Proposal for a Regulation of the European Parliament and of the Council Laying Down Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act) and Amending Certain Union Legislative Acts
PROPOSAL FOR A REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS
This document is a legislative proposal from the European Commission for a Regulation laying down harmonised rules on artificial intelligence, commonly known as the Artificial Intelligence Act. It establishes a risk-based regulatory framework for AI systems placed on the Union market, introducing prohibitions on certain harmful AI practices, mandatory requirements for high-risk AI systems, and transparency obligations for specific AI applications. Additionally, the proposal sets up a governance structure at both national and Union levels, including the establishment of a European Artificial Intelligence Board and an EU database for stand-alone high-risk AI systems.
Summary and content fields are drawn from the document text and are pending editorial review.
Who issued it
Who it governs
This document is for AI developers, deployers, importers, distributors, national competent authorities, and legal scholars seeking to understand the regulatory framework for artificial intelligence in the European Union.
What the document contains
The document covers harmonised rules for the placing on the market, putting into service, and use of AI systems within the European Union. It details prohibitions on specific manipulative and biometric practices, horizontal requirements for high-risk AI systems across various sectors, transparency obligations for interactive and generative AI systems, innovation-support measures such as regulatory sandboxes, governance frameworks, and enforcement mechanisms including penalties.
The text is a legislative proposal and does not contain final adopted legal text or the final operational start dates, which are bracketed as placeholders. Furthermore, it does not provide specific technical design instructions for individual software implementations.
- The regulation introduces a proportionate risk-based approach categorizing AI systems into unacceptable risk, high risk, and low or minimal risk.
- Certain harmful AI practices, such as manipulative techniques, exploitation of vulnerable groups, social scoring by public authorities, and real-time remote biometric identification in public spaces for law enforcement, are generally prohibited.
- High-risk AI systems must comply with strict mandatory requirements regarding data quality, technical documentation, record-keeping, transparency, human oversight, accuracy, robustness, and cybersecurity.
- Providers of high-risk AI systems must implement a quality management system, undergo conformity assessment procedures, and affix the CE marking before placing systems on the market.
- The regulation creates the European Artificial Intelligence Board and mandates an EU-wide database for stand-alone high-risk AI systems to enhance enforcement and transparency.
EXPLANATORY MEMORANDUM 1. CONTEXT OF THE PROPOSAL 2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS 4. BUDGETARY IMPLICATIONS 5. OTHER ELEMENTS PROPOSAL FOR A REGULATION · Title I: General Provisions · Title II: Prohibited Artificial Intelligence Practices · Title III: High-Risk AI Systems · Title IV: Transparency Obligations for Certain 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 IX: Codes of Conduct · Title X: Confidentiality and Penalties · Title XI: Delegation of Power and Committee Procedure · Title XII: Final Provisions
How it scores
Each score is backed by a quote verified against the document text. Editorial review has not yet confirmed them.
Accountability
4/5Clear responsibility for AI outcomes
Predictable, proportionate and clear obligations are also placed on providers and users of those systems to ensure safety and respect of existing legislation protecting fundamental rights throughout the whole AI systems’ lifecycle.
1. CONTEXT OF THE PROPOSAL
screening score · 2026-10-23
Human Dignity
4/5Respect for the inherent worth of persons
With a set of requirements for trustworthy AI and proportionate obligations on all value chain participants, the proposal will enhance and promote the protection of the rights protected by the Charter: the right to human dignity (Article 1)
3.5. Fundamental rights
screening score · 2026-10-23
Human Oversight
4/5Humans remain in control of consequential decisions
The preferred option will increase people’s trust in AI, companies will gain in legal certainty, and Member States will see no reason to take unilateral action that could fragment the single market.
3.3. Impact assessment
screening score · 2026-10-23
Enforcement
4/5Consequences and compliance mechanisms with real force
The proposed rules will be enforced through a governance system at Member States level, building on already existing structures, and a cooperation mechanism at Union level with the establishment of a European Artificial Intelligence Board
1. CONTEXT OF THE PROPOSAL
screening score · 2026-10-23
Impact Assessment
4/5Required assessment of an AI system's risks/impacts before or during use
Those AI systems will have to comply with a set of horizontal mandatory requirements for trustworthy AI and follow conformity assessment procedures before those systems can be placed on the Union market.
1. CONTEXT OF THE PROPOSAL
screening score · 2026-10-23