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Book
The EU AI Act
A Commentary
Published: 2025
Pages: 500
eBook: 9781837231089
This invaluable commentary on the EU Artificial Intelligence Act (EU AI Act) offers a thorough analysis of this groundbreaking legislation. As AI technologies become more integrated into society, it is imperative to address the potential risks and ethical concerns they bring.
It is without any doubt that artificial intelligence is transforming the way we work, the way we live, and how we perceive the world. It is, however, less clear whether – and to what extent – the law can and should respond, and has the potential to shape these changes.
This invaluable commentary on the EU Artificial Intelligence Act (EU AI Act) offers a thorough analysis of this groundbreaking legislation. As AI technologies become increasingly integrated into society, it is imperative to address the potential risks and ethical concerns they bring.
Readers will quickly get a solid foundational understanding of the EU AI Act in the introductory chapter, which provides a comprehensive overview of the act as a whole. The following chapters deliver insightful examinations of each of the act’s articles by renowned experts in the field. Lukas Feiler, Nikolaus Forgó and Michaela Nebel bring diverse perspectives and deep knowledge to the discussion, making this an essential reference for anyone involved in AI regulation and compliance.
Businesses seeking initial guidance and pragmatic solutions on how to navigate the EU AI Act will find this book particularly useful. It is also an indispensable tool for lawyers, judges and other legal professionals who need to navigate the complexities of AI-related regulations.
This invaluable commentary on the EU Artificial Intelligence Act (EU AI Act) offers a thorough analysis of this groundbreaking legislation. As AI technologies become increasingly integrated into society, it is imperative to address the potential risks and ethical concerns they bring.
Readers will quickly get a solid foundational understanding of the EU AI Act in the introductory chapter, which provides a comprehensive overview of the act as a whole. The following chapters deliver insightful examinations of each of the act’s articles by renowned experts in the field. Lukas Feiler, Nikolaus Forgó and Michaela Nebel bring diverse perspectives and deep knowledge to the discussion, making this an essential reference for anyone involved in AI regulation and compliance.
Businesses seeking initial guidance and pragmatic solutions on how to navigate the EU AI Act will find this book particularly useful. It is also an indispensable tool for lawyers, judges and other legal professionals who need to navigate the complexities of AI-related regulations.
Table of Contents
| Cover | Cover | |
|---|---|---|
| Title Page | 1 | |
| Copyright | 2 | |
| Contents | 3 | |
| Preface | 11 | |
| List of abbreviations | 13 | |
| List of recitals of the AI Act | 21 | |
| An introduction to the AI Act | 23 | |
| 1. The scope of application of the AI Act | 23 | |
| 1.1 The material scope of application: What types of AI are covered? | 23 | |
| 1.2 The personal scope of application: To whom does the AI Act apply? | 24 | |
| 1.3 The territorial scope of application: Where does the AI Act apply? | 26 | |
| 1.4 The temporal scope of application: When does the AI Act apply? | 26 | |
| 2. The AI Act as an instrument of product regulation | 28 | |
| 2.1 An overview of European Union product regulation | 28 | |
| 2.2 The role of harmonised standards and common specifications | 30 | |
| 2.3 External conformity assessment bodies and their accreditation and notification | 30 | |
| 2.4 The relationship with other harmonisation legislation | 30 | |
| 3. Risk-based regulation of AI systems and AI models | 31 | |
| 3.1 Prohibited AI systems | 31 | |
| 3.2 High-risk AI systems | 32 | |
| 3.3 GenAI and certain biometric AI systems that are subject to special transparency regulations | 34 | |
| 3.4 Other AI systems | 35 | |
| 3.5 General-purpose AI models | 35 | |
| 4. An overview of the obligations of the AI Act | 36 | |
| 4.1 Obligations of the providers | 36 | |
| 4.1.1 Obligations regarding high-risk AI systems | 36 | |
| 4.1.2 Obligations regarding GenAI systems pursuant to Article 50 | 40 | |
| 4.1.3 Obligations regarding other AI systems | 40 | |
| 4.1.4 Obligations regarding general-purpose AI models | 41 | |
| 4.1.5 Obligations regarding general-purpose AI systems | 42 | |
| 4.2 Obligations of importers | 42 | |
| 4.2.1 Obligations regarding high-risk AI systems | 42 | |
| 4.2.2 Obligations regarding other AI systems | 43 | |
| 4.3 Obligations of distributors | 43 | |
| 4.3.1 Obligations regarding high-risk AI systems | 43 | |
| 4.3.2 Obligations regarding other AI systems | 44 | |
| 4.4 Obligations of the deployers. | 44 | |
| 4.4.1 Obligations regarding high-risk AI systems | 44 | |
| 4.4.2 Obligations regarding GenAI and certain biometric AI systems pursuant to Article 50 | 46 | |
| 4.4.3 Obligations regarding other AI systems | 47 | |
| 4.5 Obligations for authorised representatives | 47 | |
| 4.5.1 Obligations regarding high-risk AI systems | 47 | |
| 4.5.2 Obligations regarding general-purpose AI models | 48 | |
| 5. Measures to promote innovation | 48 | |
| 5.1 AI regulatory sandboxes | 48 | |
| 5.2 Testing in real-world conditions | 49 | |
| 6. Enforcement by the authorities | 51 | |
| 6.1 Market surveillance of AI systems | 51 | |
| 6.1.1 Regulatory responsibility for market surveillance | 51 | |
| 6.1.2 Powers of the market surveillance authorities | 54 | |
| 6.1.3 The market surveillance procedure | 55 | |
| 6.2 The AI Office as a supervisory authority for providers of generalpurpose AI models | 56 | |
| 6.3 Fines | 57 | |
| 7. Liability law and enforcement by private individuals | 58 | |
| Text of the EU AI Act and commentary | 61 | |
| Chapter I – General provisions | 63 | |
| Article 1 Subject matter | 63 | |
| Article 2 Scope | 70 | |
| Article 3 Definition | 85 | |
| Article 4 AI literacy | 125 | |
| Chapter II – Prohibited AI practices | 127 | |
| Article 5 Prohibited AI practices | 127 | |
| Chapter III – High-risk AI systems | 149 | |
| Section 1 – Classification of AI systems as high-risk | 149 | |
| Article 6 Classification rules for high-risk AI systems | 149 | |
| Article 7 Amendments to Annex III | 158 | |
| Section 2 – Requirements for high-risk AI systems | 160 | |
| Article 8 Compliance with the requirements | 160 | |
| Article 9 Risk management system | 162 | |
| Article 10 Data and data governance | 167 | |
| Article 11 Technical documentation | 173 | |
| Article 12 Record-keeping | 175 | |
| Article 13 Transparency and provision of information to deployers | 177 | |
| Article 14 Human oversight | 181 | |
| Article 15 Accuracy, robustness and cybersecurity | 185 | |
| Section 3 – Obligations of providers and deployers of high-risk AI systems and other parties | 191 | |
| Article 16 Obligations of providers of high-risk AI systems | 191 | |
| Article 17 Quality management system | 194 | |
| Article 18 Documentation keeping | 198 | |
| Article 19 Automatically generated logs | 200 | |
| Article 20 Corrective actions and duty of information | 201 | |
| Article 21 Cooperation with competent authorities | 203 | |
| Article 22 Authorised representatives of providers of high-risk AI systems | 204 | |
| Article 23 Obligations of importers | 208 | |
| Article 24 Obligations of distributors | 212 | |
| Article 25 Responsibilities along the AI value chain | 215 | |
| Article 26 Obligations of deployers of high-risk AI systems | 221 | |
| Article 27 Fundamental rights impact assessment for high-risk AI systems | 228 | |
| Section 4 – Notifying authorities and notified bodies | 233 | |
| Article 28 Notifying authorities | 233 | |
| Article 29 Application of a conformity assessment body for notification | 235 | |
| Article 30 Notification procedure | 236 | |
| Article 31 Requirements relating to notified bodies | 238 | |
| Article 32 Presumption of conformity with requirements relating to notified bodies | 240 | |
| Article 33 Subsidiaries of notified bodies and subcontracting | 241 | |
| Article 34 Operational obligations of notified bodies | 242 | |
| Article 35 Identification numbers and lists of notified bodies | 243 | |
| Article 36 Changes to notifications | 244 | |
| Article 37 Challenge to the competence of notified bodies | 247 | |
| Article 38 Coordination of notified bodies | 248 | |
| Article 39 Conformity assessment bodies of third countries | 249 | |
| Section 5 – Standards, conformity assessment, certificates, registration | 250 | |
| Article 40 Harmonised standards and standardisation deliverables | 250 | |
| Article 41 Common specifications | 253 | |
| Article 42 Presumption of conformity with certain requirements | 256 | |
| Article 43 Conformity assessment | 257 | |
| Article 44 Certificates | 262 | |
| Article 45 Information obligations of notified bodies | 263 | |
| Article 46 Derogation from conformity assessment procedure | 264 | |
| Article 47 EU declaration of conformity | 266 | |
| Article 48 CE marking | 267 | |
| Article 49 Registration | 269 | |
| Chapter IV – Transparency obligations for providers and deployers of certain AI systems | 273 | |
| Article 50 Transparency obligations for providers and deployers of certain AI systems | 273 | |
| Chapter V – General-purpose AI models | 281 | |
| Section 1 – Classification rules | 281 | |
| Article 51 Classification of generalpurpose AI models as general-purpose AI models with systemic risk | 281 | |
| Article 52 Procedure | 285 | |
| Section 2 – Obligations for providers of general-purpose AI models | 288 | |
| Article 53 Obligations for providers of general-purpose AI models | 288 | |
| Article 54 Authorised representatives of providers of general-purpose AI models | 294 | |
| Section 3 – Obligations of providers of general-purpose AI models with systemic risk | 296 | |
| Article 55 Obligations of providers of general-purpose AI models with systemic risk | 296 | |
| Article 56 Codes of practice | 299 | |
| Chapter VI – Measures in support of innovation | 303 | |
| Article 57 AI regulatory sandboxes | 303 | |
| Article 58 Detailed arrangements for, and functioning of, AI regulatory sandboxes | 311 | |
| Article 59 Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox | 316 | |
| Article 60 Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes | 320 | |
| Article 61 Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes | 324 | |
| Article 62 Measures for providers and deployers, in particular SMEs, including start-ups | 325 | |
| Article 63 Derogations for specific operators | 326 | |
| Chapter VII – Governance | 327 | |
| Section 1 – Governance at Union level | 327 | |
| Article 64 AI Office | 327 | |
| Article 65 Establishment and structure of the European Artificial Intelligence Board | 328 | |
| Article 66 Tasks of the Board | 330 | |
| Article 67 Advisory forum | 332 | |
| Article 68 Scientific panel of independent experts | 334 | |
| Article 69 Access to the pool of experts by the Member States | 336 | |
| Section 2 – National competent authorities | 337 | |
| Article 70 Designation of national competent authorities and single points of contact | 337 | |
| Chapter VIII – EU database for high-risk AI systems | 341 | |
| Article 71 EU database for high-risk AI systems listed in Annex III | 341 | |
| Chapter IX – Post-market monitoring, information sharing and market surveillance | 343 | |
| Section 1 – Post-market monitoring | 343 | |
| Article 72 Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems | 343 | |
| Section 2 – Sharing of information on serious incidents | 346 | |
| Article 73 Reporting of serious incidents | 346 | |
| Section 3 – Enforcement | 350 | |
| Article 74 Market surveillance and control of AI systems in the Union market | 350 | |
| Article 75 Mutual assistance, market surveillance and control of general-purpose AI systems | 361 | |
| Article 76 Supervision of testing in real world conditions by market surveillance authorities | 363 | |
| Article 77 Powers of authorities protecting fundamental rights | 364 | |
| Article 78 Confidentiality | 366 | |
| Article 79 Procedure at national level for dealing with AI systems presenting a risk | 369 | |
| Article 80 Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III | 373 | |
| Article 81 Union safeguard procedure | 375 | |
| Article 82 Compliant AI systems which present a risk | 376 | |
| Article 83 Formal non-compliance | 378 | |
| Article 84 Union AI testing support structures | 379 | |
| Section 4 – Remedies | 380 | |
| Article 85 Right to lodge a complaint with a market surveillance authority | 380 | |
| Article 86 Right to explanation of individual decision-making | 381 | |
| Article 87 Reporting of infringements and protection of reporting persons | 384 | |
| Section 5 – Supervision, investigation, enforcement and monitoring in respect of providers of general-purpose AI models | 385 | |
| Article 88 Enforcement of the obligations of providers of generalpurpose AI models | 385 | |
| Article 89 Monitoring actions | 387 | |
| Article 90 Alerts of systemic risks by the scientific panel | 388 | |
| Article 91 Power to request documentation and information | 389 | |
| Article 92 Power to conduct evaluations | 391 | |
| Article 93 Power to request measures | 393 | |
| Article 94 Procedural rights of economic operators of the general-purpose AI model | 394 | |
| Chapter X – Codes of conduct and guidelines | 395 | |
| Article 95 Codes of conduct for voluntary application of specific requirements | 395 | |
| Article 96 Guidelines from the Commission on the implementation of this Regulation | 398 | |
| Chapter XI – Delegation of power and committee procedure | 401 | |
| Article 97 Exercise of the delegation | 401 | |
| Article 98 Committee procedure | 403 | |
| Chapter XII – Penalties | 405 | |
| Article 99 Penalties | 405 | |
| Article 100 Administrative fines on Union institutions, bodies, offices and agencies | 410 | |
| Article 101 Fines for providers of general-purpose AI models | 412 | |
| Chapter XIII – Final provisions | 415 | |
| Article 102 Amendment to Regulation (EC) No. 300/2008 | 415 | |
| Article 103 Amendment to Regulation (EU) No. 167/2013 | 417 | |
| Article 104 Amendment to Regulation (EU) No. 168/2013 | 418 | |
| Article 105 Amendment to Directive 2014/90/EU | 419 | |
| Article 106 Amendment to Directive (EU) 2016/797 | 420 | |
| Article 107 Amendment to Regulation (EU) 2018/858 | 421 | |
| Article 108 Amendments to Regulation (EU) 2018/1139 | 422 | |
| Article 109 Amendment to Regulation (EU) 2019/2144 | 424 | |
| Article 110 Amendment to Directive (EU) 2020/1828 | 425 | |
| Article 111 AI systems already placed on the market or put into service and general-purpose AI models already placed on the market | 426 | |
| Article 112 Evaluation and review | 428 | |
| Article 113 Entry into force and application | 432 | |
| Annex I – List of Union harmonisation legislation | 435 | |
| Annex II – List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii) | 439 | |
| Annex III – High-risk AI systems referred to in Article 6(2) | 441 | |
| Annex IV – Technical documentation referred to in Article 11(1) | 461 | |
| Annex V – EU declaration of conformity | 465 | |
| Annex VI – Conformity assessment procedure based on internal control | 467 | |
| Annex VII – Conformity based on an assessment of the quality management system and an assessment of the technical documentation | 469 | |
| Annex VIII – Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49 | 473 | |
| Section A – Information to be submitted by providers of high-risk AI systems in accordance with Article 49(1) | 473 | |
| Section B – Information to be submitted by providers of high-risk AI systems in accordance with Article 49(2) | 474 | |
| Section C – Information to be submitted by deployers of high-risk AI systems in accordance with Article 49(3) | 474 | |
| Annex IX – Information to be submitted upon the registration of high-risk AI systems listed in Annex III in relation to testing in real world conditions in accordance with Article 60 | 477 | |
| Annex X – Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice | 479 | |
| Annex XI – Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models | 483 | |
| Section 1 – Information to be provided by all providers of general-purpose AI models | 483 | |
| Section 2 – Additional information to be provided by providers of general-purpose AI models with systemic risk | 484 | |
| Annex XII – Transparency information referred to in Article 53(1), point (b) – technical documentation for providers of general-purpose AI models to downstream providers that integrate the model into their AI system | 485 | |
| Annex XIII – Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51 | 487 | |
| Index | 489 | |
| About the authors | 499 | |
| About Globe Law and Business | 501 |
Dr Lukas Feiler
Partner, Baker McKenzie
[email protected]
https://www.linkedin.com/in/lukas-feiler-77700265/
Dr Lukas Feiler is a partner at Baker McKenzie in Vienna where he heads the Data, Cyber and AI practice. He holds a fellowship at the Stanford- Vienna Transatlantic Technology Law Forum, has teaching positions for “Artificial Intelligence Law” and “European and International Privacy Law” at the University of Vienna Law School and is the co-author of multiple books on the GDPR, on cyber security and, most recently, on the AI Act. In his prior career, he worked as a software engineer and system administrator and holds certifications as a Systems Security Certified Practitioner as well as a Certified Information Privacy Professional/Europe (CIPP/E).
Prof. Dr Nikolaus Forgó
Professor, University of Vienna
[email protected]
https://www.linkedin.com/in/nikolaus-forg%C3%B3-0773a54b/
Prof. Dr Nikolaus Forgó has studied law in Vienna and Paris. From 2000 to 2017 he was full professor for legal informatics and IT law at Leibniz Universität Hannover (Germany); between 2013 and 2017 he also served as data protection officer and chief information officer of this university. He was appointed as full professor of law at the University of Vienna in October 2017 and has been head of the department of innovation and digitalisation since then. He teaches and consults in all fields of IT law, legal informatics, civil law and legal theory and has been responsible for more than 50 research projects including more than 20 EU research projects personally. He also serves as an expert adviser to the Austrian government in the Austrian Data Protection Board and the AI Advisory Board.
Dr Michaela Nebel
Partner, Baker McKenzie
[email protected]
https://www.linkedin.com/in/dr-michaela-weigl/
Dr Michaela Nebel is a partner at Baker McKenzie in Frankfurt with a practice focus on data, cyber and AI. Michaela holds a PhD in law from the University of Passau and certifications as a Certified Information Privacy Professional/Europe (CIPP/E) and a Certified Information Privacy Professional/US (CIPP/US). She is the author of numerous articles on information technology law, in particular on data protection law, and the coauthor of an English language commentary on the EU General Data Protection Regulation.