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Record STMT-WBEB926Legally binding

Proposal for a regulation of the European Parliament and of the Council on harmonised rules on Artificial Intelligence (Artificial Intelligence Act) and amending certain Union Legislative Acts

Legislation State lawEuropean Uniondraft

This document outlines the proposed Artificial Intelligence Act by the European Parliament and Council, setting harmonized rules for AI systems across the EU. It establishes a risk-based regulatory framework that prohibits certain manipulative AI practices, sets strict compliance and conformity assessment obligations for high-risk AI systems, and creates governance structures such as the European Artificial Intelligence Office and national supervisory authorities.

Summary and content fields are drawn from the document text and are pending editorial review.

Who issued it

European ParliamentLegislature
Lead issuer
Council of the European UnionGovernment
Co-issuer
Legal forceLegally binding
Under whose authorityState law
Judged fromfull text

Who it governs

AI developers and providersNational governmentRegulatorsCompaniesAI deployers and users

AI developers, deployers, importers, distributors, and regulators operating within or providing AI systems to the European Union market.

Sectors
Cross-sector

What the document contains

What's covered

The document covers comprehensive rules for AI systems, including definitions, prohibited manipulative practices, risk-classification and compliance requirements for high-risk AI, obligations for the AI value chain, standards, conformity assessments, market surveillance, governance bodies like the AI Office, and penalty frameworks.

What's missing

The text does not cover finalized enforcement dates prior to institutional implementation schedules or specific technical standards for every vertical sector, which are delegated to future standardization bodies.

Key takeaways
  • The regulation categorizes AI applications based on risk, prohibiting unacceptable practices such as subliminal manipulation and social scoring.
  • High-risk AI systems are subject to strict mandatory requirements regarding data governance, technical documentation, transparency, and human oversight.
  • Providers of high-risk AI systems must implement a quality management system and undergo conformity assessment procedures before placing systems on the market.
  • An EU Artificial Intelligence Office and national supervisory authorities are established to oversee compliance and coordinate enforcement across member states.
  • Substantial administrative fines are established for non-compliance, scaled according to the severity of the violation and the size of the enterprise.
Principles it states
human agency and oversighttechnical robustness and safetyprivacy and data governancetransparencydiversity, non-discrimination and fairnesssocial and environmental well-being
Outline
· Title I: General Provisions
· Title II: Prohibited Artificial Intelligence Practices
· Title III: High-Risk AI Systems
· Title V: Measures in Support of Innovation
· Title VI: Governance
· Title VII: EU Database for Stand-alone High-Risk AI Systems
· Title VIII: Post-Market Monitoring, Information Sharing, Market Surveillance
· Title X: Confidentiality and Penalties
· Title XI: Delegation of Power and Committee Procedure
· Title XII: Final Provisions
Issued9 May 2023
Length65,546 words · 144 pages
FormatNot recorded
Scoperegional

How it scores

Pending review

Each score is backed by a quote verified against the document text. Editorial review has not yet confirmed them.

Accountability

4/5

Clear responsibility for AI outcomes

It is appropriate that a specific natural or legal person, defined as the provider, takes the responsibility for the placing on the market or putting into service of a high-risk AI system

Recital 53

screening score · 2026-10-23

Human Dignity

4/5

Respect for the inherent worth of persons

AI systems shall be developed and used as a tool that serves people, respects human dignity and personal autonomy, and that is functioning in a way that can be appropriately controlled and overseen by humans.

Article 4a

screening score · 2026-10-23

Human Oversight

4/5

Humans remain in control of consequential decisions

To the extent deployers exercise control over the high-risk AI system, they shall i) implement human oversight according to the requirements laid down in this Regulation

Article 29

screening score · 2026-10-23

Privacy

4/5

Protection of personal data and private life

The right to privacy and to protection of personal data must be guaranteed throughout the entire lifecycle of the AI system.

Recital 45a

screening score · 2026-10-23

Transparency

4/5

Openness about how AI systems work and are used

AI systems shall be developed and used in a way that allows appropriate traceability and explainability, while making humans aware that they communicate or interact with an AI system

Article 4a

screening score · 2026-10-23

Enforcement

4/5

Consequences and compliance mechanisms with real force

Compliance with this Regulation should be enforceable by means of the imposition of fines by the national supervisory authority when carrying out proceedings under the procedure laid down in this Regulation.

Recital 84

screening score · 2026-10-23

Impact Assessment

4/5

Required assessment of an AI system's risks/impacts before or during use

Prior to putting a high-risk AI system as defined in Article 6(2) into use, with the exception of AI systems intended to be used in area 2 of Annex III, deployers shall conduct an assessment of the systems’ impact in the specific context of use.

Article 29a

screening score · 2026-10-23

Topics

artificial_intelligence risk_management conformity_assessment fundamental_rights governance