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