Impact Assessment Accompanying the Proposal for a Regulation of the European Parliament and of the Council Laying Down Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act)
Folgenabschätzung zur Verordnung über künstliche Intelligenz
This Commission Staff Working Document presents the impact assessment accompanying the European Commission's proposed Artificial Intelligence Act. It examines technological, economic, legal, and political contexts, defines key problems related to safety, fundamental rights, legal uncertainty, and fragmentation, and evaluates several policy options. The preferred option is a horizontal, risk-based regulatory framework for artificial intelligence supported by codes of conduct and governance mechanisms.
Summary and content fields are drawn from the document text and are pending editorial review.
Who issued it
Who it governs
Policymakers, regulators, researchers, and stakeholders wishing to understand the rationale, evidence, and economic impacts behind the European Union's proposed Artificial Intelligence Act.
What the document contains
The document covers the socio-economic, technological, and legal analysis of artificial intelligence, defines core problems and problem drivers, sets out intervention objectives, compares alternative policy options, outlines the preferred horizontal risk-based regulatory framework, and details monitoring and evaluation mechanisms.
It does not contain the final legal text of the enacted Artificial Intelligence Act, nor does it cover exclusive military applications of AI.
- The rapid growth of AI brings significant economic and societal benefits but also introduces distinct risks regarding safety and fundamental rights.
- Existing EU legislation lacks specific, harmonized rules and enforcement mechanisms tailored to address the unique characteristics of AI systems such as opacity and autonomy.
- Fragmented national regulatory approaches across Member States create legal uncertainty and obstacles to the single market.
- A risk-based horizontal regulatory framework targeting high-risk AI applications is the most proportionate and effective approach.
- The preferred policy combines mandatory requirements and ex-ante conformity assessments for high-risk AI with voluntary codes of conduct for non-high-risk systems.
1. Introduction: Technological, Socio-Economic, Legal and Political Context 2. Problem Definition 3. Why Should the EU Act? 4. Objectives: What Is to Be Achieved? 5. What Are the Available Policy Options? 6. What Are the Impacts of the Policy Options? 7. How Do the Options Compare? 8. Preferred Option 9. How Will Actual Impacts Be Monitored and Evaluated?
How it scores
Each score is backed by a quote verified against the document text. Editorial review has not yet confirmed them.
Transparency
4/5Openness about how AI systems work and are used
Obligation to inform people when interacting with an AI system (chatbot) in cases where individuals might believe that they are interacting with another human being
5.4.2. Risk-based approach with clear and proportionate obligations across the AI value chain
screening score · 2026-10-25
Enforcement
4/5Consequences and compliance mechanisms with real force
Sanctions will include 1) suspension of the label and 2) imposition of fines proportionate to the size of the company in case of serious and/or repeated infringements
5.2.2. Requirements for Trustworthy AI envisaged in the EU voluntary labelling scheme
screening score · 2026-10-25
Impact Assessment
4/5Required assessment of an AI system's risks/impacts before or during use
To prove compliance with the requirements outlined above, providers who choose to subscribe to the voluntary labelling scheme would also have to establish within their organisation an appropriate quality management and risk management system
5.2.2. Requirements for Trustworthy AI envisaged in the EU voluntary labelling scheme
screening score · 2026-10-25