Simplification of the implementation of harmonised rules on artificial intelligence – Digital Omnibus on AI (Omnibus VII)

It mainly affects AI providers and deployers, especially SMEs and small mid-cap enterprises. It also affects conformity assessment bodies, national authorities, and providers of AI systems used in aviation and online platforms.

• Lets SMEs and small mid-caps use simplified technical documentation and quality management rules.
• Allows limited processing of special personal data to detect and correct AI bias.
• Moves oversight of certain general-purpose and platform AI systems to the Commission’s AI Office.
• Links high-risk AI rules to available standards and guidance, and expands sandbox and real-world testing options.

Takes effect

It enters into force on the third day after publication in the Official Journal.

Transitional law

Providers of generative AI systems already on the market before 2 August 2026 get six months to meet the content-marking rules.

• Regulation (EU) 2024/1689 (32024R1689)
  • art. 1(2)(g): replaces the innovation support reference with SMCs and SMEs, including start-ups
  • art. 2(2): limits applicability for Annex I products and adds Article 60a
  • art. 3(14a): inserts SME definition
  • art. 3(14b): inserts SMC definition
  • art. 4: transforms AI literacy duty into Commission and Member State encouragement
  • art. 4a: permits limited processing of special personal data for bias detection and correction
  • art. 6(4): requires documentation when Annex III systems are considered non-high-risk
  • art. 10(1): adds Article 4a(1) to quality criteria for training data sets
  • art. 10(5): deletes the existing paragraph on special categories of personal data
  • art. 10(6): limits requirements for non-training models to testing data sets and Article 4a(1)
  • art. 11(1): allows SMEs and SMCs simplified technical documentation using a Commission form
  • art. 17(2): requires quality management measures proportionate to provider size, including SMEs and SMCs
  • art. 28(8): creates single application and single assessment for certain dual-designation bodies
  • art. 29(4): allows existing designations to support accelerated single-assessment applications
  • art. 30(2): bases notification on Annex XIV codes and empowers Commission to amend that annex
  • art. 43(3): clarifies conformity assessment for Annex I systems and dual-category high-risk systems
  • art. 49(2): deletes database registration requirement for certain Article 6(3) systems
  • art. 50(7): removes Commission empowerment and shifts code-of-practice facilitation to the AI Office
  • art. 56(6): removes Commission empowerment to adopt implementing acts on codes of practice
  • art. 57(3a): lets the AI Office establish an EU-level sandbox for Article 75(1) systems
  • art. 57(5): integrates real-world testing into sandbox plans in one document
  • art. 57(9)(e): extends sandbox access objective to SMCs and SMEs, including start-ups
  • art. 57(13): requires sandboxes to facilitate cross-border cooperation
  • art. 57(14): requires national authorities to support joint sandbox establishment and operation
  • art. 58(1): requires implementing acts on sandbox governance and procedures
  • art. 60(1): extends real-world testing to Annex I systems
  • art. 60(2): extends real-world testing conditions to Annex I systems
  • art. 60a: creates voluntary real-world testing for Annex I Section B systems
  • art. 63(1): extends simplified quality management compliance to SMEs and start-ups
  • art. 69(2): sets expert fees payable by Member States at Commission-equivalent rates
  • art. 69(3): deletes direct consultation route for scientific panel experts
  • art. 70(8): extends national guidance focus to SMCs and SMEs, including start-ups
  • art. 72(3): replaces harmonised monitoring template with Commission guidance on the plan
  • art. 75: changes heading and expands AI Office supervision, enforcement, safeguards, and pre-market assessments
  • art. 77: renames heading and expands rights of fundamental-rights authorities and cooperation rules
  • art. 95(4): requires codes of conduct to reflect SMCs and SMEs needs
  • art. 96(1): requires guidelines to pay particular attention to SMCs, SMEs, and start-ups
  • art. 99(1): requires penalties to consider SMCs and SMEs, including start-ups
  • art. 99(6): caps fines for SMCs and SMEs at the lower applicable amount
  • art. 111(2): adjusts grace period for pre-existing high-risk systems
  • art. 111(4): adds compliance deadline for synthetic-content systems
  • art. 113(3)(d): delays Chapter III application until Commission decision or fallback dates
  • art. 113(3)(e): sets application date for Articles 102 to 110
  • art. Annex VIII, section B: deletes section B of Annex VIII
  • art. Annex XIV: adds codes, categories, and AI system types for designation notifications
• Regulation (EU) 2018/1139 (32018R1139)
  • art. 27(3): requires AI Act Chapter III Section 2 to be considered in implementing acts
  • art. 31(3): requires AI Act Chapter III Section 2 to be considered in implementing acts
  • art. 32(3): requires AI Act Chapter III Section 2 to be considered in delegated acts
  • art. 36(3): requires AI Act Chapter III Section 2 to be considered in implementing acts
  • art. 39(3): requires AI Act Chapter III Section 2 to be considered in delegated acts
  • art. 50(3): requires AI Act Chapter III Section 2 to be considered in implementing acts
  • art. 53(3): requires AI Act Chapter III Section 2 to be considered in implementing acts