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EU Artificial Intelligence Act — Regulation (EU) 2024/1689
Source: European Union, Official Journal (reproduction authorised with source acknowledgement, Decision 2011/833/EU) | Chapters: 12
When to use
Use this skill when classifying an AI system under the EU risk framework, determining which obligations apply to a provider, deployer, importer, distributor, or GPAI model provider, or analysing penalties and enforcement. It is the primary reference for any EU market compliance question involving AI systems or foundation/GPAI models placed on the Union market from 2025 onward. Use it before advising on AI product design, contract structure between value-chain parties, or incident response procedures.
Prerequisites: none — plain Markdown; no MCP server, API key, or licence tier needed at runtime.
How to Use This Skill
- Without arguments — load the core frameworks and classification rules.
- With a topic — ask about "GPAI systemic risk", "biometric ID prohibition", "conformity assessment route", "FRIA", "value chain liability", "serious incident reporting", "transparency obligations", "Annex III area 4 employment AI".
- With a chapter — ask for
ch03 (classification), ch04 (requirements), ch08 (GPAI), ch12 (Annex III use cases).
Supporting files: glossary.md, patterns.md, cheatsheet.md.
Core Frameworks and Mental Models
1. The Four-Tier Risk Architecture
The Act organises AI systems into four tiers, each with escalating obligations:
| Tier | Trigger | Consequence |
|---|
| Prohibited | Art 5 — 8 specific practices | Absolute ban; no compliance route; applies from 2 Feb 2025 |
| High-risk | Art 6 Route A (Annex I product + third-party conformity assessment) OR Route B (Annex III use-case area, unless de minimis applies) | Full Ch III obligations: RMS, data governance, docs, logging, transparency, human oversight, accuracy/robustness/cybersecurity; conformity assessment; CE marking; EU database registration |
| Transparency-only | Art 50 — human-AI interaction, synthetic content generation, emotion recognition, biometric categorisation, deep fakes | Disclosure and machine-readable labelling obligations; applies to any AI system, regardless of risk tier |
| GPAI | Ch V — AI models trained at scale displaying significant generality | Baseline obligations for all GPAI; systemic-risk tier (>10^25 FLOPs or Commission designation) adds adversarial testing, incident reporting, and cybersecurity |
2. Classification Decision Logic (Art 6)
Route A (product safety): AI system = safety component of an Annex I-sector product AND that product requires third-party conformity assessment under sector law → HIGH-RISK.
Route B (use-case list): AI system falls within an Annex III area → HIGH-RISK, unless the Art 6(3) de minimis carve-out applies. De minimis applies if the system: (a) performs a narrow procedural task, OR (b) improves the result of a previously completed human activity, OR (c) detects decision-making patterns without influencing prior human assessment, OR (d) performs a preparatory task to an Annex III assessment. Override: if the system performs profiling of natural persons, de minimis never applies — it is always high-risk.
Providers claiming de minimis must document the assessment and register in the EU database (Art 6(4)).
3. The Seven High-Risk Requirements (Art 8-15)
All seven apply cumulatively to every high-risk AI system. They must be met before placement on the market and maintained throughout the system's lifecycle:
- Risk Management System (Art 9) — continuous iterative 4-step process; residual risk must be acceptable.
- Data Governance (Art 10) — training/validation/testing data quality; bias detection and mitigation; strict conditions for special-category personal data use in bias correction.
- Technical Documentation (Art 11) — Annex IV content; drawn up before placement; kept up to date; SMEs may use simplified form.
- Automatic Logging (Art 12) — technically built into the system; biometric ID systems have enhanced minimum logging requirements.
- Transparency to Deployers (Art 13) — instructions for use covering 7 content categories; enables deployer compliance with their own obligations.
- Human Oversight (Art 14) — oversight measures enabling understanding, anti-bias awareness, output interpretation, override capability, and system interruption (stop button). Biometric ID: minimum two-person verification before action.
- Accuracy, Robustness, Cybersecurity (Art 15) — declared accuracy metrics; resilience to errors; feedback-loop mitigation; AI-specific attack defence (data/model poisoning, adversarial examples).
4. Operator Roles and Liability Transfer
The Act assigns obligations by role in the supply chain:
- Provider (Art 16): Bears the heaviest burden — QMS, conformity assessment, CE marking, EU database registration, 10-year documentation retention, corrective actions.
- Deployer (Art 26): Follow instructions for use; assign and train human oversight persons; retain logs ≥6 months; notify workers; FRIA if public body; inform affected persons.
- Importer (Art 23): Verify conformity before placement; retain docs 10 years.
- Distributor (Art 24): Verify CE marking and DoC before making available.
- Liability transfer (Art 25): A party becomes the provider (and assumes all provider obligations) if it: affixes its name/trademark; makes a substantial modification; or changes the intended purpose to make a non-high-risk system high-risk.
5. GPAI Two-Tier Regime (Chapter V)
All GPAI providers: technical documentation (Annex XI), downstream provider information (Annex XII), copyright policy, training data summary. Open-source GPAI models are exempt from documentation and downstream information obligations — unless the model has systemic risk.
Systemic-risk GPAI providers additionally: adversarial testing (red-teaming), systemic risk assessment and mitigation, serious incident reporting to AI Office, cybersecurity protection. The 10^25 FLOPs training-compute threshold creates a rebuttable presumption of systemic risk. Notification to Commission required within 2 weeks of threshold being met. Commission has exclusive enforcement jurisdiction over GPAI (Art 88).
6. Governance Architecture
Union level: AI Office (Commission function, exclusive GPAI enforcement) → European AI Board (Member State representatives, advisory) → Advisory Forum (stakeholders) → Scientific Panel (independent experts, GPAI risk alerts).
Member State level: Notifying authority (notified body oversight) + Market surveillance authority (post-placement enforcement for non-GPAI AI systems). Each Member State designates one MSA as single point of contact.
7. Penalty Logic
Three national-authority tiers (Art 99): 7%/EUR 35M for prohibited practices; 3%/EUR 15M for operator/transparency obligation violations; 1%/EUR 7.5M for misleading information supply. Commission fines for GPAI violations (Art 101): 3%/EUR 15M. SMEs always pay the lower of the percentage or absolute amount. Fines are calculated on total worldwide annual turnover.
8. Key Application Dates
Prohibited practices applied from 2 February 2025. Full Act applies from 2 August 2026. GPAI obligations apply from 2 August 2025. Product-safety-route (Art 6(1)) AI applies from 2 August 2027.
Chapter Index
| # | File | Key content |
|---|
| 1 | ch01-general-provisions.md | Subject matter, scope, 68 statutory definitions, AI literacy obligation |
| 2 | ch02-prohibited-practices.md | Eight prohibited AI practices; real-time RBIS conditional ban; applies from 2 Feb 2025 |
| 3 | ch03-high-risk-classification.md | Art 6 two-route classification; Art 6(3) de minimis carve-out; Art 7 dynamic amendment; Annex III overview |
| 4 | ch04-high-risk-requirements.md | Seven requirements: RMS, data governance, technical docs, logging, transparency, human oversight, accuracy/robustness/cybersecurity |
| 5 | ch05-obligations-operators.md | Provider QMS; value-chain obligations; Art 25 liability transfer; deployer FRIA; documentation retention |
| 6 | ch06-conformity-assessment.md | Conformity assessment routes; notified bodies; harmonised standards; CE marking; EU database registration; AI regulatory sandboxes |
| 7 | ch07-transparency-obligations.md | Art 50 four transparency obligations: chatbot disclosure, synthetic content labelling, emotion/biometric disclosure, deep fake disclosure |
| 8 | ch08-general-purpose-ai.md | GPAI classification; 10^25 FLOPs threshold; baseline and systemic-risk obligations; open-source exception; codes of practice |
| 9 | ch09-governance.md | AI Office; European AI Board; Advisory Forum; Scientific Panel; national competent authorities; enforcement architecture |
| 10 | ch10-post-market-surveillance.md | EU database; post-market monitoring; serious incident reporting timelines; market surveillance powers; right to explanation; right to complain |
| 11 | ch11-penalties-enforcement.md | Three penalty tiers; GPAI fines; codes of conduct for non-high-risk AI; Commission implementation guidelines |
| 12 | ch12-annex-iii-high-risk-usecases.md | Full Annex III eight-area taxonomy with sub-category detail; classification rationale; dynamic amendment |
Topic Index
- AI system definition → ch01
- Annex III use cases / high-risk areas → ch12, ch03
- Biometric identification → ch02, ch03, ch04, ch12
- CE marking → ch06
- Chatbot / human-AI interaction disclosure → ch07
- Classification (high-risk vs not) → ch03
- Codes of conduct (voluntary) → ch11
- Codes of practice (GPAI) → ch08
- Conformity assessment → ch06
- Copyright (GPAI training data) → ch08
- Data governance / training data → ch04
- Deep fakes → ch07
- Deployer obligations → ch05
- Documentation / technical documentation → ch04, ch05, ch06
- Election / democracy AI → ch12
- Employment AI → ch12
- Enforcement / market surveillance → ch10
- EU database registration → ch06, ch10
- Fines / penalties → ch11
- FRIA (Fundamental Rights Impact Assessment) → ch05
- General-purpose AI (GPAI) models → ch08, ch09
- Governance structure → ch09
- Human oversight / automation bias → ch04
- Importer / distributor obligations → ch05
- Law enforcement AI → ch02, ch12
- Logging / record-keeping → ch04, ch05
- Open-source AI → ch01, ch08
- Post-market monitoring → ch10
- Prohibited practices → ch02
- Provider obligations → ch05
- Quality Management System (QMS) → ch05
- Real-time remote biometric identification (RBIS) → ch02
- Regulatory sandbox → ch06
- Risk management system (RMS) → ch04
- Scope / applicability → ch01
- Serious incident reporting → ch10
- SME provisions → ch04, ch06, ch11
- Social scoring → ch02
- Synthetic content / watermarking → ch07
- Systemic risk (GPAI) → ch08
- Transparency obligations → ch07
- Value chain / liability transfer → ch05
Supporting Files
- glossary.md — ~60 statutory and synthesised definitions from Art 3 and operative provisions.
- patterns.md — 12 when/how/trade-offs blocks covering classification, data governance, conformity assessment, incident reporting, GPAI self-assessment, and more.
- cheatsheet.md — Quick-reference tables: application timeline, classification decision tree, Annex III areas, penalty tiers, requirement checklist, operator obligations, GPAI obligations matrix, serious incident reporting timelines, governance architecture.
Scope and Limits
Covers: All 13 Chapters and key Annexes (I, III, IV, V, VIII, XI, XII) of Regulation (EU) 2024/1689 as published in the Official Journal on 12 July 2024. Includes all definitional, substantive, procedural, governance, and penalty provisions.
Does not cover: The proposed EU AI Liability Directive (separate instrument, not yet adopted at source knowledge date); post-July-2024 Commission guidelines, implementing acts, or delegated acts issued under the Act; national transposition measures; harmonised standards (to be developed by CEN/CENELEC); or codes of practice approved after the knowledge cutoff.
Licence: European Union, Official Journal, 12 July 2024. Reproduction authorised with source acknowledgement under Decision 2011/833/EU. No rights subsist in the synthesised analysis beyond the source text.