GLACIS·EU AI Act series·Updated August 2026
EU AI Act high-risk compliance, before the cliff edge.
The Act can apply to providers and deployers inside or outside the EU when its territorial conditions are met. Prohibited-practice fines can reach €35M or 7% of global turnover. The AI Omnibus entered into force on 27 July 2026: relevant high-risk obligations apply from 2 December 2027 for Annex III systems and 2 August 2028 for Annex I product-embedded systems. Technical documentation and Article 12 logging must be ready when the applicable duties begin.
After a provisional agreement in May 2026, the AI Omnibus was formally adopted as Regulation (EU) 2026/1744 and entered into force on 27 July 2026. Relevant Annex III high-risk obligations now apply from 2 December 2027, and relevant Annex I product-embedded obligations from 2 August 2028. Other AI Act obligations retain their own application dates; the amendment did not postpone the Act as a whole.
The dates are reflected in the consolidated AI Act on EUR-Lex. Classification and the applicable conformity pathway remain system-specific; this page is general information, not legal advice.
High-risk systems under Annex III
For an Annex III use case, Article 6(2) classification turns on the system’s intended purpose and the specific Annex III entry. Article 6(3) provides a limited route for a listed system that does not pose a significant risk of harm to health, safety, or fundamental rights, subject to its conditions; profiling systems listed in Annex III remain high-risk. A system classified high-risk is subject to Articles 9–15 (risk management, data governance, technical documentation, logging, transparency, human oversight, accuracy/robustness/cybersecurity), plus Article 17 quality management.
| Domain | Typical systems in scope |
|---|---|
| Biometrics | Remote identification, categorisation, emotion recognition (outside law-enforcement carve-outs) |
| Critical infrastructure | Safety components for water, gas, electricity, traffic management, digital networks |
| Education & vocational training | Admissions scoring, exam evaluation, attainment-level assignment, prohibited-behaviour detection |
| Employment | Recruitment, selection, performance evaluation, termination, work allocation |
| Essential services | Creditworthiness, life and health insurance pricing, public-benefit access decisions, emergency triage |
| Law enforcement | Risk assessment of natural persons, polygraphs, evidence reliability, profiling |
| Migration, asylum & border | Risk assessment, document verification, application examination support |
| Justice & democratic processes | Judicial-decision support, alternative dispute resolution, election influence systems |
Employment screening is Annex III high-risk: recruitment, ranking and evaluation systems carry the full Articles 9–15 load. See how signed runtime evidence works for hiring AI. Clinical AI embedded in regulated products follows the embedded-product track; start with medical devices.
What Articles 9–15 actually require
| Article | Requirement |
|---|---|
| Art. 9 | Risk management system across the lifecycle: identify, evaluate, mitigate, monitor. |
| Art. 10 | Data governance for training, validation, testing — relevance, representativeness, error checks. |
| Art. 11 | Technical documentation per Annex IV (nine substantive sections). |
| Art. 12 | Automatic event logging capabilities appropriate to the covered high-risk system’s intended purpose. Configured GLACIS paths can contribute scoped records for selected events. |
| Art. 13 | Transparency and instructions for downstream deployers. |
| Art. 14 | Effective human oversight measures. |
| Art. 15 | Accuracy, robustness, cybersecurity — including resilience to adversarial input. |
| Art. 17 | Quality management system covering compliance, post-market monitoring, incident reporting. |
Penalty structure under Article 99
Three penalty bands. For undertakings other than SMEs, the higher fixed amount or turnover percentage is the ceiling; for SMEs, each fine must not exceed the lower of those two ceilings. National competent authorities set the actual fine within the applicable ceiling; the AI Office handles GPAI providers directly.
| Violation | Maximum fine | Or % of global turnover |
|---|---|---|
| Prohibited practices (Article 5) | €35,000,000 | 7% |
| Other non-compliance (Articles 9–15, 17, etc.) | €15,000,000 | 3% |
| Incorrect information to authorities | €7,500,000 | 1% |
Enforcement and institutional design remain phased across the Union. Confirm the current competent authority, applicable system category, and effective date before relying on this overview for a specific deployment.
How GLACIS fits the obligations
GLACIS can connect configured controls to signed operational records for a defined AI workflow. Those records may support an organization’s Article 12 logging and review process; they do not replace technical documentation, conformity assessment, or legal analysis.
| Article | What GLACIS produces |
|---|---|
| Art. 9 Risk management | Scoped records showing which configured controls evaluated an in-scope action and which outcome was reported. |
| Art. 11 Technical docs | Operational evidence that can supplement, but does not generate or replace, Annex IV documentation. |
| Art. 12 Logging | Signed event records with explicit scope, identity, timestamps, control outcomes, and integrity checks. |
| Art. 14 Human oversight | Records of configured escalation, review, and override events for covered actions. |
| Art. 15 Robustness | Evidence from configured tests and runtime controls, interpreted alongside system-level evaluation. |
| Art. 17 QMS | Evidence artifacts that can support an organization’s quality-management and post-market processes. |
Signed, scoped records may contribute to an Article 12 evidence set when their fields and coverage are relevant; they do not replace the system’s logging design or establish conformity.
Go deeper
| Full compliance guide | Risk categories, Articles 9–15 in detail, GPAI obligations, conformity assessment paths, the Omnibus status. |
| For Chief Compliance Officers | Programme architecture, audit-readiness checklist, board reporting, certification routes. |
| For CISOs | Article 12 logging architecture, Article 15 robustness, sec-eng integration. |
| For General Counsel | Liability allocation, vendor and deployer contracts, extraterritorial scope. |
| EU AI Act vs HIPAA | Crosswalk for healthcare and life-sciences operators with US obligations. |
| Colorado ADMT law (SB 26-189) | The US transparency analogue — covered automated decision-making technology, with substantive compliance from 1 January 2027; what stacks with the EU regime. |
By member state
| Germany | Bundestag adopted KI-MIG on 11 June 2026, assigning roles to BNetzA, sector authorities and KoKIVO; verify promulgation, entry into force and the current authority route. |
| France | Decentralised model: CNIL on workplace/education emotion-recognition; ANSSI on cybersecurity; PEReN technical support; the multi-authority DDADUE bill passed the Senate on 18 February 2026 and remains before the National Assembly. |
| Italy | National AI Law No. 132/2025 in force 10 October 2025; AgID notifying authority, ACN market surveillance, Garante on data; delegated implementing decrees have a statutory deadline of 10 October 2026. |
| Spain | AESIA operational since June 2024; 16 detailed compliance guides published December 2025; regulatory sandbox; draft national AI Law (March 2025). |
| Netherlands | Proposed hybrid 10-authority model led by AP, with AP+RDI co-coordination; public consultation on the proposed Implementation Act ran 20 April – 1 June 2026 and is closed. |
| Belgium | BIPT designated main market surveillance authority (2025-2029 Federal Government Agreement); 21 fundamental-rights bodies under Article 77. |
| Poland | New body KRiBSI under construction (single-authority model); operational support nested in Ministry of Digital Affairs; UODO disputing advisory-only role. |