Council of the European Union and European Parliament 13 June 2024, Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (Text with EEA relevance) Also known as
REGULATION (EU) 2024/1689 establishes a harmonized legal framework for the development, marketing, and use of artificial intelligence (AI) systems within the European Union, aiming to ensure safety, fundamental rights protection, and the promotion of trustworthy AI. Key provisions include uniform obligations for operators, specific rules for high-risk AI systems, and safeguards for personal data processing, while facilitating innovation and the free movement of AI-based goods and services. The regulation applies across sectors and complements existing Union laws, ensuring that national laws pursuing legitimate public interests remain unaffected.AI
European Union ·
Table of Contents CHAPTER I. GENERAL PROVISIONS Article 1. Subject matter` Article 2. Scope Article 3. Definitions Article 4. AI literacy CHAPTER II. PROHIBITED AI PRACTICES Article 5. Prohibited AI practices CHAPTER III. HIGH-RISK AI SYSTEMS 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 12. Record-keeping Article 13. Transparency and provision of information to deployers Article 14. Human oversight 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 44. Certificates Article 45. Information obligations of notified bodies Article 46. Derogation from conformity assessment procedure Article 47. EU declaration of conformity Article 48. CE marking Article 49. Registration CHAPTER IV. TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS Article 50. Transparency obligations for providers and deployers of certain AI systems CHAPTER V. GENERAL-PURPOSE AI MODELS SECTION 1. Classification rules Article 51. Classification of general-purpose AI models as general-purpose AI models with systemic risk Article 52. Procedure 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 of providers of general-purpose AI models with systemic risk SECTION 4. Codes of practice Article 56. Codes of practice CHAPTER VI. MEASURES IN SUPPORT OF INNOVATION Article 57. AI regulatory sandboxes Article 58. Detailed arrangements for, and functioning of, AI regulatory sandboxes Article 59. Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox Article 60. Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes Article 61. Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes Article 62. Measures for providers and deployers, in particular SMEs, including start-ups Article 63. Derogations for specific operators CHAPTER VII. GOVERNANCE SECTION 1. Governance at Union level Article 64. AI Office Article 65. Establishment and structure of the European Artificial Intelligence Board Article 66. Tasks of the Board Article 67. Advisory forum 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 points of contact CHAPTER VIII. EU DATABASE FOR HIGH-RISK AI SYSTEMS Article 71. EU database for high-risk AI systems listed in Annex III CHAPTER IX. POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE SECTION 1. Post-market monitoring Article 72. Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems SECTION 2. Sharing of information on serious incidents Article 73. Reporting of serious incidents SECTION 3. Enforcement 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 78. Confidentiality Article 79. Procedure at national level for dealing with AI systems presenting a risk Article 80. Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III 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 SECTION 4. Remedies 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 SECTION 5. Supervision, investigation, enforcement and monitoring in respect of providers of general-purpose AI models 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 CHAPTER X. CODES OF CONDUCT AND GUIDELINES Article 95. Codes of conduct for voluntary application of specific requirements Article 96. Guidelines from the Commission on the implementation of this Regulation CHAPTER XI. DELEGATION OF POWER AND COMMITTEE PROCEDURE Article 97. Exercise of the delegation Article 98. Committee procedure CHAPTER XII. PENALTIES Article 99. Penalties Article 100. Administrative fines on Union institutions, bodies, offices and agencies Article 101. Fines for providers of general-purpose AI models CHAPTER XIII. FINAL PROVISIONS 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 Article 111. AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked Article 112. Evaluation and review Article 113. Entry into force and application ANNEX I. List of Union harmonisation legislation Official Journal
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2024/1689
12.7.2024
REGULATION (EU) 2024/1689 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 13 June 2024
laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives
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