The Digital Omnibus on AI.

Reviewed

Short answer

Regulation (EU) 2026/1744, the Digital Omnibus on AI, amended the AI Act with effect from 27 July 2026: it moved the high-risk rules to 2 December 2027 (Annex III) and 2 August 2028 (Annex I), gave providers of generative AI already on the market until 2 December 2026 to mark outputs, and added two prohibitions, on AI-generated non-consensual intimate imagery and child sexual abuse material, from 2 December 2026. It also reworded the AI literacy duty so that no specific level is required, and extended several SME reliefs to small mid-cap companies.

Official source: Regulation (EU) 2026/1744 (EUR-Lex)

Before and after

Main changes made by Regulation (EU) 2026/1744 to the AI Act
TopicBefore (2024 text)After (2026/1744)Provision
High-risk, Annex III2 August 20262 December 2027Article 113(c)(i)
High-risk, Annex I products2 August 20272 August 2028Article 113(c)(ii)
Marking AI output, systems already on the marketNo transition: 2 August 2026Until 2 December 2026Article 111(4), new
ProhibitionsEight practices in Article 5(1)Plus (ba) non-consensual intimate imagery and (bb) child sexual abuse material, from 2 December 2026Article 5(1), (1a), (1b)
AI literacy“ensure, to their best extent, a sufficient level of AI literacy”“take measures to support the development of AI literacy”; no specific level must be guaranteed; Commission publishes practical examplesArticle 4
Small mid-caps (SMCs)Not definedNew category (Recommendation (EU) 2025/1099), with lower fine caps for most infringements and the simplified documentation formArticles 3(14b), 11(1), 99(6a)
Simplified quality management systemMicroenterprises onlyAll SMEs, including start-ups, without partner or linked enterprisesArticle 63(1)
Sensitive data for bias detectionArticle 10(5), high-risk onlyNew Article 4a, with conditions; also allowed for other AI systemsArticles 4a, 10
Code of practice on marking and labellingCommission may approve the code by implementing actCommission assesses whether adherence is adequate; implementing act only if the code is inadequateArticle 50(7)
Supervision of some AI systemsAI Office may monitor and supervise AI systems built on a GPAI model by the same providerAI Office exclusively competent for those systems (with listed exceptions) and for AI systems in very large online platforms and search enginesArticle 75(1)
National regulatory sandboxesOperational by 2 August 2026Operational by 2 August 2027Article 57(1)
Fundamental rights impact assessment—May cross-refer to the GDPR data protection impact assessment; AI Office questionnaire templateArticle 27(4), (5)

Dates of the Omnibus itself

  • Adopted 8 July 2026; published in the Official Journal on 24 July 2026.
  • Entered into force on the third day after publication, 27 July 2026, and is directly applicable in all member states.
  • Articles 102 to 110 of the AI Act, which amend other EU laws, apply from 27 July 2026 (Article 113(d)).

What did not change

  • The general date of application, 2 August 2026, including Article 50 for deployers and for new systems.
  • The four risk levels and the list of high-risk areas in Annex III.
  • The dates for general-purpose AI models (2 August 2025; 2 August 2027 for earlier models).
  • The fine levels of Article 99, apart from the new SMC rule.

Questions

Did the Omnibus delay Article 50?
Only one part of it, and only for systems already on the market: providers of generative AI systems placed on the market before 2 August 2026 have until 2 December 2026 to mark their outputs (Article 111(4)). Everything else in Article 50, including deployers’ duty to disclose deepfakes, applies from 2 August 2026.
When did the Omnibus take effect?
On 27 July 2026, the third day after its publication in the Official Journal on 24 July 2026. Some changes apply later: the new prohibitions from 2 December 2026 and the high-risk rules from 2 December 2027 and 2 August 2028.

Sources

Last reviewed by Volkan Çatak, Founder, Proofcan.

Not legal advice. This page explains official texts in plain words and links each one; check the sources, or a lawyer, before relying on it for a decision.