Record STMT-WA0C551Advisory

Study to support an impact assessment of regulatory requirements for Artificial Intelligence in Europe

Report International lawEuropean Unionadopted

This study supports the Impact Assessment of the European Commission's proposed Regulation on a European approach to Artificial Intelligence. It provides a comprehensive overview of evidence and risk assessments regarding AI harms to fundamental rights and safety, analyzes emerging national regulatory frameworks, and evaluates the results of public consultations on the AI White Paper. Additionally, the report estimates the compliance costs and administrative burdens generated by the proposed AI Regulation.

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

Who issued it

European CommissionGovernment (executive)

Lead issuer

WavestoneIndustry

Contributor

CEPSAcademic

Contributor

ICFIndustry

Contributor

Legal forceAdvisory

Under whose authorityInternational law

Judged fromfull text

Who it governs

National governmentRegulatorsPublic sector bodiesResearchers and academics

Policy makers, regulators, researchers, and stakeholders interested in the impact assessment and regulatory framework for artificial intelligence in Europe.

Sectors

Cross-sector

What the document contains

What's covered

The document addresses the impact assessment of the European Commission's proposed AI regulation, detailing AI-related risks to fundamental rights and safety, comparative national regulatory approaches, public consultation findings, and compliance cost estimations.

What's missing

Not stated

Key takeaways

The study was prepared to support the Impact Assessment of the European Commission's proposed Regulation on Artificial Intelligence.
Section 1 details evidence on risks and harms generated by AI regarding fundamental rights, safety, and security.
Section 2 compares emerging national regulatory frameworks and strategies with a focus on risk governance.
Section 3 analyzes thousands of free-text responses and position papers from the public consultation on the AI White Paper.
Section 4 evaluates the compliance costs and administrative burdens associated with the proposed Regulation on Artificial Intelligence.

Outline

· Section 1: Comprehensive overview of existing evidence and prospective assessments of risks and harms generated by AI for fundamental rights, safety, and security.
· Section 2: Comparative overview of emerging national experiences in developing strategies and regulatory frameworks with emphasis on risk governance.
· Section 3: Detailed analysis of the results of the public consultation on the European Commission White Paper on Artificial Intelligence.
· Section 4: Assessment of compliance costs generated by the proposed Regulation on Artificial Intelligence.

Issued2021

Length515 words

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

0/5

Clear responsibility for AI outcomes

screening score · 2026-10-23

Fairness

1/5

Non-discrimination and equitable treatment

anti-discriminatory measure

Subject

screening score · 2026-10-23

Human Dignity

0/5

Respect for the inherent worth of persons

screening score · 2026-10-23

Human Oversight

0/5

Humans remain in control of consequential decisions

screening score · 2026-10-23

Privacy

0/5

Protection of personal data and private life

screening score · 2026-10-23

Transparency

0/5

Openness about how AI systems work and are used

screening score · 2026-10-23

Enforcement

4/5

Consequences and compliance mechanisms with real force

Section 4 is dedicated to an assessment of the compliance costs generated by the proposed Regulation on Artificial Intelligence, including both administrative burdens and substantive compliance costs.

Publication metadata

screening score · 2026-10-23

Impact Assessment

3/5

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

This Study, completed for the European Commission, DG CONNECT, supports the Impact Assessment of the European Commission’s proposed Regulation on a European approach to Artificial Intelligence (AI).

Publication metadata

screening score · 2026-10-23

Topics

impact_assessment compliance_costs risk_governance fundamental_rights public_consultation