The EU AI Act

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 tthe 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 general-purpose 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 Definitions . . . . . . . . . . . . . . . . . . . . . . . . 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 The EU AI Act: A Commentary 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 general-purpose 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 The EU AI Act: A Commentary 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 general-purpose 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