Simplification of the implementation of harmonised rules on artificial intelligence – Digital Omnibus on AI (Omnibus VII)
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Provisional agreement reached, awaiting formal adoption by Parliament and Council.
Last active 16 Jun 2026
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What this bill does
In plain terms: what it changes and who it affects.
This proposal eases and delays parts of the EU AI Act’s rollout while centralising some AI oversight and widening support for smaller businesses.
Who it affects
It affects AI system providers and deployers, especially SMEs and small mid-caps, users of high-risk AI, large online platforms and search engines, and sectors using AI-enabled products such as aviation.
Core of the proposal
- Links high-risk AI obligations to availability of standards, specifications or guidance, with backstop application dates.
- Extends SME simplifications on documentation, quality systems, support and penalties to small mid-cap enterprises.
- Moves some oversight of GPAI-based systems and AI in very large platforms/search engines to the AI Office.
- Allows special-category personal data processing for bias detection and correction, subject to safeguards.
Key provisions
- Takes effect
- The Regulation enters into force on the third day after publication in the Official Journal of the European Union.
- Transitional law
- Generative AI systems already marketed before 2 August 2026 must comply with Article 50(2) by 2 February 2027.
Articles changed · 40 across 2 laws
- Regulation (EU) 2024/1689 (32024R1689)
- art. 1(2)(g): replaces point (g) on innovation support focus
- art. 2(2): replaces paragraph on applicable provisions for Section B Annex I products
- art. 3: inserts definitions of SME and SMC as points (14a) and (14b)
- art. 4: replaces AI literacy obligation with Commission and Member State encouragement duty
- art. 4a: inserts new article on special-category personal data processing for bias detection and mitigation
- art. 6(4): replaces documentation obligation for systems considered not high-risk
- art. 10: amends paragraphs 1 and 6; deletes paragraph 5
- art. 11(1): replaces second subparagraph on technical documentation and simplified SMC/SME form
- art. 17(2): replaces paragraph on proportional quality management implementation for SMCs and SMEs
- art. 28: adds paragraph 8 on single designation application and assessment procedure
- art. 29(4): replaces paragraph on notified body designation documentation and single applications
- art. 30(2): replaces notification rules using Annex XIV codes and adds delegated power
- art. 43(3): replaces conformity assessment rules for Annex I Section A high-risk AI systems
- art. 49(2): deletes paragraph on EU database registration
- art. 50(7): replaces provision on codes of practice and implementing acts for content marking
- art. 56(6): replaces first subparagraph on monitoring and assessment of codes of practice
- art. 57: inserts paragraph 3a and amends sandbox provisions in paragraphs 5, 9, 13 and 14
- art. 58(1): replaces implementing-act empowerment for AI regulatory sandbox arrangements
- art. 60: amends real-world testing rules for Annex III and Annex I Section A systems
- art. 60a: inserts real-world testing rules for Annex I Section B high-risk AI systems
- art. 63(1): replaces simplified quality management provision for SMEs including start-ups
- art. 69: replaces paragraph 2 on fees and deletes paragraph 3
- art. 70(8): replaces guidance provision, extending focus to SMCs and SMEs
- art. 72(3): replaces post-market monitoring plan provision and Commission guidance duty
- art. 75: replaces heading and paragraph 1; inserts paragraphs 1a to 1c on AI Office powers
- art. 77: replaces heading and paragraph 1; inserts paragraphs 1a and 1b on cooperation
- art. 95(4): replaces provision to include SMCs in code of conduct support
- art. 96(1): replaces second subparagraph to include SMCs in guideline attention
- art. 99: replaces paragraphs 1 and 6 on penalties for SMCs and SMEs
- art. 111: replaces paragraph 2 and adds paragraph 4 on transitional compliance
- art. 113: adds third-paragraph points (d) and (e) on application dates
- art. Annex VIII: deletes Section B
- art. Annex XIV: adds new annex listing codes, categories and AI system types for notification procedure
- Regulation (EU) 2018/1139 (32018R1139)
- art. 27: adds paragraph 3 on AI safety component requirements in implementing acts
- art. 31: adds paragraph 3 on AI safety component requirements in implementing acts
- art. 32: adds paragraph 3 on AI safety component requirements in delegated acts
- art. 36: adds paragraph 3 on AI safety component requirements in implementing acts
- art. 39: adds paragraph 3 on AI safety component requirements in delegated acts
- art. 50: adds paragraph 3 on AI safety component requirements in implementing acts
- art. 53: adds paragraph 3 on AI safety component requirements in implementing acts
Latest update
16 Jun 2026The most recent development in this bill's progress.
Trilogues (interinstitutional negotiations) → Trilogues (interinstitutional negotiations)
Trilogues (interinstitutional negotiations) → Trilogues (interinstitutional negotiations)
Documents
1 recentSourcesOEILEUR-LexEU Law Tracker