Regulation (EU) 2024/1689 of the European Parliament and of the Council 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) – Official Journal
Provided by: reuschlaw
Table of contents
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Chapter I-General Provisions (Art. 1 - 4)
- Article 1-Subject matter
- Article 2-Scope
- Article 3-Definitions
- Article 4-AI literacy
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Chapter II-Prohibited AI practices (Art. 5)
- Article 5-Prohibited AI practices
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Chapter III-High-risk AI systems (Art. 6 - 49)
- 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
- Artikel 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
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Chapter IV-Transparency obligations for providers and deployers of certain AI systems (Art. 50)
- Article 50-Transparency obligations for providers and deployers of certain AI systems
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Chapter V-General-purpose AI models (Art. 51 - 56)
- 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
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Chapter VI-Measures in support of innovation (Art. 57 - 63)
- 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
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Chapter VII-Governance (Art. 64 - 70)
- 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
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Chapter VIII-EU database for high-risk AI systems (Art. 71)
- Article 71-EU database for high-risk AI systems listed in Annex III
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Chapter IX-Post-market monitoring, information sharing and market surveillance (Art. 72 - 94)
- 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
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Chapter X-Codes of conduct and guidelines (Art. 95 - 96)
- Article 95-Codes of conduct for voluntary application of specific requirements
- Article 96-Guidelines from the Commission on the implementation of this Regulation
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Chapter XI-Delegation of power and committee procedure (Art. 97 - 98)
- Article 97-Exercise of the delegation
- Article 98-Committee procedure
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Chapter XII-Penalties (Art. 99 - 101)
- Article 99-Penalties
- Article 100-Administrative fines on Union institutions, bodies, offices and agencies
- Article 101-Fines for providers of general-purpose AI models
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Chapter XIII-Final provisions (Art. 102 - 113)
- 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
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Concluding formulas
Annexes
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Annex I-List of Union harmonisation legislation
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Annex II-List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)
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Annex III-High-risk AI systems referred to in Article 6(2)
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Annex IV-Technical documentation referred to in Article 11(1)
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Annex V-EU declaration of conformity
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Annex VI-Conformity assessment procedure based on internal control
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Annex VII-Conformity based on an assessment of the quality management system and an assessment of the technical documentation
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Annex VIII-Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49
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Annex IX-Information to be submitted upon the registration of high-risk AI systems listed in Annex III in relation to testing in real world conditions in accordance with Article 60
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Annex X-Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice
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Annex XI-Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models
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Annex XII-Transparency information referred to in Article 53(1), point (b) — technical documentation for providers of general-purpose AI models to downstream providers that integrate the model into their AI system
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Annex XIII-Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51