EU AI Act
Amendments:
- —
Obligations Covered
AI Literacy & Training Human Oversight Transparency & Disclosure Risk Assessment Conformity Assessment Record-Keeping & Documentation
AI Literacy (Article 4) #
Requirements
| Requirement | Details |
|---|---|
| Staff AI literacy | Providers AND deployers must ensure sufficient AI literacy for staff dealing with operation and use of AI systems |
| Context-specific | Training must account for technical knowledge, experience, education, usage context, and affected persons/groups |
| No method prescribed | Compliance method is flexible; Commission Q&A confirms no strict measurement obligation |
| AI Office guidance | Commission AI Office published Q&A and repository of AI literacy practices (non-exhaustive, aligned with Article 4) |
Penalties
| Violation | Fine |
|---|---|
| Non-compliance | Up to EUR 15M or 3% global turnover (aggravating factor) |
Human Oversight (Article 14) #
Requirements
| Requirement | Details |
|---|---|
| Effective oversight | High-risk AI must enable oversight by natural persons (Article 14(1)) |
| Understand capabilities | Overseers must understand system capabilities, limitations, and purposes (Article 14(4)(a)) |
| Monitor for anomalies | Must monitor operation and detect unexpected performance, anomalies, and dysfunctions (Article 14(4)(a)) |
| Interpret output | Must be able to correctly interpret output using available tools (Article 14(4)(b)) |
| Override/reverse | Must be able to decide not to use, disregard, override, or reverse AI output (Article 14(4)(c)) |
| Intervene or halt | Must be able to intervene or interrupt system operation via stop button or equivalent halt procedure (Article 14(4)(d)) |
| Address automation bias | Must address risk of automation bias in oversight procedures (Article 14(3)) |
| Competent personnel | Deployers must assign persons with necessary competence, training, and authority (Article 26(2)) |
Penalties
| Violation | Fine |
|---|---|
| High-risk non-compliance | Up to EUR 15M or 3% global turnover |
Transparency Requirements #
Requirements
| Requirement | Details |
|---|---|
| Usage disclosure | Deployers must inform users they're interacting with AI |
| Deepfake labeling | Providers must mark AI-generated content |
| Technical docs | Providers must document system capabilities and limits |
Penalties
| Violation | Fine |
|---|---|
| Prohibited practices | Up to EUR 35M or 7% global turnover |
| High-risk non-compliance | Up to EUR 15M or 3% global turnover |
| Incorrect information | Up to EUR 7.5M or 1% global turnover |
Risk Management (Article 9) #
Requirements
| Requirement | Details |
|---|---|
| Risk management system | Establish and maintain throughout AI lifecycle (Article 9(1)) |
| Identify and analyze | Identify known and reasonably foreseeable risks to health, safety, and fundamental rights during intended use and foreseeable misuse (Article 9(2)(a)) |
| Estimate and evaluate | Estimate and evaluate risks that may emerge under intended use and misuse conditions (Article 9(2)(b)) |
| Post-market evaluation | Evaluate risks based on data from post-market monitoring (Article 9(2)(c)) |
| Risk mitigation | Take appropriate and targeted mitigation measures addressing identified risks (Article 9(2)(d)) |
| Design-based reduction | Eliminate or reduce risks through adequate design and development where technically feasible (Article 9(4)(a)) |
| Residual risk | Ensure residual risks are judged acceptable (Article 9(4)(b)) |
| Testing | Test to ensure consistent performance and compliance; test against risk measures (Article 9(5)) |
| Continuous monitoring | Ongoing performance monitoring throughout the system lifecycle |
Penalties
| Violation | Fine |
|---|---|
| High-risk non-compliance | Up to EUR 15M or 3% global turnover |
Conformity Assessment #
Requirements
| Requirement | Details |
|---|---|
| Conformity assessment | Must undergo before placing on market or putting into service (Article 43) |
| CE marking | Required for high-risk AI systems once assessment complete (Article 48) |
| Quality management | Must establish quality management system (Article 17) |
| Documentation | Maintain technical documentation throughout lifecycle (Article 18) |
| Annex III phasing | Annex III high-risk systems: 2027-12-02 (deferred from 2026-08-02 by Digital Omnibus, political agreement 2026-05-07, not yet in OJ). Annex I high-risk (safety components covered by other EU product laws, e.g., medical devices): 2028-08-02 (deferred from 2027-08-02) |
Penalties
| Violation | Fine |
|---|---|
| High-risk non-compliance | Up to EUR 15M or 3% global turnover |
Record-Keeping & Automatic Logging (Article 12) #
Requirements
| Requirement | Details |
|---|---|
| Automatic logging | High-risk AI systems must log events automatically throughout lifecycle |
| Traceability | Logs must enable risk identification and post-market monitoring |
| Deployer monitoring | Logs must support operational monitoring by deployers (Article 26(5)) |
| Immutable storage | Logs must be stored tamper-evident and immutable |
| Biometric ID specifics | Remote biometric systems must log period of use, reference database, input data, and verifying personnel |
Penalties
| Violation | Fine |
|---|---|
| High-risk non-compliance | Up to EUR 15M or 3% global turnover |