Proposal for a Regulation (EU) 2024/... 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) (COM(2021) 206 final / 2021/0106 (COD)) (updated 13 June 2024 with Legislative Acts)

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Version status: Amended

Published date: 13 June 2024

Proposal published (21 Apr '21)

Adopted texts (14 Jun '23 / 13 Mar '24)

Legislative acts (14 May '24)

Legislative acts (13 Jun '24)

Text published to OJ (TBC)

LEGISLATIVE ACTS AND OTHER INSTRUMENTS

Regulation (EU) 2024/... 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) (13 June 2024)
Regulation of the European Parliament and of the Council on 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) (14 May 2024)
Proposal for a Regulation of the European Parliament and of the Council on Laying Down Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act) and amending Certain Union Legislative Acts (COM(2021) 206 final / 2021/0106 (COD)) (21 April 2021)

Comparing proposed amendment...


	Explanatory Memorandum
Published	1. Context of the proposal
Published	2. Legal basis, subsidiarity and proportionality
Published	3. Results of ex-post evaluations, stakeholder consultations and impact assessments
Published	4. Budgetary implications
Published	5. Other elements
	REGULATION (EU) 2024/… OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of … 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)
	Recitals
	Chapter I General Provisions (arts. 1-4)
Amended	Article 1 Subject matter
Amended	Article 2 Scope
Amended	Article 3 Definitions
Amended	Article 4 AI literacy
	Chapter II Prohibited AI Practices (art. 5)
Amended	Article 5 Prohibited AI Practices
	Chapter III High-risk AI Systems (arts. 6-49)
	Section 1 Clasification of AI Systems AS High-Risk (arts. 6-7)
Amended	Article 6 Classification rules for high-risk AI systems
Amended	Article 7 Amendments to Annex III
	Section 2 Requirements for High-Risk AI Systems (arts. 8-15)
Amended	Article 8 Compliance with the requirements
Amended	Article 9 Risk management system
Amended	Article 10 Data and data governance
Amended	Article 11 Technical documentation
Amended	Article 12 Record-keeping
Amended	Article 13 Transparency and provision of information to deployers
Amended	Article 14 Human oversight
Amended	Article 15 Accuracy, robustness and cybersecurity
	Section 3 Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties (arts. 16-27)
Amended	Article 16 Obligations of providers of high-risk AI systems
Amended	Article 17 Quality management system
Amended	Article 18 Documentation keeping
Amended	Article 19 Automatically generated logs
Amended	Article 20 Corrective actions and duty of information
Amended	Article 21 Cooperation with competent authorities
Amended	Article 22 Authorised representatives of providers of high-risk AI systems
Amended	Article 23 Obligations of importers
Amended	Article 24 Obligations of distributors
Amended	Article 25 Responsibilities along the AI value chain
Amended	Article 26 Obligations of deployers of high-risk AI systems
Amended	Article 27 Fundamental rights impact assessment for high-risk AI systems
	Section 4 Notifiying Authorities and Notified Bodies (arts. 28-39)
Amended	Article 28 Notifying authorities
Amended	Article 29 Application of a conformity assessment body for notification
Amended	Article 30 Notification procedure
Amended	Article 31 Requirements relating to notified bodies
Amended	Article 32 Presumption of conformity with requirements relating to notified bodies
Amended	Article 33 Subsidiaries of notified bodies and subcontracting
Amended	Article 34 Operational obligations of notified bodies
Amended	Article 35 Identification numbers and lists of notified bodies
Amended	Article 36 Changes to notifications
Amended	Article 37 Challenge to the competence of notified bodies
Amended	Article 38 Coordination of notified bodies
Amended	Article 39 Conformity assessment bodies of third countries
	Section 5 Standards, Conformity Assessment, Certificates, Registration (arts. 40-49)
Amended	Article 40 Harmonised standards and standardisation deliverables
Amended	Article 41 Common specifications
Amended	Article 42 Presumption of conformity with certain requirements
Amended	Article 43 Conformity assessment
Amended	Article 44 Certificates
Amended	Article 45 Information obligations of notified bodies
Amended	Article 46 Derogation from conformity assessment procedure
Amended	Article 47 EU declaration of conformity
Amended	Article 48 CE marking
Amended	Article 49 Registration
	Chapter IV Transparency obligations for providers and deployers of certain AI systems (art. 50)
Amended	Article 50 Transparency obligations for providers and deployers of certain AI systems
	Chapter V General-purpose AI models (arts. 51-56)
	Section 1 Classification rules (arts. 51-52)
Amended	Article 51 Classification of general-purpose AI models as general-purpose AI models with systemic risk
Amended	Article 52 Procedure
	Section 2 Obligations for providers of general-purpose AI models (arts. 53-54)
Amended	Article 53 Obligations for providers of general-purpose AI models
Amended	Article 54 Authorised representatives of providers of general-purpose AI models
	Section 3 Obligations of providers of general-purpose AI models with systemic risk (art. 55)
Amended	Article 55 Obligations of providers of general-purpose AI models with systemic risk
	Section 4 Codes of practice (art. 56)
Amended	Article 56 Codes of practice
	Chapter VI Measures in support of innovation (arts. 57-63)
Amended	Article 57 AI regulatory sandboxes
Amended	Article 58 Detailed arrangements for, and functioning of, AI regulatory sandboxes
Amended	Article 59 Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox
Amended	Article 60 Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
Amended	Article 61 Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
Amended	Article 62 Measures for providers and deployers, in particular SMEs, including start-ups
Amended	Article 63 Derogations for specific operators
	Chapter VII Governance (arts. 64-70)
	Section 1 Governance at Union level (arts. 64-69)
Amended	Article 64 AI Office
Amended	Article 65 Establishment and structure of the European Artificial Intelligence Board
Amended	Article 66 Tasks of the Board
Amended	Article 67 Advisory forum
Amended	Article 68 Scientific panel of independent experts
Amended	Article 69 Access to the pool of experts by the Member States
	Section 2 National Competent Authorities (art. 70)
Amended	Article 70 Designation of national competent authorities and single points of contact
	Chapter VIII EU database for high-risk AI systems (art. 71)
Amended	Article 71 EU database for high-risk AI systems listed in Annex III
	Chapter IX Post-market monitoring, information sharing and market surveillance (arts. 72-94)
	Section 1 Post-Market Monitoring (art. 72)
Amended	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 (art. 73)
Amended	Article 73 Reporting of serious incidents
	Section 3 Enforcement (arts. 74-84)
Amended	Article 74 Market surveillance and control of AI systems in the Union market
Amended	Article 75 Mutual assistance, market surveillance and control of general-purpose AI systems
Amended	Article 76 Supervision of testing in real world conditions by market surveillance authorities
Amended	Article 77 Powers of authorities protecting fundamental rights
Amended	Article 78 Confidentiality
Amended	Article 79 Procedure at national level for dealing with AI systems presenting a risk
Amended	Article 80 Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
Amended	Article 81 Union safeguard procedure
Amended	Article 82 Compliant AI systems which present a risk
Amended	Article 83 Formal non-compliance
Amended	Article 84 Union AI testing support structures
	Section 4 Remedies (arts. 85-87)
Amended	Article 85 Right to lodge a complaint with a market surveillance authority
Inserted	Article 86 Right to explanation of individual decision-making
Inserted	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 (arts. 88-94)
Inserted	Article 88 Enforcement of the obligations of providers of general-purpose AI models
Inserted	Article 89 Monitoring actions
Inserted	Article 90 Alerts of systemic risks by the scientific panel
Inserted	Article 91 Power to request documentation and information
Inserted	Article 92 Power to conduct evaluations
Inserted	Article 93 Power to request measures
Inserted	Article 94 Procedural rights of economic operators of the general-purpose AI model
	Chapter X Codes of conduct and guidelines (arts. 95-96)
Inserted	Article 95 Codes of conduct for voluntary application of specific requirements
Inserted	Article 96 Guidelines from the Commission on the implementation of this Regulation
	Chapter XI Delegation of power and committee procedure (arts. 97-98)
Inserted	Article 97 Exercise of the delegation
Inserted	Article 98 Committee procedure
	Chapter XII Penalties (arts. 99-101)
Inserted	Article 99 Penalties
Inserted	Article 100 Administrative fines on Union institutions, bodies, offices and agencies
Inserted	Article 101 Fines for providers of general-purpose AI models
	Chapter XIII Final provisions (arts. 102-113)
Inserted	Article 102 Amendment to Regulation (EC) No 300/2008
Inserted	Article 103 Amendment to Regulation (EU) No 167/2013
Inserted	Article 104 Amendment to Regulation (EU) No 168/2013
Inserted	Article 105 Amendment to Directive 2014/90/EU
Inserted	Article 106 Amendment to Directive (EU) 2016/797
Inserted	Article 107 Amendment to Regulation (EU) 2018/858
Inserted	Article 108 Amendments to Regulation (EU) 2018/1139
Inserted	Article 109 Amendment to Regulation (EU) 2019/2144
Inserted	Article 110 Amendment to Directive (EU) 2020/1828
Inserted	Article 111 AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked
Inserted	Article 112 Evaluation and review
Inserted	Article 113 Entry into force and application
	Annexes
Amended	Annex I List of Union harmonisation legislation
Amended	Annex II List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)
Amended	Annex III High-risk AI systems referred to in Article 6(2)
Amended	Annex IV Technical documentation referred to in Article 11(1)
Amended	Annex V EU declaration of conformity
Amended	Annex VI Conformity assessment procedure based on internal control
Amended	Annex VII Conformity based on an assessment of the quality management system and an assessment of the technical documentation
Amended	Annex VIII Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49
Amended	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
Inserted	Annex X Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice
Inserted	Annex XI Technical documentation referred to in Article 53(1), point (a) - technical documentation for providers of general-purpose AI models
Inserted	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
Inserted	Annex XIII Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51
	Done at
Published	Legislative Financial Statement

Presidency Compromise text or Note

Note - Adoption of the legislative act - 4024th meeting of the Council of the European Union (Transport, Telecommunications and Energy) 21 May 2024, Brussels (22 May 2024)
'I/A' ITEM Note - Adoption of the legislative act (15 May 2024)
'I/A' ITEM Note = Statements (REV 1) (15 May 2024)
'I/A' ITEM Note = Statements (REV 2) (15 May 2024)
'I/A' ITEM Note - Adoption of the legislative act (14 May 2024)
'I/A' ITEM Note - Adoption of the legislative act = Statement (14 May 2024)
'I/A' ITEM Note - Approval of a non-binding instrument (13 May 2024)
Information Note - Outcome of the European Parliament's first reading (Strasbourg, 11 to 14 March 2024) (18 March 2024)
Texts Adopted (13 March 2024)
Note - Analysis of the final compromise text with a view to agreement (26 January 2024)
Texts Adopted (14 June 2023)
***I Report (22 May 2023)
DRAFT Compromise Amendments on the Draft Report (9 May 2023)
OUTCOME OF PROCEEDINGS - General approach (6 December 2022) (6 December 2022)
Note - General approach (25 November 2022)
Oponion of the Committee on Legal Affairs (12 September 2022)
Opinion of the Committee on Transport and Tourism (12 July 2022)
Opinion of the Committee on Culture and Education (16 June 2022)
Opinion of the Committee on Industry, Research and Energy (14 June 2022)
***I Draft Report (20 April 2022)
Cover Note - Opinion on the application of the Principles of Subsidiarity and Proportionality (22 April 2022)
Opinion of the Committee on the Environment, Public Health and Food Safety (22 April 2022)
Note - Presidency compromise text - Articles 8-15 and Annex IV (13 January 2022)
Cover Note - Opinion on the application of the Principles of Subsidiarity and Proportionality (18 October 2021)
Cover Note - Opinion on the application of the Principles of Subsidiarity and Proportionality (12 October 2021)
Cover Note - Opinion on the application of the Principles of Subsidiarity and Proportionality (13 August 2021)
I' ITEM NOTE - Optional consultation of the Committee of the Regions (15 June 2021)
Cover Note - Opinion on the application of the Principles of Subsidiarity and Proportionality (14 June 2021)

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Annexes 1 to 9

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