genera te 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 develop ment, 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 Counci l33, and it ensures the protection of 
ethical principles, as specifically requested by the European Parliament34. 
(6) The notion of AI system should be clearly defined to ensure legal certainty, while 
providing the flexibility to accommodate future technolog ical 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, irrespectiv e 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 Commissio n on a 
framework of ethical aspects of artificial intelligence, robotics and related technologies, 
2020/2012(INL).  EN 19  EN 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 Council35, Article 
3(18) of Regulation (EU) 2018/1725 of the European Par liament and of the Council36 
and Article 3(13) of Directive (EU) 2016/680 of the European Parliament and of the 
Council37.   
(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 be tween ‘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 s ignificant 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’ mate rial, 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 de lay. 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 thi s 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 cove r 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 factor ies.  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 Octobe r 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).  EN 20  EN particular space may apply, such as admission tickets or age restrictions, does not 
mean that the space is not publi cly 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 nor mally also publicly accessible. Whether a 
given space is accessible to the public should however be determined on a case -by-
case basis, having regard to the specificities of the individual situation at hand.   
(10) In order to ensure a level playing field a nd 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 Unio n 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 servic e, 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 hig h-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 opera tor 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 accoun t 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.  EN 21  EN (14) In order  to introduce a proportionate and effective set of binding rules for AI syste ms, 
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 inte lligence 
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 tec hnology 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 s ystems 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 syst ems 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 o r 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 freed oms 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 EN 22  EN the use is stri ctly 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/JHA38 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 
nationa l 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 a re 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, i dentification 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 regar ds 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, hav ing 
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 a n 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 requ est 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 M ember 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).  EN 23  EN 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 spa ces 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 connectio n 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 processin g 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 enfo rcement 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 R egulation (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 pe rsonal 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 o r 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 b y 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.   EN 24  EN (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 outc omes 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 th at 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 ins tance, 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 Cha rter 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 compon ents 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 Council39, Regulation (EU) No 
167/2013  of the European Parliament and of the Council40, Reg ulation (EU) No 
168/2013  of the European Parliament and of the Council41, 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).  EN 25  EN the European Parliament and of the Council42, Directive (EU) 2016/797  of the 
European Parliament and of the Council43, Regulation (EU) 2018/858  of the European 
Parliament and of the Council44, Regulation (EU) 2018/1139 of the European 
Parliament and of the Council45, and Regulation (EU) 2019/2144  of the European 
Parliament and of the Council46, it is appropriate to amend those acts to ensure that the 
Commission take s 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 fo r 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 wi thin 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 equi pment, 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 s afety 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 Europ ean 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 1 008/2008, (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 R egulation (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) N o 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).  EN 26  EN Council47 and Regulation (EU) 2017/746 of the European Parliament and of the 
Council48, where a third -party conformity assessment is provided for medium -risk and 
high-risk products.   
(32) As regards stand -alone AI sy stems, 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 identifica tion 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 i s 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 educa tional 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 therefor e 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 pe rsons 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 Europea n 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).  EN 27  EN evaluation, promo tion, 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 ori gins 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 
acces s 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 sc ale 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 apply ing 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 whet her 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, non -
discrimination, human dignity or an effective remedy. Those systems should therefore 
be classified as high -risk. Nonetheless, this Regulation should not hamper the 
development and use of innovative approaches in the public administration, which 
would stand to benefit from  a wider use of compliant and safe AI systems, provided 
that those systems do not entail a high risk to legal and natural persons. Finally, AI 
systems used to dispatch or establish priority in the dispatching of emergency first 
response services should als o 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 de gree 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 dat a, 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 unjus t 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 s ystems 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 EN 28  EN 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 proc eedings, 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 profil ing 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 no t 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, non -
discriminatory nature and transparency of the AI systems used in those contexts are 
therefore partic ularly 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 th erefore 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 s tate 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 pub lic 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 Council49, the Regulation (EC) No 
810/2009 of the European Parliament and of the Council50 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, rul e 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 actua l 
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 (Vi sa Code) ( OJ L 243, 15.9.2009, p.  1). 
 EN 29  EN (41) The fact that an AI system is classi fied 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 t he 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 
informati on 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 u sed, 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 appro priate 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 f rom 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 correct ion 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 w ill 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, EN 30  EN 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 sys tems 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 process es 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 d egree 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 incl ude 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 function ing. 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 sub ject 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 acc uracy 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, 
inconsiste ncies, 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.  EN 31  EN (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 dow n 
consistently with Regulation (EC) No 765/2008 of the European Parliament and of the 
Council51 setting out the requirements for accreditation and the market surveillance of 
products, Decision No 768/2008/EC of the European Parliament and of the Council52 
on a common framework for the marketing of products and Regulation (EU) 
2019/1020 of the European Parliament and of the Council53 on market surveillance 
and compliance of products  (‘New Legislative Framework for the marketing of 
products’).  
(53) It is appropr iate 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 pu t 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 specificitie s 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 a nd 
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 the ir 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 pri nciples, 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 Reg ulation (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 rel evance) (OJ L 169, 25.6.2019, p. 1 –44). EN 32  EN (58) Given the nature of AI systems and the risks t o 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 shou ld 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 non -
profes sional 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 provid ers 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 k ey 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 
Council54 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 trus tworthiness 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 d uplication, 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 a ssessed 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 re levant 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 re quirements 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, 95/1 6/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).  EN 33  EN The [Machinery Regulati on] 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 b e 
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 Regulati on 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 thei r 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 rea sons 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 c onformity 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 t o 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 EN 34  EN Council55. 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 
qualif y 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 
categorisatio n 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, p laces 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 
mitigati on measures. To ensure a legal framework that is innovation -friendly, future -
proof and resilient to disruption, national competent authorities from one or more 
Member States should be encouraged to establish artificial intelligence regulatory 
sandboxes to facilitate 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 innovatio n 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 
authorit ies 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 wi th 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 aut horities, 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).  EN 35  EN 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 small -
scale 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 informa tion 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 communicati on with 
operators is one which is broadly understood by the largest possible number of cross -
border 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 complian ce 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 approp riate 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 t he 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 (E U) 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 advi sory 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 a nd 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 pu blic 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 
exper ience on the use of high -risk AI systems for improving their systems and the EN 36  EN 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 al so 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 syst em 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 ens ure 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 leg islation,  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 Council56, 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 in stitutions 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. Provide rs 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 dev elop 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).  EN 37  EN 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 ty pes 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 Council57  would apply as a safety net.  
(83) In order to ensure trustful and constructive cooperation of competent authorities on 
Union and nationa l 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 thi s 
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 e stablishing 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-Making58. In particula r, 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 g roups 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 Regul ation (EU) No 182/2011 of the European 
Parliament and of the Council59. 
(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).  EN 38  EN 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 o rder 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 Commissi on 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;  EN 39  EN (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) 201 8/1139;  
(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 
internati onal 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 Council60 [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’ m eans 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).  EN 40  EN (3) ‘small -scale provider’ means a provider that is a micro or small enterprise within the 
meaning of Commission Recommendation 2003/361/EC61; 
(4) ‘user’ means any natural or legal person, public authority, agency or other body 
using an AI s ystem 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 provid er 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 o n 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 tha t 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 a n 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 ret urn 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 medium -
sized enterprises (OJ L 124, 20.5.2003, p. 36).  EN 41  EN (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 t o 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 t hird-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 
modif ication 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 o f 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) ‘marke t 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 tr aining 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 learnin g 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;  EN 42  EN (32) ‘input data’ means data provided to or directly acquired by an AI system on the ba sis 
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, an d 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 da ta, 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 threat s 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 imple mentation 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;  EN 43  EN (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 Com mission 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 simi lar 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 A I 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 t he 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 grou p 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 classifica tion 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 person s 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 a s far as 
such use is strictly necessary for one of the following objectives : EN 44  EN (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/JHA62 and punish able 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 acces sible 
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, pr obability 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 
safegu ards 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 m ay 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’ r emote 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 aut hority 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 space s 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) . 
 EN 45  EN 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 i ntended 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 para graph 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 s ystems 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 o n 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 purpo ses 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 EN 46  EN already referred to in Annex II I, 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 co mpetent 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 
depend ent 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 pos ition 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 HIG H-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:  EN 47  EN (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 A I 
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 Art icle 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 interac tions 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 informati on 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 
consideratio n 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 
appropr iate 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 i ntended 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 eve nt, 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.  EN 48  EN 8. When implementing the r isk 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 aspe cts 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 involvin g 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 syst em 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 purpos e, the characteristics or elements that are particular to 
the specific geographical, behavioural or functional setting within which the high -
risk AI system is intended to be used.  
5. To the extent that it is strictly necessary for the purposes of ensuring  bias 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 measure s, such as 
pseudonymisation, or encryption where anonymisation may significantly affect the 
purpose pursued.  EN 49  EN 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 pla ced 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 competen t 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, t o 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 ass ess 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 s ystems 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 m eaning 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;  EN 50  EN (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 th e 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 cha racteristics, 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 hig h-
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 
measur es 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 a s regards software updates.  EN 51  EN 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 peri od 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 a nd 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 tha t 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 l imitations 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 automatical ly 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 int erpret 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 other wise 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 conf irmed 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, EN 52  EN 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 a lter 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 PROVI DERS AND USERS OF HI GH-RISK AI SYSTEMS A ND 
OTHER PARTIES  
Article 16  
Obligations of providers of high -risk AI systems  
Providers of high -risk AI systems shall:  
(a) ensure that their hig h-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 r egistration 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 ; EN 53  EN (h) inform the national competent authorities of the Mem ber 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 confo rmity 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 syst em  
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 
instruc tions, 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, pro cedures 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 standa rds, 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 th e 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;  EN 54  EN (m) an accountabil ity 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 organisat ion.  
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 documen tation 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 c oncerning 
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 assessmen t 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 assessm ent, 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 gen erated 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 s hall 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 
mainta in the logs automatically generated by their high -risk AI systems as part of the 
documentation under Articles 74 of that Directive.  EN 55  EN Article 21  
Corrective actions  
Providers of high -risk AI systems which consider o r 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 s hall 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 6 5(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 certifica te 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 tha t 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 c oncerned, 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:  EN 56  EN (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 reaso ned 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 assess ment 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 documenta tion 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 na me 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 s ystem 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 req uest, 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, 
includ ing 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 
authoriti es on any action national competent authority takes in relation to that 
system.  EN 57  EN 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 conformi ty 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 require ments, 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 high -
risk 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 t his 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 syste m 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.  EN 58  EN 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 exer cises 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 s hall 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 perio d that is appropriate in the light of the intended purpose of the high -
risk 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 AUTHORITI ES AND NOTIFIED BODI ES 
Article 30  
Notifying authorities  
1. Each Member State shall de signate 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 nat ional accreditation body referred to in Regulation 
(EC) No 765/2008 as a notifying authority.  EN 59  EN 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 safegu ard 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 ass essments 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 t o 
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 devel oped and managed by the Commission.  EN 60  EN 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 b ody 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 shal l be such as to ensure that there is confidence in the 
performance by and in the results of the conformity assessment activities that the 
notified bodies conduct.  
4. Notified bodies shall be independent of the provider of a high-risk AI system in 
relation to which it performs conformity assessment activities. Notified bodies shall 
also be independent of any other operator having an economic interest in the high -
risk AI system that is assessed, as well as of any competitors of the provider.  
5. Notified bodie s 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 principl es 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 obser ve 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 liabili ty 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 capab le of carrying out all the tasks falling to them under 
this Regulation with the highest degree of professional integrity and the requisite EN 61  EN competence in the specific field, whether those tasks are carried out by notified 
bodies themselves or on their behal f 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 proced ure 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 t he 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 d irectly 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 p roviders’ 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 requirement s 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 a nd 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 numb er, 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 w hich they have been notified. The Commission shall ensure 
that the list is kept up to date.  EN 62  EN 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 do wn 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, suspe nd 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 authoriti es 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 i nvestigations 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 notifie d 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.  EN 63  EN 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 Journa l 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 Ar ticle 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 commo n 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 specificati ons 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 pr esumed 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 test ed 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).  EN 64  EN 2. High -risk AI systems that have been certi fied 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 Council63 and the references of which have 
been published in the Official Journal of the Euro pean 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  
Confor mity 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 b ody. 
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 thi s 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 Uni on 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).  EN 65  EN 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 notifie d 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 Articl e 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 provi der 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 we ll as the availability of adequate 
capacities and resources among notified bodies.  
Article 44  
Certificates  
1. Certificates issued by notified bodies in accordance with Annex VII shall be drawn -
up in 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 vali dity 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 66  EN proportionality, suspend or withdraw the certificate issued or impose any restrictions 
on it, unless compliance with those requirements is ensured by appropriate cor rective 
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 app eal 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 Un ion 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 informatio n 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 confo rmity 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 sh all be for a limited period of time, while the necessary conformity EN 67  EN 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 Commi ssion 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 rega rding 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 th eir 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 unj ustified, 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 devi ces, 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 th e 
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 co nformity 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 S tate(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 EN 68  EN 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 declara tion 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 t o 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 o f 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 accompa nying 
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 re quirements 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 documen ts 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.  EN 69  EN 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 investi gate 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 tr uthful (‘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 part ies. 
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 s upervisory remit of other 
national authorities or competent authorities providing or supporting access to data, EN 70  EN 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 legislat ion 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 f ramework 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 f or 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 refer red 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 proce ssed 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 comp etent 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;  EN 71  EN (c) there a re 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 proce ssing;  
(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 da ta 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 o r 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 p urposes 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 s mall-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.  EN 72  EN TITLE  VI 
GOVERNANCE  
CHAPTER 1 
EUROPEAN ARTIFICIAL INTELLIGENCE BOARD  
Artic le 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 co operation 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 au thorities 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 authoritie s 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 Commissio n 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 pu rsuant 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 excha nges between the Board and 
other Union bodies, offices, agencies and advisory groups.  EN 73  EN 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 cont ributions 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 specif ications 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 A UTHORITIES  
Article 59  
Designation o f 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 au thority 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 aut horities 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.  EN 74  EN 7. National competent authorities may provide gu idance 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 compe tent 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 s hall, 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 sha ll 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 propor tionate to the nature of the artificial intelligence technologies and the 
risks of the high -risk AI system.  EN 75  EN 2. The post -market monitoring system shall actively and systematically collect, 
document and analyse relevant data provided by users or collected th rough 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 f or 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 legislat ion, 
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 servi ce by credit institutions 
regulated by Directive 2013/36/EU.  
CHAPTER 2 
SHARING OF INFORMATIO N ON INCIDENTS AND M ALFUNCTIONING  
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 
surveillanc e 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 o f 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 guida nce 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 regu lated 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.  EN 76  EN CHAPTER 3 
ENFORCEMENT  
Article 63  
Market surveillance and control of AI systems in the Union market  
1. Regulation (EU) 2019/1020 shall ap ply 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 T itle 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 aut hority 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 Unio n 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 p oint 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 aut horities 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 institutio ns, 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 designate d 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 An nex III . EN 77  EN Article 64  
Access to data and documentation  
1. Access to data and documentation i n the context of their activities, t he market 
surveillance authorities shall be granted full access to the training, validation and 
testing datasets used by the provi der, 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, Chap ter 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 fu ndamental 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 fulfilm ent 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 in to 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 Co mmission 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 high -
risk AI system through technical means. The market surveillance authority shall 
organise the testing with the close involvement of the requesting public authority or 
body within reasonable time following the request.  
6. Any information and documentation obtained by the national public authorities or 
bodies referred to in paragraph 3 pursuant to the provisions of this Article shall be 
treated in compliance with the confidentiality obligations set out in Article 70.  
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 pr esenting 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 suffi cient 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. Wh en 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 EN 78  EN 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 wit hdraw 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 t he 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 th e 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 ini tiating 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 disagree ment 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.  EN 79  EN 9. The market surveillance authorities of all Member States shall ensure that 
appropriate restrictive measures are t aken 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 rai sed 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 oper ators 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 d ecision 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 accor dingly. 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, hav ing 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 obligati ons 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 mar ket 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 en sure 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 paragrap h 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 suppl y 
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 nati onal measures taken. On the basis EN 80  EN 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 non -
compliance concerned:  
(a) the conformity marking has been aff ixed 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 notifie d 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 prohibi t 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 bas is 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 o f 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 system s 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 sy stems.  EN 81  EN 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 pro tect, 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 interes ts;  
(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 d isclosure would jeopardise public and 
national security interests.  
When the law enforcement, immigration or asylum authorities are providers of high -
risk AI systems referred to in points 1, 6 and 7 of Annex III, the technical 
documentation referred to in A nnex 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 Co mmission, 
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 Mem ber 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 82  EN Artic le 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 nec essary 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 economi c 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 u p 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 Arti cle 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 t o 
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 not ified 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, whic hever 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 State s, 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.  EN 83  EN 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 Regulat ion. 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 Un ion 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.  EN 84  EN 2. The delegation of power referred to in Article 4, Article 7(1), Arti cle 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), Arti cle 
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 P arliament 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 wil l 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 me aning 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/X X [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 …).”  
Artic le 76  
Amendment to Regulation (EU) No 167/2013  
In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added:  EN 85  EN “When adopting delegated acts pursuant to the first subparagraph concerning artificial 
intelligence systems which are safet y 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 concern ing 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.  
__________  
* Regulatio n (EU) YYY/XX [on Artificial Intelligence] (OJ …).”.  EN 86  EN 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 Parl iament 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 th at 
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 II I, Chapter 2 of that Regulation  shall be taken into account.”  
(6) In Article 58, the following paragraph is added:  EN 87  EN “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) 2019/214 4, 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 Europe an 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 marke t or put into service  
1. This Regulation shall not apply to the AI systems which are components of the large -
scale IT systems established by the legal acts listed in Annex IX that have been 
placed on the market or put into service before [12 months after t he 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 ap ply 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 ta sks assigned to them under this 
Regulation;  EN 88  EN (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 Commi ssion 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  EN 89  EN 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 v alue 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 inte rvention 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)  EN 90  EN  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 appropri ations  
 3.2.4.  Compatibility with the current multiannual financial framework  
 3.2.5.  Third -party contributions  
 3.3. Estimated impact on revenueEN 91  EN 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 action64  
 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 ob jective 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 mar ket; 
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 as sessment and ex 
                                                 
64 As referred to in Article 54(2)(a) or (b) of the Financial  Regulation   EN 92  EN 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.  EN 93  EN 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 fro m 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 mo nitoring 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 ab solute 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 lo ng 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 additio nal 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 EN 94  EN safety a nd 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 a nd 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 su pervision 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 aspe cts 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 reaso n, 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 wi th 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 
requiremen ts 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 i n 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 redeploye d. 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.  EN 95  EN 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 durat ion 
– Implementation with a start -up period from one/two (tbc) year,  
– followed by full -scale operation.  
1.7. Management mode(s) planned65  
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 specifi ed); 
–  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  EN 96  EN 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 administr ative 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. Re garding 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.   
EN 97  EN 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 
framewo rk Budget line  Type of  
expenditure  Contribution  
Number  
 Diff./Non -
diff.66 from 
EFTA 
countries
67 
 from 
candidate 
countries68 
 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 t hree 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.   
EN 98  EN Heading of multiannual financial  
framework  1  
 
DG: CNECT     Year 
2022  Year 
2023  Year 
2024  Year 
2025  Year 
2026  Year 
202769 TOTAL  
 Operational appropriations          
Budget line70 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 
programmes71  
         
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 budg et 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.   
EN 99  EN  TOTAL operational appropriations  Commitments  (4)  1.000       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)         
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          
 
   
EN 100  EN 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 
Financial Statement  (Annex V to the internal rules), which is uploaded to DECIDE for interservice consultation purposes.  
EUR million (to three decimal places)  
   Year 
2023  Year 
2024  Year 
2025  Year 
2026  Year 2027  After 
202772 TOTAL  
DG: CNECT  
 Human resources  0.760  0.760  0.760  0.760  0.760  0.760  3.800  
 Other administrative expenditure  0.010  0.010  0.010  0.010  0.010  0.010  0.050  
TOTAL DG CNECT  Appropriations  0.760  0.760  0.760  0.760  0.760  0.760  3.850  
European Data Protection Supervisor   
 Human resources  0.760  0.760  0.760  0.760  0.760  0.760  3.800  
 Other administrative expenditure         
TOTAL EDPS  Appropriations  0.760  0.760  0.760  0.760  0.760  0.760  3.800  
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  7.650  
EUR million (to three decimal places)  
   Year 
2022  Year 
2023  Year 
2024  Year 
2025  Year 2026  Year 2027   TOTAL  
TOTAL appropriations  Commitments   2.770  1.770  1.770  1.770  1.770   9.850  
                                                 
72 All figures in this column are indicative and subject to the continuation of the programmes and availability of appropriations   
EN 101  EN under HEADINGS 1 to 7  
of the multiannual financial framework   Payments   2.370  1.870  1.870  1.870  1.870  9.850   
EN 102  EN 3.2.2.  Estimated output funded with operational appropriations  
Commitment appropriations in EUR million (to three decimal places)  
Indicate objectives 
and outputs  
 
   Year 
2022  Year 
2023  Year 
2024  Year 
2025  Year 
2026  Year 
2027  After 
202773 TOTAL  
 OUTPUTS  
 Type  
 Average 
cost 
No 
Cost 
No 
Cost 
No 
Cost 
No 
Cost 
No 
Cost 
No 
Cost 
No 
Cost Tota
l No Total 
cost 
SPECIFIC OBJECTIVE No 174…                 
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 appropriation s 
74 As described in point 1.4.2. ‘Specific objective(s)…’   
EN 103  EN 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)  
 Year 
2022  Year 
2023  Year 
2024  Year 
2025  Year 
2026  Year 
2027  Yearly after  
202775 TOTAL  
 
HEADING 7  
of the multiannual 
financial framework          
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  
 
Outside HEADING 776 
of the multiannual 
financial framework  
         
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   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 alloc ation 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.   
EN 104  EN 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  
 
.  Year 
2023  Year 
2024  Year 
2025  2026  2027  After 
202777  
 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)         
 External staff (in Full Time Equivalent unit: FTE)78 
 
20 02 01  (AC, END, INT from the ‘global envelope’)         
20 02 03 (AC, AL, END, INT and JPD in the delegations)         
XX 01  xx yy zz  79 
 - 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 allocatio n 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 system s 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).   
EN 105  EN External staff    
EN 106  EN 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/in itiative:  
– 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)  
 Year 
N80 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)  Total  
Specify the co -financing 
body           
TOTAL appropriations 
co-financed          
 
 
                                                 
80 Year N is the year in which implementatio n of the proposal/initiative starts. Please replace "N" by the 
expected first year of implementation (for instance: 2021). The same for the following years.   
EN 107  EN 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  Impact of the proposal/initiative81 
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.