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col-lg-4 col-xl-3 d-none d-lg-block"> <div class="left-container"> <div class="logo__container"> <a href="https://aiact.algolia.com/"> <img src="/img/logo.svg" class="logo" /> </a> <h1 class="title__container"> <a href="/"> <span class="title">AI Act</span> </a> <span class="subtitle">Made searchable by <a href="https://www.algolia.com/?utm_medium=social-owned&utm_source=aiact_search&utm_campaign=aiact_search" target="_blank"> <img src="/img/algolia-logo-white.svg" alt="Algolia logo" class="algolia-logo"> </a> </span> <span class="disclaimer">Non-official, based on provisional agreement</span> </h1> </div> <div class="mainMenu"> <p class="mainMenu__title">Table of content</p> <ul> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title I</span> <span class="mainMenu__chapter__title"> General Provisions  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 1 - 4b </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-1/"> Article 1: Subject Matter </a> </li> <li class="mainMenu__article"> <a href="/article-2/"> Article 2: Scope </a> </li> <li class="mainMenu__article"> <a href="/article-3/"> Article 3: Definitions </a> </li> <li class="mainMenu__article"> <a href="/article-4b/"> Article 4b: AI literacy </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title II</span> <span class="mainMenu__chapter__title"> Prohibited Artificial Intelligence Practices  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 5 - 5 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-5/"> Article 5: Prohibited Artificial Intelligence Practices </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title III</span> <span class="mainMenu__chapter__title"> High-Risk AI System  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 6 - 51 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-6/"> Article 6: Classification Rules for High-Risk AI Systems </a> </li> <li class="mainMenu__article"> <a href="/article-7/"> Article 7: Amendments to Annex III </a> </li> <li class="mainMenu__article"> <a href="/article-8/"> Article 8: Compliance with the Requirements </a> </li> <li class="mainMenu__article"> <a href="/article-9/"> Article 9: Risk Management System </a> </li> <li class="mainMenu__article"> <a href="/article-10/"> Article 10: Data and Data Governance </a> </li> <li class="mainMenu__article"> <a href="/article-11/"> Article 11: Technical Documentation </a> </li> <li class="mainMenu__article"> <a href="/article-12/"> Article 12: Record-Keeping </a> </li> <li class="mainMenu__article"> <a href="/article-13/"> Article 13: Transparency and Provision of Information to Deployers </a> </li> <li class="mainMenu__article"> <a href="/article-14/"> Article 14: Human Oversight </a> </li> <li class="mainMenu__article"> <a href="/article-15/"> Article 15: Accuracy, Robustness and Cybersecurity </a> </li> <li class="mainMenu__article"> <a href="/article-16/"> Article 16: Obligations of Providers of High-Risk AI Systems </a> </li> <li class="mainMenu__article"> <a href="/article-17/"> Article 17: Quality Management System </a> </li> <li class="mainMenu__article"> <a href="/article-18/"> Article 18: Documentation Keeping </a> </li> <li class="mainMenu__article"> <a href="/article-20/"> Article 20: Automatically Generated Logs </a> </li> <li class="mainMenu__article"> <a href="/article-21/"> Article 21: Corrective Actions and Duty of Information </a> </li> <li class="mainMenu__article"> <a href="/article-23/"> Article 23: Cooperation with Competent Authorities </a> </li> <li class="mainMenu__article"> <a href="/article-25/"> Article 25: Authorised Representatives </a> </li> <li class="mainMenu__article"> <a href="/article-26/"> Article 26: Obligations of Importers </a> </li> <li class="mainMenu__article"> <a href="/article-27/"> Article 27: Obligations of Distributors </a> </li> <li class="mainMenu__article"> <a href="/article-28/"> Article 28: Responsibilities Along the AI Value Chain </a> </li> <li class="mainMenu__article"> <a href="/article-29/"> Article 29: Obligations of Deployers of High-Risk AI Systems </a> </li> <li class="mainMenu__article"> <a href="/article-29a/"> Article 29a: Fundamental Rights Impact Assessment for High-Risk AI Systems </a> </li> <li class="mainMenu__article"> <a href="/article-30/"> Article 30: Notifying Authorities </a> </li> <li class="mainMenu__article"> <a href="/article-31/"> Article 31: Application of a Conformity Assessment Body for Notification </a> </li> <li class="mainMenu__article"> <a href="/article-32/"> Article 32: Notification Procedure </a> </li> <li class="mainMenu__article"> <a href="/article-33/"> Article 33: Requirements Relating to Notified Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-33a/"> Article 33a: Presumption of Conformity with Requirements Relating to Notified Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-34/"> Article 34: Subsidiaries of and Subcontracting by Notified Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-34a/"> Article 34a: Operational Obligations of Notified Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-35/"> Article 35: Identification Numbers and Lists of Notified Bodies Designated Under this Regulation </a> </li> <li class="mainMenu__article"> <a href="/article-36/"> Article 36: Changes to Notifications </a> </li> <li class="mainMenu__article"> <a href="/article-37/"> Article 37: Challenge to the Competence of Notified Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-38/"> Article 38: Coordination of Notified Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-39/"> Article 39: Conformity Assessment Bodies of Third Countries </a> </li> <li class="mainMenu__article"> <a href="/article-40/"> Article 40: Harmonised Standards and Standardisation Deliverables </a> </li> <li class="mainMenu__article"> <a href="/article-41/"> Article 41: Common Specifications </a> </li> <li class="mainMenu__article"> <a href="/article-42/"> Article 42: Presumption of Conformity with Certain Requirements </a> </li> <li class="mainMenu__article"> <a href="/article-43/"> Article 43: Conformity Assessment </a> </li> <li class="mainMenu__article"> <a href="/article-44/"> Article 44: Certificates </a> </li> <li class="mainMenu__article"> <a href="/article-46/"> Article 46: Information Obligations of Notified Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-47/"> Article 47: Derogation from Conformity Assessment Procedure </a> </li> <li class="mainMenu__article"> <a href="/article-48/"> Article 48: EU Declaration of Conformity </a> </li> <li class="mainMenu__article"> <a href="/article-49/"> Article 49: CE Marking of Conformity </a> </li> <li class="mainMenu__article"> <a href="/article-51/"> Article 51: Registration </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title IV</span> <span class="mainMenu__chapter__title"> Transparency Obligations for Providers and Deployers of Certain AI Systems and GPAI Models  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 52 - 52 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-52/"> Article 52: Transparency Obligations for Providers and Users of Certain AI Systems and GPAI Models </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title IX</span> <span class="mainMenu__chapter__title"> Codes of Conduct  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 69 - 69 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-69/"> Article 69: Codes of Conduct for Voluntary Application of Specific Requirements </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title V</span> <span class="mainMenu__chapter__title"> Measures in Support of Innovation  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 53 - 55 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-53/"> Article 53: AI Regulatory Sandboxes </a> </li> <li class="mainMenu__article"> <a href="/article-54/"> Article 54: Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox </a> </li> <li class="mainMenu__article"> <a href="/article-54a/"> Article 54a: Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes </a> </li> <li class="mainMenu__article"> <a href="/article-54b/"> Article 54b: Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes </a> </li> <li class="mainMenu__article"> <a href="/article-55/"> Article 55: Measures for Providers and Deployers, in Particular SMEs, Including Start-Ups </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title VI</span> <span class="mainMenu__chapter__title"> Governance  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 55b - 59 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-55b/"> Article 55b: Governance at Union Level 1 </a> </li> <li class="mainMenu__article"> <a href="/article-56/"> Article 56: Establishment and Structure of the European Artificial Intelligence Board </a> </li> <li class="mainMenu__article"> <a href="/article-58/"> Article 58: Tasks of the Board </a> </li> <li class="mainMenu__article"> <a href="/article-58a/"> Article 58a: Advisory Forum 1 </a> </li> <li class="mainMenu__article"> <a href="/article-58b/"> Article 58b: Scientific Panel of Independent Experts </a> </li> <li class="mainMenu__article"> <a href="/article-58c/"> Article 58c: Access to the Pool of Experts by the Member States </a> </li> <li class="mainMenu__article"> <a href="/article-59/"> Article 59: Designation of National Competent Authorities and Single Point of Contact </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title VII</span> <span class="mainMenu__chapter__title"> EU Database for High-Risk AI Systems Listed in Annex III  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 60 - 60 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-60/"> Article 60: EU Database for High-Risk AI Systems Listed in Annex III </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title VIII</span> <span class="mainMenu__chapter__title"> Post-Market Monitoring, Information Sharing, Market Surveillance  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 61 - 68a-2 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-61/"> Article 61: Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI Systems </a> </li> <li class="mainMenu__article"> <a href="/article-62/"> Article 62: Reporting of Serious Incidents </a> </li> <li class="mainMenu__article"> <a href="/article-63/"> Article 63: Market Surveillance and Control of AI Systems in the Union Market </a> </li> <li class="mainMenu__article"> <a href="/article-63a/"> Article 63a: Mutual Assistance, Market Surveillance and Control of General Purpose AI Systems </a> </li> <li class="mainMenu__article"> <a href="/article-63b/"> Article 63b: Supervision of Testing in Real World Conditions by Market Surveillance Authorities </a> </li> <li class="mainMenu__article"> <a href="/article-64/"> Article 64: Powers of Authorities Protecting Fundamental Rights </a> </li> <li class="mainMenu__article"> <a href="/article-65/"> Article 65: Procedure for Dealing with AI Systems Presenting a Risk at National Level </a> </li> <li class="mainMenu__article"> <a href="/article-65a/"> Article 65a: Procedure for Dealing with AI Systems Classified by the Provider as a Not High-Risk in Application of Annex III </a> </li> <li class="mainMenu__article"> <a href="/article-66/"> Article 66: Union Safeguard Procedure </a> </li> <li class="mainMenu__article"> <a href="/article-67/"> Article 67: Compliant AI Systems Which Present a Risk </a> </li> <li class="mainMenu__article"> <a href="/article-68/"> Article 68: Formal Non-Compliance </a> </li> <li class="mainMenu__article"> <a href="/article-68a/"> Article 68a(1): Right to Lodge a Complaint with a Market Surveillance Authority </a> </li> <li class="mainMenu__article"> <a href="/article-68c/"> Article 68c: A Right to Explanation of Individual Decision-Making </a> </li> <li class="mainMenu__article"> <a href="/article-68d/"> Article 68d: Amendment to Directive (EU) 2020/1828 </a> </li> <li class="mainMenu__article"> <a href="/article-68e/"> Article 68e: Reporting of Breaches and Protection of Reporting Persons </a> </li> <li class="mainMenu__article"> <a href="/article-68f/"> Article 68f: Enforcement of Obligations on Providers of General Purpose AI Models </a> </li> <li class="mainMenu__article"> <a href="/article-68g/"> Article 68g : Monitoring Actions </a> </li> <li class="mainMenu__article"> <a href="/article-68h/"> Article 68h: Alerts of Systemic Risks by the Scientific Panel </a> </li> <li class="mainMenu__article"> <a href="/article-68i/"> Article 68i: Power to Request Documentation and Information </a> </li> <li class="mainMenu__article"> <a href="/article-68j/"> Article 68j: Power to Conduct Evaluations </a> </li> <li class="mainMenu__article"> <a href="/article-68k/"> Article 68k: Power to Request Measures </a> </li> <li class="mainMenu__article"> <a href="/article-68m/"> Article 68m: Procedural Rights of Economic Operators of the General Purpose AI Model </a> </li> <li class="mainMenu__article"> <a href="/article-68a-2/"> Article 68a: EU AI Testing Support Structures in the Area of Artificial Intelligence </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title VIIIA</span> <span class="mainMenu__chapter__title"> General Purpose AI Models  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 52a - 52e </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-52a/"> Article 52a: Classification of General-Purpose AI Models as General Purpose AI Models with Systemic Risk </a> </li> <li class="mainMenu__article"> <a href="/article-52b/"> Article 52b: Procedure </a> </li> <li class="mainMenu__article"> <a href="/article-52c/"> Article 52c: Obligations for Providers of General Purpose AI Models </a> </li> <li class="mainMenu__article"> <a href="/article-52ca/"> Article 52ca: Authorised Representative </a> </li> <li class="mainMenu__article"> <a href="/article-52d/"> Article 52d: Obligations for Providers of General-Purpose AI Models with Systemic Risk </a> </li> <li class="mainMenu__article"> <a href="/article-52e/"> Article 52e: Codes of Practice </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title X</span> <span class="mainMenu__chapter__title"> Confidentiality and Penalties  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 70 - 72a </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-70/"> Article 70: Confidentiality </a> </li> <li class="mainMenu__article"> <a href="/article-71/"> Article 71: Penalties </a> </li> <li class="mainMenu__article"> <a href="/article-72/"> Article 72: Administrative Fines on Union Institutions, Agencies and Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-72a/"> Article 72a: Fines for Providers of General Purpose AI Models </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title XI</span> <span class="mainMenu__chapter__title"> Delegation of Power and Committee Procedure  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 73 - 74 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-73/"> Article 73: Exercise of the Delegation </a> </li> <li class="mainMenu__article"> <a href="/article-74/"> Article 74: Committee Procedure </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title XII</span> <span class="mainMenu__chapter__title"> Final Provisions  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 75 - 85 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-75/"> Article 75: Amendment to Regulation (EC) No 300/2008 </a> </li> <li class="mainMenu__article"> <a href="/article-76/"> Article 76: Amendment to Regulation (EU) No 167/2013 </a> </li> <li class="mainMenu__article"> <a href="/article-77/"> Article 77: Amendment to Regulation (EU) No 168/2013 </a> </li> <li class="mainMenu__article"> <a href="/article-78/"> Article 78: Amendment to Directive 2014/90/EU </a> </li> <li class="mainMenu__article"> <a href="/article-79/"> Article 79: Amendment to Directive (EU) 2016/797 </a> </li> <li class="mainMenu__article"> <a href="/article-80/"> Article 80: Amendment to Regulation (EU) 2018/858 </a> </li> <li class="mainMenu__article"> <a href="/article-81/"> Article 81: Amendment to Regulation (EU) 2018/1139 </a> </li> <li class="mainMenu__article"> <a href="/article-82/"> Article 82: Amendment to Regulation (EU) 2019/2144 </a> </li> <li class="mainMenu__article"> <a href="/article-83/"> Article 83: AI Systems Already Placed on the Market or put into Service </a> </li> <li class="mainMenu__article"> <a href="/article-84/"> Article 84: Evaluation and Review </a> </li> <li class="mainMenu__article"> <a href="/article-85/"> Article 85: Entry into Force and Application </a> </li> </ul> </li> </ul> </div> </div> </div> <div class="col-sm-12 col-lg-8 col-xl-6 main-column-content"> <div class="row header no-gutters"> <div class="mobile__container"> <div class="logo__container"> <a href="/"> <img src="/img/logo.svg" class="logo" 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class="mainMenu__title">Table of content</p> <ul> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title I</span> <span class="mainMenu__chapter__title"> General Provisions  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 1 - 4b </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-1/"> Article 1: Subject Matter </a> </li> <li class="mainMenu__article"> <a href="/article-2/"> Article 2: Scope </a> </li> <li class="mainMenu__article"> <a href="/article-3/"> Article 3: Definitions </a> </li> <li class="mainMenu__article"> <a href="/article-4b/"> Article 4b: AI literacy </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title II</span> <span class="mainMenu__chapter__title"> Prohibited Artificial Intelligence Practices  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 5 - 5 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-5/"> Article 5: Prohibited Artificial Intelligence Practices </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title III</span> <span class="mainMenu__chapter__title"> High-Risk AI System  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 6 - 51 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-6/"> Article 6: Classification Rules for High-Risk AI Systems </a> </li> <li class="mainMenu__article"> <a href="/article-7/"> Article 7: Amendments to Annex III </a> </li> <li class="mainMenu__article"> <a href="/article-8/"> Article 8: Compliance with the Requirements </a> </li> <li class="mainMenu__article"> <a href="/article-9/"> Article 9: Risk Management System </a> </li> <li class="mainMenu__article"> <a href="/article-10/"> Article 10: Data and Data Governance </a> </li> <li class="mainMenu__article"> <a href="/article-11/"> Article 11: Technical Documentation </a> </li> <li class="mainMenu__article"> <a href="/article-12/"> Article 12: Record-Keeping </a> </li> <li class="mainMenu__article"> <a href="/article-13/"> Article 13: Transparency and Provision of Information to Deployers </a> </li> <li class="mainMenu__article"> <a href="/article-14/"> Article 14: Human Oversight </a> </li> <li class="mainMenu__article"> <a href="/article-15/"> Article 15: Accuracy, Robustness and Cybersecurity </a> </li> <li class="mainMenu__article"> <a href="/article-16/"> Article 16: Obligations of Providers of High-Risk AI Systems </a> </li> <li class="mainMenu__article"> <a href="/article-17/"> Article 17: Quality Management System </a> </li> <li class="mainMenu__article"> <a href="/article-18/"> Article 18: Documentation Keeping </a> </li> <li class="mainMenu__article"> <a href="/article-20/"> Article 20: Automatically Generated Logs </a> </li> <li class="mainMenu__article"> <a href="/article-21/"> Article 21: Corrective Actions and Duty of Information </a> </li> <li class="mainMenu__article"> <a href="/article-23/"> Article 23: Cooperation with Competent Authorities </a> </li> <li class="mainMenu__article"> <a href="/article-25/"> Article 25: Authorised Representatives </a> </li> <li class="mainMenu__article"> <a href="/article-26/"> Article 26: Obligations of Importers </a> </li> <li class="mainMenu__article"> <a href="/article-27/"> Article 27: Obligations of Distributors </a> </li> <li class="mainMenu__article"> <a href="/article-28/"> Article 28: Responsibilities Along the AI Value Chain </a> </li> <li class="mainMenu__article"> <a href="/article-29/"> Article 29: Obligations of Deployers of High-Risk AI Systems </a> </li> <li class="mainMenu__article"> <a href="/article-29a/"> Article 29a: Fundamental Rights Impact Assessment for High-Risk AI Systems </a> </li> <li class="mainMenu__article"> <a href="/article-30/"> Article 30: Notifying Authorities </a> </li> <li class="mainMenu__article"> <a href="/article-31/"> Article 31: Application of a Conformity Assessment Body for Notification </a> </li> <li class="mainMenu__article"> <a href="/article-32/"> Article 32: Notification Procedure </a> </li> <li class="mainMenu__article"> <a href="/article-33/"> Article 33: Requirements Relating to Notified Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-33a/"> Article 33a: Presumption of Conformity with Requirements Relating to Notified Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-34/"> Article 34: Subsidiaries of and Subcontracting by Notified Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-34a/"> Article 34a: Operational Obligations of Notified Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-35/"> Article 35: Identification Numbers and Lists of Notified Bodies Designated Under this Regulation </a> </li> <li class="mainMenu__article"> <a href="/article-36/"> Article 36: Changes to Notifications </a> </li> <li class="mainMenu__article"> <a href="/article-37/"> Article 37: Challenge to the Competence of Notified Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-38/"> Article 38: Coordination of Notified Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-39/"> Article 39: Conformity Assessment Bodies of Third Countries </a> </li> <li class="mainMenu__article"> <a href="/article-40/"> Article 40: Harmonised Standards and Standardisation Deliverables </a> </li> <li class="mainMenu__article"> <a href="/article-41/"> Article 41: Common Specifications </a> </li> <li class="mainMenu__article"> <a href="/article-42/"> Article 42: Presumption of Conformity with Certain Requirements </a> </li> <li class="mainMenu__article"> <a href="/article-43/"> Article 43: Conformity Assessment </a> </li> <li class="mainMenu__article"> <a href="/article-44/"> Article 44: Certificates </a> </li> <li class="mainMenu__article"> <a href="/article-46/"> Article 46: Information Obligations of Notified Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-47/"> Article 47: Derogation from Conformity Assessment Procedure </a> </li> <li class="mainMenu__article"> <a href="/article-48/"> Article 48: EU Declaration of Conformity </a> </li> <li class="mainMenu__article"> <a href="/article-49/"> Article 49: CE Marking of Conformity </a> </li> <li class="mainMenu__article"> <a href="/article-51/"> Article 51: Registration </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title IV</span> <span class="mainMenu__chapter__title"> Transparency Obligations for Providers and Deployers of Certain AI Systems and GPAI Models  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 52 - 52 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-52/"> Article 52: Transparency Obligations for Providers and Users of Certain AI Systems and GPAI Models </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title IX</span> <span class="mainMenu__chapter__title"> Codes of Conduct  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 69 - 69 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-69/"> Article 69: Codes of Conduct for Voluntary Application of Specific Requirements </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title V</span> <span class="mainMenu__chapter__title"> Measures in Support of Innovation  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 53 - 55 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-53/"> Article 53: AI Regulatory Sandboxes </a> </li> <li class="mainMenu__article"> <a href="/article-54/"> Article 54: Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox </a> </li> <li class="mainMenu__article"> <a href="/article-54a/"> Article 54a: Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes </a> </li> <li class="mainMenu__article"> <a href="/article-54b/"> Article 54b: Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes </a> </li> <li class="mainMenu__article"> <a href="/article-55/"> Article 55: Measures for Providers and Deployers, in Particular SMEs, Including Start-Ups </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title VI</span> <span class="mainMenu__chapter__title"> Governance  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 55b - 59 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-55b/"> Article 55b: Governance at Union Level 1 </a> </li> <li class="mainMenu__article"> <a href="/article-56/"> Article 56: Establishment and Structure of the European Artificial Intelligence Board </a> </li> <li class="mainMenu__article"> <a href="/article-58/"> Article 58: Tasks of the Board </a> </li> <li class="mainMenu__article"> <a href="/article-58a/"> Article 58a: Advisory Forum 1 </a> </li> <li class="mainMenu__article"> <a href="/article-58b/"> Article 58b: Scientific Panel of Independent Experts </a> </li> <li class="mainMenu__article"> <a href="/article-58c/"> Article 58c: Access to the Pool of Experts by the Member States </a> </li> <li class="mainMenu__article"> <a href="/article-59/"> Article 59: Designation of National Competent Authorities and Single Point of Contact </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title VII</span> <span class="mainMenu__chapter__title"> EU Database for High-Risk AI Systems Listed in Annex III  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 60 - 60 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-60/"> Article 60: EU Database for High-Risk AI Systems Listed in Annex III </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title VIII</span> <span class="mainMenu__chapter__title"> Post-Market Monitoring, Information Sharing, Market Surveillance  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 61 - 68a-2 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-61/"> Article 61: Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI Systems </a> </li> <li class="mainMenu__article"> <a href="/article-62/"> Article 62: Reporting of Serious Incidents </a> </li> <li class="mainMenu__article"> <a href="/article-63/"> Article 63: Market Surveillance and Control of AI Systems in the Union Market </a> </li> <li class="mainMenu__article"> <a href="/article-63a/"> Article 63a: Mutual Assistance, Market Surveillance and Control of General Purpose AI Systems </a> </li> <li class="mainMenu__article"> <a href="/article-63b/"> Article 63b: Supervision of Testing in Real World Conditions by Market Surveillance Authorities </a> </li> <li class="mainMenu__article"> <a href="/article-64/"> Article 64: Powers of Authorities Protecting Fundamental Rights </a> </li> <li class="mainMenu__article"> <a href="/article-65/"> Article 65: Procedure for Dealing with AI Systems Presenting a Risk at National Level </a> </li> <li class="mainMenu__article"> <a href="/article-65a/"> Article 65a: Procedure for Dealing with AI Systems Classified by the Provider as a Not High-Risk in Application of Annex III </a> </li> <li class="mainMenu__article"> <a href="/article-66/"> Article 66: Union Safeguard Procedure </a> </li> <li class="mainMenu__article"> <a href="/article-67/"> Article 67: Compliant AI Systems Which Present a Risk </a> </li> <li class="mainMenu__article"> <a href="/article-68/"> Article 68: Formal Non-Compliance </a> </li> <li class="mainMenu__article"> <a href="/article-68a/"> Article 68a(1): Right to Lodge a Complaint with a Market Surveillance Authority </a> </li> <li class="mainMenu__article"> <a href="/article-68c/"> Article 68c: A Right to Explanation of Individual Decision-Making </a> </li> <li class="mainMenu__article"> <a href="/article-68d/"> Article 68d: Amendment to Directive (EU) 2020/1828 </a> </li> <li class="mainMenu__article"> <a href="/article-68e/"> Article 68e: Reporting of Breaches and Protection of Reporting Persons </a> </li> <li class="mainMenu__article"> <a href="/article-68f/"> Article 68f: Enforcement of Obligations on Providers of General Purpose AI Models </a> </li> <li class="mainMenu__article"> <a href="/article-68g/"> Article 68g : Monitoring Actions </a> </li> <li class="mainMenu__article"> <a href="/article-68h/"> Article 68h: Alerts of Systemic Risks by the Scientific Panel </a> </li> <li class="mainMenu__article"> <a href="/article-68i/"> Article 68i: Power to Request Documentation and Information </a> </li> <li class="mainMenu__article"> <a href="/article-68j/"> Article 68j: Power to Conduct Evaluations </a> </li> <li class="mainMenu__article"> <a href="/article-68k/"> Article 68k: Power to Request Measures </a> </li> <li class="mainMenu__article"> <a href="/article-68m/"> Article 68m: Procedural Rights of Economic Operators of the General Purpose AI Model </a> </li> <li class="mainMenu__article"> <a href="/article-68a-2/"> Article 68a: EU AI Testing Support Structures in the Area of Artificial Intelligence </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title VIIIA</span> <span class="mainMenu__chapter__title"> General Purpose AI Models  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 52a - 52e </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-52a/"> Article 52a: Classification of General-Purpose AI Models as General Purpose AI Models with Systemic Risk </a> </li> <li class="mainMenu__article"> <a href="/article-52b/"> Article 52b: Procedure </a> </li> <li class="mainMenu__article"> <a href="/article-52c/"> Article 52c: Obligations for Providers of General Purpose AI Models </a> </li> <li class="mainMenu__article"> <a href="/article-52ca/"> Article 52ca: Authorised Representative </a> </li> <li class="mainMenu__article"> <a href="/article-52d/"> Article 52d: Obligations for Providers of General-Purpose AI Models with Systemic Risk </a> </li> <li class="mainMenu__article"> <a href="/article-52e/"> Article 52e: Codes of Practice </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title X</span> <span class="mainMenu__chapter__title"> Confidentiality and Penalties  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 70 - 72a </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-70/"> Article 70: Confidentiality </a> </li> <li class="mainMenu__article"> <a href="/article-71/"> Article 71: Penalties </a> </li> <li class="mainMenu__article"> <a href="/article-72/"> Article 72: Administrative Fines on Union Institutions, Agencies and Bodies </a> </li> <li class="mainMenu__article"> <a href="/article-72a/"> Article 72a: Fines for Providers of General Purpose AI Models </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title XI</span> <span class="mainMenu__chapter__title"> Delegation of Power and Committee Procedure  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 73 - 74 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-73/"> Article 73: Exercise of the Delegation </a> </li> <li class="mainMenu__article"> <a href="/article-74/"> Article 74: Committee Procedure </a> </li> </ul> </li> <li class="mainMenu__chapter "> <a class="mainMenu__chapter_link"> <span class="mainMenu__chapter__index">Title XII</span> <span class="mainMenu__chapter__title"> Final Provisions  <i class="fa fa-chevron-up"></i> </span> <span class="mainMenu__chapter__articles"> Art 75 - 85 </span> </a> <ul style="display: none;"> <li class="mainMenu__article"> <a href="/article-75/"> Article 75: Amendment to Regulation (EC) No 300/2008 </a> </li> <li class="mainMenu__article"> <a href="/article-76/"> Article 76: Amendment to Regulation (EU) No 167/2013 </a> </li> <li class="mainMenu__article"> <a href="/article-77/"> Article 77: Amendment to Regulation (EU) No 168/2013 </a> </li> <li class="mainMenu__article"> <a href="/article-78/"> Article 78: Amendment to Directive 2014/90/EU </a> </li> <li class="mainMenu__article"> <a href="/article-79/"> Article 79: Amendment to Directive (EU) 2016/797 </a> </li> <li class="mainMenu__article"> <a href="/article-80/"> Article 80: Amendment to Regulation (EU) 2018/858 </a> </li> <li class="mainMenu__article"> <a href="/article-81/"> Article 81: Amendment to Regulation (EU) 2018/1139 </a> </li> <li class="mainMenu__article"> <a href="/article-82/"> Article 82: Amendment to Regulation (EU) 2019/2144 </a> </li> <li class="mainMenu__article"> <a href="/article-83/"> Article 83: AI Systems Already Placed on the Market or put into Service </a> </li> <li class="mainMenu__article"> <a href="/article-84/"> Article 84: Evaluation and Review </a> </li> <li class="mainMenu__article"> <a href="/article-85/"> Article 85: Entry into Force and Application </a> </li> </ul> </li> </ul> </div> <article class="article-container"> <div id="inner-content"> <div class="article"> <div class="chapter"> <h2 class="chapter__title"> <span class="chapter__title__index">Title I</span> <span class="chapter__title__label">General Provisions</span> </h2> </div> <h3 class="article__title"> Article 1: Subject Matter </h3> <div class="content"> <ul> <li> <p><a name="section-0">(1) The purpose of this Regulation is to improve the functioning of the internal market and promoting the uptake of human centric and trustworthy artificial intelligence, while ensuring a high level of protection of health, safety, fundamental rights enshrined in the Charter, including democracy, rule of law and environmental protection against harmful effects of artificial intelligence systems in the Union and supporting innovation. This Regulation lays down:</a></p> <ul> <li> <p><a name="section-1">(a) harmonised rules for the placing on the market, the putting into service and the use of artificial intelligence systems (‘AI systems’) in the Union;</a></p> </li> <li> <p><a name="section-2">(b) prohibitions of certain artificial intelligence practices;</a></p> </li> <li> <p><a name="section-3">(c) specific requirements for high-risk AI systems and obligations for operators of such systems;</a></p> </li> <li> <p><a name="section-4">(d) harmonised transparency rules for certain AI systems;</a></p> <ul> <li><a name="section-5">(da) harmonised rules for the placing on the market of general-purpose AI models;</a></li> </ul> </li> <li> <p><a name="section-6">(e) rules on market monitoring, market surveillance governance and enforcement;</a></p> <ul> <li><a name="section-7">(ea) measures to support innovation, with a particular focus on SMEs, including start-ups.</a></li> </ul> </li> </ul> </li> </ul> </div> </div> <a class="next-article" href="/article-2/"> <p>Next</p> <p class="name"> Article 2: Scope </p> <span class="arrow-down"> <i class="fa fa-arrow-down"></i> </span> </a> </div> </article> </div> </div> </div> <div class="col-sm-12 col-xl-3 d-none d-xl-block"> <div class="right-container"> <div class="recitals__header"> <div class="recitals__header__content"> <span class="share__title"> Share this </br> project </span> <a href="mailto:?body=https%3A%2F%2Faiact.algolia.com%2F Provisional%20text%20of%20AI-Artificial%20Intelligence-Act%20made%20searchable%20by%20Algolia.%20Search%20Easily%20in%20chapters%2c%20articles%20and%20recitals." class="share-link"> <img src='/img/ic-mail.svg' alt="Email icon" width="14px"> <span class="share__label">Email</span> </a> <a href="https://www.linkedin.com/shareArticle?url=https%3a%2f%2faiact.algolia.com%2f&mini=true" class="share-link" target="_blank"> <img src='/img/ic-linkedin.svg' alt="LinkedIn icon" width="14px"> <span class="share__label">LinkedIn</span> </a> <a href="https://twitter.com/intent/tweet?url=https%3a%2f%2faiact.algolia.com%2f" class="share-link" target="_blank"> <img src='/img/ic-x.svg' alt="Twitter icon" width="14px"> <span class="share__label">X</span> </a> </div> </div> <div class="recitals"> <div class="recitals__container"> <h3><i class="fa fa-link"></i>Suitable Recitals for article 1</h3> <ul class="list-unstyled"> <li> <span class="index">1</span> <a href="#recital-1" class="recital-link" data-recital-content="The purpose of this Regulation is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development, placing on the market, putting into service and the use of artificial intelligence systems in the Union in conformity with Union values, to promote the uptake of human centric and trustworthy artificial intelligence while ensuring a high level of protection of health, safety, fundamental rights enshrined in the Charter, including democracy and rule of law and environmental protection, against harmful effects of artificial intelligence systems in the Union and to support innovation. This regulation ensures the free movement of AI-based goods and services cross-border, thus preventing Member States from imposing restrictions on the development, marketing and use of Artificial Intelligence systems (AI systems), unless explicitly authorised by this Regulation." data-recital-index="1"> <span>The purpose of this Regulation is to improve the …</span> </a> </li> <li> <span class="index">2</span> <a href="#recital-2" class="recital-link" data-recital-content="AI systems can be easily deployed in multiple sectors of the economy and society, including cross border, and circulate throughout the Union. Certain Member States have already explored the adoption of national rules to ensure that artificial intelligence is trustworthy and safe and is developed and used in compliance with fundamental rights obligations. Differing national rules may lead to fragmentation of the internal market and decrease legal certainty for operators that develop, import or use AI systems. A consistent and high level of protection throughout the Union should therefore be ensured in order to achieve trustworthy AI, while divergences hampering the free circulation, innovation, deployment and uptake of AI systems and related products and services within the internal market should be prevented, by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market based on Article 114 of the Treaty on the Functioning of the European Union (TFEU). To the extent that this Regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of AI systems for remote biometric identification for the purpose of law enforcement, for the use of AI systems for risk assessments of natural persons for the purpose of law enforcement and for the use of AI systems of biometric categorization for the purpose of law enforcement, it is appropriate to base this Regulation, in as far as those specific rules are concerned, on Article 16 of the TFEU. In light of those specific rules and the recourse to Article 16 TFEU, it is appropriate to consult the European Data Protection Board." data-recital-index="2"> <span>AI systems can be easily deployed in multiple …</span> </a> </li> <li> <span class="index">5</span> <a href="#recital-5" class="recital-link" data-recital-content="A Union legal framework laying down harmonised rules on artificial intelligence is therefore needed to foster the development, use and uptake of artificial intelligence in the internal market that at the same time meets a high level of protection of public interests, such as health and safety and the protection of fundamental rights, including democracy, rule of law and environmental protection as recognised and protected by Union law. To achieve that objective, rules regulating the placing on the market, putting into service and use of certain AI systems should be laid down, thus ensuring the smooth functioning of the internal market and allowing those systems to benefit from the principle of free movement of goods and services. These rules should be clear and robust in protecting fundamental rights, supportive of new innovative solutions, enabling to a European ecosystem of public and private actors creating AI systems in line with Union values and unlocking the potential of the digital transformation across all regions of the Union. By laying down those rules as well as measures in support of innovation with a particular focus on SMEs including start-ups, this Regulation supports the objective of promoting the European human-centric approach to AI and being a global leader in the development of secure, trustworthy and ethical artificial intelligence as stated by the European Council[4] , and it ensures the protection of ethical principles, as specifically requested by the the European Parliament[5]. [4] European Council, Special meeting of the European Council (1 and 2 October 2020) – Conclusions, EUCO 13/20, 2020, p. 6.[5] European Parliament resolution of 20 October 2020 with recommendations to the Commission on a framework of ethical aspects of artificial intelligence, robotics and related technologies, 2020/2012(INL)." data-recital-index="5"> <span>A Union legal framework laying down harmonised …</span> </a> </li> <li> <span class="index">14</span> <a href="#recital-14" class="recital-link" data-recital-content="In order to introduce a proportionate and effective set of binding rules for AI systems, a clearly defined risk-based approach should be followed. That approach should tailor the type and content of such rules to the intensity and scope of the risks that AI systems can generate. It is therefore necessary to prohibit certain unacceptable artificial intelligence practices, to lay down requirements for high-risk AI systems and obligations for the relevant operators, and to lay down transparency obligations for certain AI systems." data-recital-index="14"> <span>In order to introduce a proportionate and …</span> </a> </li> <li> <span class="index">38</span> <a href="#recital-38" class="recital-link" data-recital-content="Given their role and responsibility, actions by law enforcement authorities involving certain uses of AI systems are characterised by a significant degree of power imbalance and may lead to surveillance, arrest or deprivation of a natural person’s liberty as well as other adverse impacts on fundamental rights guaranteed in the Charter. In particular, if the AI system is not trained with high quality data, does not meet adequate requirements in terms of its performance, its accuracy or robustness, or is not properly designed and tested before being put on the market or otherwise put into service, it may single out people in a discriminatory or otherwise incorrect or unjust manner. Furthermore, the exercise of important procedural fundamental rights, such as the right to an effective remedy and to a fair trial as well as the right of defence and the presumption of innocence, could be hampered, in particular, where such AI systems are not sufficiently transparent, explainable and documented. It is therefore appropriate to classify as high-risk, insofar as their use is permitted under relevant Union and national law, a number of AI systems intended to be used in the law enforcement context where accuracy, reliability and transparency is particularly important to avoid adverse impacts, retain public trust and ensure accountability and effective redress. In view of the nature of the activities in question and the risks relating thereto, those high-risk AI systems should include in particular AI systems intended to be used by or on behalf of law enforcement authorities or by Union agencies, offices or bodies in support of law enforcement authorities for assessing the risk of a natural person to become a victim of criminal offences, as polygraphs and similar tools , for the evaluation of the reliability of evidence in in the course of investigation or prosecution of criminal offences, and, insofar not prohibited under this regulation, for assessing the risk of a natural person of offending or reoffending not solely based on profiling of natural persons nor based on assessing personality traits and characteristics or past criminal behaviour of natural persons or groups, for profiling in the course of detection, investigation or prosecution of criminal offences, . AI systems specifically intended to be used for administrative proceedings by tax and customs authorities as well as by financial intelligence units carrying out adminstrative tasks analysing information pursuant to Union anti-money laundering legislation should not be classified as high-risk AI systems used by law enforcement authorities for the purposes of prevention, detection, investigation and prosecution of criminal offences. The use of AI tools by law enforcement and authorities should not become a factor of inequality, or exclusion. The impact of the use of AI tools on the defence rights of suspects should not be ignored, notably the difficulty in obtaining meaningful information on the functioning of these systems and the consequent difficulty in challenging their results in court, in particular by individuals under investigation." data-recital-index="38"> <span>Given their role and responsibility, actions by …</span> </a> </li> <li> <span class="index">78</span> <a href="#recital-78" class="recital-link" data-recital-content="In order to ensure that providers of high-risk AI systems can take into account the experience on the use of high-risk AI systems for improving their systems and the design and development process or can take any possible corrective action in a timely manner, all providers should have a post-market monitoring system in place. Where relevant, postmarket monitoring should include an analysis of the interaction with other AI systems including other devices and software. Post-market monitoring should not cover sensitive operational data of deployers which are law enforcement authorities. This system is also key to ensure that the possible risks emerging from AI systems which continue to ‘learn’ after being placed on the market or put into service can be more efficiently and timely addressed. In this context, providers should also be required to have a system in place to report to the relevant authorities any serious incidents resulting from the use of their AI systems, meaning incident or malfunctioning leading to death or serious damage to health, serious and irreversible disruption of the management and operation of critical infrastructure, breaches of obligations under Union law intended to protect fundamental rights or serious damage to property or the environment." data-recital-index="78"> <span>In order to ensure that providers of high-risk AI …</span> </a> </li> </ul> <button id="ot-sdk-btn" class="ot-sdk-show-settings">Cookie Settings</button> </div> </div> <div class="recital-content-container d-none d-xl-block"> <div class="inner"> <h2></h2> <p></p> <div class="recital-close"> <span class="cross">X</span> <span>Close this recital</span> </div> </div> </div> </div> </div> </div> <script type="text/javascript"> var $recitalContentContainer = 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$(document).ready(function(){ var definitionsArray = [{"label":"AI system","text":"‘AI system’ means a machine-based system designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;"},{"label":"risk","text":"(1a) ‘risk’ means the combination of the probability of an occurrence of harm and the severity of that harm;"},{"label":"provider","text":"‘provider’ means a natural or legal person, public authority, agency or other body that develops an AI system or a general purpose AI model or that has an AI system or a general purpose AI model developed and places them on the market or puts the system into service under its own name or trademark, whether for payment or free of charge;"},{"label":"authorised representative","text":"‘authorised representative’ means any natural or legal person located or established in the Union who has received and accepted a written mandate from a provider of an AI system or a general purpose AI model to, respectively, perform and carry out on its behalf the obligations and procedures established by this Regulation;"},{"label":"importer","text":"‘importer’ means any natural or legal person located or established in the Union that places on the market an AI system that bears the name or trademark of a natural or legal person established outside the Union;"},{"label":"distributor","text":"‘distributor’ means any natural or legal person in the supply chain, other than the provider or the importer, that makes an AI system available on the Union market;"},{"label":"operator","text":"‘operator’ means the provider, the product manufacturer, the deployer, the authorised representative, the importer or the distributor;"},{"label":"placing on the market","text":"‘placing on the market’ means the first making available of an AI system or a general purpose AI model on the Union market;"},{"label":"making available on the market","text":"‘making available on the market’ means any supply of an AI system or a general purpose AI model for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;"},{"label":"putting into service","text":"‘putting into service’ means the supply of an AI system for first use directly to the deployer or for own use in the Union for its intended purpose;"},{"label":"intended purpose","text":"‘intended purpose’ means the use for which an AI system is intended by the provider, including the specific context and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation;"},{"label":"reasonably foreseeable misuse","text":"‘reasonably foreseeable misuse’ means the use of an AI system in a way that is not in accordance with its intended purpose, but which may result from reasonably foreseeable human behaviour or interaction with other systems, including other AI systems;"},{"label":"safety component of a product or system","text":"‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety function for that product or system, or the failure or malfunctioning of which endangers the health and safety of persons or property;"},{"label":"instructions for use’ means the information provided by the provider to inform the user of in particular an AI system","text":"‘instructions for use’ means the information provided by the provider to inform the user of in particular an AI system’s intended purpose and proper use;"},{"label":"recall of an AI system","text":"‘recall of an AI system’ means any measure aimed at achieving the return to the provider or taking it out of service or disabling the use of an AI system made available to deployers;"},{"label":"withdrawal of an AI system","text":"‘withdrawal of an AI system’ means any measure aimed at preventing an AI system in the supply chain being made available on the market;"},{"label":"performance of an AI system","text":"‘performance of an AI system’ means the ability of an AI system to achieve its intended purpose;"},{"label":"notifying authority","text":"‘notifying authority’ means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring;"},{"label":"conformity assessment","text":"‘conformity assessment’ means the process of demonstrating whether the requirements set out in Title III, Chapter 2 of this Regulation relating to a high-risk AI system have been fulfilled;"},{"label":"conformity assessment body","text":"‘conformity assessment body’ means a body that performs third-party conformity assessment activities, including testing, certification and inspection;"},{"label":"notified body","text":"‘notified body’ means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation;"},{"label":"substantial modification","text":"‘substantial modification’ means a change to the AI system after its placing on the market or putting into service which is not foreseen or planned in the initial conformity assessment by the provider and as a result of which the compliance of the AI system with the requirements set out in Title III, Chapter 2 of this Regulation is affected or results in a modification to the intended purpose for which the AI system has been assessed;"},{"label":"CE marking of conformity’ (CE marking) means a marking by which a provider indicates that an AI system is in conformity with the requirements set out in Title III, Chapter 2 of this Regulation and other applicable Union legislation harmonising the conditions for the marketing of products (‘Union harmonisation legislation","text":"‘CE marking of conformity’ (CE marking) means a marking by which a provider indicates that an AI system is in conformity with the requirements set out in Title III, Chapter 2 of this Regulation and other applicable Union legislation harmonising the conditions for the marketing of products (‘Union harmonisation legislation’) providing for its affixing;"},{"label":"post-market monitoring system","text":"‘post-market monitoring system’ means all activities carried out by providers of AI systems to collect and review experience gained from the use of AI systems they place on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;"},{"label":"market surveillance authority","text":"‘market surveillance authority’ means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020;"},{"label":"harmonised standard","text":"‘harmonised standard’ means a European standard as defined in Article 2(c) of Regulation (EU) No 1025/2012;"},{"label":"common specification","text":"‘common specification’ means a set of technical specifications, as defined in point 4 of Article 2 of Regulation (EU) No 1025/2012 providing means to comply with certain requirements established under this Regulation;"},{"label":"training data","text":"‘training data’ means data used for training an AI system through fitting its learnable parameters;"},{"label":"validation data","text":"‘validation data’ means data used for providing an evaluation of the trained AI system and for tuning its non-learnable parameters and its learning process, among other things, in order to prevent underfitting or overfitting; whereas the validation dataset is a separate dataset or part of the training dataset, either as a fixed or variable split;"},{"label":"testing data","text":"‘testing data’ means data used for providing an independent evaluation of the AI system in order to confirm the expected performance of that system before its placing on the market or putting into service;"},{"label":"input data","text":"‘input data’ means data provided to or directly acquired by an AI system on the basis of which the system produces an output;"},{"label":"biometric data","text":"‘biometric data’ means personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, such as facial images or dactyloscopic data;"},{"label":"biometric identification’ means the automated recognition of physical, physiological, behavioural, and psychological human features for the purpose of establishing an individual","text":"(33a) ‘biometric identification’ means the automated recognition of physical, physiological, behavioural, and psychological human features for the purpose of establishing an individual’s identity by comparing biometric data of that individual to stored biometric data of individuals in a database;"},{"label":"biometric verification","text":"(33c) ‘biometric verification’ means the automated verification of the identity of natural persons by comparing biometric data of an individual to previously provided biometric data (one-to-one verification, including authentication);"},{"label":"special categories of personal data","text":"(33d) ‘special categories of personal data’ means the categories of personal data referred to in Article 9 of Regulation (EU) 2016/679, Article 10 of Directive (EU) 2016/680 and Article 10 of Regulation (EU) 2018/1725;"},{"label":"sensitive operational data","text":"(33e) ‘sensitive operational data’ means operational data related to activities of prevention, detection, investigation and prosecution of criminal offences, the disclosure of which can jeopardise the integrity of criminal proceedings."},{"label":"emotion recognition system","text":"‘emotion recognition system’ means an AI system for the purpose of identifying or inferring emotions or intentions of natural persons on the basis of their biometric data;"},{"label":"biometric categorisation system","text":"‘biometric categorisation system’ means an AI system for the purpose of assigning natural persons to specific categories on the basis of their biometric data unless ancillary to another commercial service and strictly necessary for objective technical reasons;"},{"label":"remote biometric identification system’ means an AI system for the purpose of identifying natural persons, without their active involvement, typically at a distance through the comparison of a person","text":"‘remote biometric identification system’ means an AI system for the purpose of identifying natural persons, without their active involvement, typically at a distance through the comparison of a person’s biometric data with the biometric data contained in a reference database;"},{"label":"‘real-time’ remote biometric identification system","text":"‘‘real-time’ remote biometric identification system’ means a remote biometric identification system whereby the capturing of biometric data, the comparison and the identification all occur without a significant delay. This comprises not only instant identification, but also limited short delays in order to avoid circumvention."},{"label":"‘post’ remote biometric identification system’ means a remote biometric identification system other than a ‘real-time","text":"‘‘post’ remote biometric identification system’ means a remote biometric identification system other than a ‘real-time’ remote biometric identification system;"},{"label":"publicly accessible space","text":"‘publicly accessible space’ means any publicly or privately owned physical place accessible to an undetermined number of natural persons, regardless of whether certain conditions for access may apply, and regardless of the potential capacity restrictions;"},{"label":"law enforcement authority","text":"‘law enforcement authority’ means:"},{"label":"law enforcement","text":"‘law enforcement’ means activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security;"},{"label":"Artificial Intelligence Office’ means the Commission","text":"‘Artificial Intelligence Office’ means the Commission’s function of contributing to the implementation, monitoring and supervision of AI systems, general purpose AI models and AI governance. References in this Regulation to the Artificial Intelligence office shall be understood as references to the Commission."},{"label":"national competent authority","text":"‘national competent authority’ means any of the following: the notifying authority and the market surveillance authority. As regards AI systems put into service or used by EU institutions, agencies, offices and bodies, any reference to national competent authorities or market surveillance authorities in this Regulation shall be understood as referring to the European Data Protection Supervisor;"},{"label":"serious incident","text":"‘serious incident’ means any incident or malfunctioning of an AI system that directly or indirectly leads to any of the following:"},{"label":"personal data","text":"(44a) ‘personal data’ means personal data as defined in Article 4, point of Regulation (EU) 2016/679 ;"},{"label":"non-personal data","text":"(44c) ‘non-personal data’ means data other than personal data as defined in point of Article 4 of Regulation (EU) 2016/679;"},{"label":"profiling","text":"(be) ‘profiling’ means any form of automated processing of personal data as defined in point of Article 4 of Regulation (EU) 2016/679; or in the case of law enforcement authorities – in point 4 of Article 3 of Directive (EU) 2016/680 or, in the case of Union institutions, bodies, offices or agencies, in point 5 Article 3 of Regulation (EU) 2018/1725;"},{"label":"real world testing plan","text":"(bf) ‘real world testing plan’ means a document that describes the objectives, methodology, geographical, population and temporal scope, monitoring, organisation and conduct of testing in real world conditions;"},{"label":"sandbox plan","text":"(44 eb) ‘sandbox plan’ means a document agreed between the participating provider and the competent authority describing the objectives, conditions, timeframe, methodology and requirements for the activities carried out within the sandbox."},{"label":"AI regulatory sandbox","text":"(bg) ‘AI regulatory sandbox’ means a concrete and controlled framework set up by a competent authority which offers providers or prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real world conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision."},{"label":"AI literacy","text":"(bh) ‘AI literacy’ refers to skills, knowledge and understanding that allows providers, users and affected persons, taking into account their respective rights and obligations in the context of this Regulation, to make an informed deployment of AI systems, as well as to gain awareness about the opportunities and risks of AI and possible harm it can cause."},{"label":"testing in real world conditions","text":"(bi) ‘testing in real world conditions’ means the temporary testing of an AI system for its intended purpose in real world conditions outside of a laboratory or otherwise simulated environment with a view to gathering reliable and robust data and to assessing and verifying the conformity of the AI system with the requirements of this Regulation; testing in real world conditions shall not be considered as placing the AI system on the market or putting it into service within the meaning of this Regulation, provided that all conditions under Article 53 or Article 54a are fulfilled;"},{"label":"subject","text":"(bj) ‘subject’ for the purpose of real world testing means a natural person who participates in testing in real world conditions;"},{"label":"informed consent’ means a subject’s freely given, specific, unambiguous and voluntary expression of his or her willingness to participate in a particular testing in real world conditions, after having been informed of all aspects of the testing that are relevant to the subject","text":"(bk) ‘informed consent’ means a subject’s freely given, specific, unambiguous and voluntary expression of his or her willingness to participate in a particular testing in real world conditions, after having been informed of all aspects of the testing that are relevant to the subject’s decision to participate;"},{"label":"widespread infringement","text":"(44e) ‘widespread infringement’ means any act or omission contrary to Union law that protects the interest of individuals:"},{"label":"critical infrastructure","text":"(44h) ‘critical infrastructure’ means an asset, a facility, equipment, a network or a system, or a part of thereof, which is necessary for the provision of an essential service within the meaning of Article 2 of Directive (EU) 2022/2557;"},{"label":"general purpose AI model","text":"(44b) ‘general purpose AI model’ means an AI model, including when trained with a large amount of data using self-supervision at scale, that displays significant generality and is capable to competently perform a wide range of distinct tasks regardless of the way the model is placed on the market and that can be integrated into a variety of downstream systems or applications. This does not cover AI models that are used before release on the market for research, development and prototyping activities."},{"label":"high-impact capabilities","text":"(44c) ‘high-impact capabilities’ in general purpose AI models means capabilities that match or exceed the capabilities recorded in the most advanced general purpose AI models."},{"label":"systemic risk at Union level","text":"(44d) ‘systemic risk at Union level’ means a risk that is specific to the high-impact capabilities of general purpose AI models, having a significant impact on the internal market due to its reach, and with actual or reasonably foreseeable negative effects on public health, safety, public security, fundamental rights, or the society as a whole, that can be propagated at scale across the value chain."},{"label":"general purpose AI system","text":"(44e) ‘general purpose AI system’ means an AI system which is based on a general purpose AI model , that has the capability to serve a variety of purposes, both for direct use as well as for integration in other AI systems;"},{"label":"downstream provider","text":"(44g) ‘downstream provider’ means a provider of an AI system, including a general purpose AI system, which integrates an AI model, regardless of whether the model is provided by themselves and vertically integrated or provided by another entity based on contractual relations."}] var definitions = {}; definitionsArray.forEach(function(definition) { definitions[definition.label] = definition.text; }); var terms = Object.keys(definitions); $(".content").mark(terms, { separateWordSearch: false, done: function() { $('[data-markjs="true"]').popover({ title: function() { return $(this).text(); }, content: function() { var content = definitions[$(this).text().toLowerCase()]; if (content) { return content; } else { return definitions[$(this).text()]; } }, delay: { "show": 100, "hide": 0 }, trigger: 'hover' }) } }); }); </script> <script src="/js/main.3d9edc8d51a230525aeb1b0b8d544c129a47d1d802bf2dc90833b3bdb5781ecc.js" crossorigin="anonymous"></script> </html>

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