The notion of general-purpose AI models should be clearly defined and set apart from the notion of AI systems to enable legal certainty. The definition should be based on the key functional characteristics of a general-purpose AI model, in particular the generality and the capability to competently perform a wide range of distinct tasks. These models are typically trained on large amounts of data, through various methods, such as self-supervised, unsupervised or reinforcement learning. General-purpose AI models may be placed on the market in various ways, including through libraries, application programming interfaces (APIs), as direct download, or as physical copy. These models may be further modified or fine-tuned into new models. Although AI models are essential components of AI systems, they do not constitute AI systems on their own. AI models require the addition of further components, such as for example a user interface, to become AI systems. AI models are typically integrated into and form part of AI systems. This Regulation provides specific rules for general-purpose AI models and for general-purpose AI models that pose systemic risks, which should apply also when these models are integrated or form part of an AI system. It should be understood that the obligations for the providers of general-purpose AI models should apply once the general-purpose AI models are placed on the market. When the provider of a general-purpose AI model integrates an own model into its own AI system that is made available on the market or put into service, that model should be considered to be placed on the market and, therefore, the obligations in this Regulation for models should continue to apply in addition to those for AI systems. The obligations laid down for models should in any case not apply when an own model is used for purely internal processes that are not essential for providing a product or a service to third parties and the rights of natural persons are not affected. Considering their potential significantly negative effects, the general-purpose AI models with systemic risk should always be subject to the relevant obligations under this Regulation. The definition should not cover AI models used before their placing on the market for the sole purpose of research, development and prototyping activities. This is without prejudice to the obligation to comply with this Regulation when, following such activities, a model is placed on the market.
Table of contents
Section 1: Classification of AI Systems as High-Risk
Article 6: Classification Rules for High-Risk AI Systems
Article 7: Amendments to Annex III
Section 2: Requirements for High-Risk AI Systems
Article 8: Compliance with the Requirements
Article 9: Risk Management System
Article 10: Data and Data Governance
Article 11: Technical Documentation
Article 13: Transparency and Provision of Information to Deployers
Article 15: Accuracy, Robustness and Cybersecurity
Section 3: Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties
Article 16: Obligations of Providers of High-Risk AI Systems
Article 17: Quality Management System
Article 18: Documentation Keeping
Article 19: Automatically Generated Logs
Article 20: Corrective Actions and Duty of Information
Article 21: Cooperation with Competent Authorities
Article 22: Authorised Representatives of Providers of High-Risk AI Systems
Article 23: Obligations of Importers
Article 24: Obligations of Distributors
Article 25: Responsibilities Along the AI Value Chain
Article 26: Obligations of Deployers of High-Risk AI Systems
Article 27: Fundamental Rights Impact Assessment for High-Risk AI Systems
Section 4: Notifying Authorities and Notified Bodies
Article 28: Notifying Authorities
Article 29: Application of a Conformity Assessment Body for Notification
Article 30: Notification Procedure
Article 31: Requirements Relating to Notified Bodies
Article 32: Presumption of Conformity with Requirements Relating to Notified Bodies
Article 33: Subsidiaries of Notified Bodies and Subcontracting
Article 34: Operational Obligations of Notified Bodies
Article 35: Identification Numbers and Lists of Notified Bodies
Article 36: Changes to Notifications
Article 37: Challenge to the Competence of Notified Bodies
Article 38: Coordination of Notified Bodies
Article 39: Conformity Assessment Bodies of Third Countries
Section 5: Standards, Conformity Assessment, Certificates, Registration
Article 40: Harmonised Standards and Standardisation Deliverables
Article 41: Common Specifications
Article 42: Presumption of Conformity with Certain Requirements
Article 43: Conformity Assessment
Article 45: Information Obligations of Notified Bodies
Article 46: Derogation from Conformity Assessment Procedure
Section 1: Classification Rules
Section 2: Obligations for Providers of General-Purpose AI Models
Article 53: Obligations for Providers of General-Purpose AI Models
Article 54: Authorised Representatives of Providers of General-Purpose AI Models
Section 3: Obligations of Providers of General-Purpose AI Models with Systemic Risk
Article 55: Obligations for Providers of General-Purpose AI Models with Systemic Risk
Article 57: AI Regulatory Sandboxes
Article 58: Detailed Arrangements for, and Functioning of, AI Regulatory Sandboxes
Article 60: Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes
Article 62: Measures for Providers and Deployers, in Particular SMEs, Including Start-Ups
Section 1: Governance at Union Level
Article 65: Establishment and Structure of the European Artificial Intelligence Board
Article 66: Tasks of the Board
Article 68: Scientific Panel of Independent Experts
Article 69: Access to the Pool of Experts by the Member States
Section 2: National Competent Authorities
Article 70: Designation of National Competent Authorities and Single Point of Contact
Section 1: Post-Market Monitoring
Section 2: Sharing of Information on Serious Incidents
Article 73: Reporting of Serious Incidents
Article 74: Market Surveillance and Control of AI Systems in the Union Market
Article 75: Mutual Assistance, Market Surveillance and Control of General-Purpose AI Systems
Article 76: Supervision of Testing in Real World Conditions by Market Surveillance Authorities
Article 77: Powers of Authorities Protecting Fundamental Rights
Article 79: Procedure at National Level for Dealing with AI Systems Presenting a Risk
Article 81: Union Safeguard Procedure
Article 82: Compliant AI Systems Which Present a Risk
Article 83: Formal Non-Compliance
Article 84: Union AI Testing Support Structures
Article 85: Right to Lodge a Complaint with a Market Surveillance Authority
Article 86: Right to Explanation of Individual Decision-Making
Article 87: Reporting of Infringements and Protection of Reporting Persons
Article 88: Enforcement of the Obligations of Providers of General-Purpose AI Models
Article 89 : Monitoring Actions
Article 90: Alerts of Systemic Risks by the Scientific Panel
Article 91: Power to Request Documentation and Information
Article 92: Power to Conduct Evaluations
Article 93: Power to Request Measures
Article 94: Procedural Rights of Economic Operators of the General-Purpose AI Model
Article 95: Codes of Conduct for Voluntary Application of Specific Requirements
Article 96: Guidelines from the Commission on the Implementation of this Regulation
Article 100: Administrative Fines on Union Institutions, Bodies, Offices and Agencies
Article 101: Fines for Providers of General-Purpose AI Models
Article 102: Amendment to Regulation (EC) No 300/2008
Article 103: Amendment to Regulation (EU) No 167/2013
Article 104: Amendment to Regulation (EU) No 168/2013
Article 105: Amendment to Directive 2014/90/EU
Article 106: Amendment to Directive (EU) 2016/797
Article 107: Amendment to Regulation (EU) 2018/858
Article 108: Amendments to Regulation (EU) 2018/1139
Article 109: Amendment to Regulation (EU) 2019/2144
Article 110: Amendment to Directive (EU) 2020/1828
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Annexes
Annex I: List of Union Harmonisation Legislation
Annex II: List of Criminal Offences Referred to in Article 5(1), First Subparagraph, Point (h)(iii)
Annex III: High-Risk AI Systems Referred to in Article 6(2)
Annex IV: Technical Documentation Referred to in Article 11(1)
Annex V: EU Declaration of Conformity
Annex VI: Conformity Assessment Procedure Based on Internal Control
Search within the Act
Recital 97
NOTE: This translation is a machine-generated translation. It is not the official translation provided by the European Parliament. When the AI Act is published in the official journal, the machine-generated translations will be replaced by the official translations.
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View the official text, or browse it online using our AI Act Explorer. The text used in this tool is the ‘Artificial Intelligence Act (Regulation (EU) 2024/1689), Official Journal version of 13 June 2024’. Interinstitutional File: 2021/0106(COD)