Module 4: AI Regulation, BoK IV.B

The EU AI Act and the Digital Omnibus

The EU AI Act is a risk-based regulation with extraterritorial reach. The AI Omnibus entered into force on 27 July 2026. Most of the Act applied from 2 August 2026, while the Annex III high-risk rules apply from 2 December 2027 and Annex I product rules from 2 August 2028.

The AI Act regulates defined uses and providers of AI through a risk-based framework. The AI Omnibus amended that framework and set fixed later dates for the high-risk system rules.

EU AI Act - purposes and impact
PurposesImpact
Harmonised EU rules for placing AI on the market and governing use; balance innovation with safety; promote AI literacy; ensure legal certainty to promote investment and innovation and align AI with EU core values.Extraterritorial reach can bring non-EU providers and deployers within scope when the Act's territorial tests are met. The rules distinguish prohibited practices, high-risk systems, transparency duties and general-purpose AI obligations.
The AI Omnibus is now in force

The Commission proposed the measure in November 2025. Political agreement followed on 7 May 2026, and the final AI Omnibus entered into force on 27 July 2026. It simplified parts of the AI Act and extended the application dates for high-risk systems.

  • Most provisions applied from 2 August 2026. Prohibited-practice and AI-literacy rules applied from 2 February 2025, while governance and general-purpose AI obligations applied from 2 August 2025.
  • Annex III high-risk rules apply from 2 December 2027. High-risk AI embedded in regulated products under Annex I applies from 2 August 2028.
  • Operators of earlier high-risk systems generally face the new rules only after a significant design change. Public authorities using earlier high-risk systems must take the necessary compliance steps by 2 August 2030.
Dates to distinguish

Most provisions applied from 2 August 2026. Annex III high-risk rules apply from 2 December 2027. Annex I product rules apply from 2 August 2028. The 2 August 2030 date concerns certain earlier public-authority systems.

Key terms - quick answers

What is “AI Omnibus”?
An amending regulation that entered into force on 27 July 2026 and changed parts of the AI Act, including the application dates for high-risk systems.

Sources and study method

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