European Union: European Commission announced Proposal for Digital Omnibus on AI Regulation (2025/0359) including artificial intelligency authority governance

On 19 November 2025, the European Commission announced a Proposal for the Digital Omnibus on AI Regulation (2025/0359), which amends the EU AI Act to reinforce the governance and enforcement role of the EU Artificial Intelligence Office (AI Office). The draft Regulation would make the AI Office the exclusive authority for supervising and enforcing AI Act obligations for AI systems based on general-purpose AI models under certain conditions. In carrying out this function, the AI Office's powers would be aligned with those of market surveillance authorities. The Regulation would also provide the Commission with a mandate to adopt an implementing act that sets out the AI Office’s enforcement powers and penalty procedures, while requiring the Commission to carry out pre-market conformity assessments for the AI systems based on general-purpose models under the purview of the AI Office. The AI Office would further be given the power to establish and operate an EU-level AI regulatory sandbox for the systems it supervises and support the cross-border coordination of national sandboxes. The Regulation would also require EU and national authorities to take the needs of SMEs and SMCs into account in their oversight functions.