Chapter I — GENERAL PROVISIONS

• 1Subject matter
• 2Scope
• 3Definitions
• 4AI literacy

Chapter II — PROHIBITED AI PRACTICES

• 5Prohibited AI practices

Chapter III — HIGH-RISK AI SYSTEMS

• 6Classification rules for high-risk AI systems
• 7Amendments to Annex III
• 8Compliance with the requirements
• 9Risk management system
• 10Data and data governance
• 11Technical documentation
• 12Record-keeping
• 13Transparency and provision of information to deployers
• 14Human oversight
• 15Accuracy, robustness and cybersecurity
• 16Obligations of providers of high-risk AI systems
• 17Quality management system
• 18Documentation keeping
• 19Automatically generated logs
• 20Corrective actions and duty of information
• 21Cooperation with competent authorities
• 22Authorised representatives of providers of high-risk AI systems
• 23Obligations of importers
• 24Obligations of distributors
• 25Responsibilities along the AI value chain
• 26Obligations of deployers of high-risk AI systems
• 27Fundamental rights impact assessment for high-risk AI systems
• 28Notifying authorities
• 29Application of a conformity assessment body for notification
• 30Notification procedure
• 31Requirements relating to notified bodies
• 32Presumption of conformity with requirements relating to notified bodies
• 33Subsidiaries of notified bodies and subcontracting
• 34Operational obligations of notified bodies
• 35Identification numbers and lists of notified bodies
• 36Changes to notifications
• 37Challenge to the competence of notified bodies
• 38Coordination of notified bodies
• 39Conformity assessment bodies of third countries
• 40Harmonised standards and standardisation deliverables
• 41Common specifications
• 42Presumption of conformity with certain requirements
• 43Conformity assessment
• 44Certificates
• 45Information obligations of notified bodies
• 46Derogation from conformity assessment procedure
• 47EU declaration of conformity
• 48CE marking
• 49Registration

Chapter IV — TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS

• 50Transparency obligations for providers and deployers of certain AI systems

Chapter V — GENERAL-PURPOSE AI MODELS

• 51Classification of general-purpose AI models as general-purpose AI models with systemic risk
• 52Procedure
• 53Obligations for providers of general-purpose AI models
• 54Authorised representatives of providers of general-purpose AI models
• 55Obligations of providers of general-purpose AI models with systemic risk
• 56Codes of practice

Chapter VI — MEASURES IN SUPPORT OF INNOVATION

• 57AI regulatory sandboxes
• 58Detailed arrangements for, and functioning of, AI regulatory sandboxes
• 59Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox
• 60Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
• 61Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
• 62Measures for providers and deployers, in particular SMEs, including start-ups
• 63Derogations for specific operators

Chapter VII — GOVERNANCE

• 64AI Office
• 65Establishment and structure of the European Artificial Intelligence Board
• 66Tasks of the Board
• 67Advisory forum
• 68Scientific panel of independent experts
• 69Access to the pool of experts by the Member States
• 70Designation of national competent authorities and single points of contact

Chapter VIII — EU DATABASE FOR HIGH-RISK AI SYSTEMS

• 71EU database for high-risk AI systems listed in Annex III

Chapter IX — POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE

• 72Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
• 73Reporting of serious incidents
• 74Market surveillance and control of AI systems in the Union market
• 75Mutual assistance, market surveillance and control of general-purpose AI systems
• 76Supervision of testing in real world conditions by market surveillance authorities
• 77Powers of authorities protecting fundamental rights
• 78Confidentiality
• 79Procedure at national level for dealing with AI systems presenting a risk
• 80Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
• 81Union safeguard procedure
• 82Compliant AI systems which present a risk
• 83Formal non-compliance
• 84Union AI testing support structures
• 85Right to lodge a complaint with a market surveillance authority
• 86Right to explanation of individual decision-making
• 87Reporting of infringements and protection of reporting persons
• 88Enforcement of the obligations of providers of general-purpose AI models
• 89Monitoring actions
• 90Alerts of systemic risks by the scientific panel
• 91Power to request documentation and information
• 92Power to conduct evaluations
• 93Power to request measures
• 94Procedural rights of economic operators of the general-purpose AI model

Chapter X — CODES OF CONDUCT AND GUIDELINES

• 95Codes of conduct for voluntary application of specific requirements
• 96Guidelines from the Commission on the implementation of this Regulation

Chapter XI — DELEGATION OF POWER AND COMMITTEE PROCEDURE

• 97Exercise of the delegation
• 98Committee procedure

Chapter XII — PENALTIES

• 99Penalties
• 100Administrative fines on Union institutions, bodies, offices and agencies
• 101Fines for providers of general-purpose AI models

Chapter XIII — FINAL PROVISIONS

• 102Amendment to Regulation (EC) No 300/2008
• 103Amendment to Regulation (EU) No 167/2013
• 104Amendment to Regulation (EU) No 168/2013
• 105Amendment to Directive 2014/90/EU
• 106Amendment to Directive (EU) 2016/797
• 107Amendment to Regulation (EU) 2018/858
• 108Amendments to Regulation (EU) 2018/1139
• 109Amendment to Regulation (EU) 2019/2144
• 110Amendment to Directive (EU) 2020/1828
• 111AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked
• 112Evaluation and review
• 113Entry into force and application

Annexes

• IList of Union harmonisation legislation
• IIList of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)
• IIIHigh-risk AI systems referred to in Article 6(2)
• IVTechnical documentation referred to in Article 11(1)
• VEU declaration of conformity
• VIConformity assessment procedure based on internal control
• VIIConformity based on an assessment of the quality management system and an assessment of the technical documentation
• VIIIInformation to be submitted upon the registration of high-risk AI systems in accordance with Article 49
• IXInformation 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
• XUnion legislative acts on large-scale IT systems in the area of Freedom, Security and Justice
• XITechnical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models
• XIITransparency 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
• XIIICriteria for the designation of general-purpose AI models with systemic risk referred to in Article 51